Despite differences in the safety profiles and rates of adverse events, both FOLFIRI [fluorouracil, leucovorin, irinotecan] and XELIRI [capecitabine plus irinotecan] with or without bevacizumab were safe and well-tolerated as second-line therapy among Asian patients with metastatic colorectal cancer (mCRC), according to a study being presented at the 2017 Gastrointestinal Cancers Symposium.1

For the international, open-label, non-inferiority, phase 3 AXEPT trial ( Identifier: NCT01996306), investigators compared the efficacy and safety of XELIRI with that of FOLFIRI with or without bevacizumab among patients with mCRC requiring second-line treatment.

The researchers enrolled 1275 patients from South Korea, China, and Japan with histologically-confirmed inoperable colorectal adenocarcinoma who withdrew from first-line chemotherapy due to intolerable toxicity or disease progression, or who had relapsed within 180 days after the last dose of adjuvant chemotherapy.

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Participants were randomly assigned 1:1 to receive irinotecan on day 1 plus capecitabine twice daily for 2 weeks of each 3-week cycle (XELIRI) with or without bevacizumab or FOLFIRI with or without bevacizumab. Baseline characteristics, including KRAS mutation status and UGT1A1 gene polymorphism status, were similar between the 2 arms. Nearly all patients had received prior chemotherapy with oxaliplatin.

Seventy-three percent of patients with FOLFIRI arm and 53.2% of those in the XELIRI arm had grade 3 or 4 toxicities.

FOLFIRI was associated with a higher incidence of grade 3 to 4 neutropenia and leukopenia and all-grade anemia than XELIRI, while XELIRI was associated with a higher incidence of all-grade hand-foot syndrome and grade 3 to 4 diarrhea.

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There was no significant difference in the rate of febrile neutropenia between the 2 treatment arms, though there was 1 treatment-related death in the FOLFIRI arm.

The addition of bevacizumab did not alter the safety profile of either regimen.


  1. Nakamura M, Kim TW, Xu R-h, et al. A multinational, randomized, phase III trial of XELIRI with or without bevacizumab versus FOLFIRI with or without bevacizumab as second-line therapy for metastatic colorectal cancer: Safety analysis of Asian XELIRI project (AXEPT). J Clin Oncol. 2017;35(suppl):4S. Abstract 681.