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Summary of Research: Elranatamab Fixed Dosing-A Safe, Effective, and Convenient Dosing Approach. 研究综述:埃尔那他单抗固定给药——一种安全、有效、方便的给药方法。
IF 3.4
Oncology and Therapy Pub Date : 2026-03-01 Epub Date: 2026-03-02 DOI: 10.1007/s40487-026-00415-0
Mohamed Elmeliegy, Pooneh Soltantabar, Jennifer Hibma, Olivia Ashman, Diane Wang, Hoi-Kei Lon
{"title":"Summary of Research: Elranatamab Fixed Dosing-A Safe, Effective, and Convenient Dosing Approach.","authors":"Mohamed Elmeliegy, Pooneh Soltantabar, Jennifer Hibma, Olivia Ashman, Diane Wang, Hoi-Kei Lon","doi":"10.1007/s40487-026-00415-0","DOIUrl":"10.1007/s40487-026-00415-0","url":null,"abstract":"<p><p>This is a summary of the original research article \"Elranatamab Fixed Dosing: A Safe, Effective, and Convenient Dosing Approach\". Understanding how body weight affects the safety and efficacy of a treatment is important to ensure optimal treatment outcomes. We reviewed data from the MagnetisMM-3 trial, which was designed to study the safety and efficacy of elranatamab in people with multiple myeloma. For this analysis, participants who were treated with elranatamab in the MagnestisMM-3 trial were divided into four body weight groups (i.e., quartiles). All participants received the same fixed dose of elranatamab (76 mg) while enrolled in the trial. Across the different body weight groups, there were no clinically relevant differences in the pharmacokinetics of elranatamab. Furthermore, the side effects and their severity were also similar across body weight groups. Lastly, all four body weight groups showed a clinically meaningful response rate, and the responses were comparable across groups. Collectively, this study shows that the fixed dose of elranatamab is effective and has a manageable safety profile across a wide range of body weights.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"91-94"},"PeriodicalIF":3.4,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12992842/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147327590","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}
引用次数: 0
Two-Stage Estimation of Overall Survival in the Phase 3 CheckMate 9ER Trial, Adjusting for the Impact of Subsequent Therapy. 3期CheckMate 9ER试验的两阶段总生存期估计,调整后续治疗的影响。
IF 3.4
Oncology and Therapy Pub Date : 2026-03-01 Epub Date: 2025-11-15 DOI: 10.1007/s40487-025-00393-9
Marc-Oliver Grimm, Emma Karim, Venediktos Kapetanakis, Mickael Lothgren, Alessia Ogareva, Pragya Shukla, James Truscott, Camillo Porta
{"title":"Two-Stage Estimation of Overall Survival in the Phase 3 CheckMate 9ER Trial, Adjusting for the Impact of Subsequent Therapy.","authors":"Marc-Oliver Grimm, Emma Karim, Venediktos Kapetanakis, Mickael Lothgren, Alessia Ogareva, Pragya Shukla, James Truscott, Camillo Porta","doi":"10.1007/s40487-025-00393-9","DOIUrl":"10.1007/s40487-025-00393-9","url":null,"abstract":"<p><strong>Introduction: </strong>The CheckMate 9ER (CM9ER) trial demonstrated the superiority of cabozantinib plus nivolumab (CaboNivo) over sunitinib (SUN) in patients with untreated advanced renal cell carcinoma (aRCC). We conducted a post hoc analysis using CM9ER data (median follow-up 67.6 months) and two-stage estimation (TSE) to assess the efficacy of CaboNivo versus SUN, adjusting for the impact of subsequent treatment.</p><p><strong>Methods: </strong>Patients in the intention-to-treat (ITT) CM9ER population who discontinued their randomized study therapy were included in step 1 of the TSE, which used accelerated failure time modeling to estimate the extent that subsequent therapy extended survival in each treatment arm. Step 2 adjusted the CM9ER ITT population overall survival (OS) estimates to account for this impact; an adjusted hazard ratio (HR) for OS was then calculated to evaluate the relative impact of CaboNivo versus SUN without the effects of subsequent treatment.</p><p><strong>Results: </strong>In total, 540 patients from CM9ER (CaboNivo, n = 264; SUN, n = 276) discontinued treatment and were included in the analysis, of whom 297 (CaboNivo, n = 129; SUN, n = 168) initiated subsequent systemic therapy. Patient characteristics were balanced between ITT and TSE populations. Median (interquartile range) time from randomization to treatment discontinuation was 22.2 (9.92-31.51) months for CaboNivo and 9.6 (3.48-18.62) months for SUN. The TSE-adjusted median (95% confidence interval [CI]) OS was 42.7 (38.4-49.1) months for CaboNivo and 21.3 (18.1-24.9) months for SUN (HR [95% CI] 0.53 [0.43-0.65; p < 0.001]), compared with unadjusted estimates of 46.5 (40.6-53.7) months and 35.5 (29.2-42.8) months, respectively (HR [95% CI] 0.79 [0.65-0.96; p = 0.0196]).</p><p><strong>Conclusions: </strong>Removing the effect of subsequent therapy strengthened the relative OS benefit of CaboNivo versus SUN in CM9ER. Consistent with clinical practice, these results further support first-line CaboNivo as a standard of care for aRCC. Graphical abstract available for this article.</p><p><strong>Trial registration: </strong>NCT03141177.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"253-268"},"PeriodicalIF":3.4,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12992742/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145524632","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}
引用次数: 0
Correction: Clinical Burden of Recurrent Disease in High-Risk Endometrial Cancer. 修正:高危子宫内膜癌复发疾病的临床负担。
IF 3.2
Oncology and Therapy Pub Date : 2025-12-01 DOI: 10.1007/s40487-025-00373-z
Kalé Kponee-Shovein, Vimalanand S Prabhu, Yan Song, Lei Chen, Mu Cheng, Yeran Li, Yezhou Sun, Annalise Hilts, Qi Hua, Jasmine Lichfield, Linda Duska
{"title":"Correction: Clinical Burden of Recurrent Disease in High-Risk Endometrial Cancer.","authors":"Kalé Kponee-Shovein, Vimalanand S Prabhu, Yan Song, Lei Chen, Mu Cheng, Yeran Li, Yezhou Sun, Annalise Hilts, Qi Hua, Jasmine Lichfield, Linda Duska","doi":"10.1007/s40487-025-00373-z","DOIUrl":"10.1007/s40487-025-00373-z","url":null,"abstract":"","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"1023"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647459/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144993831","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}
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 : 2025-12-01 Epub 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":"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":"837-843"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647498/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145041744","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}
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 : 2025-12-01 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":"10.1007/s40487-025-00382-y","url":null,"abstract":"","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"859"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647398/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145138765","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}
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 : 2025-12-01 Epub 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":"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":"1087-1104"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647400/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145058736","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}
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 : 2025-12-01 Epub 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":"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":"1055-1070"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647441/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145056012","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}
引用次数: 0
The Phase 2b COPERNICUS Study of Subcutaneous Amivantamab with Lazertinib as First-Line Treatment, or with Chemotherapy as Second-Line Treatment, for EGFR-Mutated Non-Small Cell Lung Cancer: a Vodcast. 皮下阿米万他单抗联合拉泽替尼作为一线治疗,或化疗作为二线治疗egfr突变的非小细胞肺癌的2b期哥白尼研究:一项Vodcast
IF 3.2
Oncology and Therapy Pub Date : 2025-12-01 Epub Date: 2025-10-11 DOI: 10.1007/s40487-025-00386-8
Balazs Halmos, Narjust Florez, Sarah Goldberg, Wade Iams, Xiuning Le, Ticiana Leal, Danny Nguyen, Luis E Raez, Jonathan W Riess, Joshua Sabari, David Bjork, Nichelle Stigger, Yichuan Xia, Paul Cifuentes, Denise D'Andrea, Farah Shanoon, Andy L Johnson, Melissa L Johnson
{"title":"The Phase 2b COPERNICUS Study of Subcutaneous Amivantamab with Lazertinib as First-Line Treatment, or with Chemotherapy as Second-Line Treatment, for EGFR-Mutated Non-Small Cell Lung Cancer: a Vodcast.","authors":"Balazs Halmos, Narjust Florez, Sarah Goldberg, Wade Iams, Xiuning Le, Ticiana Leal, Danny Nguyen, Luis E Raez, Jonathan W Riess, Joshua Sabari, David Bjork, Nichelle Stigger, Yichuan Xia, Paul Cifuentes, Denise D'Andrea, Farah Shanoon, Andy L Johnson, Melissa L Johnson","doi":"10.1007/s40487-025-00386-8","DOIUrl":"10.1007/s40487-025-00386-8","url":null,"abstract":"<p><strong>Introduction: </strong>In advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations (Ex19del/L858R), intravenous amivantamab is approved for first-line treatment with lazertinib, and second-line treatment with carboplatin-pemetrexed. Subcutaneous amivantamab demonstrated noninferior pharmacokinetics and comparable efficacy with improved safety outcomes versus intravenous amivantamab in the PALOMA-3 trial. Venous thromboembolism (VTE) was also reduced when combined with prophylactic anticoagulation. In the COCOON trial, an enhanced prophylactic dermatologic regimen with intravenous amivantamab plus lazertinib treatment lowered grade ≥ 2 dermatologic adverse events (AEs). There are no studies combining subcutaneous administration with supportive care advancements in diverse participants with EGFR-mutated NSCLC. COPERNICUS (NCT06667076), an open-label, phase 2b study aims to evaluate the efficacy and safety of subcutaneous amivantamab with lazertinib (cohort 1) or with chemotherapy (cohort 2) while preventing and proactively managing VTE and dermatologic AEs in a multinational, clinically representative population with EGFR-mutated NSCLC.</p><p><strong>Methods: </strong>Eligible participants are adults with EGFR Ex19del/L858R NSCLC. A pragmatic study approach will be used to eliminate potential barriers to enrollment and increase diversity. Cohort 1 will enroll participants without prior systemic therapy to receive subcutaneous amivantamab and oral lazertinib. Cohort 2 will enroll participants with disease progression on EGFR-tyrosine kinase inhibitors to receive subcutaneous amivantamab and chemotherapy (carboplatin-pemetrexed). Both cohorts will receive enhanced dermatologic management; cohort 1 will receive prophylactic anticoagulation for the first 4 months of treatment. The primary endpoint is investigator-assessed progression-free survival.</p><p><strong>Results: </strong>COPERNICUS is currently enrolling, with a planned enrollment in the United States of 300 and 30 participants in cohorts 1 and 2, respectively, plus 150 participants for cohort 1 in Europe.</p><p><strong>Conclusion: </strong>COPERNICUS uses a pragmatic study design to evaluate the efficacy and safety of subcutaneous amivantamab regimens combined with advancements in supportive care to prevent and proactively manage AEs in a diverse participant population. Supplementary file1 (MP4 117333 KB).</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"871-880"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647402/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145276230","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}
引用次数: 0
The Impact of Intravesical Instillations on Quality of Life in Patients with Non-Muscle-Invasive Bladder Cancer: A Systematic Review. 膀胱内灌注对非肌肉浸润性膀胱癌患者生活质量的影响:一项系统综述。
IF 3.2
Oncology and Therapy Pub Date : 2025-12-01 Epub Date: 2025-11-13 DOI: 10.1007/s40487-025-00375-x
Ingolf Griebsch, Sunil Shrestha, Yair Lotan, Chi-Fai Ng, Andrew Bottomley
{"title":"The Impact of Intravesical Instillations on Quality of Life in Patients with Non-Muscle-Invasive Bladder Cancer: A Systematic Review.","authors":"Ingolf Griebsch, Sunil Shrestha, Yair Lotan, Chi-Fai Ng, Andrew Bottomley","doi":"10.1007/s40487-025-00375-x","DOIUrl":"10.1007/s40487-025-00375-x","url":null,"abstract":"<p><strong>Background: </strong>Non-muscle invasive bladder cancer (NMIBC) is commonly treated with transurethral resection of bladder tumor (TURBT) followed by intravesical chemotherapy and/or Bacillus Calmette-Guérin (BCG) instillations. While these treatments aim to prevent recurrence and progression, the frequency of their administration and associated side effects can substantially impact patients' quality of life (QoL).</p><p><strong>Objectives: </strong>We aimed to systematically review the impact of intravesical BCG and chemotherapy instillations on QoL in patients with NMIBC, with a specific focus on how instillation frequency influences treatment adherence and withdrawal rates.</p><p><strong>Methods: </strong>A systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Over 750 abstracts were independently screened by two independent reviewers. Studies published between 2005 and 2024 were included. Data were extracted on demographics, treatment protocols, QoL outcomes, and adherence rates. Risk of bias assessments were undertaken to assess the quality of the studies.</p><p><strong>Results: </strong>A total of 17 studies were selected, comprising 6 qualitative, 8 quantitative, and 3 mixed-methods designs, totaling 20,045 patients. Frequent instillations were associated with increased urinary symptoms (e.g., urgency and dysuria), fatigue, and emotional distress. Withdrawal rates were high (up to 90%) in intensive schedules, particularly during the first year, due to treatment burden and side effects. Studies demonstrated that reduced instillation frequency could preserve treatment efficacy while improving QoL and adherence.</p><p><strong>Conclusions: </strong>Frequent intravesical instillations can significantly impair QoL, particularly among older patients. While emerging therapies and supportive strategies may help alleviate treatment burden, clinical decision-making must carefully balance QoL with oncologic outcomes. Future research should prioritize personalized approaches that integrate both clinical efficacy and patient-reported outcomes (PROs).</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"895-918"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647504/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145507525","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}
引用次数: 0
Pembrolizumab-Induced High Inflammatory Panmyelitis: Contribution of Neurochemical Markers Predicting Severity of Central Nervous Affection. 派姆单抗诱导的高炎性panmyeltis:神经化学标志物预测中枢神经影响严重程度的贡献。
IF 3.2
Oncology and Therapy Pub Date : 2025-12-01 Epub Date: 2025-09-05 DOI: 10.1007/s40487-025-00374-y
Beate Hagenkötter, Jérôme De Sèze, Faten Hammami, Timothée Klopfenstein, Souheil Zayet
{"title":"Pembrolizumab-Induced High Inflammatory Panmyelitis: Contribution of Neurochemical Markers Predicting Severity of Central Nervous Affection.","authors":"Beate Hagenkötter, Jérôme De Sèze, Faten Hammami, Timothée Klopfenstein, Souheil Zayet","doi":"10.1007/s40487-025-00374-y","DOIUrl":"10.1007/s40487-025-00374-y","url":null,"abstract":"<p><p>This is the first documented case of recurrent, severe, and highly inflammatory panmyelitis induced by pembrolizumab. A 41-year-old woman with nodular melanoma developed tetraparesis after three cycles of pembrolizumab treatment. Spinal magnetic resonance imaging (MRI) revealed extensive longitudinal panmyelitis, and cerebrospinal fluid analysis showed markedly elevated cell counts (3900/mm<sup>3</sup>). Follow-up measurements of neurofilament light chain (NfL) levels correlated with the severity of central nervous system involvement and reflected clinical, radiological, and biochemical progression. The clinical outcome was surprisingly favorable following treatment with intravenous immunoglobulins (IVIG) and corticosteroids.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"1255-1260"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12647406/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145001675","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}
引用次数: 0
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