| Resumen: |
Background: The combination chemotherapy i. v. 5-fluorouracil (5-FU), irinotecan, and aflibercept (FOLFIRI-A) is a standard second-line treatment of metastatic colorectal cancer (mCRC). The aim was to assess maintenance treatment in second-line setting in older patients (aged ≥70 years) with mCRC. Patients and methods: We evaluated FOLFIRI-A given for six cycles followed by maintenance with 5-FU/leucovorin (LV)-A (arm A) or FOLFIRI-A (arm B) until progression in older adults with mCRC in the AFEMA randomized, open-label, non-inferiority phase II trial (EudraCT2016-004076-21/NCT03279289). Patients aged ≥70 years who previously failed oxaliplatin-fluoropyrimidine were randomly allocated (1 : 1) to either arm A (experimental) or arm B (control). After enrolling 35 patients, the FOLFIRI dose was reduced to level 1 in both arms due to toxicity. The primary endpoint was median progression-free survival (PFS); and secondary endpoints were median overall survival, objective response rate, and safety. Non-inferiority required the upper confidence interval (CI) limit to not exceed a hazard ratio (HR) of 1. 5 (one-sided α = 0. 075, 80% power). Results: A total of 170 patients were randomly allocated to arm A or arm B (n = 85 each). The median follow-up was 12. 2 versus 10. 9 months in arm A versus arm B. Most patients died (83. 5% versus 88. 2% in arm A versus arm B), mainly from disease progression. PFS non-inferiority was met (HR = 0. 78, 95% CI 0. 566-1. 076, P = 0. 131) with a median PFS of 6. 1 versus 5. 5 months in arm A versus arm B. Median overall survival was similar in arms A and B (12. 2 and 11. 5 months, respectively) (HR = 0. 89, 95% CI 0. 640-1. 227, P = 0. 467). During the maintenance phase, severe asthenia (4. 5% versus 21. 6%, P = 0. 038), serious adverse events (SAEs) (17. 8% versus 37. 8%, P = 0. 049), and treatment-related SAEs (6. 7% versus 10. 8%, P = 0. 695) were reduced in arm A versus arm B. Conclusion: In older adults, induction with six cycles of FOLFIRI-A plus maintenance with 5-FU/LV-A was non-inferior to FOLFIRI-A until progression. Severe asthenia, SAEs, and treatment-related SAEs were reduced with 5-FU/LV-A maintenance. |
visitante ::
identificación
(Universidad Complutense de Madrid)
