(Urothelial Carcinoma) Is Gemcitabine Plus Eribulin Effective?

• September 10, 2019
• Reading time: 2 minutes

On August 7, 2019, Sarmad Sadeghi published in the Journal of Clinical Oncology the Phase 2 trial results: "Efficacy and safety of gemcitabine plus eribulin in platinum-ineligible patients with metastatic urothelial carcinoma."

Trial Design

This trial enrolled patients with platinum-ineligible metastatic urothelial carcinoma (defined as creatinine clearance <60 mL/min, or Grade 2 neurotoxicity or hearing impairment). Treatment was gemcitabine 1000 mg/m² + eribulin 1.4 mg/m² on Days 1 and 8 of each 21-day cycle. Primary endpoint: ORR. Secondary endpoints: PFS, OS.

Background: Gemcitabine plus carboplatin and immune checkpoint inhibitors are standard treatments for cisplatin-ineligible metastatic urothelial carcinoma. However, the FDA restricted the use of immune checkpoint inhibitors as first-line therapy in patients with low PD-L1 expression. This trial therefore evaluated gemcitabine plus eribulin in cisplatin-ineligible metastatic urothelial carcinoma.

Patient Characteristics

• Median age: 73 years (range 62–88)
  • <70 years: 46% | ≥70 years: 54%
• Sex: Male 17% / Female 83%
• Race: White 92% / Hispanic 4% / Asian 4%
• Disease: Locally advanced 21% / Metastatic 79%
• ECOG performance status: 0 (46%) / 1 (46%) / 2 (8%)
• Baseline eGFR: ≥60 mL/min: 25% / <60 mL/min: 75%

Efficacy Results

• ORR (primary endpoint): 50% (complete response 4%, partial response 46%)
• Median OS: 11.9 months
• Median PFS: 5.3 months

Safety Profile

Most common adverse events: fatigue (83%), neutropenia (79%), anemia (63%), alopecia (50%), AST elevation (50%), constipation (42%), nausea (42%), thrombocytopenia (42%)

Most common Grade 3–4 adverse events: neutropenia (63%), anemia (29%), fatigue (29%)

Conclusions

Based on the Phase 2 trial results, Sarmad Sadeghi concluded that gemcitabine plus eribulin improved ORR, PFS, and OS in platinum-ineligible patients with metastatic urothelial carcinoma.

Source: 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 Aug 7.

Tags: #UrothelialCarcinoma

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