Laura Visa1, Paula Jiménez-Fonseca2, Elena Asensio Martínez3, Raquel Hernández4, Ana Custodio5, Manuel Garrido6, Antonio Viudez7, Elvira Buxo8, Ignacio Echavarria9, Juana María Cano10, Ismael Macias11, Montserrat Mangas12, Eva Martínez de Castro13, Teresa García14, Felipe Álvarez Manceñido15, Ana Fernández Montes16, Aitor Azkarate17, Federico Longo18, Asunción Díaz Serrano19, Carlos López13, Alicia Hurtado20, Paula Cerdá21, Raquel Serrano22, Aitziber Gil-Negrete23, Alfonso Martín Carnicero24, Paola Pimentel25, Avinash Ramchandani26, Alberto Carmona-Bayonas14. 1. Medical Oncology Department, Hospital del Mar, Barcelona, Spain. Electronic address: lvisa@parcdesalutmar.cat. 2. Medical Oncology Department, Hospital Universitario Central de Asturias, Oviedo, Spain. 3. Medical Oncology Department, Hospital Universitario de Elche, Elche, Spain. 4. Medical Oncology Department, Hospital Universitario de Canarias, Tenerife. 5. Medical Oncology Department, Hospital Universitario La Paz, Madrid, CIBERONC CB16/12/00398, Spain. 6. Medical Oncology Department, Pontificia Universidad Católica de Chile, Santiago de Chile, Chile. 7. Medical Oncology Department, Complejo Hospitalario de Navarra, Pamplona, Spain. 8. Medical Oncology Department, Hospital Universitari Clinic, Barcelona, Spain. 9. Medical Oncology Department, Hospital Universitario Gregorio Marañón, Madrid, Spain. 10. Medical Oncology Department, Hospital General de Ciudad Real, Ciudad Real, Spain. 11. Medical Oncology Department, Hospital Universitario Parc Tauli, Sabadell, Spain. 12. Medical Oncology Department, Hospital Galdakao-Usansolo, Galdakao-Usansolo, Spain. 13. Medical Oncology Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain. 14. Hematology and Medical Oncology Department, Hospital Universitario Morales Meseguer, Murcia, Spain. 15. Medical Oncology Department, Pharmacy Department, Hospital Universitario Central de Asturias, Oviedo, Spain. 16. Medical Oncology Department, Complejo Hospitalario de Orense, Orense, Spain. 17. Medical Oncology Department, Hospital Universitario Son Espases, Mallorca, Spain. 18. Medical Oncology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain. 19. Medical Oncology Department, Hospital Universitario Doce de Octubre, Madrid, Spain. 20. Medical Oncology Department, Hospital Universitario Fundación Alcorcón, Madrid, Spain. 21. Medical Oncology Department, Centro Médico Teknon, Barcelona, Spain. 22. Medical Oncology Department, Hospital Universitario Virgen de las Nieves, Córdoba, Spain. 23. Medical Oncology Department, Hospital Universitario Donostia, San Sebastián, Spain. 24. Medical Oncology Department, Complejo Hospitalario San Millán-San Pedro de La Rioja, Logroño, Spain. 25. Medical Oncology Department, Hospital Santa Lucía, Cartagena, Spain. 26. Medical Oncology Department, Hospital Universitario Insular de Gran Canaria, Las Palmas, Spain.
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.<70years. 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.
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.<70years. 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.
Authors: Ana Fernández Montes; Carlos López López; Guillem Argilés Martínez; David Páez López; Ana María López Muñoz; Beatriz García Paredes; David Gutiérrez Abad; Carmen Castañón López; Paula Jiménez Fonseca; Javier Gallego Plazas; María Carmen López Doldán; Eva Martínez de Castro; Manuel Sánchez Cánovas; María Tobeña Puyal; Beatriz Llorente Ayala; Ignacio Juez Martel; Mariana López Flores; Alberto Carmona-Bayonas Journal: Oncologist Date: 2019-05-30
Authors: J Gallego Plazas; A Arias-Martinez; A Lecumberri; E Martínez de Castro; A Custodio; J M Cano; R Hernandez; A F Montes; I Macias; A Pieras-Lopez; M Diez; L Visa; R V Tocino; N Martínez Lago; M L Limón; M Gil; P Pimentel; M Mangas; M Granja; A M Carnicero; C Hernández Pérez; L G Gonzalez; P Jimenez-Fonseca; A Carmona-Bayonas Journal: ESMO Open Date: 2022-06-14
Authors: A Viúdez; A Carmona-Bayonas; J Gallego; A Lacalle; R Hernández; J M Cano; I Macías; A Custodio; E Martínez de Castro; A Sánchez; L Iglesia; P Reguera; L Visa; A Azkarate; M Sánchez-Cánovas; M Mangas; M L Limón; A Martínez-Torrón; E Asensio; A Ramchandani; A Martín-Carnicero; A Hurtado; P Cerdà; M Garrido; R Sánchez-Bayonas; R Serrano; P Jiménez-Fonseca Journal: Clin Transl Oncol Date: 2019-08-05 Impact factor: 3.405
Authors: Sandrine Boulet; Moreno Ursino; Peter Thall; Bruno Landi; Céline Lepère; Simon Pernot; Anita Burgun; Julien Taieb; Aziz Zaanan; Sarah Zohar; Anne-Sophie Jannot Journal: Stat Methods Med Res Date: 2019-04-09 Impact factor: 2.494
Authors: Almudena Cotes Sanchís; Javier Gallego; Raquel Hernandez; Virginia Arrazubi; Ana Custodio; Juana María Cano; Gema Aguado; Ismael Macias; Carlos Lopez; Flora López; Laura Visa; Marcelo Garrido; Nieves Martínez Lago; Ana Fernández Montes; María Luisa Limón; Aitor Azkárate; Paola Pimentel; Pablo Reguera; Avinash Ramchandani; Juan Diego Cacho; Alfonso Martín Carnicero; Mónica Granja; Marta Martín Richard; Carolina Hernández Pérez; Alicia Hurtado; Olbia Serra; Elvira Buxo; Rosario Vidal Tocino; Paula Jimenez-Fonseca; Alberto Carmona-Bayonas Journal: PLoS One Date: 2020-07-31 Impact factor: 3.240