Intensive first-line FIr-C/FOx-C association of triplet chemotherapy plus cetuximab in RAS wild-type metastatic colorectal cancer patients: preliminary phase II data and prediction of individual limiting toxicity syndromes by pharmacogenomic biomarkers.

ABSTRACT:

Background

Intensive triplet chemotherapy/bevacizumab significantly increased metastatic colorectal cancer (MCRC) outcome. This phase II study investigated the safety/activity of FIr-C/FOx-C triplet/cetuximab (CET) in first-line RAS wild-type and the prediction of individual limiting toxicity syndromes (LTS) by pharmacogenomic biomarkers.

Methods

A Simon two-step design was used: p0 70%, p1 85%, power 80%, α5%, β20%; projected objective response rate (ORR) I step 14/19. FIr-C/FOx-C: 5-fluorouracil (5-FU) 12h-timed flat infusion 900 mg/m² d1-2, 8-9, 15-16, 22-23; irinotecan (CPT-11) 160 mg/m² d1 and 15, oxaliplatin 80 mg/m² d8 and 22; CET 400mg/m² then 250 mg/m² d1, 8, 15, 22; every 28 days. Toxicity, and individua

SUBMITTER: Bruera G 

PROVIDER: S-EPMC6535746 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature