Highlights
- •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.
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).
Keywords
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Article info
Publication history
Published online: October 24, 2019
Accepted:
August 18,
2019
Received in revised form:
June 22,
2019
Received:
April 14,
2019
Identification
Copyright
© 2019 Elsevier Ltd. All rights reserved.
ScienceDirect
Access this article on ScienceDirectLinked Article
- Is it time to redefine cisplatin ineligibility in metastatic urothelial cancer?European Journal of CancerVol. 127
- PreviewCisplatin-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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