Efficacy and safety of chemotherapy in older versus non-older patients with advanced gastric cancer: A real-world data, non-inferiority analysis. Issue 3 (May 2018)

• Record Type: Journal Article
• Authors: Visa, Laura; Jiménez-Fonseca, Paula; Martínez, Elena Asensio; Hernández, Raquel; Custodio, Ana; Garrido, Manuel; Viudez, Antonio; Buxo, Elvira; Echavarria, Ignacio; Cano, Juana María; Macias, Ismael; Mangas, Montserrat; de Castro, Eva Martínez; García, Teresa; Manceñido, Felipe Álvarez; Montes, Ana Fernández; Azkarate, Aitor; Longo, Federico; Serrano, Asunción Díaz; López, Carlos; Hurtado, Alicia; Cerdá, Paula; Serrano, Raquel; Gil-Negrete, Aitziber; Carnicero, Alfonso Martín; Pimentel, Paola; Ramchandani, Avinash; Carmona-Bayonas, Alberto
• Is Part Of: Journal of geriatric oncology. Volume 9:Issue 3(2018)
• Page Start: 254
• Page End: 264
• Publication Date: 2018-05
• Subjects: Older -- Chemotherapy -- Gastric cancer -- Stomach -- Non-inferiority -- Survival; Geriatric oncology -- Periodicals; Neoplasms -- Periodicals; Aged -- Periodicals; Geriatric oncology; Electronic journals; Periodicals; 618.976994005
• DOI: 10.1016/j.jgo.2017.11.008
• Languages: English
• ISSNs: 1879-4068

Abstract

Abstract: Objective: 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. Materials and Methods: 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. <70 years. The fixed-margin method was used (hazard ratio [HR]<1.176) that corresponds to conserving at least 85% efficacy. Results: 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. Conclusion: 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.