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Renaud Sabatier,Véronique Diéras,Xavier Pivot,Etienne Brain,Henri Roché,Jean-Marc Extra,Audrey Monneur,Magali Provansal,Carole Tarpin,François Bertucci,Patrice Viens,Christophe Zemmour,Anthony Gonçalv 대한암학회 2018 Cancer Research and Treatment Vol.50 No.4
Purpose Eribulin is approved for advanced breast cancers refractory to anthracyclines and taxanes. Efficacy according to sensitivity to previous therapies has been poorly explored. Materials and Methods Safety data were collected prospectively and we retrospectively collected efficacy data from the five French centres that participated in the Eribulin E7389-G000-398 expanded access program. Our main objectives were exploration of safety and analysis of eribulin efficacy (progression- free survival [PFS] and overall survival [OS]) according to sensitivity to the last microtubule-inhibiting agent administered. Results Median eribulin treatment duration was 3.3 months for the 250 patients included in this prospective single-arm study. Two hundreds and thirty-nine patients (95.6%) experienced an adverse event (AE) related to treatment including 129 (51.6%) with grade 3 AEs. The most frequently observed toxicities were cytopenias (59.6% of included patients), gastrointestinal disorders (59.2%), and asthenia (56.4%). The most frequent grade 3-4 AE was neutropenia (37.2% with 4.8% febrile neutropenia). Median PFS and OS were 4.6 and 11.8 months, respectively. Patients classified as responders to the last microtubule-inhibiting therapy had a longer OS (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.51 to 0.94; p=0.017), and tended to display a better PFS (HR, 0.78; 95% CI, 0.58 to 1.04; p=0.086). OS improvement was still significant in multivariate analysis (adjusted HR, 0.53; 95% CI, 0.35 to 0.79; p=0.002). Conclusion This work based on a prospective study suggests that identification of patients likely to be more sensitive to eribulin could be based on their previous response to microtubules inhibitors.
Thomas, Eva S.,Gomez, Henry L.,Li, Rubi K.,Chung, Hyun-Cheol,Fein, Luis E.,Chan, Valorie F.,Jassem, Jacek,Pivot, Xavier B.,Klimovsky, Judith V.,de Mendoza, Fernando Hurtado,Xu, Binghe,Campone, Mario,L Grune & Stratton 2007 Journal of clinical oncology Vol.25 No.33
<B>Purpose</B><P>Effective treatment options for patients with metastatic breast cancer resistant to anthracyclines and taxanes are limited. Ixabepilone has single-agent activity in these patients and has demonstrated synergy with capecitabine in this setting. This study was designed to compare ixabepilone plus capecitabine versus capecitabine alone in anthracycline-pretreated or -resistant and taxane-resistant locally advanced or metastatic breast cancer.</P><B>Patients and Methods</B><P>Seven hundred fifty-two patients were randomly assigned to ixabepilone 40 mg/m<SUP>2</SUP>intravenously on day 1 of a 21-day cycle plus capecitabine 2,000 mg/m<SUP>2</SUP>orally on days 1 through 14 of a 21-day cycle, or capecitabine alone 2,500 mg/m<SUP>2</SUP>on the same schedule, in this international phase III study. The primary end point was progression-free survival evaluated by blinded independent review.</P><B>Results</B><P>Ixabepilone plus capecitabine prolonged progression-free survival relative to capecitabine (median, 5.8 v 4.2 months), with a 25% reduction in the estimated risk of disease progression (hazard ratio, 0.75; 95% CI, 0.64 to 0.88; P = .0003). Objective response rate was also increased (35% v 14%; P < .0001). Grade 3/4 treatment-related sensory neuropathy (21% v 0%), fatigue (9% v 3%), and neutropenia (68% v 11%) were more frequent with combination therapy, as was the rate of death as a result of toxicity (3% v 1%, with patients with liver dysfunction [≥ grade 2 liver function tests] at greater risk). Capecitabine-related toxicities were similar for both treatment groups.</P><B>Conclusion</B><P>Ixabepilone plus capecitabine demonstrates superior efficacy to capecitabine alone in patients with metastatic breast cancer pretreated or resistant to anthracyclines and resistant to taxanes.</P>