Regina Barragán-Carrillo, Hedyeh Ebrahimi, William S John, Sarah Lucht, Taavy A Miller, Prathamesh Pathak, Emily Bland, Sarah Gordon, JaLyna Laney, Andrew J Klink, Bruce Feinberg, Nisha Singh, Carmelo Alonso, Miraj Y Patel, Lisa Rosenblatt, Xin Yin, Alexander Chehrazi-Raffle
{"title":"Nivolumab治疗肌肉侵袭性尿路上皮癌患者的临床结果","authors":"Regina Barragán-Carrillo, Hedyeh Ebrahimi, William S John, Sarah Lucht, Taavy A Miller, Prathamesh Pathak, Emily Bland, Sarah Gordon, JaLyna Laney, Andrew J Klink, Bruce Feinberg, Nisha Singh, Carmelo Alonso, Miraj Y Patel, Lisa Rosenblatt, Xin Yin, Alexander Chehrazi-Raffle","doi":"10.1001/jamanetworkopen.2025.14427","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>Nivolumab is a standard-of-care adjuvant therapy for patients with muscle-invasive urothelial carcinoma (MIUC) at high risk for recurrence after radical resection. However, a better understanding of its use and clinical effectiveness in general patient populations is needed.</p><p><strong>Objective: </strong>To examine treatment patterns and clinical outcomes for patients with MIUC treated with adjuvant nivolumab in a community setting.</p><p><strong>Design, setting, and participants: </strong>This nationwide retrospective medical record review cohort study included patients with clinical stage II to IIIB MIUC who initiated adjuvant nivolumab between September 1, 2021, and November 30, 2022, with at least 6 months follow-up (unless deceased in <6 months). Managing physicians from the Cardinal Health Oncology Provider Extended Network abstracted patient data from electronic records.</p><p><strong>Exposures: </strong>Diagnosis of MIUC and receipt of adjuvant nivolumab.</p><p><strong>Main outcomes and measures: </strong>Disease-free survival (DFS) and overall survival (OS) were estimated using Kaplan-Meier methods.</p><p><strong>Results: </strong>Data from 253 patients were included in this study, with median (IQR) follow-up from adjuvant nivolumab initiation of 12.8 (9.6-15.4) months. The median (IQR) age at MIUC diagnosis was 67.8 (61.5-72.4) years, and most patients were male (169 patients [66.8%]). Overall, 141 patients (55.7%) had received neoadjuvant chemotherapy (NAC). During adjuvant nivolumab, 52 patients (20.6%) experienced an adverse event (AE). At last follow-up, the median (IQR) duration of adjuvant nivolumab was 11.2 (8.4-12.0) months, and 220 patients (87.0%) had discontinued treatment. Discontinuation was primarily due to completion of scheduled therapy duration (163 of 220 patients [74.1%]), while 10 of 220 patients (4.5%) discontinued due to AEs. Median DFS and OS were not reached, and estimates at 12 months after initiation were 86.3% (95% CI, 81.0%-90.2%) for DFS and 90.8% (95% CI, 86.0%-94.0%) for OS. Outcomes were similar in patients who did not receive NAC. At last follow-up, 226 patients (89.3%) were alive, of whom 209 (92.5%) were disease-free.</p><p><strong>Conclusions and relevance: </strong>This retrospective medical record review cohort study of patients with MIUC found clinical outcomes consistent with those observed in the CheckMate 274 trial. These results support the use of adjuvant nivolumab for patient populations in the community, including patients who did not receive NAC. Further research with extended follow-up is needed to elucidate long-term clinical outcomes of adjuvant nivolumab.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 6","pages":"e2514427"},"PeriodicalIF":10.5000,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12150186/pdf/","citationCount":"0","resultStr":"{\"title\":\"Clinical Outcomes in Patients With Muscle-Invasive Urothelial Carcinoma Treated With Nivolumab.\",\"authors\":\"Regina Barragán-Carrillo, Hedyeh Ebrahimi, William S John, Sarah Lucht, Taavy A Miller, Prathamesh Pathak, Emily Bland, Sarah Gordon, JaLyna Laney, Andrew J Klink, Bruce Feinberg, Nisha Singh, Carmelo Alonso, Miraj Y Patel, Lisa Rosenblatt, Xin Yin, Alexander Chehrazi-Raffle\",\"doi\":\"10.1001/jamanetworkopen.2025.14427\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Importance: </strong>Nivolumab is a standard-of-care adjuvant therapy for patients with muscle-invasive urothelial carcinoma (MIUC) at high risk for recurrence after radical resection. However, a better understanding of its use and clinical effectiveness in general patient populations is needed.</p><p><strong>Objective: </strong>To examine treatment patterns and clinical outcomes for patients with MIUC treated with adjuvant nivolumab in a community setting.</p><p><strong>Design, setting, and participants: </strong>This nationwide retrospective medical record review cohort study included patients with clinical stage II to IIIB MIUC who initiated adjuvant nivolumab between September 1, 2021, and November 30, 2022, with at least 6 months follow-up (unless deceased in <6 months). Managing physicians from the Cardinal Health Oncology Provider Extended Network abstracted patient data from electronic records.</p><p><strong>Exposures: </strong>Diagnosis of MIUC and receipt of adjuvant nivolumab.</p><p><strong>Main outcomes and measures: </strong>Disease-free survival (DFS) and overall survival (OS) were estimated using Kaplan-Meier methods.</p><p><strong>Results: </strong>Data from 253 patients were included in this study, with median (IQR) follow-up from adjuvant nivolumab initiation of 12.8 (9.6-15.4) months. The median (IQR) age at MIUC diagnosis was 67.8 (61.5-72.4) years, and most patients were male (169 patients [66.8%]). Overall, 141 patients (55.7%) had received neoadjuvant chemotherapy (NAC). During adjuvant nivolumab, 52 patients (20.6%) experienced an adverse event (AE). At last follow-up, the median (IQR) duration of adjuvant nivolumab was 11.2 (8.4-12.0) months, and 220 patients (87.0%) had discontinued treatment. Discontinuation was primarily due to completion of scheduled therapy duration (163 of 220 patients [74.1%]), while 10 of 220 patients (4.5%) discontinued due to AEs. Median DFS and OS were not reached, and estimates at 12 months after initiation were 86.3% (95% CI, 81.0%-90.2%) for DFS and 90.8% (95% CI, 86.0%-94.0%) for OS. Outcomes were similar in patients who did not receive NAC. At last follow-up, 226 patients (89.3%) were alive, of whom 209 (92.5%) were disease-free.</p><p><strong>Conclusions and relevance: </strong>This retrospective medical record review cohort study of patients with MIUC found clinical outcomes consistent with those observed in the CheckMate 274 trial. These results support the use of adjuvant nivolumab for patient populations in the community, including patients who did not receive NAC. 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Clinical Outcomes in Patients With Muscle-Invasive Urothelial Carcinoma Treated With Nivolumab.
Importance: Nivolumab is a standard-of-care adjuvant therapy for patients with muscle-invasive urothelial carcinoma (MIUC) at high risk for recurrence after radical resection. However, a better understanding of its use and clinical effectiveness in general patient populations is needed.
Objective: To examine treatment patterns and clinical outcomes for patients with MIUC treated with adjuvant nivolumab in a community setting.
Design, setting, and participants: This nationwide retrospective medical record review cohort study included patients with clinical stage II to IIIB MIUC who initiated adjuvant nivolumab between September 1, 2021, and November 30, 2022, with at least 6 months follow-up (unless deceased in <6 months). Managing physicians from the Cardinal Health Oncology Provider Extended Network abstracted patient data from electronic records.
Exposures: Diagnosis of MIUC and receipt of adjuvant nivolumab.
Main outcomes and measures: Disease-free survival (DFS) and overall survival (OS) were estimated using Kaplan-Meier methods.
Results: Data from 253 patients were included in this study, with median (IQR) follow-up from adjuvant nivolumab initiation of 12.8 (9.6-15.4) months. The median (IQR) age at MIUC diagnosis was 67.8 (61.5-72.4) years, and most patients were male (169 patients [66.8%]). Overall, 141 patients (55.7%) had received neoadjuvant chemotherapy (NAC). During adjuvant nivolumab, 52 patients (20.6%) experienced an adverse event (AE). At last follow-up, the median (IQR) duration of adjuvant nivolumab was 11.2 (8.4-12.0) months, and 220 patients (87.0%) had discontinued treatment. Discontinuation was primarily due to completion of scheduled therapy duration (163 of 220 patients [74.1%]), while 10 of 220 patients (4.5%) discontinued due to AEs. Median DFS and OS were not reached, and estimates at 12 months after initiation were 86.3% (95% CI, 81.0%-90.2%) for DFS and 90.8% (95% CI, 86.0%-94.0%) for OS. Outcomes were similar in patients who did not receive NAC. At last follow-up, 226 patients (89.3%) were alive, of whom 209 (92.5%) were disease-free.
Conclusions and relevance: This retrospective medical record review cohort study of patients with MIUC found clinical outcomes consistent with those observed in the CheckMate 274 trial. These results support the use of adjuvant nivolumab for patient populations in the community, including patients who did not receive NAC. Further research with extended follow-up is needed to elucidate long-term clinical outcomes of adjuvant nivolumab.
期刊介绍：
JAMA Network Open, a member of the esteemed JAMA Network, stands as an international, peer-reviewed, open-access general medical journal.The publication is dedicated to disseminating research across various health disciplines and countries, encompassing clinical care, innovation in health care, health policy, and global health.
JAMA Network Open caters to clinicians, investigators, and policymakers, providing a platform for valuable insights and advancements in the medical field. As part of the JAMA Network, a consortium of peer-reviewed general medical and specialty publications, JAMA Network Open contributes to the collective knowledge and understanding within the medical community.
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