Chung, Hyun Cheol and Kang, Yoon-Koo and Chen, Zhendong and Bai, Yuxian and Ishak, Wan Zamaniah Wan and Shim, Byoung Yong and Park, Young Lee and Koo, Dong-Hoe and Lu, Jianwei and Xu, Jianming and Chon, Hong Jae and Bai, Li-Yuan and Zeng, Shan and Yuan, Ying and Chen, Yen-Yang and Gu, Kangsheng and Zhong, Wen Yan and Kuang, Shu and Shih, Chie-Schin and Qin, Shu-Kui (2022) Pembrolizumab versus paclitaxel for previously treated advanced gastric or gastroesophageal junction cancer (KEYNOTE-063): A randomized, open-label, phase 3 trial in Asian patients. Cancer, 128 (5). pp. 995-1003. ISSN 0008-543X, DOI https://doi.org/10.1002/cncr.34019.
Full text not available from this repository.Abstract
Background KEYNOTE-063 (NCT03019588) investigated pembrolizumab versus paclitaxel as second-line therapy in Asian patients with advanced programmed death ligand 1 (PD-L1)-positive (combined positive score >= 1) gastric/gastroesophageal junction (GEJ) cancer. Methods This randomized, open-label, phase 3 study was conducted at 36 medical centers in China (mainland), Malaysia, South Korea, and Taiwan. Patients were randomly assigned 1:1 to 200 mg of pembrolizumab intravenously every 3 weeks for <= 2 years or 80 mg/m(2) of paclitaxel intravenously every week. Primary end points were overall survival (OS) and progression-free survival (PFS). Secondary end points were objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 and safety. Results Between February 16, 2017, and March 12, 2018, 94 patients were randomly assigned (47 pembrolizumab/47 paclitaxel) after screening; enrollment was stopped on March 12, 2018, based on the results of the global KEYNOTE-061 study, and patients were followed until the last patient's last visit. Median OS was 8 months (95% confidence interval CI], 4-10 months) with pembrolizumab versus 8 months (95% CI, 5-11 months) with paclitaxel (hazard ratio HR], 0.99; 95% CI, 0.63-1.54). Median PFS was 2 months (95% CI, 1-3 months) with pembrolizumab versus 4 months (95% CI, 3-6 months) with paclitaxel (HR, 1.62; 95% CI, 1.04-2.52). ORR was 13% for pembrolizumab versus 19% for paclitaxel. Any-grade treatment-related adverse events occurred in 28 pembrolizumab-treated patients (60%) and 42 paclitaxel-treated patients (96%); grades 3 to 5 events occurred in 5 patients (11%) and 28 patients (64%), respectively. Conclusions Definitive conclusions about the efficacy of second-line pembrolizumab in Asian patients with advanced PD-L1-positive gastric/GEJ cancer are limited because of insufficient power, but pembrolizumab was well tolerated in this patient population. Efficacy followed a trend similar to that observed in the phase 3 KEYNOTE-061 trial.
| Item Type: | Article |
|---|---|
| Funders: | Merck & Company |
| Uncontrolled Keywords: | Asia; Chemotherapy; Gastric cancer; Gastroesophageal junction cancer; Pembrolizumab; Programmed death 1 |
| Subjects: | R Medicine > RC Internal medicine R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer) |
| Divisions: | Faculty of Medicine > Clinical Oncology Department |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 21 Jul 2022 01:58 |
| Last Modified: | 21 Jul 2022 01:58 |
| URI: | http://eprints.um.edu.my/id/eprint/33657 |
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