Qin, Shukui and Chen, Zhendong and Fang, Weijia and Ren, Zhenggang and Xu, Ruocai and Ryoo, Baek-Yeol and Meng, Zhiqiang and Bai, Yuxian and Chen, Xiaoming and Liu, Xiufeng and Xiao, Juxiang and Ho, Gwo Fuang and Mao, Yimin and Wang, Xin and Ying, Jieer and Li, Jianfeng and Zhong, Wenyan and Zhou, Yu and Siegel, Abby B. and Hao, Chunyi (2023) Pembrolizumab Versus Placebo as second-line therapy in patients From Asia with advanced hepatocellular carcinoma: A randomized, double-blind, phase III trial. Journal of Clinical Oncology, 41 (7). 1434+. ISSN 0732-183X, DOI https://doi.org/10.1200/JCO.22.00620.
Full text not available from this repository.Abstract
We evaluated the efficacy and safety of pembrolizumab in patients from Asia with previously treated advanced hepatocellular carcinoma (HCC).METHODSIn a double-blind, phase III trial, 453 patients with advanced HCC and progression during or after treatment with or intolerance to sorafenib or oxaliplatin-based chemotherapy were randomly assigned in a 2:1 ratio to receive pembrolizumab (200 mg) or placebo once every 3 weeks for <= 35 cycles plus best supportive care. The primary end point was overall survival (one-sided significance threshold, P = .0193 final analysis]). Secondary end points included progression-free survival (PFS) and objective response rate (ORR; one-sided significance threshold, P = .0134 and .0091, respectively second interim analysis]; RECIST version 1.1, by blinded independent central review).RESULTSMedian overall survival was longer in the pembrolizumab group than in the placebo group (14.6 v 13.0 months; hazard ratio for death, 0.79; 95% CI, 0.63 to 0.99; P = .0180). Median PFS was also longer in the pembrolizumab group than in the placebo group (2.6 v 2.3 months; hazard ratio for progression or death, 0.74; 95% CI, 0.60 to 0.92; P = .0032). ORR was greater in the pembrolizumab group (12.7% 95% CI, 9.1 to 17.0]) than in the placebo group (1.3% 95% CI, 0.2 to 4.6]; P < .0001). Treatment-related adverse events occurred in 66.9% of patients (grade 3, 12.0%; grade 4, 1.3%; grade 5, 1.0%) in the pembrolizumab group and 49.7% of patients (grade 3, 5.9%; grade 4, 0%; grade 5, 0%) in the placebo group.CONCLUSIONIn patients from Asia with previously treated advanced HCC, pembrolizumab significantly prolonged overall survival and PFS, and ORR was greater versus placebo.
| Item Type: | Article |
|---|---|
| Funders: | UNSPECIFIED |
| Uncontrolled Keywords: | Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy protocols; Carcinoma, Hepatocellular; Double-blind method; Humans; Liver neoplasms |
| Subjects: | R Medicine R Medicine > RA Public aspects of medicine |
| Divisions: | Faculty of Medicine Faculty of Medicine > Clinical Oncology Department |
| Depositing User: | Ms Zaharah Ramly |
| Date Deposited: | 14 Aug 2024 06:59 |
| Last Modified: | 14 Aug 2024 06:59 |
| URI: | http://eprints.um.edu.my/id/eprint/38540 |
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