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Study protocol for HGCSG1801 : A multicenter, prospective, phase II trial of second-line FOLFIRI plus aflibercept in patients with metastatic colorectal cancer refractory to anti-EGFR antibodies

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Title: Study protocol for HGCSG1801 : A multicenter, prospective, phase II trial of second-line FOLFIRI plus aflibercept in patients with metastatic colorectal cancer refractory to anti-EGFR antibodies
Authors: Nakatsumi, Hiroshi Browse this author
Komatsu, Yoshito Browse this author →KAKEN DB
Muranaka, Tetsuhito Browse this author
Yuki, Satoshi Browse this author
Kawamoto, Yasuyuki Browse this author
Harada, Kazuaki Browse this author
Dazai, Masayoshi Browse this author
Tateyama, Miki Browse this author
Sasaki, Yusuke Browse this author
Miyagishima, Takuto Browse this author
Tsuji, Yasushi Browse this author
Katagiri, Masaki Browse this author
Nakamura, Michio Browse this author
Sogabe, Susumu Browse this author
Hatanaka, Kazuteru Browse this author
Meguro, Takashi Browse this author
Kobayashi, Tomoe Browse this author
Ishiguro, Atsushi Browse this author
Muto, Osamu Browse this author
Shindo, Yoshiaki Browse this author
Kotaka, Masahito Browse this author
Ando, Takayuki Browse this author
Takagi, Ryo Browse this author
Sakamoto, Naoya Browse this author
Sakata, Yu Browse this author
Keywords: colorectal cancer
anti-EGFR antibodies
Issue Date: 9-Nov-2022
Publisher: Frontiers Media
Journal Title: Frontiers in oncology
Volume: 12
Start Page: 939425
Publisher DOI: 10.3389/fonc.2022.939425
Abstract: Background: The first-line chemotherapy for patients with RAS and BRAF wild-type metastatic colorectal cancer (mCRC) commonly involves cytotoxic regimens, such as FOLFOX and FOLFIRI, combined with epidermal growth factor receptor (EGFR) antibodies. When progression occurs following anti-EGFR antibody-combined chemotherapy, anti-angiogenic inhibitors can be used as second-line treatment. Although randomized controlled trials have shown that anti-angiogenic inhibitors [bevacizumab, ramucirumab, and aflibercept (AFL)] carry survival benefit when combined with FOLFIRI as second-line chemotherapy, such trials did not provide data on patients with mCRC refractory to anti-EGFR antibody-combined chemotherapy. Therefore, our group planned a multicenter, nonrandomized, single-arm, prospective, phase II study to investigate the safety and efficacy of FOLFIRI plus AFL as a second-line chemotherapy for patients with mCRC refractory to oxaliplatin-based chemotherapy combined with anti-EGFR antibodies. Methods: FOLFIRI (irinotecan 180 mg/m(2), l-leucovorin 200 mg/m(2), bolus 5-FU 400 mg/m(2), and infusional 5-FU 2400 mg/m(2)/46 h) and AFL (4 mg/kg) will be administered every 2 weeks until progression or unacceptable toxicities occur. The primary endpoint will be the 6-month progression-free survival (PFS) rate, whereas the secondary endpoints will include overall survival, PFS, response rate, disease control rate, adverse events, and relative dose intensity for each drug. A sample size of 41 participants will be required. This study will be sponsored by the Non-Profit Organization Hokkaido Gastrointestinal Cancer Study Group and will be supported by a grant from Sanofi. Discussion: There is only an observational study reporting data on FOLFIRI plus AFL for patients with mCRC who previously received anti-EGFR antibodies; therefore, a prospective clinical trial is needed. This study will prospectively evaluate the efficacy and safety of FOLFIRI plus AFL in patients with mCRC who are resistant to anti-EGFR antibodies and have limited data. Moreover, this study will reveal predictive biomarkers for AFL-based chemotherapy.
Type: article
Appears in Collections:北海道大学病院 (Hokkaido University Hospital) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

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