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The Immuno-oncology-Induced Cytokine Release Syndrome Patient Diary: A Content-Valid, Patient-Reported Outcome Measure. 免疫肿瘤诱导的细胞因子释放综合征患者日记:内容有效,患者报告的结果测量。
IF 3.2
Oncology and Therapy Pub Date : 2025-10-03 DOI: 10.1007/s40487-025-00383-x
Edward Ted Wells, Laurence Lucats, Giovanni Abbadessa, James Turnbull, Joyce R Talavera, Sophie R Van Tomme, Paul Cordero, Benoit Arnould, Matthew Reaney, Catherine Coulouvrat
{"title":"The Immuno-oncology-Induced Cytokine Release Syndrome Patient Diary: A Content-Valid, Patient-Reported Outcome Measure.","authors":"Edward Ted Wells, Laurence Lucats, Giovanni Abbadessa, James Turnbull, Joyce R Talavera, Sophie R Van Tomme, Paul Cordero, Benoit Arnould, Matthew Reaney, Catherine Coulouvrat","doi":"10.1007/s40487-025-00383-x","DOIUrl":"https://doi.org/10.1007/s40487-025-00383-x","url":null,"abstract":"<p><strong>Introduction: </strong>Cytokine release syndrome (CRS) occurs when the immune system reacts excessively to infections or certain immunotherapies, leading to a systemic inflammatory response. The clinical presentation of CRS is highly variable, ranging from mild symptoms, such as fever and fatigue, to severe, life-threatening conditions. Currently, there is no standardized method for collecting patient-reported data on CRS experiences. This study aims to develop a novel patient-reported outcome measure (PROM) to capture patients' experience with CRS.</p><p><strong>Methods: </strong>A comprehensive, multistep evidence-generation process was employed, including several research steps: a literature review and analysis of Sanofi clinical trial adverse event data, semi-structured interviews with clinical experts, advisory board meetings with clinical trial investigators, concept elicitation interviews with patients who experienced CRS, a PROM development workshop, cognitive debriefing interviews with clinical trial investigators, and cognitive debriefing interviews with patients.</p><p><strong>Results: </strong>This review identified various CRS-related signs and symptoms from literature and anonymized safety data from clinical trials. Clinical experts validated the preliminary conceptual model (CM) and identified additional relevant symptoms. Patient interviews revealed further symptoms and impacts, leading to the development of the immuno-oncology (IO)-induced CRS patient diary. This PROM was refined through iterative feedback from clinical experts and patients, ensuring it effectively captures the incidence, severity, and impact of CRS symptoms.</p><p><strong>Conclusions: </strong>The \"IO-induced CRS patient diary\" can be considered a content-valid tool for capturing and monitoring the most important patient-reportable symptoms and impacts of CRS in IO clinical trials. This PROM can provide a standardized understanding of IO-induced CRS from the patient perspective, where to date this has been mainly clinically assessed using diverse assessments.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145214057","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}
引用次数: 0
Abemaciclib Persistence in Patients with HR+, HER2-, Node-Positive Early Breast Cancer: a Real-World Analysis. Abemaciclib在HR+, HER2-,淋巴结阳性早期乳腺癌患者中的持续性:一项现实世界分析
IF 3.2
Oncology and Therapy Pub Date : 2025-10-02 DOI: 10.1007/s40487-025-00385-9
Kathryn Hudson, Wambui Gathirua-Mwangi, Lindsay A Williams, Zhanglin Lin Cui, Madeline Richey, Brenda Grimes, Jingru Wang, Astra M Liepa, Erich Brechtelsbauer, Raisa Volodarsky, Katheryn Moreira, Hatem Soliman
{"title":"Abemaciclib Persistence in Patients with HR+, HER2-, Node-Positive Early Breast Cancer: a Real-World Analysis.","authors":"Kathryn Hudson, Wambui Gathirua-Mwangi, Lindsay A Williams, Zhanglin Lin Cui, Madeline Richey, Brenda Grimes, Jingru Wang, Astra M Liepa, Erich Brechtelsbauer, Raisa Volodarsky, Katheryn Moreira, Hatem Soliman","doi":"10.1007/s40487-025-00385-9","DOIUrl":"https://doi.org/10.1007/s40487-025-00385-9","url":null,"abstract":"<p><strong>Introduction: </strong>Patients with node-positive, high-risk, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC) can be treated with 2 years of abemaciclib plus endocrine therapy (ET) to improve invasive disease-free survival (IDFS; hazard ratio 0.68; absolute 7.6% 5-year IDFS benefit) over ET alone as observed in the monarchE trial. Most adverse events (AEs) from abemaciclib occurred early in treatment and could be managed with dose reductions while maintaining efficacy. Describing adjuvant abemaciclib dosing patterns and early treatment persistence in patients in a real-world node-positive EBC cohort provides new evidence on abemaciclib administration in clinical practice and may inform AE management.</p><p><strong>Methods: </strong>Using the Flatiron Health Research Database de-identified data from October 2021 to February 2023, this retrospective study included patients aged ≥ 18 years with node-positive, HR+, HER2- EBC without prior CDK4/6 inhibitor exposure who initiated adjuvant abemaciclib at 150 mg twice daily (BID) and had ≥ 3 months follow-up. Dose modifications were identified. The persistence rate (%) and reasons for treatment discontinuation were described.</p><p><strong>Results: </strong>Among 354 patients (99.7% female), 88.1% of patients continued abemaciclib beyond 3 months. Dose reductions were observed in 50.8% of patients. Median time to first dose reduction was 59 days (IQR 35, 99). Of the patients with a dose reduction, 93.3% continued abemaciclib beyond 3 months. Among patients who discontinued abemaciclib because of AEs within 3 months of initiation without evidence of reinitiation (n = 40), 70.0% had no evidence of a dose reduction.</p><p><strong>Conclusion: </strong>Eighty-eight percent of patients continued adjuvant abemaciclib beyond 3 months, demonstrating high early persistence and tolerance of abemaciclib in patients with node-positive EBC in a real-world clinical practice cohort. Persistence was 93.3% among patients who had a dose reduction, suggesting that timely dose adjustments, when needed, can promote early persistence on abemaciclib, particularly when patient-felt AEs are most frequent and can be effectively managed.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145213990","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}
引用次数: 0
Publisher Correction: Non-believer to Believer: A Podcast Conversation on the Journey from Skeptic to Proponent of Oncology Real-World Evidence. 出版商更正:非信徒到信徒:从怀疑论者到肿瘤学真实世界证据支持者的播客对话。
IF 3.2
Oncology and Therapy Pub Date : 2025-09-25 DOI: 10.1007/s40487-025-00382-y
Adam Brufsky, Raymond Liu, Joanne C Ryan
{"title":"Publisher Correction: 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/s40487-025-00382-y","DOIUrl":"https://doi.org/10.1007/s40487-025-00382-y","url":null,"abstract":"","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145138765","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}
引用次数: 0
The Role of Oncology Nurses and Advanced Practice Providers in the Treatment of Patients With HRR-Deficient mCRPC Receiving Talazoparib Plus Enzalutamide: A Podcast. 肿瘤护士和高级实践提供者在接受Talazoparib + Enzalutamide治疗hrr缺陷mCRPC患者中的作用:播客
IF 3.2
Oncology and Therapy Pub Date : 2025-09-15 DOI: 10.1007/s40487-025-00376-w
Jennifer L E Lloyd, Julia Batten
{"title":"The Role of Oncology Nurses and Advanced Practice Providers in the Treatment of Patients With HRR-Deficient mCRPC Receiving Talazoparib Plus Enzalutamide: A Podcast.","authors":"Jennifer L E Lloyd, Julia Batten","doi":"10.1007/s40487-025-00376-w","DOIUrl":"https://doi.org/10.1007/s40487-025-00376-w","url":null,"abstract":"<p><p>Homologous recombination repair (HRR) is a DNA repair pathway that helps maintain genomic stability. About one quarter of patients with metastatic castration-resistant prostate cancer (mCRPC) have alterations in HRR genes. For adult patients in the USA with mCRPC harboring HRR gene alterations, the combination of talazoparib plus enzalutamide is an approved treatment option. The objective of this podcast, featuring two nurse practitioners, is to provide information for oncology nurses and advanced practice providers (APPs) on the use of talazoparib plus enzalutamide and its practical implementation aspects in the clinic. We discuss the importance of testing for HRR gene alterations in mCRPC, appropriate dosing and administration, and our clinical experiences of adverse event monitoring and dose modifications as illustrative examples of the role of oncology nurses and APPs in the treatment of mCRPC with talazoparib plus enzalutamide. Podcast and Infographic are available for this article. Podcast Video (MP4 172565 KB).</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145070790","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}
引用次数: 0
Application and Progress of Antibody-Drug Conjugates (ADCs) in the Treatment of Metastatic Triple-Negative Breast Cancer. 抗体-药物偶联物(adc)在转移性三阴性乳腺癌治疗中的应用与进展。
IF 3.2
Oncology and Therapy Pub Date : 2025-09-15 DOI: 10.1007/s40487-025-00379-7
Banghong Xie, Chao Chen, Haolin Cai, Lili Wang, Mulan Chen, Jian Liu, Fan Wu, Weiwei Huang
{"title":"Application and Progress of Antibody-Drug Conjugates (ADCs) in the Treatment of Metastatic Triple-Negative Breast Cancer.","authors":"Banghong Xie, Chao Chen, Haolin Cai, Lili Wang, Mulan Chen, Jian Liu, Fan Wu, Weiwei Huang","doi":"10.1007/s40487-025-00379-7","DOIUrl":"https://doi.org/10.1007/s40487-025-00379-7","url":null,"abstract":"<p><p>Metastatic triple-negative breast cancer (TNBC) lacks actionable targets, and chemotherapy yields median progression-free survival (mPFS) of 4.6-9.7 months and median overall survival (mOS) of 12.6-26.3 months. Immune checkpoint inhibitors (ICIs) and poly (ADP-ribose) polymerase (PARP) inhibitors only help subsets (objective response rate [ORR] of ~ 5% and ~ 12%, respectively). Antibody-drug conjugates (ADCs) have emerged as a leading therapeutic strategy: sacituzumab govitecan extended mPFS to 5.6 months (ASCENT trial), SKB264 to 6.7 months, and datopotamab deruxtecan achieved an ORR of 79%. In Human epidermal growth factor receptor 2 (HER2)-low TNBC, trastuzumab deruxtecan prolonged OS to 18.2 months, while disitamab vedotin and SHR-A1811 achieved ORRs of 26% and 60%, respectively. ADCs targeting Human epidermal growth factor receptor 3 (HER3)-, Nectin-4-, LIV-1- and folate receptor α (FRα) showed responses in 22%-54% of cases. Resistance can arise via antigen loss, endocytic defects, lysosomal failure, and efflux pumps. Bispecific ADCs, linker optimization, and combination regimens (ICI, PARPi) are under investigation. Future efforts will focus on targeting epidermal growth factor receptor (EGFR) and FRα and on developing multimodal immunovascular strategies to sustain clinical benefit.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145065739","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}
引用次数: 0
First-Line Tislelizumab Plus Chemotherapy in Advanced Non-Squamous Non-Small Cell Lung Cancer: PD-L1 ≥ 50% Subgroup Analysis from the RATIONALE-304 Trial. 一线替利利单抗联合化疗治疗晚期非鳞状非小细胞肺癌:来自RATIONALE-304试验的PD-L1≥50%亚组分析
IF 3.2
Oncology and Therapy Pub Date : 2025-09-14 DOI: 10.1007/s40487-025-00378-8
Shun Lu, Jie Wang, Yan Yu, Xinmin Yu, Yanping Hu, Liao Wangjun, Xingya Li, Yuepeng Liu, Weidong Li, Xiaofei Qu, Yuanyuan Bao, Mengzhao Wang
{"title":"First-Line Tislelizumab Plus Chemotherapy in Advanced Non-Squamous Non-Small Cell Lung Cancer: PD-L1 ≥ 50% Subgroup Analysis from the RATIONALE-304 Trial.","authors":"Shun Lu, Jie Wang, Yan Yu, Xinmin Yu, Yanping Hu, Liao Wangjun, Xingya Li, Yuepeng Liu, Weidong Li, Xiaofei Qu, Yuanyuan Bao, Mengzhao Wang","doi":"10.1007/s40487-025-00378-8","DOIUrl":"https://doi.org/10.1007/s40487-025-00378-8","url":null,"abstract":"<p><strong>Introduction: </strong>RATIONALE-304 compared first-line tislelizumab (a programmed cell death protein 1 inhibitor) plus chemotherapy versus chemotherapy in advanced non-squamous non-small cell lung cancer (nsq-NSCLC). This exploratory analysis focused on patients with tumor cell programmed death ligand 1 (PD-L1) expression ≥ 50%.</p><p><strong>Methods: </strong>Patients with stage IIIB/IV nsq-NSCLC were randomized (2:1) to tislelizumab plus platinum-based chemotherapy and pemetrexed every 3 weeks, followed by maintenance tislelizumab and pemetrexed, or platinum-based chemotherapy and pemetrexed followed by maintenance pemetrexed. The primary endpoint was independent review committee (IRC)-assessed progression-free survival (PFS); secondary endpoints included overall survival (OS), IRC-assessed objective response rates, and safety.</p><p><strong>Results: </strong>The PD-L1 ≥ 50% population included 110 patients (tislelizumab plus chemotherapy, n = 74; chemotherapy, n = 36); 71.8% (n = 79) were male and 28.2% (n = 31) were female. Consistent with the final analysis (median follow-up 16.5 months), the 4-year follow-up data (median follow-up 23.4 months) continued to show an improvement in median PFS (17.2 vs. 4.6 months; stratified HR 0.29, 95% CI 0.17-0.50) and median OS (41.9 vs. 13.1 months; stratified HR 0.38, 95% CI 0.23-0.62) for patients who received tislelizumab plus chemotherapy versus chemotherapy. An additional post hoc analysis showed no significant differences in PFS or OS between PD-L1 50-89% and ≥ 90% subgroups in the tislelizumab plus chemotherapy arm. The safety profile of tislelizumab plus chemotherapy was manageable and consistent with previous analyses.</p><p><strong>Conclusions: </strong>In patients with advanced nsq-NSCLC and PD-L1 tumor cell expression ≥ 50%, first-line tislelizumab plus chemotherapy demonstrated clinically meaningful improvement in PFS and OS versus chemotherapy. Efficacy was consistent across subgroups of patients with high PD-L1 tumor cell expression levels (50-89% and ≥ 90%).</p><p><strong>Trial registration: </strong>Clinical Trials.gov NCT03663205.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145058736","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}
引用次数: 0
Real-World Use and Immunotherapy Rechallenge Outcomes with Nivolumab in Advanced Non-small Cell Lung Cancer in France: Interim Results of the LIST Study. 法国Nivolumab在晚期非小细胞肺癌中的实际应用和免疫治疗再挑战结果:LIST研究的中期结果
IF 3.2
Oncology and Therapy Pub Date : 2025-09-14 DOI: 10.1007/s40487-025-00381-z
Benoît Godbert, Elisa Gobbini, Chantal Decroisette, Hervé Lena, Yaacoub Khalife, Florence Brellier, Anne Fleuriet, Maeva Zysman, Thomas Egenod, Denis Moro Sibilot, Nicolas Girard
{"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":"https://doi.org/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":""},"PeriodicalIF":3.2,"publicationDate":"2025-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145058715","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}
引用次数: 0
Indirect Comparisons of the Efficacy and Safety of Zanubrutinib versus Venetoclax plus Obinutuzumab in Treatment-Naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Zanubrutinib与Venetoclax + Obinutuzumab治疗Treatment-Naïve慢性淋巴细胞白血病/小淋巴细胞淋巴瘤的疗效和安全性的间接比较
IF 3.2
Oncology and Therapy Pub Date : 2025-09-13 DOI: 10.1007/s40487-025-00380-0
Talha Munir, Nicolás Martinez-Calle, Sheng Xu, Keri Yang, Xiaoyun Ge, Ayad K Ali, Leyla Mohseninejad, Balázs Dobi, Pal Rakonczai, Han Ma, Rhys Williams, Wassim Aldairy, Nicole Lamanna
{"title":"Indirect Comparisons of the Efficacy and Safety of Zanubrutinib versus Venetoclax plus Obinutuzumab in Treatment-Naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.","authors":"Talha Munir, Nicolás Martinez-Calle, Sheng Xu, Keri Yang, Xiaoyun Ge, Ayad K Ali, Leyla Mohseninejad, Balázs Dobi, Pal Rakonczai, Han Ma, Rhys Williams, Wassim Aldairy, Nicole Lamanna","doi":"10.1007/s40487-025-00380-0","DOIUrl":"https://doi.org/10.1007/s40487-025-00380-0","url":null,"abstract":"<p><strong>Introduction: </strong>Compared with chemoimmunotherapy, both zanubrutinib monotherapy and venetoclax plus obinutuzumab prolong progression-free survival (PFS) in patients with chronic lymphocytic leukemia (CLL). Matching-adjusted indirect comparison (MAIC) can be used to compare the efficacy and safety of different treatment regimens when no head-to-head trial has compared the treatments.</p><p><strong>Methods: </strong>Patient matching was conducted using unanchored MAIC propensity-score weighting to compare PFS, overall survival (OS), tolerability, and adverse events (AEs) of interest (AEIs; grade 3-4 infections, neutropenia, febrile neutropenia, and/or thrombocytopenia and AEs leading to treatment discontinuation) on the basis of data from patients in SEQUOIA for zanubrutinib and aggregate data from CLL14 for venetoclax plus obinutuzumab. Because SEQUOIA occurred during the pandemic, analyses were also conducted to adjust for coronavirus disease 2019 (COVID-19) infections.</p><p><strong>Results: </strong>After matching and adjustment, baseline characteristics of the zanubrutinib group in SEQUOIA were well balanced with the CLL14 population (N = 216), with an effective sample size of 163 for the zanubrutinib group. After matching for baseline characteristics, zanubrutinib demonstrated a robust PFS benefit compared with venetoclax plus obinutuzumab (hazard ratio, 0.66 [95% confidence interval, 0.44-0.97]; P = 0.0351) and higher PFS probability at landmark points (60-month landmarks of 73.9% versus 63%, respectively). OS trended in favor of zanubrutinib. Overall, AEs of any grade over time were comparable in the zanubrutinib safety and venetoclax plus obinutuzumab populations. Zanubrutinib was associated with lower rates of selected AEIs compared with venetoclax plus obinutuzumab at all time points, except for grade 3-4 infections after 156 weeks. After adjusting for COVID-19, zanubrutinib was associated with a significantly lower incidence of grade 3-4 infections at 104 weeks but similar incidences of grade 3-4 infections versus venetoclax plus obinutuzumab during the overall follow-up period.</p><p><strong>Conclusions: </strong>Continuous treatment with zanubrutinib in treatment-naïve patients with CLL/small lymphocytic lymphoma resulted in prolonged PFS and a favorable safety profile compared with fixed-duration venetoclax plus obinutuzumab.</p><p><strong>Trial registration no: </strong>SEQUOIA (NCT03336333); CLL14 (NCT02242942).</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145056012","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}
引用次数: 0
Real-World Studies and Randomized Controlled Trials: A Podcast Discussion of the Relative Strengths and Limitations of These Complementary Designs for Cancer Research. 真实世界的研究和随机对照试验:播客讨论这些补充性设计在癌症研究中的相对优势和局限性。
IF 3.2
Oncology and Therapy Pub Date : 2025-09-11 DOI: 10.1007/s40487-025-00368-w
Adam Brufsky, Christos Vaklavas, Joanne C Ryan
{"title":"Real-World Studies and Randomized Controlled Trials: A Podcast Discussion of the Relative Strengths and Limitations of These Complementary Designs for Cancer Research.","authors":"Adam Brufsky, Christos Vaklavas, Joanne C Ryan","doi":"10.1007/s40487-025-00368-w","DOIUrl":"https://doi.org/10.1007/s40487-025-00368-w","url":null,"abstract":"<p><p>Randomized controlled trials (RCTs) are the benchmark for assessing the safety and efficacy of treatments but are subject to some inherent limitations, such as restrictive inclusion criteria and underrepresentation of certain patient groups. Studies based on diverse real-world data sources provide complementary evidence that can help fill knowledge gaps, particularly by providing safety and outcome data for patients not typically included in RCTs. However, real-world data studies have their own limitations. This podcast aims to be a resource for clinicians by exploring the strengths and limitations of RCTs and real-world studies in the context of cancer research. The hosts, both of whom are practicing oncologists, provide context for the emergence of modern real-world studies and advice for interpreting real-world evidence. As a supplement to learnings from RCTs, real-world evidence can inform the treatment decision-making process in the clinic and support decisions made by regulatory bodies. This podcast is part 1 of a three-part series discussing real-world studies.Podcast and infographic available for this article. Podcast video (MP4 66494 KB).</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145041744","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}
引用次数: 0
Non-believer to Believer: A Podcast Conversation on the Journey from Skeptic to Proponent of Oncology Real-World Evidence. 第3部分(播客):从非信徒到信徒:从怀疑论者到肿瘤学真实世界证据支持者的播客对话。
IF 3.2
Oncology and Therapy Pub Date : 2025-09-11 DOI: 10.1007/s40487-025-00367-x
Adam Brufsky, Raymond Liu, Joanne C Ryan
{"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":""},"PeriodicalIF":3.2,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145041759","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}
引用次数: 0
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