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Combination therapy of bevacizumab with either S-1 and irinotecan or mFOLFOX6/CapeOX as first-line treatment of metastatic colorectal cancer (TRICOLORE): Exploratory analysis of RAS status and primary tumour location in a randomised, open-label, phase III, non-inferiority trial

The TRICOLORE trial previously demonstrated that S-1 and irinotecan plus bevacizumab was non-inferior, based on progression-free survival (PFS), to 5-fluorouracil, leucovorin and oxaliplatin (mFOLFOX6)/capecitabine and oxaliplatin (CapeOX) plus bevacizumab as first-line chemotherapy for metastatic c...

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Published in:European journal of cancer (1990) 2021-09, Vol.154, p.296-306
Main Authors: Denda, Tadamichi, Takashima, Atsuo, Gamoh, Makio, Iwanaga, Ichiro, Komatsu, Yoshito, Takahashi, Masanobu, Nakamura, Masato, Ohori, Hisatsugu, Sakashita, Akiko, Tsuda, Masahiro, Kobayashi, Yoshimitsu, Baba, Hideo, Kotake, Masanori, Ishioka, Chikashi, Yamada, Yasuhide, Sato, Atsushi, Yuki, Satoshi, Morita, Satoshi, Takahashi, Shin, Yamaguchi, Tatsuro, Shimada, Ken
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Language:English
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Summary:The TRICOLORE trial previously demonstrated that S-1 and irinotecan plus bevacizumab was non-inferior, based on progression-free survival (PFS), to 5-fluorouracil, leucovorin and oxaliplatin (mFOLFOX6)/capecitabine and oxaliplatin (CapeOX) plus bevacizumab as first-line chemotherapy for metastatic colorectal cancer (mCRC). Overall survival (OS) data were immature at the time of the primary analysis. In total, 487 patients from 53 institutions with previously untreated mCRC were randomly assigned (1:1) to receive either mFOLFOX6/CapeOX plus bevacizumab (control group) or S-1 and irinotecan plus bevacizumab (experimental group; 3- or 4-week regimen). The final OS data were analysed from follow-up data collected until 30th September 2017. With a median follow-up period of 48.7 months, median survival times were 32.6 and 34.3 months (hazard ratio [HR]: 0.89, 95% confidence interval [CI]: 0.72–1.10, P = 0.293) and median PFS durations were 10.8 and 14.0 months in the control and experimental groups, respectively (HR: 0.86, 95% CI: 0.71–1.04, P 
ISSN:0959-8049
1879-0852
DOI:10.1016/j.ejca.2021.06.013