Oncology and Therapy最新文献

{"title":"Clinical Characteristics and Management of Children and Adults with Neurofibromatosis Type 1 and Plexiform Neurofibromas in Denmark: A Nationwide Study.","authors":"Cecilie Ejerskov, Stense Farholt, Flemming Secher Kromann Nielsen, Ingunn Berg, Stine Bogetofte Thomasen, Aparna Udupi, Trude Ågesen, Sofie de Fine Licht, Mette Møller Handrup","doi":"10.1007/s40487-022-00213-4","DOIUrl":"10.1007/s40487-022-00213-4","url":null,"abstract":"<p><strong>Introduction: </strong>Plexiform neurofibromas (PN) are benign nerve sheath tumours that are a frequent and potentially debilitating complication in patients with neurofibromatosis type 1 (NF1). The objective of this study was to describe the natural history of PN in children, adolescents and adults with NF1.</p><p><strong>Methods: </strong>This was a nationwide, longitudinal cohort study of patients with NF1 under observation at the two national centres of NF1 expertise in Denmark between 2000 and 2020. Patient and clinical characteristics were documented from individual medical records.</p><p><strong>Results: </strong>A total of 1099 patients with NF1 were included. Overall, 12% (35/296) of paediatric patients and 21% (172/803) of adult patients had ≥ 1 large PN (≥ 3 cm). Approximately half of patients with a large PN had ≥ 1 symptomatic PN. The most frequent symptoms were pain, neurological deficits, cosmetic issues, disfigurement, compression, increased psychosocial burden and vision loss. Clinical evaluations of PN size were available for 40 PN in 34 paediatric patients and 191 PN in 159 adult patients with large PN. Surgery (complete resection or debulking) was performed in 38% (15/40) of PN in paediatric patients and 45% (86/191) in adult patients. In addition, 35% of PN in paediatric patients and 33% in adult patients were inoperable. In a subgroup analysis, the overall PN size increased 1.06-fold per year. Malignant peripheral nerve sheath tumours (MPNST) were diagnosed in 21 patients (two paediatric and 19 adult patients).</p><p><strong>Conclusions: </strong>This study shows that PN are common, their size and prevalence increase with age, many are often inoperable and pain and other symptoms are frequently associated. The results highlight the severe sequelae and unmet need for alternatives to analgesia and surgery in patients with PN.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":"11 1","pages":"97-110"},"PeriodicalIF":2.7,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c6/10/40487_2022_Article_213.PMC9935791.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10742539","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Breast Cancer Survival Outcomes and Tumor-Associated Macrophage Markers: A Systematic Review and Meta-Analysis.","authors":"Eleanor Allison, Senarath Edirimanne, Jim Matthews, Stephen J Fuller","doi":"10.1007/s40487-022-00214-3","DOIUrl":"10.1007/s40487-022-00214-3","url":null,"abstract":"<p><strong>Introduction: </strong>Tumor-associated macrophages (TAMs) in breast cancer are associated with a poor prognosis. Early studies of TAMs were largely limited to the pan-macrophage marker CD68, however, more recently, an increasing number of studies have used CD163, a marker expressed by alternatively activated M2 macrophages and TAM subsets. We hypothesized that CD163-positive (CD163+) TAMs would be a better predictor of survival outcomes in breast cancer compared to CD68+  TAMs.</p><p><strong>Methods: </strong>We performed a systematic literature search of trials (from 1900 to August 2020) reporting overall survival (OS) or progression-free survival (PFS), breast cancer-specific survival (BCSS), TAM phenotype, and density. Thirty-two studies with 8446 patients were included. Meta-analyses were carried out on hazard ratios (HRs) for survival outcomes of breast cancer patients with a high density of TAMs (CD68+ and/or CD163+) compared to a low density of TAMs.</p><p><strong>Results: </strong>A high density of TAMs (CD68+ and/or CD163+) was associated with decreased OS (HR 1.69, 95% CI 1.37-2.07) and reduced PFS (HR 1.64; 95% CI 1.35-1.99). Subgrouping by CD marker type showed a lower OS for high density of CD163+ TAMs (HR 2.24; 95% CI 1.71-2.92) compared to a high density of CD68+  TAMs (HR 1.5; 95% CI 1.12-2). A high density of TAMs (CD68+  and/or CD163+) in triple-negative breast cancer (TNBC) cases was associated with lower OS (HR 2.81, 95% CI 1.35-5.84).</p><p><strong>Conclusion: </strong>Compared to CD68+  TAMs, a high density of CD163+ TAMs that express a similar phenotype to M2 macrophages are a better predictor of poor survival outcomes in breast cancer.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":"11 1","pages":"27-48"},"PeriodicalIF":2.7,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/53/ed/40487_2022_Article_214.PMC9935786.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10743586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Emerging Concepts Impacting Head and Neck Cancer Surgery Morbidity.","authors":"Ohad Ronen, K Thomas Robbins, Ashok R Shaha, Luiz P Kowalski, Antti A Mäkitie, Ewa Florek, Alfio Ferlito","doi":"10.1007/s40487-022-00217-0","DOIUrl":"10.1007/s40487-022-00217-0","url":null,"abstract":"<p><p>All treatment modalities for head and neck cancer carry with them a risk of adverse events. Head and neck surgeons are faced with significant challenges to minimize associated morbidity and manage its sequelae. Recognizing situations in which a surgical complication is an adverse event inherent to the procedure can alleviate the psychologic impact a complication might have on the treatment team and minimize external and internal pressures. Focusing on the complications that can be effectively modified, future complications can be avoided. Also, some surgical morbidities may not be preventable, necessitating the option to reconsider whether the incidents should be labeled toxic reactions rather than a complication. This discussion highlights some of the areas in which additional research is needed to achieve the goal of minimizing the impact of surgical morbidity.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":"11 1","pages":"1-13"},"PeriodicalIF":2.7,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/24/b1/40487_2022_Article_217.PMC9935772.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10744404","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Role of Perioperative Immune Checkpoint Inhibitors in Muscle Invasive Bladder Cancer.","authors":"Saachi Chhaya, Isabella Watts, Kenrick Ng, Rami Mustapha, Thomas Powles, Anand Sharma, Nikhil Vasdev","doi":"10.1007/s40487-022-00218-z","DOIUrl":"10.1007/s40487-022-00218-z","url":null,"abstract":"<p><strong>Objective: </strong>We aim to describe and highlight the current use of immune checkpoint inhibitors (ICIs) in the muscle invasive bladder cancer (MIBC) treatment landscape, particularly focusing on the perioperative setting. We provide a comprehensive review of key trials of the use of ICI in the perioperative setting, discussing trial outcomes and limitations and reviewing the role of biomarkers.</p><p><strong>Introduction: </strong>ICIs have recently been integrated into the treatment algorithm for metastatic urothelial carcinoma. More than 30 published studies have investigated the role of these agents in the radical treatment of MIBC. Some studies have demonstrated conflicting results, affecting widespread adoption in clinical practice.</p><p><strong>Methods: </strong>We performed a narrative overview of the literature from databases including PubMed, MEDLINE, Embase, European society of Medical Oncology/American Society of Clinical Oncology Annual Proceedings, and clinicaltrials.gov databases up until December 2021.</p><p><strong>Discussion: </strong>We described the results of key trials in the neoadjuvant and adjuvant setting, some of the reasons for conflicting study results, and the implications for clinical practice. Relevant biomarkers in the field are discussed, alongside a brief overview of the immune microenvironment in bladder cancer.</p><p><strong>Conclusions: </strong>Perioperative ICIs have shown promising efficacy with low toxicity in the neoadjuvant setting. The two large trials in the adjuvant setting have been contradictory. The efficacy of perioperative ICIs combined with favorable tolerability and better toxicity profile compared with chemotherapy, with the potential for biomarker-driven patient selection, may lead to a change in future practice. There is, however, a lack of long-term survival and toxicity data for those treated with ICIs, and this needs to be developed further to demonstrate an added survival benefit by using ICIs.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":"11 1","pages":"49-64"},"PeriodicalIF":2.7,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2e/21/40487_2022_Article_218.PMC9935774.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9292952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Healthcare Resource Utilization and Associated Costs of German Patients with Diffuse Large B-Cell Lymphoma: A Retrospective Health Claims Data Analysis.","authors":"Peter Borchmann, Jan-Michel Heger, Jörg Mahlich, Michael S Papadimitrious, Sybille Riou, Barbara Werner","doi":"10.1007/s40487-022-00211-6","DOIUrl":"10.1007/s40487-022-00211-6","url":null,"abstract":"<p><strong>Introduction: </strong>Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin's lymphoma with increasing prevalence. Although the disease burden associated with DLBCL is high, only limited data on healthcare resource utilization (HCRU) and associated costs of German patients with DLBCL is available.</p><p><strong>Methods: </strong>Using a large claims database of the German statutory health insurance with 6.7 million enrollees, we identified patients who were newly diagnosed with DLBCL between 2011 and 2018 (index date). Treatment lines were identified based on a predefined set of medication. HCRU and related costs were collected for the entire post index period and per treatment line.</p><p><strong>Results: </strong>A total of 2495 incident DLBCL patients were eligible for the analysis. The average follow-up time after index was 41.7 months. During follow-up, 1991 patients started a first-line treatment, 868 a second-line treatment, and 354 a third-line treatment. Overall, patients spent on average (SD) 5.24 (6.17) days per month in hospital after index. While on anti-cancer treatment, this number increased to nine (10.9) in first-line, 8.7 (13.7) in second-line, and 9.4 (15.8) in third-line treatments. Overall costs per patient per month (PPPM) increased from €421 (875.70) before to €3695 (4652) after index. While on a treatment line, PPPM costs were €17,170 (10,246) in first-line, €13,362 (12,685) in second-line, and €12,112 (16,173) in third-line treatments. Time-unadjusted absolute costs sum up to €59,868 (43,331), €35,870 (37,387), and €28,832 (40,540) during first-line, second-line, and third-line treatments, respectively. The main cost drivers were hospitalizations (71% of total costs) and drug acquisition costs (18% of total costs).</p><p><strong>Conclusions: </strong>The financial burden of DLBCL in Germany is high, mainly due to hospitalization and drug costs. Therefore, there is a high medical need for new cost-effective therapeutic options that can lower the disease burden and remain financially viable to support the growing number of patients with this aggressive disease.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":"11 1","pages":"65-81"},"PeriodicalIF":2.7,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ea/ec/40487_2022_Article_211.PMC9935789.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9292945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Mixed-Methods Study to Better Measure Patient-Reported Pain and Fatigue in Soft Tissue Sarcoma.","authors":"Louise Barrett, Emma Elliott, Maarten Voorhaar, Anders Ingelgård, Ingolf Griebsch, Brendon Wong, Jessica Mills, Phoebe Heinrich, Stefan Cano","doi":"10.1007/s40487-022-00219-y","DOIUrl":"10.1007/s40487-022-00219-y","url":null,"abstract":"<p><strong>Introduction: </strong>Pain and fatigue are commonly reported by patients with soft tissue sarcoma (STS) as distressing symptoms, yet no patient-reported outcome (PRO) measures have been validated or developed specifically for STS. This study aimed to develop novel PRO scales using existing item banks to measure pain and fatigue in STS.</p><p><strong>Methods: </strong>A three-stage mixed-methods approach was used. Stage 1: a literature review examined the development and validation of the European Organization for Research and Treatment of Cancer (EORTC) library, Patient-Reported Outcomes Measurement Information System (PROMIS) pain/fatigue item banks, Functional Assessment of Cancer Therapy-General, and FACIT-Fatigue. Conceptual models were developed for pain and fatigue. Stage 2: semi-structured interviews were conducted with clinical experts (n = 3) and STS patients (n = 28) to ensure conceptual coverage and cognitively debrief the selected PRO items. Stage 3: exploratory Rasch measurement theory (RMT) analyses were performed to examine the measurement properties of the proposed scales.</p><p><strong>Results: </strong>Stage 1: The conceptual model for fatigue was organized into two overarching domains: fatigability and fatigue, further split into two subdomains: symptoms and impact. The conceptual model for pain had one overarching domain split into two subdomains: descriptors and impact. Pain (n = 56) and fatigue (n = 40) items were selected from the EORTC item library. Stage 2: qualitative findings ensured conceptual coverage, provided insight into the relevance and comprehension of the items, and informed subsequent item reduction. Stage 3: The total item number was reduced to 43 (pain n = 18, fatigue n = 25). Exploratory RMT analyses supported the final scales' psychometric properties.</p><p><strong>Conclusions: </strong>This mixed-methods research generated important information on the experience of pain and fatigue in specific subtypes of STS. Five novel PRO scales have been developed through careful item selection in consultation with experts and supported by qualitative and quantitative evidence. These scales may be of value to future clinical trials for STS.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":"11 1","pages":"129-143"},"PeriodicalIF":2.7,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/46/ec/40487_2022_Article_219.PMC9935765.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10743590","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP).","authors":"Adrián Alegre, Gonzalo Benzo, Rafael Alonso, Joaquín Martínez-López, Ana Jimenez-Ubieto, Clara Cuéllar, Elham Askari, Elena Prieto, Concepción Aláez, Beatriz Aguado, Alberto Velasco, Isabel Krsnik, Ana Bocanegra, Laura Llorente, Cristina Muñoz-Linares, Ana Morales, Eugenio Giménez, Rebeca Iglesias, Carmen Martínez-Chamorro, Aránzazu Alonso, Carmen Jiménez-Montes, María J Blanchard","doi":"10.1007/s40487-022-00212-5","DOIUrl":"10.1007/s40487-022-00212-5","url":null,"abstract":"<p><strong>Introduction: </strong>Belantamab mafodotin (BM) is a new anti-BCMA antibody-drug conjugate, recently approved for triple-class relapsed and refractory multiple myeloma (RRMM). We assessed real-world outcomes with BM in patients under the Spanish Expanded Access Program (EAP).</p><p><strong>Methods: </strong>We conducted an observational, retrospective, multicenter study including RRMM patients who received ≥ 1 dose of BM (Nov 2019 to Jun 2021). The primary endpoint was overall response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and incidence of treatment-emergent adverse events (TEAEs).</p><p><strong>Results: </strong>Thirty-three patients were included with a median of 70 years of age (range, 46-79 years). Median time from diagnosis was 71 months (range, 10-858 months). Median prior lines was 5 (range, 3-8 lines); 90% of patients were triple-/quad-/penta-refractory; 48% showed high-risk cytogenetics. Median BM doses was 3 (range 1-16 doses), with a median follow-up of 11 months (6-15 months). ORR was 42.2% (≥ VGPR, 18.2%). Median PFS was 3 months (95% CI 0.92-5.08) in the overall population, and 11 months (HR 0.26; 95% CI 0.10-0.68) for patients who achieved ≥ PR. PFS was not significantly different according to age, cytogenetic risk, and prior therapy lines. OS was 424 days (95% CI 107-740). Non-hematological TEAEs (57.6% of patients; 30.3% ≥ G3) included keratopathy (51.5%; 21.2% ≥ G3) and patient-reported vision-related symptoms (45.5%). Keratopathy was resolved in 70.6% of patients. G3 hematological TEAEs was 18.2%, thrombocytopenia (21.2%). Dose reductions due to TEAEs: 30.3%; delays: 36.4%. Treatment discontinuation causes: progression (54.5%), toxicity (non-ocular; 6%/ocular; 6% /ocular + non-ocular toxicity; 3%), death (6%), and patient's decision (3%).</p><p><strong>Conclusions: </strong>BM showed relevant anti-myeloma activity in RRMM with a manageable safety profile. These results corroborate those observed in the BM pivotal trial.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":"11 1","pages":"83-96"},"PeriodicalIF":3.2,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6f/c1/40487_2022_Article_212.PMC9744371.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10750051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Liposomal Irinotecan Shows a Larger Therapeutic Index than Non-liposomal Irinotecan in Patient-Derived Xenograft Models of Pancreatic Cancer.","authors":"Sandrine Barbier, Benjamin Beaufils, Ricardo de Miguel, Melissa Reyre, Yannick Le Meitour, Andreanne Lortie, Marc Hillairet de Boisferon, Sophie Chaumeron, Anne Espirito, Lina Fossati, Pauline Lagarde, Stephan Klinz, Arunthathi Thiagalingam, Stéphane Lezmi, Florence Meyer-Losic","doi":"10.1007/s40487-022-00215-2","DOIUrl":"10.1007/s40487-022-00215-2","url":null,"abstract":"<p><strong>Introduction: </strong>Liposomal irinotecan promotes controlled sustained release of irinotecan (CPT-11), therefore, we hypothesize that the therapeutic index (quantitative measurement of the relative efficacy/safety ratio of a drug) will be higher for liposomal than non-liposomal irinotecan.</p><p><strong>Methods: </strong>We compared the therapeutic indexes of liposomal and non-liposomal irinotecan in mice bearing subcutaneous patient-derived xenograft (PDX) pancreatic tumors under dosing regimens approximating the clinical setting. Following preliminary drug sensitivity/antitumor activity analyses on three PDX tumor models, one model was selected for analyses of efficacy, biomarker, toxicology, pharmacokinetics in mice receiving liposomal irinotecan (2.5, 10, 50 mg/kg/week) or non-liposomal irinotecan (10, 25, 50 mg/kg/week). The maximum tolerated dose (MTD) for each treatment was 50 mg/kg/week.</p><p><strong>Results: </strong>Using the selected IM-PAN-001 model at the MTD (both treatments, 50 mg/kg/week), antitumor activity, phospho-histone gamma-H2AX protein staining in cancer cell nuclei, histological tumor regression, and plasma levels of CPT-11 and its active metabolite SN-38 after 24 h were greater with liposomal than non-liposomal irinotecan, but tumor SN-38 levels were similar. At the lowest doses assessed, antitumor activity, histological tumor regression, and jejunum and bone marrow toxicity were similar. Based on these findings, liposomal and non-liposomal irinotecan had therapeutic indexes of 20 and 5, respectively.</p><p><strong>Conclusion: </strong>This non-clinical study showed a fourfold broader therapeutic index with liposomal than non-liposomal irinotecan in mice bearing IM-PAN-001 PDX pancreatic tumors, even at optimal dosing for the two drugs. These findings support the clinical benefit observed with liposomal irinotecan in patients with pancreatic cancer.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":"11 1","pages":"111-128"},"PeriodicalIF":2.7,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/89/f2/40487_2022_Article_215.PMC9935793.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10750059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lanreotide Depot to Treat Gastroenteropancreatic Neuroendocrine Tumors in a US Community Oncology Setting: A Prospective, Observational Study.","authors":"Scott Paulson,&nbsp;David Ray,&nbsp;Sharan Aranha,&nbsp;Amy Scales,&nbsp;Yunfei Wang,&nbsp;Eric Liu","doi":"10.1007/s40487-022-00208-1","DOIUrl":"https://doi.org/10.1007/s40487-022-00208-1","url":null,"abstract":"<p><strong>Introduction: </strong>Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) can result in symptoms such as diarrhea, flushing, abdominal pain, and fatigue and are often associated with a significant disease burden and poor prognosis. This non-interventional, prospective, observational study evaluated the real-world safety and effectiveness of lanreotide depot, a somatostatin analog (SSA) used to treat GEP-NETs, in a community setting.</p><p><strong>Methods: </strong>In this prospective, non-interventional study (NCT02730104), adult patients with locally advanced (inoperable), metastatic GEP-NETs treated with lanreotide depot were evaluated by their physician every 6 months from enrollment for 24 months. Clinically defined time to disease progression (TTDP) and overall survival (OS) were estimated for the total population and by primary tumor type (gastrointestinal [GI], pancreatic, unknown origin), and an exploratory analysis determined the rate of progression-free survival (PFS) at 12 and 24 months. Patient satisfaction was evaluated via the Treatment Satisfaction Questionnaire for Medication (TSQM-9), and safety information was recorded.</p><p><strong>Results: </strong>Of 99 patients, the 24-month PFS rate was 73.7% (95% confidence interval [CI] 63.1-81.7) and 24-month OS rate was 84.2% (95% CI 74.0-90.7). Median TTDP was not reached because few patients experienced disease progression during the study period. The majority of responding patients expressed satisfaction with treatment on each domain of the TSQM-9. Treatment-related adverse events (AEs) occurred in 19.2% of patients, while no serious AEs (SAEs) were related to the study drug.</p><p><strong>Conclusions: </strong>Lanreotide depot is an effective and well-tolerated treatment for GEP-NETs in the real-world community setting.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT02730104.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":"10 2","pages":"463-479"},"PeriodicalIF":2.7,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/87/a7/40487_2022_Article_208.PMC9681944.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33470816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Role of Electronic Patient-Reported Outcome Measures in Assessing Smoking Status and Cessation for Patients with Lung Cancer.","authors":"James Convill,&nbsp;Fiona Blackhall,&nbsp;Janelle Yorke,&nbsp;Corrine Faivre-Finn,&nbsp;Fabio Gomes","doi":"10.1007/s40487-022-00210-7","DOIUrl":"https://doi.org/10.1007/s40487-022-00210-7","url":null,"abstract":"<p><strong>Introduction: </strong>Smoking cessation following lung cancer diagnosis is recommended to improve patient outcomes. Electronic Patient Reported Outcome Measures (ePROMs) may be useful for identifying and facilitating cessation support in patients that continue to smoke after a cancer diagnosis. The primary aim was to investigate the level of agreement between clinician-reported and self-reported patient smoking status during the first visit to a cancer centre (I). Secondary aims included investigating differences between cancer-specific characteristics between never smokers and current/ex-smokers (IIA), and the self-reported frequency of smoking cessation after diagnosis of lung cancer (IIB).</p><p><strong>Methods: </strong>Retrospective single-centre study carried out at a tertiary cancer centre in the UK. Lung cancer patients that completed at least one ePROM questionnaire within 6 weeks of their first visit to the cancer centre (baseline), between February 2019 and February 2020, were included in the study. All ePROM questionnaires included a question regarding smoking status to allow comparison with the clinician records. Patients were offered these electronic questionnaires at each subsequent visit to the hospital.</p><p><strong>Results: </strong>Of 195 patients included, 24 (12.3%) demonstrated discordance between clinician-reported and self-reported smoking status at the baseline assessment. Clinician-reported 'current smokers' were more likely to be discordant with self-reported smoking status, compared with clinician-reported 'ex-smokers' and 'never smokers' (P = 0.017). Never smokers were more likely to have adenocarcinoma (P < 0.005), present with stage IV cancer (P = 0.023) and receive treatment with palliative intention (P = 0.042), compared with current and ex-smokers. Of those that were reported by clinicians as being current smokers, 9/38 (23.7%) were self-reported ex-smokers. A sub-group of 137 patients completed at least one additional ePROM questionnaire after the baseline and were included in the smoking cessation analysis. Thirty-eight patients were clinician-reported as 'current smokers' at baseline. Of these, 9 subsequently stopped smoking, 17 continued and 3 had short periods of cessation, identified through self-reporting.</p><p><strong>Conclusion: </strong>In most cases, there is concordance between clinician- and self-reported smoking status. A small area of discordance was identified where clinicians reported some patients as 'current smokers', whilst patients self-reported having stopped. The causes for this were not explored and require further investigation. This study supports the use of ePROMs as a helpful tool to assess smoking status, and it can be used to identify patients for smoking cessation referral.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":"10 2","pages":"481-491"},"PeriodicalIF":2.7,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/59/2b/40487_2022_Article_210.PMC9681961.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33525003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}