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Combo Therapy Promising for Cisplatin-Ineligible Metastatic Urothelial Cancer
Results from a phase 2 trial show that gemcitabine–eribulin is a favorable combination treatment for cisplatin-ineligible patients with metastatic urothelial cancer (J Clin Oncol. 2019 Aug 7. Epub ahead of print)
“Patients with metastatic urothelial carcinoma are often ineligible for cisplatin-based treatments,” Sarmad Sadeghi, MD, PhD, Keck School of Medicine, University of Southern California, Los Angeles, and his fellow investigators stated.
Thus, to determine whether a gemcitabine–eribulin combination regimen is a tolerable and efficient option for cisplatin-ineligible patients with metastatic urothelial carcinoma, Dr Sadeghi et al examined 24 patients (median age, 73 years) who received the therapy between June 2015 and March 2017.
Gemcitabine 1000 mg/m2 was administered followed by eribulin 1.4 mg/m2 on days 1 and 8, repeated in 21-day cycles, until disease progression or unacceptable toxicity occurred. The median number of cycles patients received was 4.
Dr Sadeghi and colleagues used a Simon 2-stage phase 2 study design to distinguish between RECIST, version 1.1 objective response rates (ORRs) of 20% versus 50%.
Ultimately, the ORR was 50% (95% CI, 29%-71%), median overall survival was 11.9 months (95% CI, 5.6-20.4 months), and median progression-free survival was 5.3 months (95% CI, 4.5-6.7 months).
Frequently reported treatment-related toxicities included fatigue (83% of patients), neutropenia (79%), anemia (63%), alopecia (50%), and elevated aspartate aminotransferase levels (50%).
“Gemcitabine-eribulin treatment response and survival for cisplatin-ineligible patients compare favorably to other regimens,” concluded Dr Sadeghi and co-investigators, adding that further research is required.—Kaitlyn Manasterski
