Detalle Publicación

Exploratory outcome analyses according to stage and/or residual disease in the ICON7 trial of carboplatin and paclitaxel with or without bevacizumab for newly diagnosed ovarian cancer

Autores: González Martín, Antonio (Autor de correspondencia); Oza, A. M. ; Embleton, A. C.; Pfisterer, J. ; Ledermann, J. A.; Pujade-Lauraine, E.; Kristensen, G. ; Bertrand, M. A. ; Beale, P.; Cervantes, A.; Kent, E.; Kaplan, R. S. ; Parmar, M. K. B.; Scotto, N.; Perren, T. J.
Título de la revista: GYNECOLOGIC ONCOLOGY
ISSN: 0090-8258
Volumen: 152
Número: 1
Páginas: 53 - 60
Fecha de publicación: 2019
Objective. In the randomized phase 3 ICON7 trial (ISRCTN91273375), adding bevacizumab to chemotherapy for newly diagnosed ovarian cancer significantly improved progression-free survival (PFS; primary endpoint) but not overall survival (OS; secondary endpoint) in the intent-to-treat (FIT) population. We explored treatment effect according to stage and extent of residual disease. Methods. Patients with stage IIB-IV or high-risk (grade 3/clear-cell) stage 1-IIA ovarian cancer were randomized to receive six cycles of carboplatin and paclitaxel either alone or with bevacizumab 7.5 mg/kg every 3 weeks followed by single-agent bevacizumab for 12 further cycles (total duration 12 months). Post hoc exploratory analyses of subgroups defined by stage and extent of residual disease at diagnosis within the stage IIIB-IV population (European indication) was performed. Results. The PFS benefit from bevacizumab was seen consistently in all subgroups explored. The PFS hazard ratio was 0.77 (95% confidence interval [CI], 0.59-0.99) in 411 patients with stage IIIB-IV ovarian cancer with no visible residuum and 0.81 (95% CI, 0.69-0.95) in 749 patients with stage IIIB-IV disease and visible residuum. As in the ITT population, no OS difference was detected in any subgroup except the previously described 'high-risk' subgroup. Safety results in analyzed subgroups were consistent with the overall population. Conclusions. Adding bevacizumab to front-line chemotherapy improves PFS irrespective of stage/residual disease. In patients with stage III with >1 cm residuum, stage IV or inoperable disease, this translates into an OS benefit. No OS benefit or detriment was seen in other subgroups explored. (C) 2018 The Authors. Published by Elsevier Inc.