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Pembrolizumab versus paclitaxel for previously treated PD-L1-positive advanced gastric or gastroesophageal junction cancer: 2-year update of the randomized phase 3 KEYNOTE-061 trial
DC Field | Value | Language |
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dc.contributor.author | Fuchs, Charles S. | - |
dc.contributor.author | Ozguroglu, Mustafa | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.contributor.author | Di Bartolomeo, Maria | - |
dc.contributor.author | Mandala, Mario | - |
dc.contributor.author | Ryu, Min-Hee | - |
dc.contributor.author | Fornaro, Lorenzo | - |
dc.contributor.author | Olesinski, Tomasz | - |
dc.contributor.author | Caglevic, Christian | - |
dc.contributor.author | Chung, Hyun C. | - |
dc.contributor.author | Muro, Kei | - |
dc.contributor.author | Van Cutsem, Eric | - |
dc.contributor.author | Elme, Anneli | - |
dc.contributor.author | Thuss-Patience, Peter | - |
dc.contributor.author | Chau, Ian | - |
dc.contributor.author | Ohtsu, Atsushi | - |
dc.contributor.author | Bhagia, Pooja | - |
dc.contributor.author | Wang, Anran | - |
dc.contributor.author | Shih, Chie-Schin | - |
dc.contributor.author | Shitara, Kohei | - |
dc.date.accessioned | 2023-03-20T08:44:24Z | - |
dc.date.available | 2023-03-20T08:44:24Z | - |
dc.date.created | 2022-01-13 | - |
dc.date.created | 2022-01-13 | - |
dc.date.issued | 2022-01-01 | - |
dc.identifier.citation | Gastric Cancer, Vol.25 No.1, pp.197-206 | - |
dc.identifier.issn | 1436-3291 | - |
dc.identifier.uri | https://hdl.handle.net/10371/189486 | - |
dc.description.abstract | Background In the phase 3 KEYNOTE-061 study (cutoff: 10/26/2017), pembrolizumab did not significantly prolong OS vs paclitaxel as second-line (2L) therapy in PD-L1 combined positive score (CPS) >= 1 gastric/GEJ cancer. We present results in CPS >= 1, >= 5, and >= 10 populations after two additional years of follow-up (cutoff: 10/07/2019). Methods Patients were randomly allocated 1:1 to pembrolizumab 200 mg Q3W for <= 35 cycles or standard-dose paclitaxel. Primary endpoints: OS and PFS (CPS >= 1 population). HRs were calculated using stratified Cox proportional hazards models. Results 366/395 patients (92.7%) with CPS >= 1 died. Pembrolizumab demonstrated a trend toward improved OS vs paclitaxel in the CPS >= 1 population (HR, 0.81); 24-month OS rates: 19.9% vs 8.5%. Pembrolizumab incrementally increased the OS benefit with PD-L1 enrichment (CPS >= 5: HR, 0.72, 24-month rate, 24.2% vs 8.8%; CPS >= 10: 0.69, 24-month rate, 32.1% vs 10.9%). There was no difference in median PFS among treatment groups (CPS >= 1: HR, 1.25; CPS >= 5: 0.98; CPS >= 10: 0.79). ORR (pembrolizumab vs paclitaxel) was 16.3% vs 13.6% (CPS >= 1), 20.0% vs 14.3% (CPS >= 5), and 24.5% vs 9.1% (CPS >= 10); median DOR was 19.1 months vs 5.2, 32.7 vs 4.8, and NR vs 6.9, respectively. Fewer treatment-related AEs (TRAEs) occurred with pembrolizumab than paclitaxel (53% vs 84%). Conclusion In this long-term analysis, 2L pembrolizumab did not significantly improve OS but was associated with higher 24-month OS rates than paclitaxel. Pembrolizumab also increased OS benefit with PD-L1 enrichment among patients with PD-L1-positive gastric/GEJ cancer and led to fewer TRAEs than paclitaxel. | - |
dc.language | 영어 | - |
dc.publisher | Springer Verlag | - |
dc.title | Pembrolizumab versus paclitaxel for previously treated PD-L1-positive advanced gastric or gastroesophageal junction cancer: 2-year update of the randomized phase 3 KEYNOTE-061 trial | - |
dc.type | Article | - |
dc.identifier.doi | 10.1007/s10120-021-01227-z | - |
dc.citation.journaltitle | Gastric Cancer | - |
dc.identifier.wosid | 000691966900003 | - |
dc.identifier.scopusid | 2-s2.0-85114044149 | - |
dc.citation.endpage | 206 | - |
dc.citation.number | 1 | - |
dc.citation.startpage | 197 | - |
dc.citation.volume | 25 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordAuthor | Pembrolizumab | - |
dc.subject.keywordAuthor | Chemotherapy | - |
dc.subject.keywordAuthor | Gastric cancer | - |
dc.subject.keywordAuthor | Gastroesophageal junction cancer | - |
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