Sadeghi S, Groshen SG, Tsao-Wei DD, et al. - Given the frequent ineligibility of patients with metastatic urothelial carcinoma for cisplatin-based treatments, a National Cancer Institute Cancer Therapy Evaluation Program–sponsored trial was conducted to determine the tolerability and efficacy of a gemcitabine-eribulin combination in this population. Creatinine clearance less than 60 mL/min (but ≥ 30 mL/min), grade 2 neuropathy, or grade 2 hearing loss defined cisplatin ineligibility. Twenty-four patients with treatment-naïve advanced or recurrent metastatic urothelial carcinoma of the bladder, ureter, or urethra not amenable to curative surgery and not candidates for cisplatin-based therapy were provided treatment with gemcitabine 1,000 mg/m² intravenously followed by eribulin 1.4 mg/m², both on days 1 and 8, repeated in 21-day cycles until progression or unacceptable toxicity. The confirmed response was observed in 12 of 24 patients; the observed objective response rate was 50%. Median overall survival and median progression-free survival was 11.9 months (95% CI, 5.6 to 20.4 months) and 5.3 months (95% CI, 4.5 to 6.7 months), respectively. Treatment-related toxicities comprised fatigue (83% of patients), neutropenia (79%), anemia (63%), alopecia (50%), elevated AST (50%), and constipation, nausea, and thrombocytopenia (42% each). Outcomes suggest that compared with other regimens, gemcitabine-eribulin treatment response and survival were favorable for cisplatin-ineligible patients.