Oncology and Therapy最新文献

{"title":"A Retrospective Observational Study of Extended Adjuvant Neratinib for HER2-Positive Early-Stage Breast Cancer in a European Early Access Program.","authors":"Marija Križić, Tajana Silovski, Griet Hoste, Natalija Dedić Plavetić, Olivier Romano, Xavier González Farre, Alicia Cano Jimenez, Angel Guerrero Zotano, Jeanne Suissa, Farida Beghdad, Olivia Dialla, Marta Zivanov, Michelino De Laurentiis","doi":"10.1007/s40487-025-00392-w","DOIUrl":"10.1007/s40487-025-00392-w","url":null,"abstract":"<p><strong>Introduction: </strong>Neratinib is approved in Europe as extended adjuvant therapy in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-positive (HER2+) early-stage breast cancer (EBC) who completed adjuvant trastuzumab-based therapy within 1 year. Real-world data are necessary to define the role of neratinib in the evolving treatment landscape.</p><p><strong>Methods: </strong>NEAR was a retrospective, observational study evaluating treatment patterns, safety and effectiveness of neratinib during a European early access program (EAP). Eligible patients had HER2+ EBC and received neratinib between August 2017 and December 2020. Data were extracted from medical records up to July 2022. The primary endpoint was the patient demographic and clinical profile.</p><p><strong>Results: </strong>Among 108 eligible patients, most had HR+ disease (n = 92) and a high risk of recurrence (defined as stage II-III or node-positive disease, or non-pathological complete response after neoadjuvant therapy; n = 87); 74 were treated as per the neratinib European label. Trastuzumab plus pertuzumab and trastuzumab alone were the most common anti-HER2+ adjuvant therapies (9.3% and 88.4% of patients, respectively). Median duration of neratinib treatment was 12.3 months. Diarrhoea was the most common adverse event (58.3%). Prophylactic anti-diarrhoeal therapy reduced the occurrence of grade ≥ 3 diarrhoea (4.3% versus 13.2% without prophylaxis) and neratinib discontinuation (22.2% versus 35.7%, respectively). Exploratory invasive disease-free survival rates were 93.3% at 24 months and 89.9% at 36 months, with no central nervous system events.</p><p><strong>Conclusion: </strong>These results provide additional data supporting the safety and exploratory effectiveness of neratinib in the EAP, reflecting real-world clinical practice.</p><p><strong>Clinicaltrials: </strong></p><p><strong>Gov identifier: </strong>NCT05599334 (31 October 2022, retrospectively registered).</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"1205-1224"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647500/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145402362","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 Impact of the COVID-19 Pandemic on an Immunocompromised Patient with Allogeneic Haematopoietic Stem Cell Transplant: A Dual Perspective from Patient and Physician Standpoints.","authors":"Stephanie Nguyen, Isabelle","doi":"10.1007/s40487-025-00364-0","DOIUrl":"10.1007/s40487-025-00364-0","url":null,"abstract":"<p><p>This collaborative article is co-authored by a haematologist and her patient who was immunocompromised following a bone marrow transplant for acute myeloid leukaemia (AML), which was probably chemotherapy-induced following treatment for a BReast CAncer gene 1 (BRCA1)-mutated breast cancer. The patient shares her story of resilience up to her AML diagnosis and treatment, through the bone marrow transplant, and then on to the challenges faced as an immunocompromised patient during the coronavirus disease 2019 (COVID-19) pandemic. The haematologist offers detailed insights into AML and treatment options, including chemotherapy and allogeneic haematopoietic stem cell transplantation. She comments on the challenging journey of her patient, and the complexities of managing immunocompromised patients during the pandemic, who failed to respond sufficiently to vaccination. In addition, she outlines the prophylactic strategy implemented in her centre, and the introduction of alternative immunisation with monoclonal antibodies for this high-risk immunocompromised patient population. This case provides a unique combination of personal patient experience during the COVID-19 pandemic and medical insights.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"825-835"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647450/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144973295","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":"Non-believer to Believer: A Podcast Conversation on the Journey from Skeptic to Proponent of Oncology Real-World Evidence.","authors":"Adam Brufsky, Raymond Liu, Joanne C Ryan","doi":"10.1007/s40487-025-00367-x","DOIUrl":"10.1007/s40487-025-00367-x","url":null,"abstract":"<p><p>The proliferation of modern real-world studies is a relatively recent development in oncology and has been met with skepticism by some clinicians. In this podcast, the hosts share their personal experiences with real-world evidence (RWE) and how they have come to be advocates for considering RWE as a supplement to randomized controlled trial (RCT) findings to help guide decision making in the clinic. They discuss the limitations of RCTs in capturing diverse patient populations and highlight the value of RWE in providing insights into underrepresented groups, such as patients with high Eastern Cooperative Oncology Group (ECOG) performance status scores or cardiovascular comorbidities. While recognizing barriers to RWE acceptance, the hosts emphasize the growing profile of real-world studies and the need for clinicians to be aware of the data they are generating. Overall, the conversation aims to provide practical examples of the potential utility of RWE for enhancing care and outcomes for patients with cancer.Podcast and infographic available for this article. Podcast video (MP4 54067 KB).</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"853-858"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647463/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145041759","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 Use and Immunotherapy Rechallenge Outcomes with Nivolumab in Advanced Non-small Cell Lung Cancer in France: Interim Results of the LIST Study.","authors":"Benoît Godbert, Elisa Gobbini, Chantal Decroisette, Hervé Lena, Yaacoub Khalife, Florence Brellier, Anne Fleuriet, Maeva Zysman, Thomas Egenod, Denis Moro Sibilot, Nicolas Girard","doi":"10.1007/s40487-025-00381-z","DOIUrl":"10.1007/s40487-025-00381-z","url":null,"abstract":"<p><strong>Introduction: </strong>Nivolumab is approved in France as monotherapy for the treatment of advanced (locally advanced or metastatic) non-small cell lung cancer (aNSCLC) after prior chemotherapy. The Lung Initiative on Sequence Therapy (LIST) study is evaluating the real-world effectiveness, safety and immunotherapy-rechallenge outcomes with nivolumab in previously treated French patients with aNSCLC.</p><p><strong>Methods: </strong>This longitudinal, prospective, observational study enrolled patients with aNSCLC who received ≥ 1 prior line of treatment that included chemotherapy. Three patient cohorts, based on prior treatment, were assessed: immunotherapy-naïve (cohort 1; prior chemotherapy, no prior immunotherapy), and immunotherapy-experienced, including patients who discontinued prior immunotherapy for reasons other than immunotherapy-related toxicity (cohort 2) and those who discontinued because of immunotherapy-related toxicity (cohort 3). The primary endpoint was time to treatment discontinuation (TTD). Results after at least 12 months of follow-up are reported.</p><p><strong>Results: </strong>At data cut-off (September 2024), 522 patients were enrolled. In cohort 1 (N = 280), cohort 2 (N = 197) and cohort 3 (N = 45), the 12-month TTD rate was 17.7% (95% CI 13.4, 22.5), 14.4% (95% CI 9.8, 19.8) and 16.7% (95% CI 7.3, 29.2), respectively. The main reason for nivolumab discontinuation was disease progression. Younger patients, those with better performance status (PS), longer prior immunotherapy duration and prolonged benefit with prior immunotherapy had numerically higher discontinuation-free rates. Median PFS was 3.2, 2.7 and 3.9 months (95% CI 2.7-4.1, 2.2-3.4, 2.2-7.4), and median overall survival (OS) was 12.3, 9.5 and 10.4 months (95% CI 8.6-13.7, 7.2-11.3, 7.6-20.1) in cohorts 1, 2 and 3, respectively. Any-grade treatment-related adverse events were reported in 36.1%, 25.0% and 37.0% of patients in the respective cohorts.</p><p><strong>Conclusions: </strong>The 1-year results of LIST show consistent effectiveness and safety of nivolumab in immunotherapy-experienced patients, especially in specific subgroups. Nivolumab safety in patients with prior immunotherapy-related toxicity appeared to be consistent with its expected safety profile.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier NCT04500535.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"1071-1086"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647469/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145058715","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":"Overlapping Extremes: An Analysis of Avelumab Maintenance and Pembrolizumab in Advanced Urothelial Carcinoma.","authors":"Martina Catalano, Irene de Gennaro Aquino, Ismaela Anna Vascotto, Adriana Guarino, Silvia Mancini, Laura Doni, Alexandra Paulet, Virginia Rossi, Roberta Giorgione, Gabriella Nesi, Lorenzo Antonuzzo, Giandomenico Roviello","doi":"10.1007/s40487-025-00387-7","DOIUrl":"10.1007/s40487-025-00387-7","url":null,"abstract":"<p><strong>Introduction: </strong>Avelumab and pembrolizumab are approved immune checkpoint inhibitors (ICIs) for advanced urothelial carcinoma (UC) that are used as maintenance and salvage therapies, respectively. The aim of this study was to highlight patterns of extreme response and support the development of biomarker-driven strategies to optimise patient selection and treatment sequencing.</p><p><strong>Methods: </strong>This was a prospective study that included 79 patients with advanced UC treated with avelumab (n = 32) or pembrolizumab (n = 47) following platinum-based chemotherapy. Outcomes included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS).</p><p><strong>Results: </strong>Avelumab was associated with a DCR of 84.4% and a complete response (CR) rate of 34.4%, while pembrolizumab was associated with a DCR of 55.3% and a CR rate of 12.8%. Progressive disease (PD) occurred in 15.6% and 44.7% of patients, respectively. Despite differences in treatment indications and timing, median PFS and OS in patients with CR and PD were surprisingly comparable across the two agents.</p><p><strong>Conclusions: </strong>These findings suggest that extreme responses to ICIs in advanced UC-ranging from complete response to primary progression-may occur irrespective of treatment setting, underscoring the pivotal role of tumour-immune biology. Biomarker-driven strategies are needed to optimise patient selection.</p><p><strong>Trial registration: </strong>OBSERVE-UC study; registration ID: CEAVC 25351.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"1155-1167"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647452/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145303908","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 Phase 3 Study of the Efficacy and Safety of Pexidartinib in East Asian Patients with Tenosynovial Giant Cell Tumor.","authors":"Hairong Xu, Po-Kuei Wu, Zhaoming Ye, Zhengfu Fan, Tao Li, Tom Wei-Wu Chen, Jingnan Shen, Wangjun Yan, Issei Achiwa, Kazukoh Yoh, Kunika Kikumori, Yoshiharu Hiruma, Jonathan Greenberg, Xiaohui Niu","doi":"10.1007/s40487-025-00365-z","DOIUrl":"10.1007/s40487-025-00365-z","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study was to assess the efficacy and safety of pexidartinib, an inhibitor of colony-stimulating factor 1 receptor, in East Asian patients with tenosynovial giant cell tumor (TGCT).</p><p><strong>Methods: </strong>This multicenter, single-arm, phase 3 study (NCT04488822) enrolled patients with symptomatic TGCT to receive pexidartinib 400 mg twice daily. The primary efficacy endpoint was overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) per central review at week 25. Secondary endpoints included ORR by tumor volume score (TVS), change in range of motion (ROM) of the affected joint, best overall response (BOR), and treatment-emergent adverse events (TEAEs).</p><p><strong>Results: </strong>A total of 40 East Asian patients with TGCT received pexidartinib. RECIST v1.1 ORR was 22.5% (95% confidence interval [CI] 10.8-38.5), with no complete responses (CRs), 9 partial responses (PRs), 21 patients with stable disease (Sd), and 1 patient with progressive disease (PD). TVS ORR was 47.5% (95% CI 31.5-63.9), with no CRs, 19 PRs, 12 patients with Sd, and none with PD. At week 25, mean (standard error [SE]) change in ROM was 23.05 (3.207), with improvement noted at week 13 (15.64 [3.312]). RECIST v1.1 BOR was 30.0% (95% CI 16.6-46.5), and TVS BOR was 47.5% (95% CI 31.5-63.9). All patients had TEAEs, and grade ≥ 3 TEAEs were reported in 16 (40.0%) patients. The most common TEAEs were hair color changes (77.5%); increases in alanine aminotransferase (60.0%), aspartate aminotransferase (57.5%), and blood lactate dehydrogenase (47.5%); and pruritus (47.5%).</p><p><strong>Conclusions: </strong>In East Asian patients with symptomatic TGCT, pexidartinib demonstrated clinical benefits, with a safety profile comparable to previous reports.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier NCT04488822.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"1025-1039"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144973324","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 Practical Approach to Understanding Real-World Study Methodology in Cancer Research: A Vodcast.","authors":"Adam Brufsky, Winson Cheung, Joanne C Ryan","doi":"10.1007/s40487-025-00366-y","DOIUrl":"10.1007/s40487-025-00366-y","url":null,"abstract":"<p><p>Real-world studies have become more common in clinical literature in recent years, but many clinicians remain unfamiliar with real-world study design and statistical approaches. This vodcast intends to be a practical guide for clinicians by clarifying aspects of real-world study methodology. As both practicing oncologists and researchers with extensive real-world data experience, the hosts discuss types of study designs and real-world data source considerations. An overview of statistical techniques for mitigating treatment-selection bias is also provided, including propensity score matching, inverse probability of treatment weighting, and multivariable analysis. By combining high-quality data sources, careful sample size considerations, and rigorous statistical techniques, real-world studies can offer valuable insights into therapeutic effectiveness in routine clinical practice that supplement learnings from randomized clinical trials. This vodcast is designed to equip clinicians with the knowledge to critically evaluate real-world evidence and potentially apply it to their practice.Vodcast and infographic available for this article. Vodcast (MP4 1207725 KB) INFOGRAPHIC.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"845-852"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647456/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145041778","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":"Systematic Review and Meta-Analysis of the Management of Relapsed Germ Cell Tumours Following Cisplatin-Based Chemotherapy.","authors":"Nasreen Abdul Aziz, Didjier Danger Masangwi, Pinky Kotecha, Gustavo Loback, Kenrick Ng, Prabhakar Rajan, Jonathan Shamash","doi":"10.1007/s40487-025-00391-x","DOIUrl":"10.1007/s40487-025-00391-x","url":null,"abstract":"<p><strong>Introduction: </strong>Salvage treatment options after cisplatin-based chemotherapy for germ cell tumours (GCT) are either conventional-dose chemotherapy (CDCT) or high-dose chemotherapy (HDCT). However, the optimal sequencing of these strategies remains debated owing to limited comparative data guiding the choice of first-line salvage. Here, we evaluated the efficacy and safety of CDCT and HDCT, focusing on survival rates, objective response rate (ORR) and treatment-related deaths (TRD).</p><p><strong>Methods: </strong>The protocol was registered on PROSPERO (CRD42024526637). Three databases were searched and reference lists were manually screened. Two reviewers independently screened articles and extracted data, with quality and bias assessed using Risk of Bias in Non-randomised Studies of Interventions (ROBINS-I) tools. Studies of patients with metastatic GCT who relapsed after cisplatin-based chemotherapy, whether receiving first-line salvage or subsequent lines of treatment, were included in the study. In the meta-analysis, 1-, 2- and 3-year survival rates and ORR were pooled using logit transformation, back-transformed to proportions and compared between CDCT and HDCT groups.</p><p><strong>Results: </strong>Out of 2435 studies screened, 65 (5745 patients) met the inclusion criteria. Only nine studies reported International Prognostic Factor Study Group (IPFSG) scores. Median overall survival (OS) was 27 months for CDCT and 21 months for HDCT (p = 0.4035). The 1-, 2-, and 3-year survival rates were higher with CDCT (81.7%, 61.6%, 47.0%) compared with HDCT (70.0%, 57.4%, 39.1%), though not statistically significant. The pooled ORR was 53% with CDCT and 61% with HDCT. TRD were significantly lower with CDCT (3%) compared with HDCT (7.5%) (p = 0.0002). In subgroup analysis of studies evaluating second-line treatment, median OS was 23.9 months for CDCT and 19.4 months for HDCT.</p><p><strong>Conclusions: </strong>CDCT was associated with higher survival rates compared with HDCT, though the differences were not statistically significant. Larger prospective studies are needed to directly compare these strategies and guide personalised treatment selection in relapsed GCT.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"977-1006"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647420/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145349113","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 Epidemiology, Clinical Characteristics and Outcomes of Women with Germline BRCA Mutation and Early Breast Cancer in China.","authors":"Zhen Hu, Qianqian Yu, Liqin Chen, Tingting Su, Luis C Berrocal-Almanza, Miguel Miranda, Xiaoqing Xu, Meng Ru, Tianyu Zhao, Feng Miao, Mengyu Xie, Zhimin Shao","doi":"10.1007/s40487-025-00384-w","DOIUrl":"10.1007/s40487-025-00384-w","url":null,"abstract":"<p><strong>Introduction: </strong>The poly(ADP-ribose) polymerase inhibitor olaparib was recently approved in China for adjuvant treatment of certain patients with high-risk, human epidermal growth factor (HER2)-negative early breast cancer (eBC) and germline pathogenic/likely pathogenic mutations in BRCA1 and BRCA2 (gBRCAm). Further evidence on demographics, clinical characteristics, treatment patterns and outcomes is needed to inform local guideline updates and clinical decision-making for patients in China with gBRCAm and eBC who may be eligible for olaparib treatment.</p><p><strong>Methods: </strong>This retrospective study analysed deidentified electronic health records at the Fudan University Shanghai Cancer Center. Women ≥ 18 years of age diagnosed with eBC between 1 January 2012 and 31 December 2019 who had undergone definitive BC surgery were included. Patients with accessible gBRCA status were included alongside a similar-sized cohort of randomly selected, untested patients. Demographics, clinical characteristics, treatment patterns, pathological complete response (pCR) and invasive disease-free survival (IDFS) were described by tumour subtype and gBRCAm status.</p><p><strong>Results: </strong>In total, 949 patients were included (gBRCA tested: n = 466; untested: n = 483). Among 89/466 (19.1%) tested patients with gBRCAm, 29/89 (32.6%) had no family history of breast/ovarian/pancreatic/prostate cancer, and 46/88 (52.3%) with known tumour subtype had hormone receptor-positive tumours. Patients with HER2-negative eBC and gBRCAm had more advanced disease, differing treatment patterns and shorter IDFS versus those with non-gBRCAm. pCR rates among patients who received neoadjuvant therapy were 23.1% in the overall population (n = 91) and 10.9% in patients with HER2-negative eBC (n = 55), 52 (94.5%) of whom received chemotherapy only.</p><p><strong>Conclusion: </strong>Characteristics, treatment patterns and outcomes were distinct among patients in China with gBRCAm eBC. Our findings support wider implementation of gBRCA testing for all patients in China with HER2-negative eBC, beyond those with triple-negative tumour subtype and/or family history of cancer, to identify more patients who may benefit from targeted therapy. Infographic available for this article.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"1187-1204"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647501/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145372417","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":"Treatment Optimization and Management of AEs with Enfortumab Vedotin + Pembrolizumab for Untreated Locally Advanced/Metastatic Urothelial Cancer: A Podcast.","authors":"Thomas Powles, Maria Lapuente, Benjamin Garmezy","doi":"10.1007/s40487-025-00369-9","DOIUrl":"10.1007/s40487-025-00369-9","url":null,"abstract":"<p><p>In the EV-302/KEYNOTE-A39 trial (NCT04223856), enfortumab vedotin + pembrolizumab (EV + P) became the first treatment in decades to demonstrate significant survival benefit compared with platinum-based chemotherapy in the first-line setting for patients with locally advanced or metastatic urothelial cancer. The safety profile of EV + P in EV-302/KEYNOTE-A39 was consistent with previous clinical studies and with the expected safety profiles of each agent alone; however, real-world experience in the management of adverse events (AEs) resulting from treatment with EV + P in patients with locally advanced or metastatic urothelial cancer is still evolving. Historically, healthcare professionals have been familiar with the management of EV and pembrolizumab as monotherapies, with guidance available for management of AEs with either drug alone. However, management of AEs with EV + P can sometimes be more complex since some of the AEs associated with EV also occur with pembrolizumab. Such AEs include skin reactions, hyperglycemia, and pneumonitis, all of which have been reported with either therapy alone and with increased incidence with the combination. In this podcast, we discuss the management of AEs with EV + P on the basis of our personal experiences with clinical trials and in our practices and provide perspectives for healthcare professionals on practical management of common AEs and effective dose management strategies. This may help improve the patient experience and allow patients to stay on therapy for longer, leading to optimized treatment outcomes. Podcast video (MP4 3,14,449 kb).</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"811-823"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647415/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144856651","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}