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
| Autor: | M. Olivo, David R. Spigel, J. Kim, Enriqueta Felip, Nobuyuki Katakami, Nicholas Iannotti, Miyako Satouchi, Hiroshi Nokihara, Fabrice Barlesi, Matthew Guo, James Chih-Hsin Yang |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male 0301 basic medicine Oncology medicine.medical_specialty Lung Neoplasms Thoracic Tumors Phases of clinical research Antineoplastic Agents chemotherapy Vinorelbine 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Carcinoma Non-Small-Cell Lung Internal medicine medicine Clinical endpoint Humans Furans eribulin non-small cell lung cancer Aged Aged 80 and over business.industry Surrogate endpoint Original Articles Hematology Ketones Middle Aged Survival Analysis Gemcitabine 030104 developmental biology Pemetrexed chemistry Docetaxel phase 3 030220 oncology & carcinogenesis Female business medicine.drug Eribulin |
| Zdroj: | Annals of Oncology |
| ISSN: | 0923-7534 |
| Popis: | 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. Trial registration ID www.ClinicalTrials.gov ; NCT01454934. |
| Databáze: | OpenAIRE |
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