Efficacy of Sequential Ipilimumab Monotherapy versus Best Supportive Care for Unresectable Locally Advanced/Metastatic Gastric or Gastroesophageal Junction Cancer
DC Field | Value | Language |
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dc.contributor.author | Bang, Yung-Jue | - |
dc.contributor.author | Cho, Jae Yong | - |
dc.contributor.author | Kim, Yeul Hong | - |
dc.contributor.author | Kim, Jin Won | - |
dc.contributor.author | Di Bartolomeo, Maria | - |
dc.contributor.author | Ajani, Jaffer A. | - |
dc.contributor.author | Yamaguchi, Kensei | - |
dc.contributor.author | Balogh, Agnes | - |
dc.contributor.author | Sanchez, Teresa | - |
dc.contributor.author | Moehler, Markus | - |
dc.date.accessioned | 2021-09-03T00:15:50Z | - |
dc.date.available | 2021-09-03T00:15:50Z | - |
dc.date.created | 2021-06-19 | - |
dc.date.issued | 2017-10-01 | - |
dc.identifier.issn | 1078-0432 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/81952 | - |
dc.description.abstract | Purpose: Ipilimumab, a monoclonal antibody that blocks cytotoxic T-lymphocyte-associated protein-4 interactions, enhances T-cell activation and promotes tumor immunity. This phase II study evaluated the safety and efficacy of ipilimumab monotherapy versus best supportive care (BSC) among patients with advanced/metastatic gastric or gastroesophageal junction cancer who achieved at least stable disease with first-line chemotherapy. Experimental Design: Eligible patients were randomized to ipilimumab 10 mg/kg every 3 weeks for four doses, then 10 mg/kg every 12 weeks for up to 3 years, or BSC, which could include continuation of fluoropyrimidine until progression or toxicity. The primary endpoint was immune-related progression-free survival (irPFS); secondary endpoints included PFS by modified World Health Organization criteria and overall survival (OS). Results: Of 143 patients screened, 57 were randomized to each arm. irPFS with ipilimumab versus BSC was not improved 2.92 months, 95% confidence interval (CI), 1.61-5.16 vs. 4.90 months, 95% CI, 3.45-6.54, HR = 1.44; 80% CI, 1.09-1.91; P = 0.097], resulting in study cessation. At study closeout, which occurred 8 months after the interim analysis, the median OS durations were 12.7 months (95% CI, 10.5-18.9) and 12.1 months (95% CI, 9.3-not estimable), respectively. Grade 3/4 treatment-related adverse events occurred in 23% of ipilimumab-treated patients, in whom diarrhea (9%) and fatigue (5%) were most frequent, and in 9% of active BSC-treated patients. Conclusions: Although ipilimumab at 10 mg/kg was manageable, it did not improve irPFS versus BSC. However, comparable median OS of approximately 1 year and a favorable safety profile support the investigation of ipilimumab in combination with other therapies for advanced gastric cancer. (C) 2017 AACR. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | AMER ASSOC CANCER RESEARCH | - |
dc.subject | PHASE-III | - |
dc.subject | DOUBLE-BLIND | - |
dc.subject | OPEN-LABEL | - |
dc.subject | 1ST-LINE THERAPY | - |
dc.subject | ADENOCARCINOMA | - |
dc.subject | PLUS | - |
dc.subject | MULTICENTER | - |
dc.subject | COMBINATION | - |
dc.subject | CAPECITABINE | - |
dc.subject | PACLITAXEL | - |
dc.title | Efficacy of Sequential Ipilimumab Monotherapy versus Best Supportive Care for Unresectable Locally Advanced/Metastatic Gastric or Gastroesophageal Junction Cancer | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Yeul Hong | - |
dc.identifier.doi | 10.1158/1078-0432.CCR-17-0025 | - |
dc.identifier.scopusid | 2-s2.0-85032002887 | - |
dc.identifier.wosid | 000412160500003 | - |
dc.identifier.bibliographicCitation | CLINICAL CANCER RESEARCH, v.23, no.19, pp.5671 - 5678 | - |
dc.relation.isPartOf | CLINICAL CANCER RESEARCH | - |
dc.citation.title | CLINICAL CANCER RESEARCH | - |
dc.citation.volume | 23 | - |
dc.citation.number | 19 | - |
dc.citation.startPage | 5671 | - |
dc.citation.endPage | 5678 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.subject.keywordPlus | PHASE-III | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | 1ST-LINE THERAPY | - |
dc.subject.keywordPlus | ADENOCARCINOMA | - |
dc.subject.keywordPlus | PLUS | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | CAPECITABINE | - |
dc.subject.keywordPlus | PACLITAXEL | - |
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