A Phase II Study of Eribulin Mesylate (E7389) in Patients With Advanced, Previously Treated Non–Small-Cell Lung Cancer

Abstract Introduction This open-label phase II study assessed the efficacy and tolerability of eribulin, a non- taxanemicrotubule dynamics inhibitor with novel mechanism of action, as monotherapy in patients who have advanced non–small-cell lung cancer (NSCLC). Patients and Methods Enrolled patients had progressed during or after platinum-based doublet chemotherapy. Initially, two patient cohorts ( taxane–pre-treated and taxane-naive) received eribulin mesylate(1.4 mg/m 2 ) as a 2- to 5-minute intravenous infusion on days 1, 8, and 15 of a 28-day cycle. To assess tolerability of a second dosing schedule, a cohort of taxane–pre-treated patients received eribulinon days 1 and 8 of a 21-day cycle. The primary endpoint was objective response rate (ORR) evaluated using Response Evaluation Criteriain Solid Tumors(RECIST) by independent radiographic review. Results One hundred three patients received eribulin. The ORR was 9.7% (all partial responses [PR]). Overall disease control rate (PR + stable disease) was 55.3%. Median duration of response, progression-free survival, and overall survival were 5.8, 3.4, and 9.4 months, respectively. The most common drug-related adverse events were neutropenia (54%; 49% grade 3/4); fatigue (49%; 11% grade 3, no grade 4); nausea (38%; 1% grade 3, no grade 4); alopecia (32%); anemia (29%, 4% grade 3/4) and neuropathy (23%; 2% grade 3, no grade 4). The 28-day schedule was associated with many dose delays, interruptions, or omissions due to neutropenia (day 15). The 21-day cycle was well-tolerated. Conclusions Eribulinmonotherapy administered on days 1 and 8 of a 21-day cycle is active and tolerated as second- or later-linechemotherapy for NSCLC.