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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
| 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 | | chemotherapy | | FOLFIRI | | aflibercept | | 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 |
| URI: | http://hdl.handle.net/2115/87942 |
| 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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