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Gemcitabine plus carboplatin versus gemcitabine plus oxaliplatin in cisplatin-unfit patients with advanced urothelial carcinoma: a randomised phase II study (COACH, KCSG GU10-16)

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dc.contributor.authorPark, Inkeun-
dc.contributor.authorKim, Bong-Seog-
dc.contributor.authorLim, Ho Yeong-
dc.contributor.authorKim, Hee-Jun-
dc.contributor.authorLee, Hyo Jin-
dc.contributor.authorChoi, Yoon Ji-
dc.contributor.authorPark, Kyong Hwa-
dc.contributor.authorLee, Kyung Hee-
dc.contributor.authorYoon, Shinkyo-
dc.contributor.authorHong, Bumsik-
dc.contributor.authorHong, Jun Hyuk-
dc.contributor.authorAhn, Hanjong-
dc.contributor.authorLee, Jae Lyun-
dc.date.available2020-04-06T06:37:38Z-
dc.date.created2020-04-02-
dc.date.issued2020-03-
dc.identifier.issn0959-8049-
dc.identifier.urihttps://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/26093-
dc.description.abstractPurpose: Gemcitabineeoxaliplatin (GEMOX) demonstrated mild toxicity and promising effectiveness in patients with advanced urothelial cell cancer (UCC). We investigated the activity and safety of first-line GEMOX compared with gemcitabine-carboplatin (GCb) in cisplatin-ineligible patients with advanced UCC. Methods: Treatment-naive, cisplatin-ineligible patients with advanced UCC were randomly assigned to GEMOX (gemcitabine 1000 mg/m(2), oxaliplatin 100 mg/m(2) on day 1 [D1] every 2 weeks) or GCb (1000 mg/m(2) of gemcitabine on D1 and D8 and carboplatin area under the curve of 4.5 mg/mL/min on D1 every 3 weeks). We evaluated the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS). Results: Between January 2011 and March 2017, 80 patients were enrolled; 39 and 40 patients were allocated to GCb and GEMOX arms, respectively. The ORR was 48.7% in the GCb arm and 55.0% in the GEMOX arm. The median follow-up duration was 37.8 months; the median PFS and OS in the GCb and GEMOX arms were 5.5 months (95% confidence interval [CI], 4.8 -6.2) vs. 4.4 months (95% CI, 2.7-6.1) and 9.1 months (95% CI, 5.2-13.0) vs. 11.0 months (95% CI, 6.9-15.0), respectively. >= Leucopenia, neutropenia and fatigue of >= grade III were significantly more common in the GCb arm (26% vs. 3%, P = 0.003; 33% vs. 10%, P = 0.014; 15% vs. 3%, P = 0.012), whereas any-grade neuropathy was more common in the GEMOX arm (8% vs. 60%). Conclusions: GEMOX showed similar efficacy with GCb and a favourable haematologic toxicity profile. GEMOX may be an additional chemotherapy option for patients with UCC ineligible for cisplatin-containing chemotherapy (C) 2019 Elsevier Ltd. All rights reserved.-
dc.language영어-
dc.language.isoen-
dc.publisherELSEVIER SCI LTD-
dc.relation.isPartOfEUROPEAN JOURNAL OF CANCER-
dc.subjectTRANSITIONAL-CELL CARCINOMA-
dc.subject1ST-LINE TREATMENT-
dc.subjectCANCER-
dc.subjectCOMBINATION-
dc.subjectMULTICENTER-
dc.subjectTRIAL-
dc.subjectCHEMOTHERAPY-
dc.subjectMETHOTREXATE-
dc.subjectVINBLASTINE-
dc.subjectDOXORUBICIN-
dc.titleGemcitabine plus carboplatin versus gemcitabine plus oxaliplatin in cisplatin-unfit patients with advanced urothelial carcinoma: a randomised phase II study (COACH, KCSG GU10-16)-
dc.typeArticle-
dc.type.rimsART-
dc.description.journalClass1-
dc.identifier.wosid000514572100019-
dc.identifier.doi10.1016/j.ejca.2019.08.034-
dc.identifier.bibliographicCitationEUROPEAN JOURNAL OF CANCER, v.127, pp.183 - 190-
dc.identifier.scopusid2-s2.0-85074427378-
dc.citation.endPage190-
dc.citation.startPage183-
dc.citation.titleEUROPEAN JOURNAL OF CANCER-
dc.citation.volume127-
dc.contributor.affiliatedAuthorPark, Inkeun-
dc.type.docTypeArticle-
dc.subject.keywordAuthorUrothelial cancer-
dc.subject.keywordAuthorCisplatin-unfit-
dc.subject.keywordAuthorOxaliplatin-
dc.subject.keywordAuthorCarboplatin-
dc.subject.keywordAuthorGemcitabine-
dc.subject.keywordPlusTRANSITIONAL-CELL CARCINOMA-
dc.subject.keywordPlus1ST-LINE TREATMENT-
dc.subject.keywordPlusCANCER-
dc.subject.keywordPlusCOMBINATION-
dc.subject.keywordPlusMULTICENTER-
dc.subject.keywordPlusTRIAL-
dc.subject.keywordPlusCHEMOTHERAPY-
dc.subject.keywordPlusMETHOTREXATE-
dc.subject.keywordPlusVINBLASTINE-
dc.subject.keywordPlusDOXORUBICIN-
dc.relation.journalResearchAreaOncology-
dc.relation.journalWebOfScienceCategoryOncology-
dc.description.journalRegisteredClassscie-
dc.description.journalRegisteredClassscopus-
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