Portal de Periódicos da CAPES

Geriatric analysis from PRODIGE 20 randomized phase II trial evaluating bevacizumab + chemotherapy versus chemotherapy alone in older patients with untreated metastatic colorectal cancer

2018; Elsevier BV; Volume: 97; Linguagem: Inglês

10.1016/j.ejca.2018.03.030

1879-0852

Thomas Aparicio, Olivier Bouché, E. François, F. Rétornaz, Emilie Barbier, Julien Taı̈eb, Sylvie Kirscher, Pierre-Luc Etienne, Roger Faroux, F. Khemissa Akouz, Farid El Hajbi, C. Locher, Yves Rinaldi, Thierry Lecomte, Sandrine Lavau‐Denès, Mathieu Baconnier, A. Oden-Gangloff, Dominique Genet, Laurent Bedenne, Éléna Paillaud, Mohamed-Ayman Zawadi, Julien Volet, Gérard Cavaglione, Céline Lepère, Philippe Rougier, Aziz Zaanan, Dominique Besson, Kara Slimane Fawzi, Antoine Adenis, Gilles Gatineau-Sailliant, Catherine Brézault, Romain Coriat, David Tougeron, Vincent Hautefeuille, Laurence Choné, Yann Molin, Jean‐François Seitz, V. Jestin Le Tallec, Méher Ben Abdelghani, Anne-Laure Villing, Amar Aouakli, Virginie Sebbagh, Ahmed Bedjaoui, Emmanuel Mitry, Élisabeth Carola, Olivier Boulat, Anne-Marie Queuniet, Olivier Capitain, Jean–Louis Jouve, Isabelle Baumgaertner, Françoise Almaric, Franck Bonnetain, Fabien Subtil,

Nutrition and Health in Aging

Background Older patients have frailty characteristics that impair the transposition of treatment results found in younger patients. Predictive factors are needed to help with treatment choices for older patients. The PRODIGE 20 study is a randomized phase II study that evaluated chemotherapy associated with bevacizumab (BEV) or not (CT) in patients aged 75 years or older. Patients and methods Patients underwent a geriatric assessment at randomization and at each evaluation. The predictive value of geriatric and oncologic factors was determined for the primary composite end-point assessing safety and efficacy of treatment (BEV or CT) simultaneously and also progression-free survival (PFS) and overall survival (OS). Results 102 patients were randomized (51 BEV and 51 CT; median age 80 years [range 75–91]). On multivariate analysis, baseline normal independent activity of daily living (IADL) score and no previous cardiovascular disease predicted the primary end-point. High (versus low) baseline Köhne score predicted short PFS and baseline Spitzer quality of life (QoL) score 2 LN levels above normal and high baseline Köhne score predicted short OS. Survival without deteriorated QoL and autonomy was similar with BEV and CT. On subgroup analyses, the benefit of bevacizumab seemed to be maintained in patients with baseline impaired IADL or nutritional status. Conclusion Normal IADL score was associated with a good efficacy and safety of both BEV and CT. Köhne criteria may be relevant prognostic factors in older patients. Adding bevacizumab to chemotherapy does not impair patient autonomy or QoL.