A phase III trial of exemestane plus bevacizumab maintenance therapy in patients with metastatic breast cancer after first-line taxane and bevacizumab: a GINECO group study |
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| Affiliation: | 1. Department of Medical Oncology, Centre Léon Bérard, Lyon;2. CNRS UMR5286, Cancer Research Center of Lyon, Lyon;3. Department of Medical Oncology, Centre Antoine Lacassagne, Nice;4. Department of Medical Oncology, Clinique de la Sauvegarde, Lyon;5. Direction of Clinical Research and Innovation, Centre Léon Bérard, Lyon;6. Department of Medical Oncology, Centre Hospitalier de Senlis, Senlis;7. Department of Medical Oncology, Hôpital Mont-De-Marsan, Mont-De-Marsan;8. Department of Medical Oncology, CHU Dupuytren, Limoges;9. Department of Medical Oncology, Institut Curie, Paris;10. Department of Medical Oncology, Hôpital Privé Jean Mermoz, Lyon;11. Department of Medical Oncology, Hôpitaux Drôme Nord, Site de Romans, Romans-sur-Isère;12. Department of Medical Oncology, Hôpital Fleyriat, Bourg-en Bresse;13. Department of Medical Oncology, Centre Hospitalier de la Région d''Annecy, Pringy;14. Department of Medical Oncology, Institut Jean Godinot, Reims;15. Department of Medical Oncology, Clinique de l''Union, Saint-Jean;16. Department of Medical Oncology, Centre Paul Strauss, Strasbourg;17. Department of Medical Oncology, Centre Hospitalier la Dracénie, Draguignan;18. Department of Medical Oncology, Oracle, Centre d''Oncologie de Gentilly, Nancy;19. Department of Medical Oncology, Centre Hospitalier Bretagne Atlantique, Vannes;20. Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Site Hôtel-Dieu, Paris, France |
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| Abstract: | BackgroundMaintenance strategies beyond response or tumor stabilization with first-line chemotherapy in metastatic breast cancer (MBC) have not been extensively studied. Endocrine therapy combined with continued bevacizumab may be a helpful option for estrogen receptor (ER)-positive MBC.Patients and methodsIn this prospective, open-label, phase III study, patients with histologically confirmed ER-positive, HER2-negative MBC and non-progressive disease after 16–24 weeks of taxane plus bevacizumab (T + BEV) were randomized to continuation of T + BEV or maintenance bevacizumab plus exemestane (E + BEV). The primary end point was progression-free survival (PFS) from randomization. To have 80% power to detect an improvement in the 6-month PFS rate (PFS6m) from 50% to 65%, 186 assessable patients were needed for a total of 141 PFS events. An interim analysis was planned after 40% of the required events.ResultsThe interim analysis with 98 patients showed that the probability of reaching a statistically significant improvement in PFS by the end of the study was only 7%. This led the Independent Data and Monitoring Committee to recommend termination of patient enrollment. After a median of 21-month follow-up of all randomized patients (117 in total), PFS6m from randomization was 67.2% [95% confidence interval (CI) 53.6–77.7] with T + BEV and 55.2% (95% CI 41.5–66.9) with E + BEV [hazard ratio (HR): 1.0, 95% CI 0.7–1.5, P = 0.998]. Median PFS from BEV initiation was 12.5 and 12.3 months in the T + BEV and E + BEV arms, respectively. In the T + BEV arm, taxane was prematurely stopped for the majority of patients (94.9%), mainly due to toxicity (49.2%). Updated data after 35 months' median follow-up showed death rates of 44% and 55% in T + BEV and E + BEV arms, respectively.ConclusionIn this trial, maintenance therapy with E + BEV in ER-positive, HER2-negative MBC patients with no evidence of progression after first-line T + BEV did not achieve longer PFS compared with continuation of T + BEV.ClinicalTrials.govNCT01303679 |
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