A Carmona-Bayonas1, P Jiménez-Fonseca2, A Custodio3, M Sánchez Cánovas4, R Hernández5, C Pericay6, I Echavarria7, A Lacalle8, L Visa9, A Rodríguez Palomo10, M Mangas11, J M Cano12, E Buxo13, F Álvarez-Manceñido10, T García4, J E Lorenzo5, M Ferrer-Cardona6, A Viudez8, A Azkarate14, A Ramchandani15, D Arias16, F Longo17, C López18, R Sánchez Bayona19, M L Limón20, A Díaz-Serrano21, A Fernández Montes16, P Sala19, P Cerdá22, F Rivera18, J Gallego23. 1. Hematology and Medical Oncology Department, Hospital Universitario Morales Meseguer, IMIB, Avenida Marqués de los Vélez, 30008, Murcia, Spain. alberto.carmonabayonas@gmail.com. 2. Medical Oncology Department, Hospital Universitario Central de Asturias, Oviedo, Spain. 3. Medical Oncology Department, Hospital Universitario La Paz, Madrid, Spain. 4. Hematology and Medical Oncology Department, Hospital Universitario Morales Meseguer, IMIB, Avenida Marqués de los Vélez, 30008, Murcia, Spain. 5. Medical Oncology Department, Hospital Universitario de Canarias, Tenerife, Spain. 6. Medical Oncology Department, Corporació Sanitària Parc Taulí , Sabadell, Spain. 7. Medical Oncology Department, Hospital Universitario Gregorio Marañón, Madrid, Spain. 8. Medical Oncology Department, Complejo Hospitalario de Navarra, Pamplona, Spain. 9. Medical Oncology Department, Hospital Universitario Del Mar, Barcelona, Spain. 10. Pharmacy Department, Hospital Universitario Central de Asturias, Oviedo, Spain. 11. Medical Oncology Department, Hospital Galdakao-Usansolo, Galdakao-Usansolo, Spain. 12. Medical Oncology Department, Hospital General de Ciudad Real, Ciudad Real, Spain. 13. Medical Oncology Department, Hospital Universitario Clinic, Barcelona, Spain. 14. Medical Oncology Department, Hospital Universitario Son Espases, Mallorca, Spain. 15. Medical Oncology Department, Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain. 16. Medical Oncology Department, Complejo Hospitalario de Orense, Orense, Spain. 17. Medical Oncology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain. 18. Medical Oncology Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain. 19. Medical Oncology Department, Clínica Universidad de Navarra, Pamplona, Spain. 20. Medical Oncology Department, Hospital Universitario Virgen del Rocío, Seville, Spain. 21. Medical Oncology Department, Hospital Universitario Doce de Octubre, Madrid, Spain. 22. Medical Oncology Department, Clínica Tecknon de Barcelona, Barcelona, Spain. 23. Medical Oncology Department, Hospital General Universitario de Elche, Elche, Spain.
Abstract
BACKGROUND: Although anthracycline-based triplets are one of the most widely used schedules to treat advanced gastric cancer (AGC), the benefit of including epirubicin in these therapeutic combinations remains unknown. This study aims to evaluate both the efficacy and tolerance of triplets with epirubicin vs. doublets with platinum-fluoropyrimidine in a national AGC registry. METHODS: Patients with AGC treated with polychemotherapy without trastuzumab at 28 hospitals in Spain between 2008 and 2016 were included. The effect of anthracycline-based triplets against doublets was evaluated by propensity score matching (PSM) and Cox proportional hazards (PH) regression. RESULT: A total of 1002 patients were included (doublets, n = 653; anthracycline-based triplets, n = 349). The multivariable Cox PH regression failed to detect significantly increased OS in favor of triplets with anthracyclines: HR 0.90 (95% CI, 0.78-1.05), p = 0.20035. After PSM, the sample contained 325 pairs with similar baseline characteristics. This method was also unable to reveal an increase in OS: 10.5 (95% CI, 9.7-12.3) vs. 9.9 (95% CI, 9.2-11.4) months, HR 0.91 (CI 95%, 0.76-1.083), and (log-rank test, p = 0.226). Response rates (42.1 vs. 33.1%, p = 0.12) and PFS (HR 0.95, CI 95%, 0.80-1.13, log-rank test, p = 0.873) were not significantly higher with epirubicin-based regimens. The triplets were associated with greater grade 3-4 hematological toxicity, and increased hospitalization due to toxicity by 68%. The addition of epirubicin is viable, but 23.7% discontinued treatment because of adverse effects or patient decision. CONCLUSION: Anthracyclines added to platinum-fluoropyrimidine doublets did not improve the response rate or survival outcomes in patients with AGC but entailed greater toxicity.
BACKGROUND: Although anthracycline-based triplets are one of the most widely used schedules to treat advanced gastric cancer (AGC), the benefit of including epirubicin in these therapeutic combinations remains unknown. This study aims to evaluate both the efficacy and tolerance of triplets with epirubicin vs. doublets with platinum-fluoropyrimidine in a national AGC registry. METHODS:Patients with AGC treated with polychemotherapy without trastuzumab at 28 hospitals in Spain between 2008 and 2016 were included. The effect of anthracycline-based triplets against doublets was evaluated by propensity score matching (PSM) and Cox proportional hazards (PH) regression. RESULT: A total of 1002 patients were included (doublets, n = 653; anthracycline-based triplets, n = 349). The multivariable Cox PH regression failed to detect significantly increased OS in favor of triplets with anthracyclines: HR 0.90 (95% CI, 0.78-1.05), p = 0.20035. After PSM, the sample contained 325 pairs with similar baseline characteristics. This method was also unable to reveal an increase in OS: 10.5 (95% CI, 9.7-12.3) vs. 9.9 (95% CI, 9.2-11.4) months, HR 0.91 (CI 95%, 0.76-1.083), and (log-rank test, p = 0.226). Response rates (42.1 vs. 33.1%, p = 0.12) and PFS (HR 0.95, CI 95%, 0.80-1.13, log-rank test, p = 0.873) were not significantly higher with epirubicin-based regimens. The triplets were associated with greater grade 3-4 hematological toxicity, and increased hospitalization due to toxicity by 68%. The addition of epirubicin is viable, but 23.7% discontinued treatment because of adverse effects or patient decision. CONCLUSION:Anthracyclines added to platinum-fluoropyrimidine doublets did not improve the response rate or survival outcomes in patients with AGC but entailed greater toxicity.
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