Gemcitabine plus carboplatin versus gemcitabine plus oxaliplatin in cisplatin-unfit patients with advanced urothelial carcinoma: a randomised phase II study (COACH, KCSG GU10-16)
- Authors
- Park, Inkeun; Kim, Bong-Seog; Lim, Ho Yeong; Kim, Hee-Jun; Lee, Hyo Jin; Choi, Yoon Ji; Park, Kyong Hwa; Lee, Kyung Hee; Yoon, Shinkyo; Hong, Bumsik; Hong, Jun Hyuk; Ahn, Hanjong; Lee, Jae Lyun
- Issue Date
- 3월-2020
- Publisher
- ELSEVIER SCI LTD
- Keywords
- Urothelial cancer; Cisplatin-unfit; Oxaliplatin; Carboplatin; Gemcitabine
- Citation
- EUROPEAN JOURNAL OF CANCER, v.127, pp.183 - 190
- Indexed
- SCIE
SCOPUS
- Journal Title
- EUROPEAN JOURNAL OF CANCER
- Volume
- 127
- Start Page
- 183
- End Page
- 190
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/57514
- DOI
- 10.1016/j.ejca.2019.08.034
- ISSN
- 0959-8049
- Abstract
- Purpose: 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.
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