1. Randomized phase II–III study of bevacizumab in combination with chemotherapy in previously untreated extensive small-cell lung cancer: results from the IFCT-0802 trial†
- Author
-
Julien Mazieres, P.-J. Souquet, G. Jeannin, J. Tredaniel, P. Dumont, H. Le Caer, Gérard Zalcman, F. Vaylet, L. Petit, C. Dayen, B. Coudert, Virginie Westeel, M. Poudenx, P. Barre, F. Goutorbe, H. Monnot, P. Deguiral, C. Raspaud, S. Schneider, P. Chatellain, A. Lavole, A. Dixmier, D. Coëtmeur, D. Moro-Sibilot, J. Dauba, R. Gervais, E. Pichon, H. Berard, J.P. Oster, Olivier Molinier, Pierre-Jean Lamy, P. Mourlanette, Franck Morin, Fabrice Barlesi, Luc Thiberville, M. Zaegel, Yves Martinet, M. Derollez, J-P. Duhamel, Elisabeth Quoix, P. Romand, A. Renault, A. Langlais, H. Laize, Pascal Foucher, Debra S. Herman, H. Doubre, Jean-Louis Pujol, S. Dehette, J-P. Gury, N. Baize, P. Fournel, Département pneumologie et addictologie [Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Arnaud de Villeneuve, Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Service de Pneumologie - Oncologie Thoracique - Maladies Pulmonaires Rares [CHU Tenon], CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Strasbourg, Centre Hospitalier Le Mans (CH Le Mans), Service de pneumologie [Centre Hospitalier Lyon Sud - HCL], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Oncologie multidisciplinaire et innovations thérapeutiques [Hôpital Nord - APHM], Aix Marseille Université (AMU)- Hôpital Nord [CHU - APHM]-Assistance Publique - Hôpitaux de Marseille (APHM), Centre Hospitalier de la Dracénie [Draguignan], Clinique de pneumologie, CHU Grenoble, Institut de Cancérologie Lucien Neuwirth, CHU Saint-Etienne, CH Colmar, Centre Hospitalier Alpes Léman (CHAL), Centre hospitalier Jean Rougier, CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand, Centre Hospitalier Pierre Bérégovoy [Nevers], Centre hospitalier de Pau, Centre hospitalier de Saint-Quentin, Institut Régional du Cancer, Intergroupe Francophone de Cancérologie Thoracique [Paris] (IFCT), Intergroupe Francophone de Cancérologie thoracique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
- Subjects
Male ,Oncology ,Lung Neoplasms ,Time Factors ,anti-angiogenesis therapy ,medicine.medical_treatment ,Angiogenesis Inhibitors ,Kaplan-Meier Estimate ,chemotherapy ,Gastroenterology ,0302 clinical medicine ,Risk Factors ,Antineoplastic Combined Chemotherapy Protocols ,Clinical endpoint ,small-cell lung cancer ,Etoposide ,0303 health sciences ,Hazard ratio ,Induction Chemotherapy ,Hematology ,Middle Aged ,Chemotherapy regimen ,3. Good health ,Treatment Outcome ,030220 oncology & carcinogenesis ,Disease Progression ,Female ,France ,medicine.drug ,Adult ,medicine.medical_specialty ,Randomization ,Bevacizumab ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,bevacizumab ,Disease-Free Survival ,Young Adult ,03 medical and health sciences ,Internal medicine ,medicine ,Humans ,Lung cancer ,Cyclophosphamide ,Aged ,Epirubicin ,Proportional Hazards Models ,030304 developmental biology ,Chemotherapy ,business.industry ,Induction chemotherapy ,medicine.disease ,Small Cell Lung Carcinoma ,Cisplatin ,business - Abstract
IFCT study administering 7.5 mg/kg Bevacizumab plus chemotherapy after chemotherapy induction did not improve outcomes in extensive SCLC patients. Background This randomized phase II–III trial sought to evaluate the efficacy and safety of adding bevacizumab (Bev) following induction chemotherapy (CT) in extensive small-cell lung cancer (SCLC). Patients and methods Enrolled SCLC patients received two induction cycles of CT. Responders were randomly assigned 1:1 to receive four additional cycles of CT alone or CT plus Bev (7.5 mg/kg), followed by single-agent Bev until progression or unacceptable toxicity. The primary end point was the percentage of patients for whom disease remained controlled (still in response) at the fourth cycle. Results In total, 147 patients were enrolled. Partial response was observed in 103 patients, 74 of whom were eligible for Bev and randomly assigned to the CT alone group (n = 37) or the CT plus Bev group (n = 37). Response assessment at the end of the fourth cycle showed that disease control did not differ between the two groups (89.2% versus 91.9% of patients remaining responders in CT alone versus CT plus Bev, respectively; Fisher's exact test: P = 1.00). Progression-free survival (PFS) since randomization did not significantly differ, with a median PFS of 5.5 months [95% confidence interval (CI) 4.9% to 6.0%] versus 5.3 months (95% CI 4.8% to 5.8%) in the CT alone and CT plus Bev groups, respectively [hazard ratio (HR) for CT alone: 1.1; 95% CI 0.7% to 1.7%; unadjusted P = 0.82]. Grade ≥2 hypertension and grade ≥3 thrombotic events were observed in 40% and 11% of patients, respectively, in the CT plus Bev group. Serum vascular endothelial growth factor (VEGF) and soluble VEGF receptor titrations failed to identify predictive biomarkers. Conclusion Administering 7.5 mg/kg Bev after induction did not improve outcome in extensive SCLC patients.
- Published
- 2015
- Full Text
- View/download PDF