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- Title
A phase II study of eribulin mesylate (E7389) in patients with advanced, previously treated non-small-cell lung cancer.
- Authors
Spira AI; Iannotti NO; Savin MA; Neubauer M; Gabrail NY; Yanagihara RH; Zang EA; Cole PE; Shuster D; Das A; Spira, Alexander I; Iannotti, Nicholas O; Savin, Michael A; Neubauer, Marcus; Gabrail, Nashat Y; Yanagihara, Ronald H; Zang, Edith A; Cole, Patricia E; Shuster, Dale; Das, Asha
- Abstract
<bold>Introduction: </bold>This open-label phase II study assessed the efficacy and tolerability of eribulin, a non-taxane microtubule dynamics inhibitor with novel mechanism of action, as monotherapy in patients who have advanced non-small-cell lung cancer (NSCLC).<bold>Patients and Methods: </bold>Enrolled patients had progressed during or after platinum-based doublet chemotherapy. Initially, two patient cohorts (taxane-pre-treated and taxane-naïve) 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 eribulin on days 1 and 8 of a 21-day cycle. The primary endpoint was objective response rate (ORR) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) by independent radiographic review.<bold>Results: </bold>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.<bold>Conclusions: </bold>Eribulin monotherapy administered on days 1 and 8 of a 21-day cycle is active and tolerated as second- or later-line chemotherapy for NSCLC.
- Publication
Clinical Lung Cancer, 2012, Vol 13, Issue 1, p31
- ISSN
1525-7304
- Publication type
journal article
- DOI
10.1016/j.cllc.2011.06.010