Gemcitabine-eribulin offers an alternative in metastatic urothelial cancer

  • Sadeghi S & al.
  • J Clin Oncol
  • 7 Aug 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • First-line gemcitabine+eribulin is well tolerated and shows an overall response rate (ORR) of 50% in cisplatin-ineligible patients with metastatic urothelial carcinoma.

Why this matters

  • The response rate was higher than standard-of-care gemcitabine-carboplatin and immunotherapy.
  • Overall response, OS, and PFS with gemcitabine+eribulin were higher than those previously reported with eribulin monotherapy.

Study design

  • Phase 2 study of 24 cisplatin-ineligible patients (performance status, 0-2; median age, 73 years) with treatment-naive advanced/recurrent metastatic urothelial bladder cancer not amenable to surgery received gemcitabine+eribulin.
  • Funding: Pfizer; MSD.

Key results

  • Median number of cycles, 4.
  • Median follow-up, 16.8 months.
  • Confirmed ORR was 50% (95% CI, 29%-71%).
  • Median duration of response was 3.1 months.
  • Median OS was 11.9 (95% CI, 5.6-20.4) months; median PFS was 5.3 (95% CI, 4.5-6.7) months.
  • Common treatment-related toxicities included fatigue (83%), neutropenia (79%), anemia (63%), alopecia (50%), elevated aspartate aminotransferase (50%).
  • 13% of patients experienced febrile neutropenia.
  • 2 deaths were reported.

Limitations

  • Single-group, small study.