https://scholars.lib.ntu.edu.tw/handle/123456789/594883
標題: | Pembrolizumab as second-line therapy for advanced hepatocellular carcinoma: A subgroup analysis of asian patients in the phase 3 KEYNOTE-240 trial | 作者: | Kudo M. Lim H.Y. ANN-LII CHENG Chao Y. Yau T. Ogasawara S. Kurosaki M. Morimoto N. Ohkawa K. Yamashita T. Lee K.-H. Chen E. Siegel A.B. Ryoo B.-Y. |
關鍵字: | Hepatocellular carcinoma; Pembrolizumab; Programmed death 1 | 公開日期: | 2021 | 出版社: | S. Karger AG | 卷: | 10 | 期: | 3 | 起(迄)頁: | 275-284 | 來源出版物: | Liver Cancer | 摘要: | Introduction: KEYNOTE-240 investigated the efficacy and safety of pembrolizumab plus best supportive care (BSC) in sorafenib-treated patients with advanced hepatocellular carcinoma (HCC). Results for the subgroup of patients from Asia are described. Methods: Adults with advanced HCC previously treated with sorafenib were randomized 2:1 to pembrolizumab or placebo plus BSC. Here, the Asian subgroup comprised patients enrolled in Hong Kong, Japan, Korea, the Philippines, Taiwan, and Thailand. Primary endpoints were progression-free survival (PFS) per blinded central imaging review and overall survival (OS). Secondary endpoints included objective response rate (ORR) per blinded central imaging review, duration of response (DOR), and safety. Results: The Asian subgroup included 157 patients. As of January 2, 2019, the median follow-up in this subgroup was 13.8 months for pembrolizumab and 8.3 months for placebo. The median PFS was 2.8 months for pembrolizumab (95% confidence interval [CI] 2.6-4.1) versus 1.4 months (95% CI 1.4-2.4) for placebo (hazard ratio [HR] 0.48; 95% CI 0.32-0.70). The median OS was 13.8 months (95% CI 10.1-16.9) for pembrolizumab versus 8.3 months (95% CI 6.3-11.8) for placebo (HR 0.55; 95% CI 0.37-0.80). ORR was 20.6% (95% CI 13.4-29.5) for pembrolizumab versus 2.0% (95% CI 0.1-10.6) for placebo (difference: 18.5%; 95% CI 8.3-27.6). The median DOR was 8.6 and 2.8 months for pembrolizumab and placebo, respectively. Any grade treatment-related adverse events (TRAEs) occurred in 63 patients (58.9%) receiving pembrolizumab and 24 patients (48.0%) receiving placebo; 14 (13.1%) and 2 (4.0%) patients experienced grade 3-5 TRAEs, respectively. No treatment-related deaths occurred. Conclusion: Pembrolizumab demonstrated antitumor activity and was well tolerated in the Asian subgroup of KEYNOTE-240. A trend toward greater benefit with pembrolizumab in the Asian subgroup was observed compared with the overall cohort, supporting further evaluation of pembrolizumab treatment in this population. ? 2021 The Author(s) Published by S. Karger AG, Basel. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85105131627&doi=10.1159%2f000515553&partnerID=40&md5=b80743514379ac9471cde0a6af465cb0 https://scholars.lib.ntu.edu.tw/handle/123456789/594883 |
ISSN: | 2235-1795 | DOI: | 10.1159/000515553 | SDG/關鍵字: | pembrolizumab; placebo; sorafenib; adult; advanced cancer; aged; Article; Asian; cancer chemotherapy; cancer growth; cancer survival; Chinese; cohort analysis; controlled study; drug safety; drug withdrawal; female; Filipino (citizen); follow up; hepatitis; human; immunopathology; Japanese (people); liver cell carcinoma; major clinical study; male; median survival time; overall response rate; overall survival; phase 3 clinical trial (topic); post hoc analysis; progression free survival; randomized controlled trial (topic); South Korean; Taiwanese; Thai (citizen); unspecified side effect |
顯示於: | 腫瘤醫學研究所 |
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