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

被引：29

作者：

Aparicio, T. ^{[1
,2
]}

Bouche, O. ^{[3
]}

Francois, E. ^{[4
]}

Retornaz, F. ^{[5
]}

Barbier, E. ^{[6
]}

Taieb, J. ^{[7
]}

Kirscher, S. ^{[8
]}

Etienne, P-L. ^{[9
]}

Faroux, R. ^{[10
]}

Akouz, F. Khemissa ^{[11
]}

El Hajbi, F. ^{[12
]}

Locher, C. ^{[13
]}

Rinaldi, Y. ^{[14
]}

Lecomte, T. ^{[15
]}

Lavau-Denes, S. ^{[16
]}

Baconnier, M. ^{[17
]}

Oden-Gangloff, A. ^{[18
]}

Genet, D. ^{[19
]}

Bedenne, L. ^{[20
]}

Paillaud, E. ^{[21
]}

机构：

[1] CHU St Louis, AP HP, Dept Gastroenterol, Paris, France

[2] Univ Paris 07, Sorbonne Paris Cite, Paris, France

[3] CHU Robert Debre, Digest Oncol Dept, Reims, France

[4] Ctr Antoine Lacassagne, Dept Gastroenterol, Nice, France

[5] Hop Europeen, Dept Geriatr, Marseille, France

[6] Federat Francophone Cancerol Digest, Dept Stat, Dijon, France

[7] CHU Georges Pompidou, AP HP, Digest Oncol Dept, Paris, France

[8] Inst St Catherine, Dept Oncol, Avignon, France

[9] HPCA, CARIO, Dept Oncol, Plerin, France

[10] CHG Vendee, Dept Gastroenterol, La Roche Sur Yon, France

[11] CH St Jean, Dept Gastroenterol, Perpignan, France

[12] Ctr Oscar Lambret, Dept Oncol, Lille, France

[13] CH Meaux, Dept Gastroenterol, Meaux, France

[14] Hop Europeen, Dept Gastroenterol, Marseille, France

[15] CHU Trousseau, Dept Gastroenterol, Tours, France

[16] CHU Dupuytren, Dept Oncol, Limoges, France

[17] CH Annecy Genevois, Dept Gastroenterol, Pringy, France

[18] CHU Charles Nicolle, Dept Gastroenterol, Rouen, France

[19] Clin Chenieux, Dept Oncol, Limoges, France

[20] CHU Bocage, INSERM U866, Dept Gastroenterol, Dijon, France

[21] CHU Henri Mondor, AP HP, Dept Geriatr, Creteil, France

来源：

EUROPEAN JOURNAL OF CANCER | 2018年 / 97卷

关键词：

Geriatric assessment; Colon cancer; Predictive factors; Bevacizumab; Elderly; QUALITY-OF-LIFE; ELDERLY-PATIENTS; 1ST-LINE CHEMOTHERAPY; SURVIVAL; RISK; CAPECITABINE; VALIDATION; ONCOLOGY; HEALTH; MITOMYCIN;

D O I：

10.1016/j.ejca.2018.03.030

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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 Kohne score predicted short PFS and baseline Spitzer quality of life (QoL) score <8, albumin level <= 35 g/L, CA19.9 > 2 LNlevels above normal and high baseline Kohne 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. Kohne criteria may be relevant prognostic factors in older patients. Adding bevacizumab to chemotherapy does not impair patient autonomy or QoL. (C) 2018 Elsevier Ltd. All rights reserved.

引用

页码：16 / 24

页数：9

共 37 条

[21] Factors influencing inclusion in digestive cancer clinical trials: A population-based study [J].