Poster Abstracts

Abstract

Dianheng Bu¹, Javier Torres^1,2, Arvind Sahu¹ 

¹Goulburn Valley Health, Shepperton, Australia

²Department of Rural Health, Shepparton Medical School, Melbourne University, Shepperton, Australia 

Background: Long-term adherence to endocrine therapy is challenging, even in the clinical trial setting. Non-adherence to treatment has an increased risk of cancer recurrence and poorer survival.¹ The evidence surrounding the adherence rate to endocrine therapy is sparse overall. The study aims to measure the adherence rate to adjuvant endocrine therapy for early breast cancer and factors contributing to non-adherence in the regional setting.

Methods: A cross-sectional survey was conducted at Goulburn Valley Health between January and June 2023. Female patients receiving adjuvant oral endocrine therapy were included. Adherence was measured using the validated 6-item Simplified Medication Adherence Questionnaire (SMAQ).²

Results: Fifty-one patients (mean age: 60.1 years) participated. The adherence rate, as determined by the SMAQ, was 64.7% (33 out of 51). Age and the number of side effects significantly impacted adherence. Adherent patients had a mean age of 64.3 years, while non-adherent patients had a mean age of 52.4 years (p < 0.001) (Figure 1). The mean number of side effects was 1.8 for adherent patients and 3.8 for non-adherent patients (p < 0.01). No significant differences were found in adherence based on cancer stage, ECOG status, or type of endocrine therapy.

Conclusion: The prevalence of adherence to oral adjuvant endocrine therapy for early breast cancer in the regional population was below 65%. Younger age and experiencing more side effects were associated with lower adherence rates. These findings emphasize the need for early interventions to improve adherence and optimize treatment outcomes in this population.

References:

1. Chlebowski RT, Kim J, Haque R. Adherence to endocrine therapy in breast cancer adjuvant and prevention settings. Cancer Prev Res. 2014;7(4):378-387.

2. Ortega Suarez FJ, Sanchez Plumed J, Lorenzo AD. Validation on the simplified medication adherence questionnaire (SMAQ) in renal transplant patients on tacrolimus. Nefrologia. 2011;31(6):690-696.

Caitlin Cocks¹, Sowmya Cheruvu¹, Hilary L. Martin¹

¹Fiona Stanley Hospital, Murdoch, Australia 

Background: COVID-19 mortality rates of up to 24% have been reported in oncology patient cohorts prior to the availability of antiviral medications and vaccinations.¹ The COVID-19 pandemic was managed in Western Australia (WA) with strict vaccination mandates and border restrictions. This study aims to assess the impact of COVID-19 infection on oncology patients following the WA border opening in March 2022.

Methods: Medical oncology patients at a tertiary hospital in WA who tested positive for COVID-19 between March and May 2022 were prospectively identified. Case notes were reviewed for data collection, including treatment delays, cancer outcomes, and mortality at 30 days, 60 days, and 12 months post-infection.

Results: Thirty-seven patients tested positive for COVID-19 with 64.9% symptomatic. 78.4% of patients had received at least two COVID-19 immunizations prior to infection. Breast cancer was the most common malignancy (40.5%), followed by non-small cell lung cancer (21.6%). Twenty-nine patients were on active therapy, nine on chemotherapy, and three on immunotherapy. Twenty patients were treated with anti-viral therapy. Eight patients were hospitalized. Treatment delays affected 76.9% of survivors with a median delay of 2 weeks. Ten patients had disease progression in the subsequent 12 months. Five patients reported a second COVID-19 infection and recovered without complication. A total of 13 patients died during follow-up: eight within 30 days, three between 30 and 60 days, and two between 60 days and 12 months. No direct deaths related to COVID-19 were reported.

Conclusion: Reassuringly, there were no deaths directly related to COVID-19. These findings support the use of antivirals and vaccination in this cancer patient population and contrast with the early high rates of COVID-19 mortality.

Reference:

Russell B, Moss CL, Shah V, et al. Risk of COVID-19 death in cancer patients: an analysis from Guy's Cancer Centre and King's College Hospital in London. Br J Cancer. 2021;125(7):939-947. https://doi.org/10.1038/s41416-021-01500-z.

Andrew Fantoni¹, Brandon Lau², Jess McNeill³, Christine Henneker³, Shaouli Shahid⁴, Wei-Sen Lam¹ 

¹Department of Medical Oncology, Fiona Stanley Hospital, Murdoch, Australia

²Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia

³WA Country Health Service, Central Office, East Perth, Australia

⁴Centre for Aboriginal Studies, Curtin University of Technology, Bentley, Australia 

Background: Telehealth could offer greater availability to specialist oncology care whilst maintaining patient proximity to home. The Western Australia Country Health Service (WACHS) TeleChemotherapy model was implemented in the Pilbara (Karratha) in September 2019, and in the Kimberley (Broome) and Wheatbelt (Narrogin) in March 2020. We examined the safety of this model with regards to treatment utilization and toxicity outcomes.

Methods: Retrospective data were collected for all patients referred to a WACHS TeleChemotherapy service between September 2019 and February 2022; including patient demographics, cancer diagnosis, treatment intent, cycles and lines of treatment received, treatment delays, and toxicity (adverse events [AEs] as per CTCAEv5.0, deaths, and hospital admissions). Descriptive statistics were used to report safety outcomes.

Results: Of 159 patients referred for treatment, 154 (97%) were accepted. Twenty-one withdrew due to progressive deterioration or preference for metropolitan treatment. The final cohort (n = 133) had a median age of 61 years (range 24–90) with 54% male, 23% Aboriginal and 94% ECOG≤1. A total of 1034 cycles of treatment were delivered, representing 171 lines of therapy. 74% were palliative in intent. Mean dose intensity was maintained at 90% (±14%). Forty-seven treatment lines (27%) were subject to dose reduction, 62% prior to TeleChemotherapy. Fifty-eight lines (34%) were subject to significant dose delay, due to toxicity (53%) or patient preference (38%). Sixty-three lines (37%) were associated with grade ≥3 AEs. There were no significant associations between incidence of AEs and regimen. ≥1 hospitalization occurred in 32% (n = 54) of treatment lines. Eleven deaths were recorded, one related to toxicity. Forty-eight immunotherapy-containing lines were delivered, four lines (8%) with grade≥3 immune-related AEs and no deaths.

Conclusion: This study affirms the safety of the WACHS TeleChemotherapy model including low rates of immune-mediated toxicity. Dose intensity was not compromised, and treatment delays were due to expected toxicities or patient preferences rather than logistical issues.

Jocelyn Finney¹, Isabella Wilson¹, Ben Felmingham^2,3,4, Sanjeev Kumar¹, Alina Mahmood¹, Lisa Horvath^1,5, David Celermajer⁶, Rachel Conyers⁷ 

¹Chris O'Brien Lifehouse, Sydney, Australia

²Murdoch Children's Research Institute, Melbourne, Australia

³Children's Cancer Centre, The Royal Children's Hospital, Melbourne, Australia

⁴Cardiac Regeneration Laboratory, Murdoch Children's Research Institute, Melbourne, Australia

⁵Sydney Medical School, University of Sydney, Sydney, Australia

⁶Department of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia

⁷Department of Paediatrics, University of Melbourne, Melbourne, Australia 

Background: Cancer therapy related cardiac dysfunction (CTRCD) is a significant side effect of several chemotherapy therapies, targeted agents, and immunotherapies integral to treatment. Anthracyclines are an example of a commonly used chemotherapy drug that can cause irreversible early and late onset heart failure which are currently under-documented. In Australia, there are currently no other multi-center, longitudinal studies examining CTRCD in adults. COBLH aims to use the Australian Cardio-Oncology Registry (ACOR) to explore the epidemiology, clinical presentation, and management of CTRCD amongst adults receiving cardiotoxic therapies. Additionally, a biobanking sub-study will attempt to identify gene polymorphisms predisposing individuals to developing anthracycline cardiotoxicity (ACT).

Methods: ACOR is a prospective observational study involving 14 sites across Australia. COBLH patient criteria includes non-palliative, high-risk adult patients treated with cardiotoxic therapies within the last 5 years. Information is obtained from medical records and de-identified upon entry into ACOR. ACOR collects data on patient demographics, medical history, cancer diagnosis and treatment, cardiac assessments, and the management of CTRCD. These instruments are collected at baseline prior to treatment, and at 6-month intervals thereafter. Patients who have developed ACT will be asked to participate in the biobanking study, which will involve a one-off 12 mL peripheral blood draw to be processed at an external site for whole genome exome sequencing and the development of pluripotent stem cell derived cardiomyocytes.

Results: At the time of submission, 19 of 220 recruited patients at COBLH have developed CTRCD. This includes 10 patients with ACT, three with left ventricular dysfunction, three with suspected anthracycline related cardiomyopathies, and three with symptomatic heart failure. ACOR anticipates full registered site capacity to capture 600 patients annually.

Conclusion: COBLH will use ACOR to study long-term CTRCD in adult patients with the biobanking study seeking to prove a causal association between genetic predisposition and ACT.

Acknowledgments: 2,3.

Adriana Gangemi, Bella Nguyen, Wei-sen Lam 

Fiona Stanley Hospital, Perth, Australia 

Background: Anaplastic thyroid cancers (ATCS) are rare aggressive tumors, with extremely poor prognosis despite multimodality treatments. Recently data have shown that a combination of lenvatinib, a tyrosine kinase inhibitor, and pembrolizumab, a checkpoint inhibitor that functions by inhibition of PD-1, can improve response rate and survival in patients with ATC.^1,2 Our case showcases a real-world example of this combination treatment.

Methods and results: This case describes a 67-year-old female initially diagnosed in September 2021, presenting with enlarging neck lump. Thyroidectomy and bilateral neck dissection revealed a 42 mm anaplastic thyroid carcinoma, vascular invasion present, extrathyroidal extension in strap muscle, 0/25 lymph node involved, clear margins. This patient completed adjuvant chemoradiation with low dose doxorubicin in December 2021. Disease recurred locally in August 2022 and was deemed not suitable for resection. She was started on pembrolizumab and lenvatinib (20 mg) on September 9, 2022 and her symptoms improved over 4 weeks. The PET scan after 8 weeks of treatment showed almost a complete response and a PET 6 months post-treatment continued to show no convincing evidence of recurrence (Figure 1).

Conclusion: In the context of an extremely poor prognostic disease, this case showed that the combination of lenvatinib and pembrolizumab for ATCs is a game-changer.

References:

1. Dierks C, Seufert J, Ruf J, et al. 1915P The lenvatinib/pembrolizumab combination induces long lasting and complete responses in patients with metastatic anaplastic or poorly differentiated thyroid carcinoma: results from a retrospective study and first results from the prospective phase II ATLEP trial. Ann Oncol. 2020;31:S1085.

2. Luongo C, Porcelli T, Sessa F, et al. Combination of lenvatinib and pembrolizumab as salvage treatment for paucicellular variant of anaplastic thyroid cancer: a case report. Curr Oncol. 2021;28(6):5401-5407.

Grace Gard, Joanna Oakley, Vanessa Wong, Kelsey Serena, Michael Harold, Jo Cockwill, Katya Gray, Helen Anderson, Graeme Down, Judi Price, Peter Gibbs 

WEHI, Parkville, Australia 

Background/aims: In cancer research, there is growing interest in consumers and researchers working together in partnership, yet the practicalities of partnering and how to optimize the co-design process have not been well established. A research group of health care professionals and consumers aimed to create a Personalized Care Plan for patients with newly diagnosed locally advanced rectal cancer. The group has reflected on and documented their experience of co-design.

Methods: Our research group includes consumers from the consumer program at WEHI, multidisciplinary colorectal cancer clinicians, and project officers. Together they created the Personalized Care Plan template, to be provided to patients and their general practitioner. The team's reflections on the co-design process have been captured using Gibbs’ Reflective Cycle. Patients are currently enrolling into a prospective cohort to evaluate the impact of the Personalized Care Plan.

Results: In 2022, over six meetings, we created a two-page Personalized Care Plan to embed into the WEHI-CRC database. Personalized information for individual patients includes disease stage, planned treatment, and scheduled follow-up. Reflection on the co-design process highlighted the importance of establishing expectations, having expertise within the consumer group, and open communication and respect. Challenges included time commitment, power dynamics, diversity of representation, and loss of consumers due to health reasons and time availability. Responses reflected a positive attitude-change of the researchers on the value of consumer input. Both consumers and researchers communicated the high objective and affective value of contributing to the project.

Conclusion: Reflecting on the co-design process for a patient education sheet, we found that essential components of a co-design group are having clear expectations, and strategies to address challenges such as time commitment and entrenched power dynamics. Meaningful input from consumers can objectively improve the outcome of the project while offering positive personal value for consumers and researchers involved.

Tushar Goyal, Jennifer Zhang, Bianca Devitt 

Eastern Health, Melbourne, Australia 

Background: There is growing interest and variability in the choice and timing of antibiotics in transitioning from intravenous to oral therapy. We aimed to understand the treatment and prescribing practices of neutropenic sepsis in our institution.

Methods: A retrospective study was performed at a tertiary hospital across two sites in Melbourne. Adult patients admitted with solid organ malignancies who met the criteria for neutropenic sepsis between January 2020 and December 2021 were eligible. Analysis was performed using descriptive statistics (Table 1).

Results: Sixty-nine patients were identified. Median time from presentation to intravenous antibiotics (ivABx) was 2 h (IQR = 3 h), duration of ivABx was 3 days and total duration of antibiotics was 7 days (IQR = 4 days), with no significant association between the duration and ANC nadir. Sixty-one patients (88%) were culture negative. Fifty-seven patients (83%) received oral (PO) antibiotic tail upon completion of ivAbx, with amoxicillin-clavulanate being the most commonly used (69%), and cephalosporins (13%) being more commonly prescribed after an infective focus was clinically evident. Fifty-three patients (77%) had been clinically stable and afebrile for more than 48 h before being switched to PO antibiotics. Patients with high-severity MASCC scores received a longer duration of total antibiotics and had longer length of stay as inpatients. Seven of these patients (21.2%) required ICU admission, with no patients from the low severity group being admitted to ICU. One patient experienced gastrointestinal adverse effects during deescalated antibiotic therapy. Hospital readmission rates due to recurrence of neutropenic sepsis were similar in patients who received oral antibiotics versus others.

Conclusion: There were notable variations in the selection and duration of antibiotics for the management of culture-negative neutropenic sepsis, in comparison to guidelines. Future investigations could explore the potential benefits of early transition to oral antibiotics to assess their impact on clinical outcomes.

Nikki How¹, Dhanvee Kandadai², Paul Moroz³, David Morris⁴, David Ransom¹ 

¹Department of Medical Oncology, Fiona Stanley Hospital, Murdoch, Australia

²Royal Perth Hospital, Perth, Australia

³Western Australian Peritonectomy Service, Joondalup, Australia

⁴St. George Peritonectomy Unit, Kogarah, Australia 

Background: CRS-HIPEC is a potential treatment option for patients with primary peritoneal malignancies or secondary peritoneal carcinomatosis from dissemination of intraabdominal malignancies. Accumulating evidence for the survival benefits of CRS-HIPEC has contributed to its increasing use, with the aim of prolonged survival and curative intent. This study aims to report the long-term survival outcomes for Western Australian patients who had access to CRS-HIPEC through an Australian interstate program.

Methods: This was a retrospective observational study of Western Australian patients who were transferred to St George Hospital in New South Wales for CRS-HIPEC between 2008 and 2013. Data was obtained from multiple Western Australian registers, supplemented by review of individual patient records. Overall survival was assessed using Kaplan–Meier methods and comparison with log-rank tests.

Results: Forty-two patients received CRS-HIPEC in the period of assessment and had follow-up data available. Median time from diagnosis to CRS-HIPEC was 8.5 months. The most common diagnoses included 13 patients with disseminated peritoneal adenomucinosis (DPAM), 11 with appendiceal adenocarcinoma (AA), nine with colorectal cancer (CRC), three with peritoneal mesothelioma (PM), and three with peritoneal mucinous carcinomatosis (PMCA). Median overall survival across all patients was 50 months, with a 5-year overall survival of 50%. The 5-year overall survival rates for DPAM, AA, and CRC were 75%, 32%, and 40%, respectively. Survival beyond 6 years occurred in 16 patients including nine patients with DPAM, three with AA, two with ovarian malignancies, one with CRC, and one with PM. Patients with PMCA had a comparatively lower survival probability (p < 0.0001).

Conclusion: These outcomes are consistent with results from other centers. The increasing demand led to the establishment of a state CRS-HIPEC Centre in Western Australia. It is worth noting that even with peritoneal metastases, survival beyond 6 years can be achieved in patients with AA, CRC, and PM.

Joshua Hurwitz^1,2,3, Greta Beale¹, James Pham^1,2, Lauren Brown^1,3, Anthony Rodrigues^1,2,3, Anthony M Joshua^1,2,3, Susan Clark^1,2,3 

¹The Kinghorn Cancer Centre, Darlinghurst, Australia

²St Vincent's Clinical School, University of New South Wales, Darlinghurst, Australia

³Gavan Institute of Medical Research, Darlinghurst, Australia 

Background: Vitamin C is a key cofactor in modulating epigenetic landscapes, genomic stability, and potential cancer growth (1). While rare in the general population, vitamin C deficiency is frequently observed in cancer patients. Denmark and New Zealand research identified inadequate vitamin C levels in cancer patients at baseline and further reduction with treatment (2, 3, 4). This study aimed to determine baseline vitamin C levels in solid cancer patients and the impact of systemic therapy in our own patient cohort.

Methods: This prospective observational study aimed to recruit 31 subjects, 25 metastatic cancer patients and six healthy controls. Patients were recruited at The Kinghorn Cancer Centre. Information collected included demographics, patient characteristics, and malignancy type. Plasma vitamin C concentrations were collected before systemic therapy and after two treatment cycles. The normal vitamin C reference range was 40–80 μmol/L, and low was <40 μmol/L.

Results: Twenty-eight patients were recruited; five did not provide pathology samples for vitamin C levels – of the 23 remaining, 14 patients had a second vitamin C level (Table 1). At baseline, healthy controls had lower vitamin C levels (55 vs. 57) than their cancer counterparts. Vitamin C levels were higher after systemic therapy than before treatment (57 vs. 49). Three patients had weight loss before diagnosis, and one required nutritional supplementation. Treatment included multi-agent chemotherapy (38%), immunotherapy (24%), and single-agent chemotherapy (19%).

Conclusion: In our cohort, vitamin C levels pre- and post-systemic therapy were within physiological parameters, in contrast to prior cancer studies across larger patient cohorts reporting marked vitamin C deficiency (2, 3, 4). Baseline vitamin C was lower, but not significantly, in the healthy controls. Further research with larger sample sizes is required to investigate vitamin C levels in solid malignancies, with systemic therapy and its role in cancer management.

Mandeep Singh Kalsi, Inosha Jayasekara, Frances Barnett 

Northern Health, Epping, Melbourne, Australia 

Background: Chemotherapy that was usually delivered only in hospital environments is now administered primarily in outpatient (OP) environment. There are financial incentives for OP chemotherapy delivery.

Methods: We conducted a retrospective analysis to evaluate the outcomes of patients who were given inpatient (IP) chemotherapy agents for solid organ malignancies over a period of 3 years at a metropolitan hospital.

Results: Small cell cancer of lung primary (20) was the common malignancy in 47 patients who received inpatient chemotherapy. There were 13 patients with gastro-intestinal primary, five patients with testicular cancer, four with breast cancer, three with ovarian cancer, one with cancer of unknown primary, and one with Kaposi sarcoma. Most patients’ inferred Eastern Cooperative Oncology Group (ECOG) performance status was 0% and 15% patients had ECOG status of 3. Thirty-day mortality was 6% and 60-day mortality was 23%. Sixty-day mortality was associated with higher ECOG status. Thirty-nine patients received subsequent chemotherapy sessions.

Conclusion: IP chemotherapy administration was associated with high 60-day mortality. And high mortality was associated with higher ECOG score. More detailed analysis of patient characteristics is required to co-relate with mortality that may help in decision making for oncologists to decide for inpatient chemotherapy.

Muhammad A. Khattak¹, Georgina V. Long², Alexander M. M. Eggermont³, Jeffrey E. Gershenwald⁴, Dirk Schadendorf⁵, Paolo A. Ascierto⁶, Reinhard Dummer⁷, Axel Hauschild⁸, Matteo S. Carlino⁹, Antoni Ribas¹⁰, Caroline Robert¹¹, Richard A. Scolyer¹², Vernon K. Sondak¹³, Jonathan E. Cohen¹⁴, Jinchun Zhang¹⁵, Dmitri Grebennik¹⁵, Clemens Krepler¹⁵, Jason J. Luke¹⁶ 

¹Fiona Stanley Hospital and Edith Cowan University, Perth, Australia

²Melanoma Institute Australia, The University of Sydney, Mater and Royal North Shore Hospitals, Sydney, Australia

³Faculty of Medicine University Medical Center and Princess Máxima Center, Utrecht, The Netherlands; Comprehensive Cancer Center Munich, Technical University Munich and Ludwig Maximilian University, Munich, Germany

⁴The University of Texas MD Anderson Cancer Center, Houston, Texas, USA

⁵University Hospital Essen, University Duisburg-Essen, West German Cancer Centre (WTZ), and German Cancer Consortium, Partner Site Essen, Essen, Germany

⁶Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy

⁷University of Zurich and University Hospital Zurich, Zurich, Switzerland

⁸University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany

⁹Sydney Medical School, Faculty of Medicine and Health Sciences, University of Sydney, Camperdown, Melanoma Institute Australia, Crown Princess Mary Cancer Centre, Westmead and Blacktown Hospitals, Sydney, Australia

¹⁰Jonsson Comprehensive Cancer Center, UCLA and Parker Institute for Cancer Immunotherapy, Los Angeles, California, USA

¹¹Université Paris Saclay, Le Kremlin Bicêtre and Gustave Roussy, Villejuif, France

¹²Melanoma Institute Australia, The University of Sydney, Faculty of Medicine and Health, The University of Sydney, Charles Perkins Centre, The University of Sydney, Royal Prince Alfred Hospital and NSW Health Pathology, Sydney, Australia

¹³H. Lee Moffitt Cancer Center, Tampa, Florida, USA

¹⁴Sharett Institute of Oncology and The Wohl Institute for Translational Medicine, Hadassah Hebrew University Medical Center, Jerusalem, Israel

¹⁵Merck & Co., Inc., Rahway, New Jersey, USA

¹⁶UPMC Hillman Cancer Center and University of Pittsburgh, Pittsburgh, Pennsylvania, USA 

Background: Adjuvant pembrolizumab monotherapy improved recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) in patients with high-risk resected melanoma. Vibostolimab, an anti-TIGIT antibody, demonstrated antitumor activity and manageable safety in combination with pembrolizumab in solid tumors in the phase 1 KEYVIBE-001 study. The efficacy and safety of adjuvant coformulated vibostolimab with pembrolizumab in patients with resected high-risk melanoma in the double-blind, randomized, phase 3 KEYVIBE-010 study (NCT05665595).

Methods: Patients ≥12 years old, with surgically resected stage IIB or IIC (pathologic or clinical), III, or IV cutaneous melanoma, and an ECOG PS of 0 or 1 (>18 years), Karnofsky performance status ≥70 (≥16–<18 years), or Lansky play-performance scale ≥70 (<16 years) and have no evidence of metastatic disease will be enrolled. Patients with ocular, mucosal, or conjunctival melanoma will be excluded. Resection must occur within 12 weeks before randomization. Patients will need to provide an archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated. Patients will be stratified by risk (stage IIB/IIC/clinical IIB and stage IIC/IIIA/IIIB vs. stage IIIC/IIID/IV) and region (Asia vs. rest of the world). Approximately 1560 patients will be randomly assigned 1:1 to intravenous coformulated vibostolimab 200 mg with pembrolizumab 200 mg or pembrolizumab 200 mg (2 mg/kg up to 200 mg for adolescents) every 3 weeks for up to 17 cycles. The primary end point is RFS by investigator review. Secondary end points are DMFS by investigator review, overall survival, safety, and quality-of-life. Hazard ratios and 95% CIs will be estimated using a stratified Cox regression model with the Efron methods of handling ties, with treatment as a covariate. Between-treatment differences will be evaluated using a stratified log-rank test. Enrollment is ongoing.

Chee Lee¹, Sandy Simon¹, Danka Zebic¹, Yeh Chen Lee¹, Katrina Diamante¹, Lenna Lai¹, Rachel O'Connell¹, Anna deFazio², Sonia Yip¹, Lyndal Anderson³, Bo Gao⁴, Jeffrey C. Goh⁵, Kate Webber⁶, Sally Baron-Hay⁷, Christopher Steer⁸, Linda Mileshkin⁹, Tarek Meniawy¹⁰, Janine Lombard¹¹, Martin Stockler¹, Michael Friedlander¹² 

¹NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, Australia

²The University of Sydney, The Westmead Institute for Medical Research and Westmead Hospital, Westmead, Australia

³Royal Prince Alfred Hospital, Camperdown, Australia

⁴Westmead Hospital, Westmead, Australia

⁵Royal Brisbane and Women's Hospital, Brisbane, Australia

⁶Monash Medical Centre, Clayton, Australia

⁷Royal North Shore Hospital, St Leonards, Australia

⁸Border Medical Oncology Research Unit, Albury, Australia

⁹Peter MacCallum Cancer Centre, Melbourne, Australia

¹⁰Sir Charles Gairdner Hospital, Nedlands, Australia

¹¹Newcastle Private Hospital, New Lambton Heights, Australia

¹²Prince of Wales Hospital and Royal Hospital for Women, Randwick, Australia 

Aromatase inhibitors (AIs) are used to treat hormone receptor positive (HR+) advanced gynecological cancers. However, response rates are significantly lower than HR+ breast cancer treated with AIs. Alterations in the CDK4/6 pathway and mutations of phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) are postulated to cause AI resistance. In HR+ metastatic breast cancer, combination of AI plus CDK4/6 inhibitor (ribociclib) or PIK3CA inhibitor (alpelisib) improves clinical outcomes. PARAGON-II trial (ACTRN12621000639820) aims to evaluate the activity of letrozole plus alpelisib or ribociclib, in PIK3CA mutant (mut) and PIK3CA wild-type (wt) HR+ advanced gynecological cancers, respectively.

This is a phase II, open label, basket trial, with six cohorts of common and rare HR+ gynecological cancers. Target population is patients with recurrent/metastatic cancer, with good performance status and for whom chemotherapy is not indicated. PIK3CA mutational status is determined by tissue or ctDNA analysis. The study consists of PIK3CA mut endometrial cancer (cohort A) and any other PIK3CA mut tumors (F). PIK3CA wt/unknown cohorts consist of endometrial cancer (B), platinum resistant high-grade epithelial ovarian cancers (C), endometrial stromal sarcoma, leiomyosarcoma, granulosa cell tumors (D), and low grade serous ovarian cancers (E). In the PIK3CA mut cohorts (A and F), participants will receive letrozole 2.5 mg plus alpelisib 300 mg daily until disease progression or intolerance. In the PIK3CA wt/unknown cohorts (B–E), participants will receive letrozole 2.5 mg daily plus ribociclib 600 mg daily (3-weeks-on/1-week-off). A total of 182 participants will be recruited. The primary endpoint is objective response rate. Secondary endpoints include disease control rate, duration of response, 6-month progression free survival (PFS), and median PFS, patient reported outcomes and adverse events. Tumor and blood samples are being collected for translational studies.

PARAGON-II trial started recruitment in May 2022. As of June 30, 2023, 64 participants have been recruited from 13 sites. Recruitment is expected to be completed by December 2024.

AIs are used to treat hormone receptor positive (HR+) advanced gynecological cancers. However, response rates are significantly lower than HR+ breast cancer treated with AIs. Alterations in the CDK4/6 pathway and mutations of phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) are postulated to cause AI resistance. In HR+ metastatic breast cancer, combination of AI plus CDK4/6 inhibitor (ribociclib) or PIK3CA inhibitor (alpelisib) improves clinical outcomes.

Su Saint Lee^1,2,3, Wei Chua^1,4,5, Nancy Huang^1,2,3, Weng Ng^1,4,5, Aflah Roohullah^1,2, Annette Tognela², Ray Asghari³, Mahtab Farzin⁶, Tara Roberts^4,5,7, Therese Becker^4,5,7, Bin Wang⁶, Soon Lee^5,6,7, Stephanie Lim^3,4,5

¹Department of Medical Oncology, Liverpool Hospital, Liverpool, Australia

²Department of Medical Oncology, Macarthur Cancer Therapy Centre, Campbelltown Hospital, Campbelltown, Australia

³School of Medicine, Western Sydney University, Campbelltown, Australia

⁴Department of Medical Oncology, Bankstown-Lidcombe Hospital, Bankstown, Australia

⁵Department of Anatomical Pathology, Liverpool Hospital, Liverpool, Australia

⁶Ingham Institute of Applied Medical Research, Liverpool, Australia

⁷South Western Clinical School, University of New South Wales, Liverpool, Australia

Background: Tumor mutational profile affects prognosis in metastatic colorectal cancer (mCRC) but it remains unclear why some tumors behave exceptionally well or poorly. We aim to identify genes associated with exceptional cases using targeted next generation sequencing (NGS).

Methods: Patients with RAS/BRAF-wildtype and MMR-proficient mCRC from the South Western Sydney Anatomical Pathology tissue bank from 2010 to 2018 with overall survival of <6 months or >3 years or atypical treatment responses were identified. Clinicopathological variables and survival outcomes were obtained. Random sample of eight patients underwent testing with a 30-gene (Qiagen) or 50-gene or 161-gene (ThermoFisher) NGS panel to establish workflow, feasibility and obtain preliminary data. Mutations identified were classified according to ESCAT tiers of significance. All cases will have 161-gene panel NGS.

Results: Fifty-two good performers (GP) and 14 poor performers (PP) were identified. Median age was 65 years in GP and 51 in PP. Tumors were left-sided in 87% of GP and 77% of PP. Median overall survival from diagnosis of metastatic disease was 56.4 months (20.6–127.1 months) in GP and 4.8 months (1.4–15.4 months) in PP. 58% of GP and 14% of PP had ≥2 lines of chemotherapy. To date we have NGS data for six GP and two PP patients (four patients with 30-gene, two with 50-gene, and two with 161-gene panels). Two GP patients had TP53 mutations, another a PIK3CA mutation (all Tier II), while a fourth had an EGFR mutation of unknown significance. No mutations were detected in 2GP and two PP patients. 161-Gene panel testing is underway for patients who so far had limited testing.

Conclusion: Targeted NGS panels may identify genes in exceptional performers in RAS/BRAF-wildtype mCRC, whose overall survival varies by more than 10-fold. Preliminary data shows differences in TP53 and PIK3CA in GP. Final 161-gene NGS results of all cases are underway.

Yeh Chen Lee¹, Elizabeth Barnes¹, Katherine Francis¹, Danka Zebic^1,2, Sandy Simon¹, Gemma Blunt¹, Pearly Khaw³, Viet Do⁴, Elizabeth Christie³, Rachel Delahunty³, Rebecca Mercieca-Bebber¹, Sonia Yip¹, Jeffrey Goh⁵, Janine Lombard⁶, Kate Webber⁷, Sudarshan Selva-Nayagam⁸, Ganessan Kichenadasse⁹, Tarek Meniawy¹⁰, Michelle Harrison¹¹, Michelle Wilson¹², Martin Stockler¹, Linda Mileshkin³ 

¹NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia

²Prince of Wales Hospital and Royal Hospital for Women, Randwick, Australia

³PeterMacCallum Cancer Centre, Melbourne, Australia

⁴Liverpool Cancer Therapy Centre, Liverpool, Australia

⁵Royal Brisbane and Women's Hospital, Brisbane, Australia

⁶Calvary Mater Newcastle, Newcastle, Australia

⁷Monash Medical Centre, Clayton, Australia

⁸Royal Adelaide Hospital, Adelaide, Australia

⁹Flinders Medical Centre, Bedford Park, Australia

¹⁰Sir Charles Gairdner Hospital, Nedlands, Australia

¹¹Chris O'Brien Lifehouse, Camperdown, Australia

¹²Auckland City Hospital, Auckland, New Zealand 

Background: Despite primary surgery, adjuvant chemoradiation, and chemotherapy, people with high-risk endometrial cancer (EC) remain at significant risk of relapse, following which the median survival time is approximately 12 months. Immune checkpoint inhibitors have shown activity in advanced EC. It is recognized that radiation and chemotherapy can have immune-stimulating properties and can synergize with immunotherapy, providing rationale for combining these treatments in high-risk curable EC. The aim of ADELE is to determine if adding tislelizumab to standard adjuvant chemotherapy after post-operative pelvic chemoradiation for high-risk EC improves outcomes.

Methods: This is an open label, non-comparative, multicenter, randomized (2:1) phase 2 trial (Figure 1). The target population is people with high-risk FIGO stage IA–IVA EC who have had primary surgery and are planned for adjuvant pelvic chemoradiation followed by chemotherapy. Participants will be registered prior to commencing adjuvant pelvic chemoradiation and vaginal vault brachytherapy (if cervical stromal invasion) and subsequently randomized to one of two treatment groups in a ratio of 2:1 (experimental to control). The control group will receive chemotherapy (carboplatin plus paclitaxel) for four cycles. The experimental group will receive tislelizumab with chemotherapy for four cycles, followed by tislelizumab alone for another eight cycles. The primary outcome is failure free survival at 1 year. Secondary outcomes include feasibility, adverse events, effects on patient-reported outcomes, failure free survival, and overall survival. Tumor and blood samples will be collected for translational studies, with correlative objectives including impact of adjuvant therapy on ctDNA levels and potential predictive or prognostic biomarkers for response to immunotherapy.

Progress: ADELE started recruitment in March 2022 and will enroll 135 participants. As of June 30, 2023, 17 participants have been randomized from 11 sites. Clinical trial identifier: ACTRN12621000273886.

Acknowledgments: ADELE is an investigator-initiated study, funded by an MRFF Research Grant and Beigene Ltd.

Meghana Maddula^1,2,3, Peter Fox^1,4 

¹Central West Cancer Centre, Orange Health Service, Orange, Australia

²Crown Princess Mary Cancer Centre, Westmead Hospital, Sydney, Australia

³Blacktown Haematology and Cancer Centre, Blacktown Hospital, Sydney, Australia

⁴Western Sydney University, Bathurst Clinical School, Bathurst, Australia 

Background: Positron emission tomography (PET) is integral to the diagnosis, monitoring, and treatment of malignancy. Whilst PET utilization has increased, inequity in access remains across Australia. The OECD average in 2019 was 4 PET per 1000 persons. In this study, we aim to identify local trends in PET usage and evaluate geospatial disparity.

Methods: In this retrospective population study, we evaluated PET scan utilization for Medicare funded oncological indications between 2001 and 2022. Data was extracted from public Medicare statistics and stratified by population density, state/territory, and tumor type. Additional Remoteness Area data were obtained from 2018 to 2021 and AIHW data informed cancer incidence.

Results: Over 22 years, 1,124,431 PET scans were attended, with 2,746,117 incident cancers. This corresponds to 2.2 PET per 1000 persons and 40.9 per 100 cancers but had increased to 5.4 per 1000 persons and 89.2 per 100 cancers by the end of study period (Table 1). PET uptake per capita increased nationwide with a compound annual growth rate of 18.4%. The greatest per capita usage of PET scans was in New South Wales followed by Western Australia, with the greatest annualized growth in the Northern Territory (28.6%) and Tasmania (24.2%). PET scanner availability by state/territory did not correlate with PET utilization (R = .15, p = 0.72). PET scans per 100 incident cancers was highest in lymphoma (201.9) and head and neck (147.0), and lowest in neurological (14.1) and colorectal cancers (39.4). By Remoteness Area, PET per 1000 persons was lower in remote (3.1) and very remote (1.9) compared to major cities (4.4).

Conclusion: Australian PET scan usage has increased significantly since the introduction of Medicare subsidized PET in 2001 and is now above the OECD average. Geospatial disparity remains in PET usage between states/territories and based on rurality. Further research into variations in PET utilization is required to bridge the gap.

Rhiannon Mellor^1,2,3*, Jessica Smith^4,5*, Anna Mislang^6,7* 

^*All first authors

¹Chris O'Brien Lifehouse, Camperdown, Australia

²University of New South Wales, Sydney, Australia³The Garvan Institute of Medical Research, Darlinghurst, Australia

⁴Macquarie University Hospital, Macquarie University, Australia

⁵Western Sydney University, Parramatta, Australia

⁶Department of Medical Oncology, Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Bedford Park, Australia

⁷College of Medicine and Public Health, Flinders University, Bedford Park, Australia 

Background: Medical oncologists operate in an increasingly complex environment, regardless of their practice location. Over the last 3 years, the COVID-19 pandemic has increased this complexity. International studies report that up to 71% of oncologists exhibit evidence of burnout,¹ and this has worsened since COVID-19.² Burnout negatively impacts the psychological well-being of the individual healthcare professional and the level of care they provide, significantly costing individuals and the broader healthcare organization. This is a critical issue that must be urgently addressed.

Aims and objectives: This study aims to determine the current prevalence of burnout amongst trainees and Fellows of the Royal Australasian College of Physicians (FRACP) in Medical Oncology in Australia. Secondary objectives are to (1) examine the drivers of burnout among oncologists in Australia, (2) assess the impact of burnout, and (3) collect data on potential interventions to address burnout and clinician wellbeing, as identified by oncologists.

Methods and results: In this cross-sectional study, FRACP and trainee medical oncologists in Australia will be invited to complete an anonymous online questionnaire. The questionnaire will assess burnout with the Maslach Burnout Inventory (MBI) and measure the consequences of burnout using the Patient Health Questionnaire-4 (PHQ-4) to screen for anxiety and depression, and the Stanford self-valuation tool. Factors that contribute to both wellbeing and burnout will also be examined, along with potential work-based interventions to improve wellbeing.

Conclusion: The prevalence and drivers of burnout amongst medical oncologists in Australia are poorly understood. This study will provide essential data for a solutions-based, multifactorial approach to improve clinician wellbeing.

Acknowledgments: Thank you to Bethan Richards and Jia Liu for their input on questionnaire development.

References:

1. Banerjee S, Califano R, Corral J, et al. Professional burnout in European young oncologists. Ann Oncol. 2017; 28(7):1590-1596.

2. Banerjee S, Lim KHJ, Murali K, et al. The impact of COVID-19 on oncology professionals. ESMO Open. 2021;6(2):100058.

Hanh Nguyen, Bella Nguyen 

Fiona Stanley Hospital, Murdoch, Australia 

Background: For patients with borderline resectable (BR) and locally advanced (LA) pancreatic cancers, neoadjuvant chemotherapy (NAT) is routinely offered to downstage their disease for potential pancreatectomy. In many cases, however, pancreatectomy remains contraindicated after NAT and alternative therapies are required. This study aims to retrospectively compare the characteristics of patients with BR and LA pancreatic cancer who received versus those who did not receive pancreatectomy after NAT within the South Metropolitan Health Service (SMHS) in Perth Australia from 2015 to 2022.

Methods: Patient electronic medical records (eMR) were used to identify patients who received NAT for their BR or LA pancreatic cancer. Data on patient demographics, clinical characteristics, and adjuvant therapies received post-NAT were attained for further analysis.

Results: There were 19 patients who received NAT to downstage their BR or LA disease for potential resection. Out of these patients, 36.8% (n = 7) successfully underwent pancreatectomy whilst 57.9% (n = 11) did not qualify for surgery and 5.3% (n = 1) were lost to follow-up. Patients undergoing pancreatectomy were more likely to have a recorded ECOG status of zero (85.7% vs. 54.5%). Other characteristics were comparable between patients who underwent pancreatectomy versus those who did not undergo pancreatectomy, respectively; mean age (61 vs. 59 years), sex (male = 72.7% vs. 71.4%), tumor location (pancreatic head = 90.9% vs. 100%), and CA-19-9 level at diagnosis (2448.5 vs. 2999.4). Adjuvant chemotherapy (42.9% vs. 91%) and radiation therapy (28.6% vs. 63.6%) were less frequently utilized for patients who did versus those who did not receive pancreatectomy, respectively.

Conclusion: Aside from ECOG status, there were no significant demographic or clinical differences amongst BR or LA pancreatic patients who did versus those who did not undergo pancreatectomy after NAT. Patients who underwent pancreatectomy were less likely to require subsequent adjuvant chemotherapy and radiation therapy.

Hanh Nguyen, Bella Nguyen 

Fiona Stanley Hospital, Murdoch, Australia 

Background: Whilst surgery is the only curative treatment modality for pancreatic cancer, local blood vessel involvement often precludes its resectability and classifies the disease as borderline resectable (BR) or locally advanced (LA). Neoadjuvant chemotherapy (NAT) is often offered to downstage BR and LA pancreatic cancers for potential resection. This study aims to retrospectively review the clinical management of patients with BR and LA pancreatic cancer within the South Metropolitan Health Service (SMHS) in Perth Australia from 2015 to 2022. Primary outcomes include pancreatectomy rates post-NAT, patient progression-free survival, and overall survival (OS).

Methods: Patient electronic medical records (eMR) were used to identify all pancreatic cancer patients who received FOLFIRINOX or GnP (nanoparticle albumin-bound paclitaxel) as NAT for their BR or LA pancreatic cancer within the SMHS from 2015 to 2022.

Results: Of 19 patients who received NAT, 15 received FOLFIRINOX and four received GnP. Of those who received FOLFIRINIX, 40.0% (n = 6) successfully underwent pancreatectomy whilst 53.3% (n = 8) did not qualify for surgery and 6.7% (n = 1) were lost to follow-up. Of those who received GnP, only one patient underwent pancreatectomy. Reasons precluding pancreatectomy after NAT included inadequate NAT response/progressive disease (63.6%, n = 7) and poor performance status (36.4%, n = 11). Pancreatectomy specimens were staged from IA–IIB, most were grade 2 (85.7%; n = 6) and resected with negative margins (R0) (57.1%, n = 4). The median survival (30 vs. 13 months) and median progression-free survival (20 vs. 7 months) for patients who underwent pancreatectomy were higher than those who did not undergo pancreatectomy, respectively.

Conclusion: Pancreatectomy was performed in two in five patients after FOLFIRINOX NAT and one in four patients after GnP NAT. These rates reflect real-world patients who are less likely to be surgically fit compared to published trial data such as CONKO-007.7.

Ek Leone Oh, Elizabeth Steinepreis, Hilary Martin 

Fiona Stanley Hospital, Murdoch, Australia 

Background: Management for lobular breast cancer, which comprises approximately 10% of breast cancer, is generally extrapolated from trials comprised predominantly of ductal breast cancer patients. This study aims to investigate treatment outcomes of patients treated for metastatic lobular breast cancer.

Methods: We performed a retrospective review of patients diagnosed with metastatic lobular breast cancer at a single center between January 2017 and April 31, 2023. Clinical benefit from treatment was defined as stable disease, partial response, or complete response.

Results: Twenty-one patients with metastatic lobular breast cancer were identified. Sixteen (76.2%) had hormone-receptor positive HER2-negative breast cancer (HR+ HER2−), two (9.5%) had triple-negative breast cancer, and three (14.3%) had HER2-positive hormone-receptor positive (HER2+HR+) disease. Treatment and outcomes for HR+HER2− subgroup are shown in Table 1. Among the patients with HR+HER2− subgroup, 14 (87.5%) received a combination of CDK4/6 inhibitors and non-steroidal aromatase inhibitor (NSAI) of whom 13 started this as first-line therapy for metastatic disease and six (42.9%) remain on this treatment at data-cutoff. Seven (43.8%) patients with HR+HER− disease received chemotherapy at some point in their treatment. Both patients with triple-negative lobular breast cancer experienced rapidly progressive disease on all agents trialled (olaparib, paclitaxel, carboplatin/gemcitabine, and eribulin). The three patients with HER2+HR+ disease received a combination of taxane or vinorelbine, pertuzumab, and trastuzumab as first-line therapy. All remain on this treatment with a median duration of 34 months (range 19–68 months) at data-cutoff.

Conclusion: HR+ HER2− lobular breast cancer treated with CDK4/6 inhibitors and NSAI had similar PFS compared to the registration trial data supporting the use of this combination for lobular cancer. There were also some responses seen to chemotherapy, with all patients who received capecitabine obtaining clinical benefit. Patients with HER2-positive disease had excellent outcomes, while outcomes were poor for triple-negative lobular breast cancer. Both patients with triple-negative lobular breast cancer experienced rapidly progressive disease on all agents trialed (olaparib, paclitaxel, carboplatin/gemcitabine, and eribulin). The three patients with HER2+HR+ disease received a combination of taxane or vinorelbine, pertuzumab, and trastuzumab as first-line therapy. All remain on this treatment with a median duration of 34 months (range 19–68 months) at data-cutoff.

Hayley Roberts^1,2, Benjamin Solomon², Susan Harden², Senthil Lingaratnam², Marliese Alexander² 

¹Alfred Health, Melbourne, Australia, Australia

²Peter MacCallum Cancer Centre, Melbourne, Australia 

Background: Lung cancer remains the leading cause of cancer death in Australia, despite recent progress in immunotherapy, tyrosine kinase inhibitors (TKIs), and radiotherapy. Thirty-day mortality after systemic anti-cancer therapy (SACT) has been suggested as a quality indicator for lung cancer and introduced as a benchmark in the UK. However, while multiple international researchers have reported 30-day mortality rates, the exact method for calculating these rates differs widely between studies.

Methods: Patients ≥18 years of age with a histologically confirmed diagnosis of lung cancer who received palliative systemic anti-cancer treatment at Peter MacCallum Cancer Centre between January 2015 and December 2022 were identified using a lung cancer database (AURORA). Information was collected on patient, disease, and treatment characteristics. An annual 30-day mortality index following SACT was calculated (patients who died within 30 days of SACT, as a proportion of all patients given palliative-intent treatment for lung cancer in that year).

Results: We found annual rates of 30-day mortality after palliative-intent SACT for lung cancer of between 9% and 15% (Figure 1). Patients who received SACT within 30 days of death were more likely to have received TKIs or immunotherapy, and to have had an ECOG performance status of two or more, and less likely to have had small cell histology. 

Conclusions: The rates of 30-day mortality in our center are comparable to internationally published rates. While 30-day mortality after SACT is a useful benchmark, several factors must be taken into account when comparing between institutions, including SACT intent (curative or palliative), number of lines of treatment, histological subtype, and type of treatment (especially for TKIs). Ensuring consistent methods of calculation is important, especially reporting time period and denominator population (total number of patients on SACT over a period of time, or total number of patients who have died).

Rahul Solanki^1,2, Dylan Bartholomeusz^1,2, Michael Cilento^3,4, Eve Hopping³, Harsh Kanhere^1,2,3, Timothy Price^1,2,3 

¹Royal Adelaide Hospital, Adelaide, Australia

²The University of Adelaide, Adelaide, Australia

³The Queen Elizabeth Hospital, Woodville South, Australia

⁴South Australian Immunogenomics Cancer Institute, The University of Adelaide, Adelaide, Australia

Background: A 78-year-old lady was referred for an FDG PET scan for staging of esophageal cancer. She was receiving endoscopic surveillance for Barrett's esophagus. Her last endoscopy showed two nodular lesions in the distal esophagus and biopsies revealed HER2 positive poorly differentiated esophageal adenocarcinoma.

Methods: The CT staging scan showed distal esophageal thickening and enlarged regional lymph nodes. Her 18FDG staging PET scan showed increased FDG uptake in the distal esophagus at the primary site but also revealed extensive non-regional bilateral FDG avid lymphadenopathy and skeletal lesions suggesting metastatic disease.

Results: After review in the upper gastrointestinal (UGI) multidisciplinary team (MDT) meeting, noting a past history of sarcoidosis, she underwent biopsy of the right axillary and right inguinal lymph nodes, which showed well-formed non-necrotizing granulomas suggestive of granulomatous lymphadenitis. There were no malignant cells detected. Following repeat review in the UGI MDT, the consensus decision was that this was a case of localized esophageal cancer with FDG avid nodal and bony lesions likely due to sarcoidosis. She was commenced on trimodality treatment with neoadjuvant chemoradiotherapy (chemoRT), which included weekly administration of dexamethasone along with chemotherapy, with the plan for subsequent curative esophageal resection. The repeat 18FDG PET scan post-chemoRT showed significant reduction of FDG uptake in the primary site and also reduction of the widespread 18FDG avid lymph nodes and bony lesions. The sarcoidosis is thought to have responded with dexamethasone with a plan for close follow-up Figure 1).

Conclusion: This case emphasizes the complexity of decision making in staging patients with malignancy and concomitant inflammatory granulomatous disease and reveals the benefit of clinical history, MDT discussion and biopsy when clinical discrepancies arise.

Jennifer Soon^1,2, Fanny Franchini¹, Maarten IJzerman^1,3, Grant McArthur^1,2,4 

¹University of Melbourne, Parkville, Australia

²Peter MacCallum Cancer Centre, Melbourne, Australia

³Erasmus School of Health Policy and Management, Rotterdam, The Netherlands

⁴Victorian Comprehensive Cancer Centre Alliance, Melbourne, Australia 

Purpose: With healthcare costs rising, focus is shifting toward maximizing health outcomes per dollar. One approach to optimizing value is through de-escalation, which is the rationalization of routine treatment without compromising patient outcomes. Since 2013, successful clinical trials of high-cost immune checkpoint, BRAF and MEK inhibition have led to these drugs becoming ubiquitous in melanoma management. Pipeline therapies such as relatlimab and tumor infiltrating lymphocyte (TIL) therapy are expected to have a similar or even greater cost. The purpose of this scoping review is to establish current and emerging opportunities to de-escalate the use of systemic therapies in the treatment of cutaneous melanoma. It will also seek to comment on the proportion of studies that include patient-reported outcomes and quality of life measures. We hypothesize that neoadjuvant and response-directed strategies will be identified as well as the emerging potential of prognostic and predictive tools.

Methods: A systematic search strategy has been developed for MEDLINE and PubMed from January 1, 2013 to June 30, 2023. Additional texts will be sourced from grey literature and reference scanning. Two authors will screen abstracts and full-texts facilitated by the Covidence software. Disagreements will be resolved by consensus or a third reviewer. The first author will perform data extraction whilst a second author will review a random selection of papers to ensure consistent interpretation. De-escalation strategies will be categorized by concept, potential impact on resource utilization and patient outcomes, and strength of evidence. Data will be synthesized qualitatively and quantitatively. Results will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Preliminary results will be available in August 2023. The final results of this scoping review will directly inform a melanoma consumer and clinician survey exploring their perspectives on de-escalation strategies.

Joanne Tang, Sudarshan Selva-Nayagam 

Central Adelaide Local Health Network, Adelaide, Australia 

Background: Sequencing of adjuvant treatment and the use of weekly cisplatin with concurrent radiotherapy in endometrial cancer has not been clearly established. This audit aims to compare toxicity and treatment completion rates in patients who undergo chemotherapy then radiotherapy ± chemotherapy (ChtRt) to patients who undergo radiotherapy ± chemotherapy then chemotherapy (RttCh), and to establish the toxicity and completion rates of concurrent weekly cisplatin (1WC) versus 3-weekly cisplatin (3WC) during radiotherapy (CRTx).

Methods: Patient demographics, treatment regimens, and toxicity profiles were collected for endometrial cancer patients who were treated with adjuvant radiotherapy ± chemotherapy, with chemotherapy preceding or following. Data from patient medical records were extracted across two tertiary hospitals between January 2015 and October 2021 and analyzed.

Results: The study included 19 patients in the ChtRt and 15 patients in the RttCh group. Overall toxicity outcomes were similar between ChtRt and RttCh groups, except patients in the ChtRt group had higher rates of diarrhea during radiotherapy (74% vs. 20%). Hematological toxicity during CRTx was higher in ChtRt group (n = 6) (64% vs. 11% all grade toxicity). ChtRt patients had a higher rate of chemotherapy cessation during radiotherapy (67% vs. 18%), whilst RttCh patients had a higher rate of chemotherapy interruption/cessation (60% vs. 42%) (Table 1). Across both groups, 16 patients had 1WC, and five had 3WC. Overall grade >3 toxicity was higher in the 1WC group (56% vs. 20%), with 31% of patients ceasing 1WC during CRTx, compared to none in the 3WC.

Conclusion: In this small retrospective study, overall toxicity was similar across sequencing approaches, however treatment completion of each modality was higher in whichever modality was started first. 1WC CRTx had a higher toxicity profile compared to 3WC, and the ongoing use of this modified protocol in the absence of clear benefit is currently under review.

Christina Teng, Anew Killen, Charlotte Lemech 

Scientia Clinical Research, Randwick, Australia 

Aim: To identify and summarize the demographic factors of patients referred and enrolled to Scientia Clinical Research (SCR) Phase 1 oncology trials.

Background: Phase 1 trials are first-in-human studies evaluating the safety, efficacy, and pharmacokinetics of newly developed medications. SCR is a dedicated Phase 1 trial unit located in NSW, Australia.

Methods: Descriptive statistics were used to summarize de-identified data from the clinical records of patients referred to the SCR Phase 1 unit.

Results: In the 2022 calendar year, 168 patients were referred to SCR for an opinion about early phase clinical trials, from 51 referrers. Of those referred, 139 patients had a first consultation. Figure 1 summarizes the outcomes of the patients referred. The mean age at time of referral was 59 years, (standard deviation 12, median 61, range 12–83). The most common primary diagnoses were upper gastrointestinal (29%), colorectal (23%), and gynecological (23%) cancers. Of the patients where referral location was available, the majority resided in metropolitan Sydney (47%). Regional NSW residents comprised 29% and interstate referrals 9%. Five initial consultations were conducted with the assistance of an interpreter (three Mandarin, one Cambodian, one Auslan). Of these, two patients proceeded to trial participation. In 2022, 52 patients consented and commenced trial screening over 21 trials; 29 were female (56%). Median age was 71. Residents of metropolitan Sydney comprised 50% of screened patients. Four patients were ineligible at screening; 48 commenced trial treatment. Median time from referral to starting trial was 14 days. The most common diagnosis of recruited patients was gynecological cancer (31%), followed by upper gastrointestinal (21%) and colorectal (20%) cancers.

Conclusion: In 2022, referrals and trial participants to phase 1 oncology trials at SCR represented a diverse geographical population. Patients from culturally and linguistically diverse backgrounds were under-represented.

Lucy Porter¹, Phillip Parente^2,3, Grace Gard^4,5, Benjamin Brady⁶, Wasek Faisal^7,8, Dishan Herath⁴, Margaret Lee^2,3, Peter Gibbs^4,5, Ben Markman^5,6, Rachel Wong^2,3 

¹School of Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia

²Department of Medical Oncology, Eastern Health, Melbourne, Australia,

³Eastern Health Clinical School, Monash University, Melbourne, Australia

⁴Department of Medical Oncology, Western Health, Melbourne, Australia,

⁵Walter and Eliza Hall Institute of Medical Research, Melbourne, Australia

⁶Department of Medical Oncology, Cabrini Health, Melbourne, Australia

⁷Grampians Integrated Cancer Service, Grampians Health, Ballarat, Australia

⁸School of Health, La Trobe University, Melbourne, Australia 

Background: The treatment of early-stage non-small cell lung cancer (NSCLC) is evolving, with data increasingly supporting the role of immunotherapy and targeted agents in adjuvant and neo-adjuvant settings. Atezolizumab, a PD-L1 inhibitor, has been PBS-subsidized since November 2022 for resected Stage II–IIIa NSCLC patients with PD-L1 ≥ 50 who are EGFR/ALK wild-type and treated with platinum-based chemotherapy. The proportion of patients who receive molecular testing and are eligible for PBS-subsidized atezolizumab treatment in Australian hospitals is unknown.

Methods: Patients enrolled in the multi-site INHALE lung cancer registry between February 2020 and January 2023 at four Australian sites (n = 448) were retrospectively analyzed. NSCLC patients who underwent surgical resection were included (n = 115) and analyzed for stage, molecular testing, treatment details, and outcomes.

Results: A total of 90/115 resected NSCLC patients were treated with curative intent. 63/90 received surgery alone, 25/90 received adjuvant systemic therapy and/or radiotherapy, and 2/90 received neo-adjuvant systemic therapy and/or radiotherapy. 7/90 experienced disease recurrence/progression.

A total of 70/90 curative-intent resected patients had PD-L1 testing. 62/70 within 30 days and 67/70 within 90 days of surgery. 56/90 underwent genomic testing. Testing results are shown in Table 1.

Of 70 PD-L1 tested patients, one was eligible for adjuvant atezolizumab as per current PBS criteria. 67/70 were ineligible (PD-L1 < 50%, ineligible-stage, no platinum-based chemotherapy), and 2/70 were PBS-eligibility unknown (genomic testing not performed). PD-L1 and genomic testing rates were higher in metropolitan versus regional settings (70%–90% vs. 40% and 15%–88% vs. 50%, respectively), and private versus public settings (90% vs. 70% and 88% vs. 15%–65%, respectively).

Conclusion: In this real-world analysis of resected NSCLC patients, very few routine care patients were eligible for PBS-subsidized atezolizumab. We anticipate that PD-L1 and genomic testing rates will increase in response to the availability of adjuvant atezolizumab on the PBS and as evidence supporting neo-adjuvant/adjuvant use of immunotherapy and/or targeted agents continues to emerge.

Joanne Tang¹, Brian Stein^2,3 

¹Central Adelaide Local Health Network, Adelaide, Australia

²Icon Cancer Centre, Adelaide, Australia,

³University of Adelaide, Adelaide, Australia 

Background: EviQ is a consensus driven evidence-based repository of cancer treatment protocols widely used in Australia and serves as a de facto standard. A standardized assessment of the clinical benefit of the protocols published on EviQ has not been undertaken. Based on the references in EviQ we aimed to determine the feasibility of scoring all solid tumor protocols to assess the benefit of protocols and explore correlations between ESMO-MCBS scoring and treatment indication, tumor stream and trial endpoint.

Methods: We graded all solid tumor protocols published on EviQ until April 31, 2022 with ESMO-MBCS version 1.1, excluding functional duplicates (e.g., weight-based vs. flat dose immunotherapy). We only used the “Evidence” section for reference as this is the evidentiary justification for protocol publication. In addition to technically unevaluable protocols, we regarded protocols using phase II data in common scenarios, lacking a standard comparator, or based on conglomerated data as unevaluable.

Results: Of 478 included protocols, 301 (63%) were evaluable. Intent was curative in 97 and palliative in 204. Overall, 140 (47%) of evaluated protocols met the MCBS threshold for significant benefit; with 75% of curative but only 33% of palliative protocols being of “substantive benefit”. Of the 57 protocols that had toxicity or quality-of-life benefit, 88% were palliative and 47% were chemotherapy regimens. Of low benefit protocols, 49% were chemotherapy-based, and response-based outcomes were over-represented in palliative protocols. There was no difference in scores by tumor stream. Of the 177 unevaluable protocols, 31% lacked a standard comparator and 42% used phase II data in non-orphan settings.

Conclusion: Within EviQ, 47% of evaluable protocols are ESMO-MCBS “substantial benefit”; most are curative. Few protocols gained points for less toxicity. We suggest adding ESMO-MCBS score to EviQ to aid in regimen consideration.

Sophie Tran^1,2, Cassana Moore², Danielle Roscoe², Hieu Chau², Sachin Joshi^2,3, Quan Tran², Rohan Nair^2,3, Mahesh Iddawela^2,3,4 

¹Eastern Health, Box Hill, Australia

²Latrobe Regional Health, Traralgon, Australia

³Alfred Health, Melbourne, Australia

⁴Department of Rural Health, Monash University, Traralgon, Australia 

Background: Brain metastases (BM) is a common occurrence in non-small cell lung cancer (NSCLC) and is associated with high morbidity and mortality. The advent of new systemic treatments and radiation techniques has led to improved outcomes in this prognostically poor group. As such, early detection at diagnosis and surveillance is important. This project aims to review the characteristics, current practice, management and outcomes of lung cancer BM at a single regional center to help inform development of local protocols.

Methods: Patients with lung cancer BM were identified from the William Buckland Radiotherapy Centre medical records and Latrobe Regional Health lung cancer database. A total of 101 patients were identified between 2017 and 2022. Demographic and clinical information data were collected.

Results: The median age at lung cancer diagnosis was 68 years, 59% were male and 71% ECOG 0 or 1. At initial diagnosis, 66% (67/101) had metastatic disease and of these patients, 60% (40/67) had BM. Initial brain imaging was performed in 68% (67/101). Targetable oncogenic aberrations were found in 13% (13/101). The median time to BM was 10 months and median survival from BM diagnosis was 4 months. 37% (37/101) of patients had surgical resection, 20% (20/101) had stereotactic radiation (SRS) alone, 32% (32/101) had whole brain radiation therapy (WBRT) and 12% (12/101) had no local therapy. The surgery or SRS group had better survival outcomes compared to those who had WBRT or no local treatment following BM diagnosis (log rank χ²(2) = 7.590, p = 0.02) (Figure 1).

Conclusion: The incidence of BM at initial diagnosis is higher than published data with prognosis following BM diagnosis poor. This may be reflective of the regional demographic of patients who present more advanced. This underlines the importance of establishing local guidelines in intracranial disease detection and screening for earlier diagnosis and timely management to improve outcomes.

Niamh Walsh^1,2, Rosalie Stephens³, Alvin Tan⁴, Vanessa Durandt⁵, Jennifer McLachlan⁶, Jody Jordan⁷, Kate Gregory⁸, Sean Sutton², Catherine Barrow², Annie Wong^1,2 

¹University of Otago, Wellington, New Zealand

²Wellington Blood & Cancer Centre, Wellington, New Zealand

³Regional Blood and Cancer Service, Auckland, New Zealand

⁴Medical Oncology, Waikato, New Zealand

⁵Oncology and Haematology, Dunedin, New Zealand

⁶Canterbury Regional Cancer and Haematology Service, Christchurch, New Zealand

⁷Midcentral District Cancer, Hawkes Bay, New Zealand

⁸Nelson Cancer Centre, Nelson, New Zealand 

Background: Most patients with metastatic melanoma will develop brain metastases (BM), with poor prognosis. Immune checkpoint inhibitors (ICI) are active for melanoma BM. However, landmark clinical trials are not representative of the “real-world” population, due to exclusion of patients with symptomatic BM, poor performance status or steroid use.^1,2 This study reports the real-world outcomes of ICI for melanoma BM in New Zealand (NZ).

Methods: A retrospective audit of patients with melanoma BM treated with ICI between September 1, 2016, and September 1, 2020 was conducted across seven NZ cancer centers. Baseline demographics, tumor characteristics, treatment, intracranial tumor response rates, intracranial progression-free survival (iPFS), and overall survival (OS) were recorded.

Results: A total of 144 patients received at least one dose of ICI. Most patients (93%) received anti-PD1 monotherapy. Almost a quarter of patients had baseline performance status (ECOG 2–3), 56% were symptomatic and 33% had corticosteroids. Intracranial response was seen in 36%, and median-iPFS was 9 months. The 6- and 12-month-iPFS rates were 55% and 45%, respectively. Seventy-seven (53%) patients received local therapies, for example, surgery or radiation. The median OS was 15 months, and a third of patients were alive at 2 years (Figure 1). The toxicity of ICI was 28% and 15% for grade 1–2 and 3–4 events, respectively. Of those patients still alive at 2 years, 23% were asymptomatic.

Conclusions: Most patients had symptomatic disease and received anti-PD1 monotherapy. The intracranial tumor response rate for anti-PD1 monotherapy was higher than expected in this symptomatic population. However, this must be interpreted with caution given the retrospective study design. Nonetheless, this study provides real-world data for melanoma BM in NZ.

Acknowledgments: Cancer Society Central Districts and Graduate Women Otago Scholarship.

References:

1. Tawbi HA, Forsyth PA, Algazi A, et al. Combined Nivolumab and Ipilimumab in Melanoma Metastatic to the Brain. N Engl J Med. 2018;379(8):722–730. https://doi.org/10.1056/NEJMoa1805453

2. Long GV, Atkinson V, Lo S, Sandhu, et al. Combination nivolumab and ipilimumab or nivolumab alone in melanoma brain metastases: a multicentre randomised phase 2 study. Lancet Oncol. 2018;19(5):672–681. https://doi.org/10.1016/S1470-2045(18)30139-6

Isabella Wilson¹, Madeleine Strach^1,2, Vivek Bhai¹, Michelle Harrison¹, Whiter Tang¹, Peter Grimison¹ 

¹Chris O'Brien Lifehouse, Sydney, Australia

²The University of Sydney Faculty of Medicine and Health, Sydney, Australia 

Background: Gemcitabine and docetaxel (GD) is a standard chemotherapy regimen for soft tissue sarcoma (STS). The GeDDiS phase 3 trial compared GD with doxorubicin in the 1st-line setting, using a 90-min gemcitabine infusion time, reporting a response rate of 20% and median progression-free survival (PFS) of 5.4 months.¹ We examined the real-world efficacy and toxicity of GD in the 1st and later line using a 30-min gemcitabine infusion time.

Methods: A retrospective analysis was conducted of patients with unresectable or metastatic STS receiving ≥1 cycle of GD between July 2018 and October 2022. Data collected included demographics, tumor characteristics, dose intensity, toxicity, response, PFS, and overall survival (OS).

Results: Thirty-eight patients were included for analysis. Median follow-up was 19 months (range 3–30). Histologic subtypes (n) were leiomyosarcoma (20), synovial sarcoma (4), undifferentiated pleomorphic sarcoma (4), other (10). Line of treatment (n) was 1st line (10), 2nd line (13), and ≥3rd line (15). Median number of cycles was 6 (range 1–12). Sixteen patients (42%) required dose modification during the 1st three cycles. Response rate was 42%, including 5% with complete response. At the time of data collection, 33 patients had disease progression and 24 patients had died. PFS (median, 6-month rate) was 4.5 months and 44%. OS (median, 12-month rate) was 15 months and 65% (Figure 1). Grade 3/4 toxicity included neutropenia (8%), febrile neutropenia (3%), and anemia (21%). There was one death possibly attributable to GD.

Conclusion: This data demonstrates efficacy of GD comparable to other published data and favorable toxicity in a real-world population despite shorter gemcitabine infusion time and heavily pre-treated population.

Reference:

1. Seddon B, Strauss SJ, Whelan J, et al. Gemcitabine and docetaxel versus doxorubicin as first-line treatment in previously untreated advanced unresectable or metastatic soft-tissue sarcomas (GeDDiS): a randomized controlled phase 3 trial. Lancet Oncol. 2017;18(10):1397-1410.

Vanessa Wong^1,2,3, Michael Harold¹, Bill Karanatsios², Eleonora Kay⁴, Duncan Colyer⁴, Peter Gibbs^1,2, Shehara Mendis^1,2 

¹Walter & Eliza Hall Institute of Medical Research, Parkville, Australia

²Western Health, St Albans, Australia

³Ballarat Health Services, Ballarat, Australia

⁴Victorian Comprehensive Cancer Centre (VCCC) Alliance, Parkville, Australia

Background: Cancer clinical trials are becoming progressively more complicated and expensive to run, making pragmatic trial designs that limit complexity and/or cost an attractive alternative. One such pragmatic trial design is to conduct a clinical trial using an existing prospective clinical registry to collect patient, treatment, and trial endpoint data. As such, investigator-initiated registry-based clinical trials (Reg-CTs) in cancer populations are emerging in Victoria, supported by the Victorian Comprehensive Cancer Centre (VCCC) Alliance. The perspectives of clinicians and study staff actively involved in this novel trial methodology is of interest.

Methods: A survey was constructed by a panel of clinicians and trials staff. The key focus was barriers and enablers of Reg-CTs. Invitations to participate in the survey were sent to clinical investigators, study coordinators, research nurses, research officers and clinical trials assistants at Victorian sites involved in Reg-CTs.

Results: A total of 42/100 (42%) potential respondents replied, including 18 (43%) investigators and 16 (38%) study coordinators. Thirty-eight (90%) were actively recruiting to Reg-CTs and 20 (48%) had been involved in Reg-CTs for over 2 years. The most important benefits perceived were involvement in trials asking relevant unanswered clinical questions and reduced study-related activity for site staff and patients. Funding was seen as the most important barrier to initiating Reg-CTs, and patient eligibility the largest barrier to enrollment. The single greatest challenge perceived in running Reg-CTs was having clear demarcation of staff responsibility for trial data entry versus registry data entry.

Conclusion: Clinical trial teams overall appreciate multiple benefits of involvement in Reg-CTs, including reduced burden of trial-related procedures. Identifying sufficient patient candidates remains a challenge in Reg-CTs. Though generally considered cost-effective in design and conduct, adequate funding for sites to run these trials was perceived as the single most important barrier to increasing uptake of Reg-CT trials.

Nicholas Yeo¹, Sayeda Naher² 

¹Sutherland Hospital Day Oncology Unit, Caringbah, Australia

²Illawarra Cancer Care Centre, Wollongong, Australia 

Background: Metastatic breast cancer represents a heterogenous group of patients. Whilst treatment and survival have improved, it remains the 5th most common cause of cancer death in Australia. There is a paucity of data describing the outcomes for patients with metastatic breast cancer treated in regional centers. We aim to describe the experiences within the Illawarra Shoalhaven Local Health District (ISLHD) and provide real-world data on the treatment patterns for these patients, including any factors influencing treatment response.

Methods: We retrospectively reviewed patients with metastatic breast cancer with available electronic medical records from 2011 to 2020, in the ISLHD. Standard demographic, clinicopathological characteristics, treatment data, and outcomes were assessed.

Results: We identified 169 patients with a mean age of 65 (interquartile range [IQR] 53–79). Most women had hormone-receptor positive breast cancers number (n = 104, 62%), followed by HER2-positive (n = 45, 26%), and triple negative breast cancers (TNBC) (n = 20, 12%). Amongst them, 125 (73.5%) of patients had de novo metastatic disease. The average number of lines of treatment received was 2 (IQR 1–3). The most prescribed chemotherapy regimens were taxanes (38.2%), followed by capecitabine (13.2%). Number of metastases (odds ratio [OR] 1.33, 95% CI 1.03–1.71, p = 0.03) and triple negative disease (OR 8.17, 95% CI 4.6–14.5, p < 0.001) were associated with poorer survival. There were no significant differences between de novo and recurrent disease (OR .80, 95% CI .53–1.22, p = 0.30).

Conclusion: This is the first retrospective review describing the treatment patterns and outcomes for patients with metastatic breast cancer within the Illawarra Shoalhaven Local Health District. Whilst treatment and survival have improved, it is evident that triple negative breast cancers remain an aggressive subgroup. There is a need for better treatments for this subgroup of patients.