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Efficacy of Sequential Ipilimumab Monotherapy versus Best Supportive Care for Unresectable Locally Advanced/Metastatic Gastric or Gastroesophageal Junction Cancer

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dc.contributor.author조재용-
dc.date.accessioned2018-07-20T08:25:02Z-
dc.date.available2018-07-20T08:25:02Z-
dc.date.issued2017-
dc.identifier.issn1078-0432-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/161165-
dc.description.abstractPurpose: 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.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherAmerican Association for Cancer Research-
dc.relation.isPartOfCLINICAL CANCER RESEARCH-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.titleEfficacy of Sequential Ipilimumab Monotherapy versus Best Supportive Care for Unresectable Locally Advanced/Metastatic Gastric or Gastroesophageal Junction Cancer-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Internal Medicine-
dc.contributor.googleauthorYung-Jue Bang-
dc.contributor.googleauthorJae Yong Cho-
dc.contributor.googleauthorYeul Hong Kim-
dc.contributor.googleauthorJin Won Kim-
dc.contributor.googleauthorMaria Di Bartolomeo-
dc.contributor.googleauthorJaffer A. Ajani-
dc.contributor.googleauthorKensei Yamaguchi-
dc.contributor.googleauthorAgnes Balogh-
dc.contributor.googleauthorTeresa Sanchez-
dc.contributor.googleauthorMarkus Moehler-
dc.identifier.doi10.1158/1078-0432.CCR-17-0025-
dc.contributor.localIdA03899-
dc.relation.journalcodeJ00564-
dc.identifier.pmid28655793-
dc.identifier.urlhttp://clincancerres.aacrjournals.org/content/23/19/5671.long-
dc.contributor.alternativeNameCho, Jae Yong-
dc.contributor.affiliatedAuthorCho, Jae Yong-
dc.citation.volume23-
dc.citation.number19-
dc.citation.startPage5671-
dc.citation.endPage5678-
dc.identifier.bibliographicCitationCLINICAL CANCER RESEARCH, Vol.23(19) : 5671-5678, 2017-
dc.identifier.rimsid61090-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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