Romain Corre1, Laurent Greillier2, Hervé Le Caër2, Clarisse Audigier-Valette2, Nathalie Baize2, Henri Bérard2, Lionel Falchero2, Isabelle Monnet2, Eric Dansin2, Alain Vergnenègre2, Marie Marcq2, Chantal Decroisette2, Jean-Bernard Auliac2, Suzanna Bota2, Régine Lamy2, Bartomeu Massuti2, Cécile Dujon2, Maurice Pérol2, Jean-Pierre Daurès2, Renaud Descourt2, Hervé Léna2, Carine Plassot2, Christos Chouaïd2. 1. Romain Corre and Hervé Léna, Centre Hospitalier Universitaire de Rennes, Rennes; Laurent Greillier, Université de Médecine, Marseille; Hervé Le Caër, Centre Hospitalier de Draguignan, Draguignan; Clarisse Audigier-Valette, Centre Hospitalier Intercommunal de Toulon; Henri Bérard, Hôpital Inter Armées Sainte-Anne, Toulon; Nathalie Baize, Centre Hospitalier Universitaire d'Angers, Angers; Lionel Falchero, Centre Hospitalier de Villefranche sur Saône, Villefranche sur Saône; Isabelle Monnet and Christos Chouaïd, Centre Hospitalier Intercommunal de Créteil, Créteil; Eric Dansin, Centre Oscar Lambret, Lille; Alain Vergnenègre, Centre Hospitalier Universitaire du Cluzeau, Limoges; Marie Marcq, Centre Hospitalier Départemental les Oudairies, La Roche-sur-Yon; Chantal Decroisette, Centre Hospitalier d'Annecy, Annecy; Jean-Bernard Auliac, Centre Hospitalier de Mantes La Jolie, Mantes la Jolie; Suzanna Bota, Centre Hospitalier Universitaire Charles Nicolle, Rouen; Régine Lamy, Centre Hospitalier de Bretagne Sud, Lorient; Cécile Dujon, Hôpital A. Mignot, Le Chesnay; Maurice Pérol, Centre Léon Bérard, Lyon; Jean-Pierre Daurès and Carine Plassot, Université Montpellier 1, Montpellier; Renaud Descourt, Centre Hospitalier Universitaire de Brest, Brest, France; and Bartomeu Massuti, Hospital General Universitario de Alicante, Alicante, Spain. romain.corre@chu-rennes.fr. 2. Romain Corre and Hervé Léna, Centre Hospitalier Universitaire de Rennes, Rennes; Laurent Greillier, Université de Médecine, Marseille; Hervé Le Caër, Centre Hospitalier de Draguignan, Draguignan; Clarisse Audigier-Valette, Centre Hospitalier Intercommunal de Toulon; Henri Bérard, Hôpital Inter Armées Sainte-Anne, Toulon; Nathalie Baize, Centre Hospitalier Universitaire d'Angers, Angers; Lionel Falchero, Centre Hospitalier de Villefranche sur Saône, Villefranche sur Saône; Isabelle Monnet and Christos Chouaïd, Centre Hospitalier Intercommunal de Créteil, Créteil; Eric Dansin, Centre Oscar Lambret, Lille; Alain Vergnenègre, Centre Hospitalier Universitaire du Cluzeau, Limoges; Marie Marcq, Centre Hospitalier Départemental les Oudairies, La Roche-sur-Yon; Chantal Decroisette, Centre Hospitalier d'Annecy, Annecy; Jean-Bernard Auliac, Centre Hospitalier de Mantes La Jolie, Mantes la Jolie; Suzanna Bota, Centre Hospitalier Universitaire Charles Nicolle, Rouen; Régine Lamy, Centre Hospitalier de Bretagne Sud, Lorient; Cécile Dujon, Hôpital A. Mignot, Le Chesnay; Maurice Pérol, Centre Léon Bérard, Lyon; Jean-Pierre Daurès and Carine Plassot, Université Montpellier 1, Montpellier; Renaud Descourt, Centre Hospitalier Universitaire de Brest, Brest, France; and Bartomeu Massuti, Hospital General Universitario de Alicante, Alicante, Spain.
Abstract
PURPOSE:Comprehensive geriatric assessment (CGA) is recommended to assess the vulnerability of elderly patients, but its integration in cancer treatment decision making has never been prospectively evaluated. Here, in elderly patients with advanced non-small-cell lung cancer (NSCLC), we compared a standard strategy of chemotherapy allocation on the basis of performance status (PS) and age with an experimental strategy on the basis of CGA. PATIENTS AND METHODS: In a multicenter, open-label, phase III trial, elderly patients ≥ 70 years old with a PS of 0 to 2 and stage IV NSCLC were randomly assigned between chemotherapy allocation on the basis of PS and age (standard arm: carboplatin-based doublet if PS ≤ 1 and age ≤ 75 years; docetaxel if PS = 2 or age > 75 years) and treatment allocation on the basis of CGA (CGA arm: carboplatin-based doublet for fit patients, docetaxel for vulnerable patients, and best supportive care for frail patients). The primary end point was treatment failure free survival (TFFS). Secondary end points were overall survival (OS), progression-free survival, tolerability, and quality of life. RESULTS:Four hundred ninety-four patients were randomly assigned (standard arm, n = 251; CGA arm, n = 243). Median age was 77 years. In the standard and CGA arms, 35.1% and 45.7% of patients received a carboplatin-based doublet, 64.9% and 31.3% received docetaxel, and 0% and 23.0% received best supportive care, respectively. In the standard and CGA arms, median TFFS times were 3.2 and 3.1 months, respectively (hazard ratio, 0.91; 95% CI, 0.76 to 1.1), and median OS times were 6.4 and 6.1 months, respectively (hazard ratio, 0.92; 95% CI, 0.79 to 1.1). Patients in the CGA arm, compared with standard arm patients, experienced significantly less all grade toxicity (85.6% v 93.4%, respectively P = .015) and fewer treatment failures as a result of toxicity (4.8% v 11.8%, respectively; P = .007). CONCLUSION: In elderly patients with advanced NSCLC, treatment allocation on the basis of CGA failed to improve the TFFS or OS but slightly reduced treatment toxicity.
RCT Entities:
PURPOSE: Comprehensive geriatric assessment (CGA) is recommended to assess the vulnerability of elderly patients, but its integration in cancer treatment decision making has never been prospectively evaluated. Here, in elderly patients with advanced non-small-cell lung cancer (NSCLC), we compared a standard strategy of chemotherapy allocation on the basis of performance status (PS) and age with an experimental strategy on the basis of CGA. PATIENTS AND METHODS: In a multicenter, open-label, phase III trial, elderly patients ≥ 70 years old with a PS of 0 to 2 and stage IV NSCLC were randomly assigned between chemotherapy allocation on the basis of PS and age (standard arm: carboplatin-based doublet if PS ≤ 1 and age ≤ 75 years; docetaxel if PS = 2 or age > 75 years) and treatment allocation on the basis of CGA (CGA arm: carboplatin-based doublet for fit patients, docetaxel for vulnerable patients, and best supportive care for frail patients). The primary end point was treatment failure free survival (TFFS). Secondary end points were overall survival (OS), progression-free survival, tolerability, and quality of life. RESULTS: Four hundred ninety-four patients were randomly assigned (standard arm, n = 251; CGA arm, n = 243). Median age was 77 years. In the standard and CGA arms, 35.1% and 45.7% of patients received a carboplatin-based doublet, 64.9% and 31.3% received docetaxel, and 0% and 23.0% received best supportive care, respectively. In the standard and CGA arms, median TFFS times were 3.2 and 3.1 months, respectively (hazard ratio, 0.91; 95% CI, 0.76 to 1.1), and median OS times were 6.4 and 6.1 months, respectively (hazard ratio, 0.92; 95% CI, 0.79 to 1.1). Patients in the CGA arm, compared with standard arm patients, experienced significantly less all grade toxicity (85.6% v 93.4%, respectively P = .015) and fewer treatment failures as a result of toxicity (4.8% v 11.8%, respectively; P = .007). CONCLUSION: In elderly patients with advanced NSCLC, treatment allocation on the basis of CGA failed to improve the TFFS or OS but slightly reduced treatment toxicity.
Authors: L Decoster; C Kenis; D Schallier; J Vansteenkiste; K Nackaerts; L Vanacker; N Vandewalle; J Flamaing; J P Lobelle; K Milisen; J De Grève; H Wildiers Journal: Lung Date: 2017-06-20 Impact factor: 2.584
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Authors: Elisabeth J M Driessen; Judith G M van Loon; Huub A Maas; Anne-Marie C Dingemans; Maryska L G Janssen-Heijnen Journal: Lung Date: 2018-04-12 Impact factor: 2.584
Authors: Karlijn J G Schulkes; Carin A M Pouw; Elisabeth J M Driessen; Leontine J R van Elden; Frederiek van den Bos; Maryska L G Janssen-Heijnen; Jan-Willem J Lammers; Marije E Hamaker Journal: Lung Date: 2017-06-19 Impact factor: 2.584
Authors: Harvey Jay Cohen; David Smith; Can-Lan Sun; William Tew; Supriya G Mohile; Cynthia Owusu; Heidi D Klepin; Cary P Gross; Stuart M Lichtman; Ajeet Gajra; Julie Filo; Vani Katheria; Arti Hurria Journal: Cancer Date: 2016-08-16 Impact factor: 6.860