Safety and efficacy of FOLFOXIRI with or without targeted agents as first-line treatment of selected elderly metastatic colorectal cancer patients: A pooled analysis of GONO studies in Journal of Clinical Oncology
2016
AO Cuneo
Tipo pubblicazione
Conference Abstract
Autori/Collaboratori (20)Vedi tutti...
Casagrande M
Moretto R
Loupakis F
et alii...
Abstract
Background: Elderly metastatic colorectal cancer (mCRC) patients (pts) are underrepresented in clinical trials and present heterogeneous physiological and chronological age, general conditions, and comorbidities. Pts between 71 and 75 years old, with ECOG PS 0 were eligible for GONO studies investigating the intensified triple regimen FOLFOXIRI with or without targeted agents as first-line treatment of mCRC. The aim of this analysis was to assess the safety and efficacy of FOLFOXIRI-based regimens in this subpopulation. Methods: Pts between 71 and 75 years old, receiving the triplet with or without targeted agents in GONO-FOLFOXIRI (NCT01219920 ), FOIB (NCT01163396 ), TRIP (NCT01358812 ), TRIBE (NCT00719797 ), MACBETH (NCT02295930 ) and MOMA (NCT02271464 ) studies were identified. Baseline characteristics, safety and efficacy data were reviewed. Results: Out of 784 pts treated with FOLFOXIRI-based regimens, 92 (12%) were ? 71 years old, 14 had received FOLFOXIRI, 68 FOLFOXIRI plus bevacizumab and 10 FOLFOXIRI plus cetuximab or panitumumab. Baseline clinical and molecular characteristics were in line with those of the overall population of each trial, except for age (median: 73 years) and a predominance of male gender (67%). No unexpected adverse events or safety issues emerged. Mean relative dose intensities of 5- fluorouracil, oxaliplatin and irinotecan were 73%, 79% and 74%, respectively. Most frequent ( > 5%) grade 3 or 4 adverse events were neutropenia (51%), febrile neutropenia (10%), diarrhea (21%) and thromboembolism (11%). An ORR of 65%, leading to a radical (R0/R1) resection rate of 15% (31% in the liver-limited subgroup) was reported. Median PFS and OS were 10.6 (95%CI 9.9 - 12.5) and 23.7 months (95% CI 20.9 - 28.6), respectively. Conclusions: In mCRC pts between 71 and 75 years old with optimal ECOG PS, FOLFOXIRI-based regimens achieved activity and efficacy results consistent with those reported in the overall population with an acceptable toxi
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Keywords
bevacizumab; cetuximab; fluorouracil; irinotecan; oxaliplatin; panitumumab; radical; adverse drug reaction; aged; cancer patient; controlled study; diarrhea; disease course; febrile neutropenia; female; gender; genetic polymorphism; human; liver; male; meta analysis; metastatic colorectal cancer; safety; thromboembolism; toxicity;