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Assessment of Pembrolizumab Therapy for the Treatment of Microsatellite Instability-High Gastric or Gastroesophageal Junction Cancer Among Patients in the KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 Clinical Trials
DC Field | Value | Language |
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dc.contributor.author | Chao, Joseph | - |
dc.contributor.author | Fuchs, Charles S. | - |
dc.contributor.author | Shitara, Kohei | - |
dc.contributor.author | Tabernero, Josep | - |
dc.contributor.author | Muro, Kei | - |
dc.contributor.author | Van Cutsem, Eric | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.contributor.author | De Vita, Ferdinando | - |
dc.contributor.author | Landers, Gregory | - |
dc.contributor.author | Yen, Chia-Jui | - |
dc.contributor.author | Chau, Ian | - |
dc.contributor.author | Elme, Anneli | - |
dc.contributor.author | Lee, Jeeyun | - |
dc.contributor.author | Ozguroglu, Mustafa | - |
dc.contributor.author | Catenacci, Daniel | - |
dc.contributor.author | Yoon, Harry H. | - |
dc.contributor.author | Chen, Erluo | - |
dc.contributor.author | Adelberg, David | - |
dc.contributor.author | Shih, Chie-Schin | - |
dc.contributor.author | Shah, Sukrut | - |
dc.contributor.author | Bhagia, Pooja | - |
dc.contributor.author | Wainberg, Zev A. | - |
dc.date.accessioned | 2022-04-18T09:24:24Z | - |
dc.date.available | 2022-04-18T09:24:24Z | - |
dc.date.created | 2021-07-07 | - |
dc.date.created | 2021-07-07 | - |
dc.date.issued | 2021-06 | - |
dc.identifier.citation | JAMA oncology, Vol.7 No.6, pp.895-902 | - |
dc.identifier.issn | 2374-2437 | - |
dc.identifier.other | 137173 | - |
dc.identifier.uri | https://hdl.handle.net/10371/178102 | - |
dc.description.abstract | IMPORTANCE Immunotherapy has been associated with improved outcomes among patients who have received previous treatment for microsatellite instability-high (MSI-H) tumors. OBJECTIVE To evaluate the antitumor activity of pembrolizumab therapy vs chemotherapy among patients with MSI-H advanced gastric or gastroesophageal junction (G/GEJ) cancer regardless of the line of therapy in which it was received. DESIGN, SETTING, AND PARTICIPANTS This post hoc analysis of the phase 2 KEYNOTE-059 (third-line treatment or higher) single-arm trial and the phase 3 KEYNOTE-061 (second-line treatment) and KEYNOTE-062 (first-line treatment) randomized trials included patients with advanced G/GEJ cancer from 52 sites in 16 countries enrolled in KEYNOTE-059, 148 sites in 30 countries enrolled in KEYNOTE-061, and 200 sites in 29 countries enrolled in KEYNOTE-062. Patients were enrolled from March 2, 2015, to March 26, 2016, in KEYNOTE-059; from June 4, 2015, to July 26, 2016, in KEYNOTE-061; and from September 18, 2015, to May 26, 2017, in KEYNOTE-062, with data cutoff dates of August 8, 2018; October 26, 2017; and March 26, 2019; respectively. INTERVENTIONS Pembrolizumab monotherapy in KEYNOTE-059, pembrolizumab monotherapy or chemotherapy (paclitaxel) in KEYNOTE-061, and pembrolizumab monotherapy, pembrolizumab plus chemotherapy (cisplatin and 5-fluorouracil or capecitabine), or chemotherapy alone in KEYNOTE-062. MAIN OUTCOMES AND MEASURES Response was assessed centrally using Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1; MSI-H status was determined centrally by polymerase chain reaction testing. RESULTS At data cutoff, 7 of 174 patients (4.0%) in KEYNOTE-059, 27 of 514 patients (5.3%) in KEYNOTE-061, and 50 of 682 patients (7.3%) in KEYNOTE-062 had MSI-H tumors. Among those with MSI-H tumors, the median overall survival was not reached (NR) for pembrolizumab in KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 or for pembrolizumab plus chemotherapy in KEYNOTE-062. The median progression-free survival (PFS) for pembrolizumab was NR (95% CI, 1.1 months to NR) in KEYNOTE-059 and 17.8 months (95% CI, 2.7 months to NR) in KEYNOTE-061 (vs 3.5 months [95% CI, 2.0-9.8 months] for chemotherapy). In KEYNOTE-062, the median PFS was 11.2 months (95% CI, 1.5 months to NR) for pembrolizumab, NR (95% CI, 3.6 months to NR) for pembrolizumab plus chemotherapy, and 6.6 months (95% CI, 4.4-8.3 months) for chemotherapy. The objective response rate (ORR) for pembrolizumab was 57.1% in KEYNOTE-059 and 46.7%(vs 16.7% for chemotherapy) in KEYNOTE-061. In KEYNOTE-062, the ORR was 57.1% for pembrolizumab, 64.7% for pembrolizumab plus chemotherapy, and 36.8% for chemotherapy. CONCLUSIONS AND RELEVANCE Findings from this study indicate that MSI-H status may be a biomarker for pembrolizumab therapy among patients with advanced G/GEJ cancer regardless of the line of therapy in which it was received. | - |
dc.language | 영어 | - |
dc.publisher | American Medical Association | - |
dc.title | Assessment of Pembrolizumab Therapy for the Treatment of Microsatellite Instability-High Gastric or Gastroesophageal Junction Cancer Among Patients in the KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 Clinical Trials | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 방영주 | - |
dc.identifier.doi | 10.1001/jamaoncol.2021.0275 | - |
dc.citation.journaltitle | JAMA oncology | - |
dc.identifier.wosid | 000635985600004 | - |
dc.identifier.scopusid | 2-s2.0-85103576191 | - |
dc.citation.endpage | 902 | - |
dc.citation.number | 6 | - |
dc.citation.startpage | 895 | - |
dc.citation.volume | 7 | - |
dc.identifier.sci | 000635985600004 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
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