Phase II California Cancer consortium trial of gemcitabine-eribulin combination in cisplatin-ineligible patients with metastatic urothelial carcinoma: Final Report (NCI-9653)

Sarmad Sadeghi, Susan G. Groshen, Denice D. Tsao-Wei, Rahul Parikh, Amir Mortazavi, Tanya B. Dorff, Cheryl Kefauver, Christopher Hoimes, Laurence Doyle, David I. Quinn, Edward Newman, Primo N. Lara

Research output: Contribution to journalArticle

Abstract

PURPOSE Patients with metastatic urothelial carcinoma are often ineligible for cisplatin-based treatments. A National Cancer Institute Cancer Therapy Evaluation Program–sponsored trial assessed the tolerability and efficacy of a gemcitabine-eribulin combination in this population. METHODS 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 eligible. Cisplatin ineligibility was defined as creatinine clearance less than 60 mL/min (but $ 30 mL/min), grade 2 neuropathy, or grade 2 hearing loss. Treatment was 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. A Simon two-stage phase II trial design was used to distinguish between Response Evaluation Criteria in Solid Tumors, version 1.1 objective response rates of 20% versus 50%. RESULTS Between June 2015 and March 2017, 24 eligible patients with a median age of 73 years (range, 62 to 88 years) underwent therapy. Performance status of 0, 1, or 2 was seen in 11, 11, and two patients, respectively. Sites of disease included: lymph nodes, 16; lungs, nine; liver, seven; bladder, five; bones, two. Median number of cycles received was four (range, one to 16). Of 24 patients, 12 were confirmed responders; the observed objective response rate was 50% (95% CI, 29% to 71%). 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). The most common treatment-related any-grade toxicities were fatigue (83% of patients), neutropenia (79%), anemia (63%), alopecia (50%), elevated AST (50%), and constipation, nausea, and thrombocytopenia (42% each). CONCLUSION Gemcitabine-eribulin treatment response and survival for cisplatin-ineligible patients compare favorably to other regimens. Additional research is needed.

Original languageEnglish (US)
Pages (from-to)2682-2688
Number of pages7
JournalJournal of Clinical Oncology
Volume37
Issue number29
DOIs
StatePublished - Oct 10 2019

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Sadeghi, S., Groshen, S. G., Tsao-Wei, D. D., Parikh, R., Mortazavi, A., Dorff, T. B., Kefauver, C., Hoimes, C., Doyle, L., Quinn, D. I., Newman, E., & Lara, P. N. (2019). 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, 37(29), 2682-2688. https://doi.org/10.1200/JCO.19.00861