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Exploratory subgroup analysis of patients with prior trastuzumab use in the ATTRACTION-2 trial: a randomized phase III clinical trial investigating the efficacy and safety of nivolumab in patients with advanced gastric/gastroesophageal junction cancer
DC Field | Value | Language |
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dc.contributor.author | 정현철 | - |
dc.contributor.author | 조재용 | - |
dc.date.accessioned | 2020-04-13T16:56:03Z | - |
dc.date.available | 2020-04-13T16:56:03Z | - |
dc.date.issued | 2020 | - |
dc.identifier.issn | 1436-3291 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/175570 | - |
dc.description.abstract | BACKGROUND: Data on immune checkpoint inhibitor efficacy in patients with human epidermal growth factor receptor 2-positive (HER2+) advanced gastric/gastroesophageal junction (G/GEJ) cancer are lacking. Because HER2 status was not captured in the ATTRACTION-2 trial, we used patients with prior trastuzumab use (Tmab+) as surrogate for HER2 expression status to evaluate the efficacy and safety of nivolumab as third- or later-line therapy in these patients. METHODS: In ATTRACTION-2, a randomized, double-blind, placebo-controlled, phase 3 multicenter trial, patients were randomized (2:1) to receive nivolumab (3 mg/kg) or placebo every 2 weeks until disease progression or toxicity requiring study discontinuation. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety were assessed. RESULTS: Of 493 enrolled patients, 81 (nivolumab, n = 59; placebo, n = 22) were Tmab+ and 412 (nivolumab, n = 271; placebo, n = 141) were Tmab-. In both groups, patients receiving nivolumab showed a longer median OS vs placebo (Tmab+, 8.3 [95% confidence interval, 5.3-12.9] vs 3.1 [1.9-5.3] months, hazard ratio, 0.38 [0.22-0.66]; P = 0.0006; Tmab-, 4.8 [4.1-6.0] vs 4.2 [3.6-4.9] months, 0.71 [0.57-0.88]; P = 0.0022). PFS was longer in both groups receiving nivolumab vs placebo (Tmab+, 1.6 [1.5-4.0] vs 1.5 [1.3-2.9] months, 0.49 [0.29-0.85]; P = 0.0111; Tmab-, 1.6 [1.5-2.4] vs 1.5 [1.5-1.5] months, 0.64 [0.51-0.80]; P = 0.0001). CONCLUSIONS: Nivolumab was efficacious and safe as third- or later-line therapy regardless of prior trastuzumab use in patients with advanced G/GEJ cancer. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Springer-Verlag Tokyo | - |
dc.relation.isPartOf | GASTRIC CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | Exploratory subgroup analysis of patients with prior trastuzumab use in the ATTRACTION-2 trial: a randomized phase III clinical trial investigating the efficacy and safety of nivolumab in patients with advanced gastric/gastroesophageal junction cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Taroh Satoh | - |
dc.contributor.googleauthor | Yoon-Koo Kang | - |
dc.contributor.googleauthor | Yee Chao | - |
dc.contributor.googleauthor | Min-Hee Ryu | - |
dc.contributor.googleauthor | Ken Kato | - |
dc.contributor.googleauthor | Hyun Cheol Chung | - |
dc.contributor.googleauthor | Jen-Shi Chen | - |
dc.contributor.googleauthor | Kei Muro | - |
dc.contributor.googleauthor | Won Ki Kang | - |
dc.contributor.googleauthor | Kun-Huei Yeh | - |
dc.contributor.googleauthor | Takaki Yoshikawa | - |
dc.contributor.googleauthor | Sang Cheul Oh | - |
dc.contributor.googleauthor | Li-Yuan Bai | - |
dc.contributor.googleauthor | Takao Tamura | - |
dc.contributor.googleauthor | Keun-Wook Lee | - |
dc.contributor.googleauthor | Yasuo Hamamoto | - |
dc.contributor.googleauthor | Jong Gwang Kim | - |
dc.contributor.googleauthor | Keisho Chin | - |
dc.contributor.googleauthor | Do-Youn Oh | - |
dc.contributor.googleauthor | Keiko Minashi | - |
dc.contributor.googleauthor | Jae Yong Cho | - |
dc.contributor.googleauthor | Masahiro Tsuda | - |
dc.contributor.googleauthor | Mitsunobu Tanimoto | - |
dc.contributor.googleauthor | Li-Tzong Chen | - |
dc.contributor.googleauthor | Narikazu Boku | - |
dc.identifier.doi | 10.1007/s10120-019-00970-8 | - |
dc.contributor.localId | A03773 | - |
dc.contributor.localId | A03899 | - |
dc.relation.journalcode | J00916 | - |
dc.identifier.eissn | 1436-3305 | - |
dc.identifier.pmid | 31087200 | - |
dc.subject.keyword | Gastric cancer | - |
dc.subject.keyword | Gastroesophageal junction cancer | - |
dc.subject.keyword | Nivolumab | - |
dc.subject.keyword | Trastuzumab | - |
dc.contributor.alternativeName | Chung, Hyun Cheol | - |
dc.contributor.affiliatedAuthor | 정현철 | - |
dc.contributor.affiliatedAuthor | 조재용 | - |
dc.citation.volume | 23 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 143 | - |
dc.citation.endPage | 153 | - |
dc.identifier.bibliographicCitation | GASTRIC CANCER, Vol.23(1) : 143-153, 2020 | - |
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