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, H.; Lee, Jae Lyun.
- Issue Date
- Mar-2020
- Publisher
- Elsevier Ltd
- Keywords
- Carboplatin; Cisplatin-unfit; Gemcitabine; Oxaliplatin; Urothelial cancer
- Citation
- European Journal of Cancer, v.127, pp 183 - 190
- Pages
- 8
- Journal Title
- European Journal of Cancer
- Volume
- 127
- Start Page
- 183
- End Page
- 190
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/39076
- DOI
- 10.1016/j.ejca.2019.08.034
- ISSN
- 0959-8049
1879-0852
- Abstract
- Purpose: Gemcitabine–oxaliplatin (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/m2, oxaliplatin 100 mg/m2 on day 1 [D1] every 2 weeks) or GCb (1000 mg/m2 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 (NCT01487915). © 2019 Elsevier Ltd
- Files in This Item
- There are no files associated with this item.
- Appears in
Collections - College of Medicine > College of Medicine > 1. Journal Articles
![qrcode](https://api.qrserver.com/v1/create-qr-code/?size=55x55&data=https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/39076)
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.