Yong-Man Kim, Shin Nishio, Se Ik Kim, Kosei Hasegawa, Coraline Dubot, M Valeria Cáceres, Krishnansu S Tewari, Domenica Lorusso, Jeong-Won Lee, Wen-Shiung Liou, Kan Li, Cumhur Tekin, Nicoletta Colombo, Bradley J Monk
{"title":"KEYNOTE-826最终分析的结果：东亚患者持续性、复发性或转移性宫颈癌患者的派姆单抗联合化疗（含或不含贝伐单抗）","authors":"Yong-Man Kim, Shin Nishio, Se Ik Kim, Kosei Hasegawa, Coraline Dubot, M Valeria Cáceres, Krishnansu S Tewari, Domenica Lorusso, Jeong-Won Lee, Wen-Shiung Liou, Kan Li, Cumhur Tekin, Nicoletta Colombo, Bradley J Monk","doi":"10.3802/jgo.2025.36.e110","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>In the phase 3 KEYNOTE-826 study (NCT03635567), pembrolizumab plus chemotherapy with or without bevacizumab significantly improved progression-free survival (PFS) and overall survival (OS) in participants with persistent, recurrent, or metastatic cervical cancer. We report an exploratory analysis of outcomes for participants enrolled in East Asia based on the final analysis of KEYNOTE-826.</p><p><strong>Methods: </strong>Participants were randomized 1:1 to receive pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles. All participants received chemotherapy with paclitaxel and cisplatin or carboplatin for up to 6 cycles, and optionally received bevacizumab at the investigator's discretion. PFS and OS were dual primary endpoints.</p><p><strong>Results: </strong>Ninety-seven participants from East Asia were enrolled in the intention-to-treat population. At data cutoff (October 3, 2022), in the intention-to-treat population, median PFS in the pembrolizumab plus chemotherapy and placebo plus chemotherapy groups was 18.0 and 10.4 months, respectively (hazard ratio [HR]=0.42; 95% confidence interval [CI]=0.23-0.77); median OS was not reached and 20.4 months, respectively (HR=0.53; 95% CI=0.28-0.99). In the programmed cell death ligand 1 combined positive score (CPS) ≥1 population, median PFS was 29.3 and 10.9 months, respectively (HR=0.36; 95% CI=0.19-0.68); median OS was not reached and 17.4 months, respectively (HR=0.43; 95% CI=0.22-0.86). The most common adverse events with pembrolizumab plus chemotherapy versus placebo plus chemotherapy were alopecia (75% vs. 68%) and anemia (67% vs. 65%).</p><p><strong>Conclusion: </strong>These data support the use of pembrolizumab plus chemotherapy with or without bevacizumab for the treatment of persistent, recurrent, or metastatic cervical cancer in East Asian patients.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03635567.</p>","PeriodicalId":15868,"journal":{"name":"Journal of Gynecologic Oncology","volume":"36 4","pages":"e110"},"PeriodicalIF":3.7000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12226315/pdf/","citationCount":"0","resultStr":"{\"title\":\"Pembrolizumab plus chemotherapy with or without bevacizumab in East Asian participants with persistent, recurrent, or metastatic cervical cancer: results from KEYNOTE-826 final analysis.\",\"authors\":\"Yong-Man Kim, Shin Nishio, Se Ik Kim, Kosei Hasegawa, Coraline Dubot, M Valeria Cáceres, Krishnansu S Tewari, Domenica Lorusso, Jeong-Won Lee, Wen-Shiung Liou, Kan Li, Cumhur Tekin, Nicoletta Colombo, Bradley J Monk\",\"doi\":\"10.3802/jgo.2025.36.e110\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>In the phase 3 KEYNOTE-826 study (NCT03635567), pembrolizumab plus chemotherapy with or without bevacizumab significantly improved progression-free survival (PFS) and overall survival (OS) in participants with persistent, recurrent, or metastatic cervical cancer. We report an exploratory analysis of outcomes for participants enrolled in East Asia based on the final analysis of KEYNOTE-826.</p><p><strong>Methods: </strong>Participants were randomized 1:1 to receive pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles. All participants received chemotherapy with paclitaxel and cisplatin or carboplatin for up to 6 cycles, and optionally received bevacizumab at the investigator's discretion. PFS and OS were dual primary endpoints.</p><p><strong>Results: </strong>Ninety-seven participants from East Asia were enrolled in the intention-to-treat population. At data cutoff (October 3, 2022), in the intention-to-treat population, median PFS in the pembrolizumab plus chemotherapy and placebo plus chemotherapy groups was 18.0 and 10.4 months, respectively (hazard ratio [HR]=0.42; 95% confidence interval [CI]=0.23-0.77); median OS was not reached and 20.4 months, respectively (HR=0.53; 95% CI=0.28-0.99). In the programmed cell death ligand 1 combined positive score (CPS) ≥1 population, median PFS was 29.3 and 10.9 months, respectively (HR=0.36; 95% CI=0.19-0.68); median OS was not reached and 17.4 months, respectively (HR=0.43; 95% CI=0.22-0.86). The most common adverse events with pembrolizumab plus chemotherapy versus placebo plus chemotherapy were alopecia (75% vs. 68%) and anemia (67% vs. 65%).</p><p><strong>Conclusion: </strong>These data support the use of pembrolizumab plus chemotherapy with or without bevacizumab for the treatment of persistent, recurrent, or metastatic cervical cancer in East Asian patients.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03635567.</p>\",\"PeriodicalId\":15868,\"journal\":{\"name\":\"Journal of Gynecologic Oncology\",\"volume\":\"36 4\",\"pages\":\"e110\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2025-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12226315/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Gynecologic Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3802/jgo.2025.36.e110\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Gynecologic Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3802/jgo.2025.36.e110","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的：在KEYNOTE-826 iii期研究（NCT03635567）中，派姆单抗加化疗加或不加贝伐单抗可显著改善持续性、复发性或转移性宫颈癌患者的无进展生存期（PFS）和总生存期（OS）。我们报告了一项基于KEYNOTE-826最终分析的东亚参与者结果的探索性分析。方法：参与者按1:1随机分组，每3周接受派姆单抗200mg或安慰剂治疗，疗程长达35个周期。所有参与者接受紫杉醇和顺铂或卡铂的化疗长达6个周期，并根据研究者的判断选择性地接受贝伐单抗。PFS和OS为双主要终点。结果：来自东亚的97名参与者被纳入意向治疗人群。截至数据截止日期（2022年10月3日），在意向治疗人群中，派姆单抗加化疗组和安慰剂加化疗组的中位PFS分别为18.0和10.4个月(风险比[HR]=0.42；95%置信区间[CI]=0.23-0.77)；中位OS未达到，中位OS 20.4个月(HR=0.53；95% CI = 0.28 - -0.99)。在程序性细胞死亡配体1联合阳性评分(CPS)≥1的人群中，中位PFS分别为29.3和10.9个月(HR=0.36；95%可信区间= 0.19 - -0.68);中位OS未达到，中位OS 17.4个月(HR=0.43；95% CI = 0.22 - -0.86)。派姆单抗联合化疗与安慰剂联合化疗最常见的不良事件是脱发（75%对68%）和贫血（67%对65%）。结论：这些数据支持使用派姆单抗加化疗联合或不联合贝伐单抗治疗东亚患者的持续性、复发性或转移性宫颈癌。试验注册：ClinicalTrials.gov标识符：NCT03635567。
Pembrolizumab plus chemotherapy with or without bevacizumab in East Asian participants with persistent, recurrent, or metastatic cervical cancer: results from KEYNOTE-826 final analysis.
Objective: In the phase 3 KEYNOTE-826 study (NCT03635567), pembrolizumab plus chemotherapy with or without bevacizumab significantly improved progression-free survival (PFS) and overall survival (OS) in participants with persistent, recurrent, or metastatic cervical cancer. We report an exploratory analysis of outcomes for participants enrolled in East Asia based on the final analysis of KEYNOTE-826.
Methods: Participants were randomized 1:1 to receive pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles. All participants received chemotherapy with paclitaxel and cisplatin or carboplatin for up to 6 cycles, and optionally received bevacizumab at the investigator's discretion. PFS and OS were dual primary endpoints.
Results: Ninety-seven participants from East Asia were enrolled in the intention-to-treat population. At data cutoff (October 3, 2022), in the intention-to-treat population, median PFS in the pembrolizumab plus chemotherapy and placebo plus chemotherapy groups was 18.0 and 10.4 months, respectively (hazard ratio [HR]=0.42; 95% confidence interval [CI]=0.23-0.77); median OS was not reached and 20.4 months, respectively (HR=0.53; 95% CI=0.28-0.99). In the programmed cell death ligand 1 combined positive score (CPS) ≥1 population, median PFS was 29.3 and 10.9 months, respectively (HR=0.36; 95% CI=0.19-0.68); median OS was not reached and 17.4 months, respectively (HR=0.43; 95% CI=0.22-0.86). The most common adverse events with pembrolizumab plus chemotherapy versus placebo plus chemotherapy were alopecia (75% vs. 68%) and anemia (67% vs. 65%).
Conclusion: These data support the use of pembrolizumab plus chemotherapy with or without bevacizumab for the treatment of persistent, recurrent, or metastatic cervical cancer in East Asian patients.
期刊介绍：
The Journal of Gynecologic Oncology (JGO) is an official publication of the Asian Society of Gynecologic Oncology. Abbreviated title is ''J Gynecol Oncol''. It was launched in 1990. The JGO''s aim is to publish the highest quality manuscripts dedicated to the advancement of care of the patients with gynecologic cancer. It is an international peer-reviewed periodical journal that is published bimonthly (January, March, May, July, September, and November). Supplement numbers are at times published. The journal publishes editorials, original and review articles, correspondence, book review, etc.
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