Cisplatin-ineligibility was defined as a creatinine clearance <60 ml/min and ≥30ml/min, grade 2 or above hearing loss and grade 2 or higher neuropathy. The study enrolled twenty-four patients between 2015 and 2017. Subjects received 1,000 mg/m2 of gemcitabine intravenously 30 minutes before 1.4 mg/m2 eribulin on day 1 and 8 in 21-day cycles until progression or unacceptable toxicity. The median age of enrolled patients was 73 years (range 62-88 years). Most patients had a performance status of 0 or 1. The majority of patients (16/24) had lymph node metastases, and several patients had visceral metastases.
The observed objective response rate was 50% (95% CI, 29% to 71%) in 12/24 patients. The median overall survival was 11.9 months (95% CI, 5.6 to 20.4 months), and median progression-free survival was 5.3 months (95% CI, 4.5 to 6.7 months). Common toxicities included fatigue (83% of patients), neutropenia (79%), anemia (63%), alopecia (50%), elevated AST (50%), constipation, nausea, and thrombocytopenia (42% each).
This study demonstrated the efficacy of the combination of gemcitabine-eribulin in cisplatin-ineligible metastatic urothelial cancer patients. Prospective trials comparing the efficacy of carboplatin-based regimens, immunotherapy, and gemcitabine-eribulin combinations are needed to determine the optimal treatment regimen.
Written by: Bishoy M. Faltas, MD, Director of Bladder Cancer Research, Englander Institute for Precision Medicine, Weill Cornell Medicine
1. Sadeghi, Sarmad, Susan G. Groshen, Denice D. Tsao-Wei, Rahul Parikh, Amir Mortazavi, Tanya B. Dorff, Cheryl Kefauver et al. "Phase II California Cancer Consortium Trial of Gemcitabine-Eribulin Combination in Cisplatin-Ineligible Patients With Metastatic Urothelial Carcinoma: Final Report (NCI-9653)." Journal of Clinical Oncology (2019): JCO-19.
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