E. Torlakovic, S. R. Sompuram, K. Vani, Lili Wang, Anika K Schaedle, P. DeRose, S. Bogen
{"title":"Abstract PS5-46: Introduction and clinical validation of metrology standards for immunohistochemistry (IHC); New tool for standardization of estrogen receptor (ER) IHC assay in breast cancer","authors":"E. Torlakovic, S. R. Sompuram, K. Vani, Lili Wang, Anika K Schaedle, P. DeRose, S. Bogen","doi":"10.1158/1538-7445.SABCS20-PS5-46","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS20-PS5-46","url":null,"abstract":": Traceability of measurement to a higher order reference standard is a foundation of laboratory testing. There is as yet no method for creating reference standards for cellular proteins in situ in an analogous fashion as for soluble analytes. At present, IHC laboratories produce results for breast cancer hormone receptors without connection to a reference standard. Not surprisingly, high rates of testing variation as well as discrepancies among IHC laboratories have been reported. To address this need, we developed a system of measurement traceability using a linked fluorescein tag for creating reference standards for any cellular analyte and, as a first test, validate it for estrogen receptor (ER) testing. In this study, the newly developed ER standard defines and compares the thresholds separating “high positive”, “low positive”, and “negative” tests according to updated ASCO/CAP guidelines as detected by clinical IHC laboratories in a national external quality assessment survey. This reference standard utilizes NIST Standard Reference Material (SRM) 1934 as a universal IHC standard. We calculated ER concentration based on a linked fluorescence measurement traceable to NIST SRM 1934 as each ER is linked to","PeriodicalId":20307,"journal":{"name":"Poster Session Abstracts","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87986305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
R. Coleman, G. Fried, Sung-Bae Kim, I. Kuchuk, D. Kiesl, M. Ramos, J. Sohn, J. Siegel, Rui Li, D. Uema, V. Wagner, H. Rugo
{"title":"Abstract PS14-01: Radium-223 in women with HR-positive bone-metastatic breast cancer receiving endocrine therapy: International phase 2, randomized, double-blind, placebo-controlled trial","authors":"R. Coleman, G. Fried, Sung-Bae Kim, I. Kuchuk, D. Kiesl, M. Ramos, J. Sohn, J. Siegel, Rui Li, D. Uema, V. Wagner, H. Rugo","doi":"10.1158/1538-7445.SABCS20-PS14-01","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS20-PS14-01","url":null,"abstract":"Background: Approximately 65-75% of women with metastatic breast cancer (mBC) have skeletal involvement, which can result in bone pain, pathologic fractures, and spinal-cord compression (SCC), impairing quality of life and function. Radium-223 dichloride (Ra-223) is a targeted alpha-emitting radionucleotide therapy that is approved for treatment of bone metastases from castration-resistant prostate cancer, but has been little studied in mBC. Objective: To assess the efficacy and safety of Ra-223 in women with bone-metastatic hormone receptor (HR)-positive breast cancer receiving endocrine monotherapy. Methods: This international, phase 2, randomized, double-blind, placebo-controlled trial (NCT02258464) involved women ≥18 years with HER2-negative, HR-positive, bone-dominant (≥2 skeletal lesions) mBC. Women with 1-2 skeletal-related events before study entry, treated with ≥1 line of hormonal therapy in the metastatic setting and bone-supportive agents, were randomized 1:1 to receive Ra-223 55 kBq/kg or placebo intravenously every 4 weeks for up to 6 cycles, combined with local standard of practice endocrine monotherapy and bone-targeted therapy with denosumab or a bisphosphonate. The primary endpoint was symptomatic skeletal event-free survival (SSE-FS). SSE was defined as external beam radiotherapy to relieve skeletal symptoms, symptomatic pathologic fractures, SCC, cancer-related orthopedic surgery, or death from any cause. Secondary endpoints included overall survival (OS), radiologic progression-free survival (rPFS), pain measurements, and safety. Results: Considering the evolving treatment landscape and slow recruitment, enrollment was closed early, and patients who completed treatment were permitted to roll over early to a follow-up study. Of the planned 227 women, 99 were randomized (Ra-223 n=49, placebo n=50; median age 57 years, range 28-85 years; 89% postmenopausal). The median number of injections received was 6 (range 1-6) in both arms. Median SSE-FS was 30 months (80% confidence interval [CI] 22, 43) in the Ra-223 arm vs 18 months (80% CI 9, 28) in the placebo arm; hazard ratio 0.75 (95% CI 0.41, 1.36; P=0.334). Trends in favor of Ra-223 over placebo were found for OS and pain measurements (Table). Treatment-emergent adverse events (TEAEs) occurred in 96% of patients in the Ra-223 arm and 94% in the placebo arm; drug-related TEAEs occurred in 44% and 33% of patients, respectively, and grade 3/4 TEAEs in 31% and 39%, respectively. In the Ra-223 vs placebo arms, there were fewer serious TEAEs (6% vs 25%, respectively, most commonly bone pain), bone-associated TEAEs (21% vs 27%, respectively; fracture 4% vs 12%, respectively), and TEAEs leading to treatment discontinuation (2% vs 6%, respectively). Conclusion: Although the primary endpoint was not met, possibly because of the small sample size, early discontinuation of follow-up, and lower than anticipated event rates, numerical trends consistently favored Ra-223 over placebo for SSE-FS, ","PeriodicalId":20307,"journal":{"name":"Poster Session Abstracts","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74368736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joanna Kufel-Grabowska, T. San, A. Bernardo, L. Cavanna, I. Pérez, G. Suchodolska, J. Hippenmeyer, P. Gokani, M. Lillie, C. Rodríguez
{"title":"Abstract PS10-50: Patterns of use of a trastuzumab biosimilar (ABP 980) in patients with HER2+ breast cancer treated in clinical practice in Europe: An interim analysis from an observational chart review study (GARDENIA)","authors":"Joanna Kufel-Grabowska, T. San, A. Bernardo, L. Cavanna, I. Pérez, G. Suchodolska, J. Hippenmeyer, P. Gokani, M. Lillie, C. Rodríguez","doi":"10.1158/1538-7445.SABCS20-PS10-50","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS20-PS10-50","url":null,"abstract":"Background: Over recent years, therapeutic biosimilars have started to be licensed as oncology treatments in both palliative and potentially curative settings, but little is known about their uptake and usage in routine clinical practice. ABP 980 is a trastuzumab biosimilar that is licensed in Europe and the USA for the treatment of HER2+ early or metastatic breast cancer and metastatic gastric cancer. This European real-world study aimed to describe patterns of ABP 980 usage in clinical practice in patients with breast cancer. Methods: This descriptive observational chart review study included consecutive patients aged ≥18 years with HER2+ breast cancer (any disease stage or treatment phase) who were receiving or had previously received ABP 980 and had medical charts available for data extraction. Patients were followed up from ABP 980 initiation to withdrawal of consent, death, loss to follow up, entry into an interventional trial, or study end (12 months after last patient enrolled). Follow-up data from ABP 980 initiation to enrolment were retrospectively collected; data after enrolment were prospectively collected. Data were extracted into electronic case report forms quarterly. The primary objective is to describe patient demographics and disease characteristics by treatment phase and prior trastuzumab exposure and communication with patients about biosimilar use is an exploratory objective. Other exploratory endpoints are ABP 980 safety (including cardiac dysfunction, infusion-related reactions and other adverse events of interest) and efficacy (both to be assessed in the final analysis). This planned interim analysis was performed approximately 6 months after the first patient enrolled and provides baseline data on patient characteristics. Results: At the time of analysis, 135 women were included from five countries (Poland n=42; Italy n=38; the Netherlands n=32; France n=21; Spain n=2). Patients were mostly recruited from hospital-based sites (61%), including a mixture of academic/non-academic and publicly/privately funded centers. A policy on biosimilar use was documented in 28% of sites and 36% of patients were informed they were starting a biosimilar, with the brand mentioned to 34% of patients. Mean (standard deviation [SD]) age at ABP 980 initiation was 58.3 (11.5) years and mean (SD) time from ABP 980 initiation to enrolment was 7.3 (4.8) months. At ABP 980 initiation, 22%, 27%, 13% and 28% of patients had Stage I, II, III or IV disease, respectively. Overall, 68% of patients had estrogen/progesterone receptor-positive tumors and all patients with known ECOG performance status (n=73) had a score of 0 or 1. ABP 980 usage was approximately equally distributed across neoadjuvant (39%), adjuvant (30%), and metastatic settings (30%). Of the patients receiving treatment for metastatic disease (n=41), most received ABP 980 as their 1st- (56%) or 2nd- (20%) line treatment. Overall, 40% of patients had switched to ABP 980 from another trastu","PeriodicalId":20307,"journal":{"name":"Poster Session Abstracts","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75643690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Goyal, Shama Puri, A. Marshall, K. Valassiadou, M. Hoosein, A. Carmichael, Gabriella Erdelyi, Nitasha Sharma, J. Dunn, J. York
{"title":"Abstract PS1-32: A multicentre prospective feasibility study of carbon dye tattooing of biopsied axillary node and surgical localisation in breast cancer patients","authors":"A. Goyal, Shama Puri, A. Marshall, K. Valassiadou, M. Hoosein, A. Carmichael, Gabriella Erdelyi, Nitasha Sharma, J. Dunn, J. York","doi":"10.1158/1538-7445.sabcs20-ps1-32","DOIUrl":"https://doi.org/10.1158/1538-7445.sabcs20-ps1-32","url":null,"abstract":"","PeriodicalId":20307,"journal":{"name":"Poster Session Abstracts","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74805939","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
E. Obeid, R. Parikh, E. Esterberg, B. Arondekar, A. Hitchens, L. S. Arruda, A. Niyazov
{"title":"Abstract PS11-42: Treatment patterns and clinical outcomes among patients (pts) with HER2- advanced breast cancer (ABC) and germlineBRCA1/2mutation(s) (gBRCA1/2mut): results from a US real-world study","authors":"E. Obeid, R. Parikh, E. Esterberg, B. Arondekar, A. Hitchens, L. S. Arruda, A. Niyazov","doi":"10.1158/1538-7445.sabcs20-ps11-42","DOIUrl":"https://doi.org/10.1158/1538-7445.sabcs20-ps11-42","url":null,"abstract":"","PeriodicalId":20307,"journal":{"name":"Poster Session Abstracts","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84683491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Abstract PS19-04: Standard temperature husbandry increases tumor aggressiveness via chronic cold stress in murine mammary cancer models","authors":"Darius O Gaymon, M. Lippman, P. Foley, P. Miller","doi":"10.1158/1538-7445.SABCS20-PS19-04","DOIUrl":"https://doi.org/10.1158/1538-7445.SABCS20-PS19-04","url":null,"abstract":"Correct interpretation of disease progression and therapeutic responses in mouse models of breast cancer requires interrogation of models and conditions that faithfully recapitulate human disease and conditions that mimic clinical intervention. Historically, standard temperature (ST) for in vivo murine research has been approximately 70-72°F (21-22°C), mimicking ambient temperatures in laboratories that are comfortable for researchers. However, previous work from the Repasky lab demonstrated that ST housing results in chronic cold stress and immune suppression mediated by an increase in norepinrephrine (NE) levels, leading to increased tumor aggressiveness. In contrast, syngeneic murine mammary tumors in mice housed at higher temperatures [~ 82°F] grew more slowly and resulted in fewer metastases. Based on these findings, we investigated tumor progression and metastasis in a temperature dose response in two syngeneic murine mammary tumor models: the balb/c-4T1 model and the c57bl6/E0771-LMB (a lung metastatic variant of E0771 cells) model.Mice were acclimatized in rooms with three different ambient temperaures and challenged with tumor cells. ST was maintained at 70-72°F, while mid-temperature (MT) was maintained at 78-80°F, and high temperature (HT) was maintained at 84-85°F. Compared to ST and MT, an ambient temperature of 84-85°F resulted in a statistically significant delay in tumor formation and decreased primary tumor growth by unpaired t-test (p=.0006) At day 13, when 4T1 tumors are typically well-initiated and measurable by caliper, mean tumor volumes in the ST-housed mice were significantly larger than the HT group. At day 21, ST tumors means were 4 times larger than HT. In the E0771-LMB model, mean tumor volumes on day 14 were nearly 3 times larger in ST-housed mice than HT. At day 27, the mean tumor volumes were 2 times larger in the ST group compared to HT-housed mice. Data on metastasis will be presented at the meeting. Mean NE levels in mice housed at ST were twice as high as those at HT, providing ancillary evidence that traditional “standard” temperatures are a significant stressor for mice (p=.0091).These data demonstrate the potential for misleading interpretations of biological significance of chronic cold stress when modeling immunocompetent tumor progression [conditions almost universally employed in most studies]. Furthermore, these data demonstrate that the presence of chronic cold stress and its immunosuppressive effects call into question the interpretation of many previous studies completed at or near standard temperature and may suggest the need to increase ambient temperatures in syngeneic experiments in order to more accurately model human disease. Citation Format: Darius O Gaymon, Marc Lippman, Patricia Foley, Philip Miller. Standard temperature husbandry increases tumor aggressiveness via chronic cold stress in murine mammary cancer models [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Sym","PeriodicalId":20307,"journal":{"name":"Poster Session Abstracts","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85636980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Nagalingam, N. Muniraj, S. Siddharth, D. Avtanski, S. Parida, Pajamurthy Kuppusamy, N. Saxena
{"title":"Abstract PS18-32: Hyperleptinemia in obese state renders luminal breast cancers refractory to tamoxifen coordinating a crosstalk between Med1, miR205 and Erb B kinases","authors":"A. Nagalingam, N. Muniraj, S. Siddharth, D. Avtanski, S. Parida, Pajamurthy Kuppusamy, N. Saxena","doi":"10.1158/1538-7445.sabcs20-ps18-32","DOIUrl":"https://doi.org/10.1158/1538-7445.sabcs20-ps18-32","url":null,"abstract":"","PeriodicalId":20307,"journal":{"name":"Poster Session Abstracts","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90333300","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Abstract PS9-48: Depression, sexual dysfunction and quality of life among breast cancer patients with ovarian function suppression: A cross sectional study between ovarian ablation verse GnRH agonists","authors":"Junnnan Xu, T. Sun","doi":"10.21203/rs.3.rs-66195/v1","DOIUrl":"https://doi.org/10.21203/rs.3.rs-66195/v1","url":null,"abstract":"\u0000 Background: Ovarian function suppression is being widely utilized as endocrine therapy to reduce estrogen release in premenopausal breast cancer patients and was achieved either by medical treatment with bilateral oophorectomy, irradiation, or the Gonadotropin releasing hormone (GnRH) agonist. This study aimed to examine whether GnRHa differed from ovarian ablation on depression, sexual dysfunction and quality of life.Methods: The premenopausal breast cancer patients who received ovarian function suppression were enrolled from seven hospital between June 2019 and June 2020. Our independent variable was the type of ovarian suppression, categorized as Ovarian Ablation (OA cohort, n=174) and medical GnRH agonist (GnRHa cohort, n=389). The self-administered questionnaire (OFS-Q5) was developed and used in this study aimed to assess the depression (PHQ-9), sexual dysfunction (FSFI) and quality of life (EORTC QLQ-BR23).Results: In this cross-sectional study, 563 patients with ovarian function suppression completed surveys were collected. The mean sum score of the PHQ-9 tend to be slight decrease in GnRHa cohort than that in ovarian ablation (OA) cohort (11.4 ±5.7 vs. 12.8 ±5.8, OR=1.910, P=0.079). Patients with major depression (PHQ-9≧15) was indicated significantly fewer in GnRHa cohort (31.1% vs 40.2%, P=0.025). The more surprising correlation is less patients with sexual dysfunction (61.5%, FSFI< 23) in OA cohort, a remarkable increase in GnRHa cohort (72.2%, P = 0.011). The ratio of sexual dysfunction remained lower for ovarian ablation women in long-term ovarian suppression (duration of ovarian suppression > 2 years: OA vs GnRHa, OR=1.555, P=0.037). No significantly difference for most subscales of QLQ-BR23 between two cohorts was evident.Conclusions: Our current investigation demonstrate here for the first time that medical GnRHa resulted in favour depression, worse sexual function than those with ovarian ablation, with similar quality of life. This new understanding should help to improve and alleviate adverse effect in patients with diverse ovarian function suppression.","PeriodicalId":20307,"journal":{"name":"Poster Session Abstracts","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78191197","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Abstract PS7-60: Adenosquamous carcinoma of the breast: A population-based study using the SEER database","authors":"Zhangyuan Gu, Juan Liu, Xiaoyan Lin, Cheng Wang, Jiejing Li, Yun Fu, Xiaolin Cheng, Cheng Xu, Zhigang Zhuang","doi":"10.21203/rs.3.rs-50772/v1","DOIUrl":"https://doi.org/10.21203/rs.3.rs-50772/v1","url":null,"abstract":"\u0000 Background: The present study is aimed at summarizing the clinicopathological characteristics, prognosis, and management of breast adenosquamous carcinoma (ASC). Methods: A population-based study was performed using retrospectively extracted data from the Surveillance, Epidemiology and End Results database for breast cancer patients with histological diagnoses of ASC, infiltrating duct carcinoma (IDC) and squamous cell carcinoma (SCC) from 2004 to 2016. End-points were overall survival (OS) and breast cancer-specific mortality (BCSM). Propensity Score Matching (PSM) was employed to minimize selection bias of baseline characteristics. Univariable and multivariable analyses were used for identifying valuable prognostic factors. Results: ASC presented similar tumor size but low histological grade and less lymph node metastasis compared to IDC. ASC expressed less positive rate of hormone receptors and barely HER2, which was similar with SCC (estrogen receptor (ER): ASC 27.74% and SCC 21.53%, progesterone receptor (PR): ASC 18.06% and SCC 12.85%, HER2: ASC 4.44% and SCC 7.53%). ASC patients underwent the same treatment as IDC (chemotherapy 36.99% vs. 41.86%, BCS 50.58% vs 52.83%, P >0.05), only with less radiotherapy (39.88% vs. 48.34%, P<0.05). Median follow-up data of 78 months showed that the prognosis of IDC patients was better than that of ASC patients (all P <0.05 for BCSM and OS). After adjustment for clinicopathological and therapeutic factors in Cox proportional hazards models, ASC was no longer an independent poor prognosis factor. In matched groups, no significant difference in BCSM nor OS was observed between ASC and IDC groups. In HR-negative patients, the prognosis of ASC was similar with that of IDC, and both were superior to SCC. In HR-positive patients, the five-year survival rate of ASC was only about 60%, which was far less than that in ASC of HR-negative, the poor prognosis of ASC was closer to that of SCC. Multivariate analysis showed that older age (age≥60) and advanced AJCC stage (III and IV) were independent factors of poor prognosis in ASC, breast-conserving surgery was also ideally suited for ASC. Conclusions: ASC has unique clinicopathological characteristics and prognosis. To improve the clinical and biological understanding of ASC can make breast cancer patients get more individualized treatment.","PeriodicalId":20307,"journal":{"name":"Poster Session Abstracts","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89902784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
I. Nivar, Tara Kauffman, L. Bayne, P. Wiley, B. Goodspeed, Michael D. Feldman, L. Chodosh, A. Clark, A. DeMichele
{"title":"Abstract P2-12-01: Patient attitudes, experience and results of screening for minimal residual disease (MRD) for therapeutic intervention","authors":"I. Nivar, Tara Kauffman, L. Bayne, P. Wiley, B. Goodspeed, Michael D. Feldman, L. Chodosh, A. Clark, A. DeMichele","doi":"10.1158/1538-7445.sabcs19-p2-12-01","DOIUrl":"https://doi.org/10.1158/1538-7445.sabcs19-p2-12-01","url":null,"abstract":"Background: Patients (pts) treated for early stage breast cancer (BC) have a 30% lifetime risk of developing incurable, distant metastatic disease. Yet, standard monitoring after definitive therapy for primary disease is passive observation. Numerous studies have demonstrated that dormant bone marrow (BM) disseminated tumor cells (DTCs) are independently associated with recurrence, but assessment of DTCs is not performed in clinical practice, largely because of concerns about the acceptability and logistics of bone marrow aspiration (BMA) and lack of established therapies that target DTCs. As part of a large scale screening study for a clinical trial targeting DTCs, we examined pt attitudes about DTC screening and subsequently assessed feasibility and tolerability of BM DTC assessment. Methods: The PENN-SURMOUNT (Surveillance Markers of Utility for Recurrence after (Neo)adjuvant Therapy) Screening Study is a single center prospective, longitudinal cohort study examining BM and blood biomarkers of minimal residual disease (MRD) among pts within 5 years of BC diagnosis, who meet one of the following high risk criteria: positive axillary nodes, triple negative biology, ER+ with Oncotype Dx ≥ 25 and/or high risk Mammaprint, or residual disease (RD) after neoadjuvant chemotherapy (NACT). Consented pts undergo a baseline outpatient BMA; if negative, pts can repeat screening annually. During trial design, we surveyed 25 women with stage 2-3 BC at random from the breast clinic at the University of Pennsylvania to assess feasibility. On the SURMOUNT Study, we collected demographic and clinical characteristics of pts, and patient-centered survey data regarding feasibility and acceptability of the BMA that is administered within 48 hours of the procedure. Results: In the pre-trial feasibility survey, 21/25 (84%) pts indicated they were very/definitely interested in knowing if they harbored DTCs. Of those, 18 (86%) indicated moderate/definite interest in testing for DTCs with BMA after the BMA was described to them in detail. 20 (95%) of pts indicated moderate/definite interest in taking oral therapy to eradicate DTCs. 14 (67%) pts stated undergoing up to 3 additional BMA would not change their likelihood of undergoing the clinical trial; only 1 stated much less likely. In the subsequent SURMOUNT study, 361 pts have been referred to date; 167 were eligible, and 136 (81%) subsequently enrolled. 21 (13%) are still in screening. 130 pts have had at least 1 BMA with annual re-screens in 37 (year 1) and 8 (year 2). 39% traveled >50 miles to participate. Post-BMA symptoms were rare (bleeding 2%; redness 12%) though 59%/70% reported mild-moderate pain/tenderness. After BMA, 47%/29%/25% reported it was better/same/worse than expected. 30%/32%/22% reported minimal/moderate/high anxiety prior to the BMA. Afterward, only 20%/5%/4% reported minimal/moderate/high residual anxiety. In 128 pts with results, 38 (30%) have ≥ 1 DTC (30 initial, 8 on follow-up); by risk group:","PeriodicalId":20307,"journal":{"name":"Poster Session Abstracts","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80914516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}