Original Research| Volume 127, P183-190, March 2020

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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)

Published:October 24, 2019DOI:


      • Gemcitabine/carboplatin and gemcitabine/oxaliplatin had similar efficacy.
      • The toxicity profile differed between the two regimens.
      • Haematological toxicities and fatigue were more common in the gemcitabine/carboplatin arm.
      • Peripheral sensory neuropathy was more common in the gemcitabine/oxaliplatin arm.



      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.


      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).


      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%).


      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).


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      Linked Article

      • Is it time to redefine cisplatin ineligibility in metastatic urothelial cancer?
        European Journal of CancerVol. 127
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          Cisplatin-based combination chemotherapy remains the standard of care in first-line metastatic urothelial carcinoma (mUC) with response rates of approximately 50% and a median overall survival of 13–15 months [1]. However, due to renal dysfunction, poor performance status and comorbidities, many patients will be considered cisplatin-ineligible and be offered regimens such as gemcitabine and carboplatin (GCa). Although better tolerated, GCa is inferior to cisplatin-based regimens, underscoring the need for novel therapeutic strategies in the cisplatin-ineligible setting [2].
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