A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin to Treatment of Physician’s Choice in Patients With Advanced Non−Small Cell Lung Cancer

Abstract

Background: Eribulin is a microtubule dynamics inhibitor with a novel mechanism of action. This phase 3 study aimed to compare overall survival in patients with heavily pretreated non–small cell lung cancer receiving eribulin to treatment of physician's choice (TPC).Patients and methods: Patients with advanced non–small cell lung cancer who had received ≥ two prior therapies, including platinum-based doublet and epidermal growth factor receptor tyrosine kinase inhibitor, were randomly assigned to receive eribulin or TPC (gemcitabine, pemetrexed, vinorelbine, docetaxel). The primary endpoint was overall survival. Secondary endpoints were progression-free survival and objective response rate.Results: Five hundred and forty patients were randomized to either eribulin (n=270) or TPC (n=270). Median overall survival for eribulin and TPCwas the same: 9.5 months (hazard ratio [HR]: 1.16; 95% CI: 0.95–1.41; P=.13). Progression-free survival for eribulin and TPC was 3.0 and 2.8 months, respectively (HR: 1.09; 95% CI: 0.90–1.32; P=.39). The objective response rate was 12% for eribulin and 15% for TPC. Clinical benefit rate (eribulin, 57%; TPC, 55%) and disease control rate (eribulin, 63%; TPC, 58% were similar between treatment arms. The most common adverse event was neutropenia, which occurred in 57% of eribulin patients and 49% of TPC patients at all grades. Other non-hematologic side effects were manageable and similar in both groups except for peripheral neuropathy (all grades; eribulin, 16%; TPC, 9%).Conclusion: This phase 3 study did not demonstrate superiority of eribulin over TPC with regard to overall survival. However, eribulin does show activity in the third-line setting for non–small cell lung cancer.

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