title: Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy.
abstract: Based on data from two multicenter, phase III clinical trials (Studies 301 and 305), eribulin (a microtubule dynamics inhibitor) is indicated in the European Union (EU) for patients with locally advanced or metastatic breast cancer (MBC) after ≥1 prior chemotherapy for advanced disease, including an anthracycline and a taxane in either the adjuvant or metastatic setting. Data from Studies 305 and 301 were pooled to investigate the efficacy of eribulin in various subgroups of patients who matched the EU label, including those with human epidermal growth factor receptor 2 (HER2)-negative and triple-negative disease.
  
  
  
  In Study 305 (NCT00388726), patients were randomized 2:1 to eribulin mesylate 1.4 mg/m(2) (equivalent to eribulin 1.23 mg/m(2) [expressed as free base]) intravenously on days 1 and 8 every 21 days] or treatment of physician's choice after 2-5 prior chemotherapies (≥2 for advanced disease), including an anthracycline and a taxane (in early/advanced setting). In Study 301 (NCT00337103), patients were randomized 1:1 to eribulin (as above) or capecitabine (1.25 g/m(2) orally twice daily on days 1-14 every 21 days) following ≤3 prior chemotherapies (≤2 for advanced disease), including an anthracycline and a taxane. Efficacy end points were investigated in the intent-to-treat population and subgroups, pooled as discussed above.
  
  
  
  Overall, 1644 patients were included (eribulin: 946; control: 698); baseline characteristics were well matched. Overall survival was significantly longer with eribulin versus control (P < 0.01), as were progression-free survival and clinical benefit rate (both P < 0.05). Significant survival benefits with eribulin versus control were observed in a wide range of patient subgroups, including HER2-negative or triple-negative disease (all P < 0.05).
  
  
  
  Our findings underline the survival benefit achieved by eribulin used according to EU label in the overall MBC population and in various subgroups of interest, including patients with HER2-negative and triple-negative disease.
authors.affiliation: Department of Oncology, Centre Hospitalier Universitaire de Besançon, Service d'Oncologie Médicale, Besançon cedex, France xavierpivot@univ-fcomte.fr.
authors.forename: X
authors.initials: X
authors.lastname: Pivot
authors.affiliation: National Centre for Tumour Diseases, Heidelberg, Department of Gynecologic Oncology, University Hospital, Heidelberg, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Marmé
authors.affiliation: 3rd Medical Department-Centre for Oncology and Haematology, Ludwig Boltzmann Institute for Applied Cancer Research (LBI-ACR VIEnna)-LB Cluster Translational Oncology, Kaiser Franz Josef-Spital, Vienna 3. Med. Abt.-Zentrum für Onkologie und Hämatologie, Ludwig Boltzmann Institut für angewandte Krebsforschung (LBI-ACR VIEnna), Kaiser Franz Josef-Spital, Wien, Austria.
authors.forename: R
authors.initials: R
authors.lastname: Koenigsberg
authors.affiliation: Departments of Biostatistics, Oncology PCU.
authors.forename: M
authors.initials: M
authors.lastname: Guo
authors.affiliation: Oncology, Eisai Inc., Woodcliff Lake, USA.
authors.forename: E
authors.initials: E
authors.lastname: Berrak
authors.affiliation: Department of Medical Oncology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.
authors.forename: A
authors.initials: A
authors.lastname: Wolfer
mesh_terms: D000277:Adjuvants, Pharmaceutic; D018943:Anthracyclines / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001952:Bridged-Ring Compounds / Q000008:administration & dosage / Q000009:adverse effects; D017326:Clinical Trials, Phase III as Topic; D018572:Disease-Free Survival; D005260:Female; D005663:Furans / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007659:Ketones / Q000009:adverse effects / Q000627:therapeutic use*; D009362:Neoplasm Metastasis; D016032:Randomized Controlled Trials as Topic; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000037:antagonists & inhibitors / Q000235:genetics*; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D064726:Triple Negative Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D000095662:Polyether Polyketides
chemical_list: D000277:Adjuvants, Pharmaceutic; D018943:Anthracyclines; D000970:Antineoplastic Agents; D001952:Bridged-Ring Compounds; D005663:Furans; D007659:Ketones; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; C080625:taxane; C508053:ERBB2 protein, human; C490954:eribulin; D000095662:Polyether Polyketides
keywords: clinical trial; eribulin; metastatic breast cancer; pooled analysis; survival; triple-negative breast cancer