Gemcitabine/Eribulin in Cisplatin-Ineligible Metastatic Urothelial Carcinoma


Key Points

  • Objective response was observed in 50% of patients.
  • Median overall survival was 11.9 months.

In the final analysis from a phase II California Cancer Consortium trial (NCI-9653) reported in the Journal of Clinical Oncology, Sadeghi et al found the combination of gemcitabine and eribulin showed activity in cisplatin-ineligible patients with metastatic urothelial carcinoma.

Study Details

The study included 24 evaluable patients with previously untreated advanced or recurrent metastatic urothelial carcinoma of the bladder, ureter, or urethra not amenable to curative surgery who were also not candidates for cisplatin-based therapy. Patients were enrolled between June 2015 and March 2017 and received gemcitabine 1,000 mg/m2 followed by eribulin 1.4 mg/m2 on days 1 and 8 of 21-day cycles until progression or unacceptable toxicity. Patients had a median age of 73 years (range = 62–88 years).

Treatment Outcomes

Patients received a median of four treatment cycles (range = 1–16). Objective response was observed in 12 patients (50%), with stable disease observed in an additional 6 patients (25%). Median duration of response was 3.1 months, with four responses lasting more than 6 months. Median progression-free survival was 5.3 months and median overall survival was 11.9 months.

Adverse Events

The most common treatment-related adverse events of any grade were fatigue (83%), neutropenia (79%), anemia (63%), alopecia (50%), elevated aspartate transaminase (50%), constipation (42%), nausea (42%), and thrombocytopenia (42%). The most common treatment-related grade 3 or 4 toxicities were neutropenia (63%), anemia (29%), and fatigue (29%).

The investigators concluded, “Gemcitabine/eribulin treatment response and survival for cisplatin-ineligible patients compare favorably to other regimens. Additional research is needed.”

Sarmad Sadeghi, MD, PhD, of the University of Southern California Norris Comprehensive Cancer, is the corresponding author for the Journal of Clinical Oncology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.