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
Journal
Annals of Oncology
Journal Volume
28
Journal Issue
9
Pages
2241-2247
Date Issued
2017
Author(s)
Katakami N
Felip E
Spigel D.R
Kim J.-H
Olivo M
Guo M
Nokihara H
Iannotti N
Satouchi M
Barlesi F.
Abstract
Background: Eribulin is a microtubule dynamics inhibitor with a novel mechanism of action. This phase 3 study aimed to compare overall survival (OS) in patients with heavily pretreated non-small cell lung cancer (NSCLC) receiving eribulin to treatment of physician's choice (TPC). Patients and methods: Patients with advanced NSCLC who had received?2 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 OS. 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 OS for eribulin and TPC was the same: 9.5 months [hazard ratio (HR): 1.16; 95% confidence interval: 0.95-1.41; P=0.13]. Progression-free survival for eribulin and TPC was 3.0 and 2.8 months, respectively (HR: 1.09; 95% confidence interval: 0.90-1.32; P=0.39). 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 sensory 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 NSCLC. ? The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Subjects
Chemotherapy; Eribulin; Non-small cell lung cancer; Phase 3
SDGs
Other Subjects
docetaxel; eribulin; gemcitabine; pemetrexed; vinorelbine tartrate; antineoplastic agent; eribulin; furan derivative; ketone; adult; aged; alopecia; anemia; Article; asthenia; cancer control; constipation; controlled study; coughing; diarrhea; drug efficacy; drug response; drug safety; dyspnea; fatigue; female; fever; headache; human; leukopenia; major clinical study; malaise; male; multicenter study; myalgia; nausea; neutropenia; non small cell lung cancer; overall survival; peripheral edema; phase 3 clinical trial; priority journal; progression free survival; randomized controlled trial; sensory neuropathy; stomatitis; very elderly; vomiting; clinical trial; lung tumor; middle aged; non small cell lung cancer; pathology; survival analysis; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Non-Small-Cell Lung; Female; Furans; Humans; Ketones; Lung Neoplasms; Male; Middle Aged; Survival Analysis
Publisher
Oxford University Press
Type
journal article