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

T. Aparicio (1) , O. Bouché (2) , E. Francois (3) , F. Retornaz (4) , E. Barbier (5) , J. Taieb (6) , S. Kirscher (7) , P.-L. Etienne (8) , R. Faroux (9) , F. Khemissa Akouz (10) , F. El Hajbi (11) , C. Locher (12) , Y. Rinaldi (13) , T. Lecomte (14) , S. Lavau-Denes (15) , M. Baconnier (16) , A. Oden-Gangloff (17) , D. Genet (18) , L. Bedenne (19, 20) , E. Paillaud (21) , Mohamed-Ayman Zawadi , Julien Volet , Gérard Cavaglione , Céline Lepère , Philippe Rougier , Aziz Zaanan , Dominique Besson , Kara Slimane Fawzi , Antoine Adenis , Gilles Gatineau-Sailliant , Catherine Brezault , Romain Coriat , David Tougeron , Vincent Hautefeuille , Laurence Choné , Yann Molin , Jean-François Seitz , Véronique Jestin Le Tallec , Meher Ben Abdelghani , Anne-Laure Villing , Amar Aouakli , Virginie Sebbagh , Ahmed Bedjaoui , Emmanuel Mitry , Elisabeth Carola , Olivier Boulat , Anne-Marie Queuniet , Olivier Capitain , Jean-Louis Jouve , Isabelle Baumgaertner , Françoise Almaric , Franck Bonnetain , Fabien Subtil

1 Service d'hépato-gastro-entérologie [Hôpital Saint-Louis]
2 Hôpital universitaire Robert Debré [Reims]
3 UNICANCER/CAL - Centre de Lutte contre le Cancer Antoine Lacassagne [Nice]
4 Hôpital Européen [Fondation Ambroise Paré - Marseille]
5 Fédération Francophone de la Cancérologie Digestive, FFCD
6 HEGP - Hôpital Européen Georges Pompidou [APHP]
7 Institut Sainte Catherine [Avignon]
8 CARIO - Centre Armoricain de Radiothérapie, d'Imagerie médicale et d'Oncologie [Plérin, Saint-Brieuc]
9 Service de gastroentérologie (CHD Vendee - Hopital Les Oudairies, La Roche Sur Yon)
10 Service de hépato-gastro-entérologie - cancérologie digestive [CH de Perpignan]
11 UNICANCER/Lille - Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille]
12 Centre Hospitalier de Meaux
13 Service de gastro-entérologie (Hôpital Européen de Marseille)
14 Département d'Hépato-Gastroentérologie [Hôpital Trousseau, Tours]
15 CHU Limoges
16 CH Annecy
17 CHU Rouen
18 Polyclinique de Limoges - site François Chénieux [Limoges]
19 Service d'Hépato-Gastro-Entérologie (CHU de Dijon)
20 LNC - Lipides - Nutrition - Cancer [Dijon - U1231]
21 Gériatrie - Henri Mondor - Unité de médecine gériatrique

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 <8, albumin level ≤35 g/L, CA19.9 >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.

Mots clés: Bevacizumab; Colon cancer; Elderly; Geriatric assessment; Predictive factors

Domaines: Cancer

T. Aparicio, O. Bouché, E. Francois, F. Retornaz, E. Barbier, et al.. Geriatric analysis from PRODIGE 20 randomized phase II trial evaluating bevacizumab + chemotherapy versus chemotherapy alone in older patients with untreated metastatic colorectal cancer. European Journal of Cancer, 2018, 97, pp.16-24. ⟨10.1016/j.ejca.2018.03.030⟩. ⟨hal-02012206⟩