Gemcitabine plus eribulin for the first-line treatment of cisplatin-ineligible patients with metastatic urothelial carcinoma is well tolerated and compares favorably with other regimens with regard to treatment response and survival, investigators concluded.

In a phase 2 trial sponsored by the National Cancer Institute Cancer Therapy Evaluation Program, Sarmad Sadeghi, MD, PhD, of the University of Southern California’s Norris Comprehensive Cancer Center in Los Angeles, and colleagues enrolled 24 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, the current standard of care for the first-line treatment of metastatic urothelial carcinoma. Patients had a median age of 73 years (range 62 to 88 years). Patients received gemcitabine 1000 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. Patients completed a median of 4 cycles.

Of the 24 patients, 5 ended treatment before radiologic disease evaluation for various reasons, Dr Sadeghi’s team reported in the Journal of Clinical Oncology. The observed objective response rate was 50%. One patient had a confirmed complete response, 11 had a confirmed partial response, 6 had stable disease, and 1 experienced progressive disease at the time of the first evaluation as their best response. The median overall survival time was 11.9 months and the median progression-free survival time was 5.3 months, according to the investigators.

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Dr Sadeghi’s team evaluated all 24 patients for toxicity. Fatigue (83%) neutropenia (79%), anemia (63%), alopecia (50%), elevated aspartate transaminase (50%), and constipation, nausea, and thrombocytopenia (42%) were the most common treatment-related toxicities.

Immunotherapy became available to patients with metastatic urothelial carcinoma in April 2017, as their trial completed accrual, the authors noted. “Unfortunately, immunotherapy, although an important step in the right direction, was not as effective as it was hoped to be,” Dr Sadeghi and his collaborators wrote. “With objective response rates of 23% to 29%, the need for a more effective first-line and salvage option remains.”

Reference

Sadeghi S, Groshen SG, Tsao-Wei DD, et al. Phase II California Cancer Consortium Trial of Gemcitabine-Eribulin Combination in Cisplatin-Ineligible Patients With Metastatic Urothelial Carcinoma: Final Report (NCI-9653). J Clin Oncol 2019. doi: 10.1200/JCO.19.00861