Pilar García-Alfonso1, Eduardo Díaz-Rubio2, Albert Abad3,4, Alfredo Carrato5, Bartomeu Massutí6, María José Ortiz-Morales7, José Luis Manzano Mozo3, Andrés Muñoz8, Gema Durán9, Javier Sastre2, María José Safont10, Reyes Ferreiro5, Fernando Rivera11, Encarnación González12, Manuel Valladares-Ayerbes13, Cristina Grávalos14, Vicente Alonso-Orduña15, José María Viéitez16, Alfonso Yubero17, Enrique Aranda7. 1. Servicio de Oncología, Instituto de Investigación Sanitaria Gregorio Marañón, Hospital General Universitario Gregorio Marañón, Madrid, Spain. pgarcaalfonso@gmail.com. 2. CIBERONC, Hospital Clínico San Carlos, Instituto de Investigación Hospital Clinico San Carlos (IdISSC), Madrid, Spain. 3. ICO, Hospital Germans Trias i Pujol, Badalona, Spain. 4. IOR Hospital Universitario Dexeus, Barcelona, Spain. 5. IRYCIS, CIBERONC, Hospital Universitario Ramón y Cajal, Alcalá University, Madrid, Spain. 6. Hospital General Universitario de Alicante, Alicante, Spain. 7. IMIBIC, CIBERONC, Reina Sofía Hospital, Instituto de Salud Carlos III, University of Córdoba, Córdoba, Spain. 8. Servicio de Oncología, Instituto de Investigación Sanitaria Gregorio Marañón, Hospital General Universitario Gregorio Marañón, Madrid, Spain. 9. Hospital Universitario Regional y Virgen de la Victoria, Malaga, Spain. 10. Hospital General Universitario de Valencia, Valencia, Spain. 11. Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain. 12. Hospital Virgen de las Nieves, Granada, Spain. 13. Instituto de Investigación Biomédica (INIBIC), Complejo Hospitalario Universitario A Coruña, A Coruña, Spain. 14. Hospital Universitario, 12 de Octubre, Madrid, Spain. 15. Instituto de Investigación Sanitaria de Aragón (IISA), Hospital Universitario Miguel Servet, Zaragoza, Spain. 16. Hospital Universitario Central de Asturias, Oviedo, Spain. 17. Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
Abstract
BACKGROUND: Biologicals, in combination with chemotherapy, are recommended as first-line treatment of metastatic colorectal cancer (mCRC); however, evidence guiding the appropriate management of older patients with mCRC is limited. OBJECTIVE: This study was undertaken to compare the efficacy and safety outcomes in older versus younger patients with mCRC who received first-line biological therapy. METHODS: This retrospective analysis used pooled data from five trials undertaken by the Spanish Cooperative Group for the Treatment of Digestive Tumours. All were studies of adults with advanced CRC who received first-line treatment with chemotherapy plus bevacizumab, cetuximab or panitumumab, stratified by age (≥ 65 vs. < 65 years). Endpoints included progression-free survival (PFS), overall survival (OS), overall response rate (ORR) and safety. RESULTS: In total, 999 patients from five studies were included in the analysis: 480 (48%) were aged ≥ 65 years, and 519 (52%) were aged < 65 years. Median PFS did not differ significantly between patients aged ≥ 65 and < 65 years (9.9 vs. 9.4 months; hazard ratio [HR] 1.01; 95% confidence interval [CI] 0.88-1.17). Median OS was significantly shorter in older than in younger patients (21.3 vs. 25.0 months; HR 1.21; 95% CI 1.04-1.41). There was no significant difference between older and younger patients in ORR (59 vs. 62%). Patients aged ≥ 65 years experienced significantly more treatment-related grade 3 or higher adverse events (61.67%) than did patients aged < 65 years (45.86%). CONCLUSIONS: Biologicals plus chemotherapy is an effective first-line treatment option for selected patients aged ≥ 65 years with mCRC and has a manageable safety profile and efficacy comparable to that observed in younger patients.
BACKGROUND: Biologicals, in combination with chemotherapy, are recommended as first-line treatment of metastatic colorectal cancer (mCRC); however, evidence guiding the appropriate management of older patients with mCRC is limited. OBJECTIVE: This study was undertaken to compare the efficacy and safety outcomes in older versus younger patients with mCRC who received first-line biological therapy. METHODS: This retrospective analysis used pooled data from five trials undertaken by the Spanish Cooperative Group for the Treatment of Digestive Tumours. All were studies of adults with advanced CRC who received first-line treatment with chemotherapy plus bevacizumab, cetuximab or panitumumab, stratified by age (≥ 65 vs. < 65 years). Endpoints included progression-free survival (PFS), overall survival (OS), overall response rate (ORR) and safety. RESULTS: In total, 999 patients from five studies were included in the analysis: 480 (48%) were aged ≥ 65 years, and 519 (52%) were aged < 65 years. Median PFS did not differ significantly between patients aged ≥ 65 and < 65 years (9.9 vs. 9.4 months; hazard ratio [HR] 1.01; 95% confidence interval [CI] 0.88-1.17). Median OS was significantly shorter in older than in younger patients (21.3 vs. 25.0 months; HR 1.21; 95% CI 1.04-1.41). There was no significant difference between older and younger patients in ORR (59 vs. 62%). Patients aged ≥ 65 years experienced significantly more treatment-related grade 3 or higher adverse events (61.67%) than did patients aged < 65 years (45.86%). CONCLUSIONS: Biologicals plus chemotherapy is an effective first-line treatment option for selected patients aged ≥ 65 years with mCRC and has a manageable safety profile and efficacy comparable to that observed in younger patients.