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Efficacy and safety of chemotherapy in older versus non-older patients with advanced gastric cancer: A real-world data, non-inferiority analysis

2017; Elsevier BV; Volume: 9; Issue: 3 Linguagem: Inglês

10.1016/j.jgo.2017.11.008

1879-4076

Laura Visa, Paula Jiménez‐Fonseca, Elena Asensio, Raquel Hernández, Ana Custodio, Manuel M. Garrido, A. Viúdez, Elvira Buxó, Ignacio Echavarria, Juana María Cano, Ismael Macías, Montserrat Mangas, Eva Martínez de Castro, Teresa García, Felipe Álvarez Manceñido, Ana Fernández Montés, Aitor Azkárate, Federico Longo, Asunción Díaz Serrano, Carlos López, Alicia Hurtado, Paula Cerdà, Raquel Serrano, A. Gil-Negrete, Alfonso Martín Carnicero, Paola Pimentel, Avinash Ramchandani, Alberto Carmona‐Bayonas,

Cholangiocarcinoma and Gallbladder Cancer Studies

Advanced gastric cancer (AGC) is a common neoplasm in older adults. Nevertheless, there are few specific management data in the literature. The aim of this study was to assess non-inferiority of survival and efficacy-related outcomes of chemotherapy used in older vs non-older patients with AGC.We recruited 1485 patients from the AGAMENON registry of AGC treated with polychemotherapy between 2008-2017. A statistical analysis was conducted to prove non-inferiority for overall survival (OS) associated with the use of chemotherapy schedules in individuals ≥70 vs.<70years. The fixed-margin method was used (hazard ratio [HR]<1.176) that corresponds to conserving at least 85% efficacy.33% (n=489) of the cases analyzed were ≥70 years. Two-agent chemotherapies and combinations with oxaliplatin (48% vs. 29%) were used more often in the older patients, as were modified schedules and/or lower doses. Toxicity grade 3-4 was comparable in both groups, although when looking at any grade, there were more episodes of enteritis, renal toxicity, and fatigue in older patients. In addition, toxicity was a frequent cause for discontinuing treatment in older patients. The response rate was similar in both groups. After adjusting for confounding factors, the non-inferiority of OS associated with schedules administered to the older vs. younger subjects was confirmed: HR 1.02 (90% CI, 0.91-1.14), P (non inferiority)=0.018, as well as progression-free survival: HR 0.97 (90% CI, 0.87-1.08), P(non-inferiority)=0.001.In this AGC registry, the use of chemotherapy with schedules adapted to patients ≥70 years provided efficacy that was not inferior to that seen in younger cases, with comparable adverse effects.