Chan, A. T. C. and Lee, V. H. F. and Hong, R-L and Ahn, M. -J. and Chong, W. Q. and Kim, S. -B. and Ho, G. F. and Caguioa, P. B. and Ngamphaiboon, N. and Ho, C. and Aziz, M. A. S. A. and Ng, Q. S. and Yen, C. -J. and Soparattanapaisarn, N. and Ngan, R. K. -C and Kho, S. K. and Tiambeng, M. L. A. and Yun, T. and Sriuranpong, V. and Algazi, A. P. and Cheng, A. and Massarelli, E. and Swaby, R. F. and Saraf, S. and Yuan, J. and Siu, L. L. (2023) Pembrolizumab monotherapy versus chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal cancer (KEYNOTE-122): an open-label, randomized, phase III trial. Annals of Oncology, 34 (3). pp. 251-261. ISSN 0923-7534, DOI https://doi.org/10.1016/j.annonc.2022.12.007.
Full text not available from this repository.Abstract
Background: Pembrolizumab previously demonstrated robust antitumor activity and manageable safety in a phase Ib study of patients with heavily pretreated, programmed death ligand 1 (PD-L1)-positive, recurrent or metastatic nasopharyngeal carcinoma (NPC). The phase III KEYNOTE-122 study was conducted to further evaluate pembrolizumab versus chemotherapy in patients with platinum-pretreated, recurrent and/or metastatic NPC. Final analysis results are presented. Patients and methods: KEYNOTE-122 was an open-label, randomized study conducted at 29 sites, globally. Participants with platinum-pretreated recurrent and/or metastatic NPC were randomly assigned (1 : 1) to pembrolizumab or chemotherapy with capecitabine, gemcitabine, or docetaxel. Randomization was stratified by liver metastasis (present versus absent). The primary endpoint was overall survival (OS), analyzed in the intention-to-treat population using the stratified log-rank test (superiority threshold, one-sided P = 0.0187). Safety was assessed in the as-treated population. Results: Between 5 May 2016 and 28 May 2018, 233 participants were randomly assigned to treatment (pembrolizumab, n = 117; chemotherapy, n = 116); Most participants (86.7%) received study treatment in the second-line or later setting. Median time from randomization to data cut-off (30 November 2020) was 45.1 months (interquartile range, 39.0-48.8 months). Median OS was 17.2 months 95% confidence interval (CI) 11.7-22.9 months] with pembrolizumab and 15.3 months (95% CI 10.9-18.1 months) with chemotherapy hazard ratio, 0.90 (95% CI 0.67-1.19; P = 0.2262)]. Grade 3-5 treatment-related adverse events occurred in 12 of 116 participants (10.3%) with pembrolizumab and 49 of 112 participants (43.8%) with chemotherapy. Three treatment-related deaths occurred: 1 participant (0.9%) with pembrolizumab (pneumonitis) and 2 (1.8%) with chemotherapy (pneumonia, intracranial hemorrhage). Conclusion: Pembrolizumab did not significantly improve OS compared with chemotherapy in participants with platinum-pretreated recurrent and/or metastatic NPC but did have manageable safety and a lower incidence of treatment-related adverse events.
| Item Type: | Article |
|---|---|
| Funders: | Merck Sharp & Dohme LLC |
| Uncontrolled Keywords: | Key words; nasopharyngeal cancer; programmed death-1 (PD-1); immunotherapy; pembrolizumab |
| Subjects: | R Medicine > R Medicine (General) 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: | 18 Sep 2025 07:54 |
| Last Modified: | 18 Sep 2025 07:54 |
| URI: | http://eprints.um.edu.my/id/eprint/50407 |
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