التفاصيل البيبلوغرافية
| العنوان: |
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 |
| المؤلفون: |
Nakatsumi, Hiroshi, Komatsu, Yoshito, Muranaka, Tetsuhito, Yuki, Satoshi, Kawamoto, Yasuyuki, Harada, Kazuaki, Dazai, Masayoshi, Tateyama, Miki, Sasaki, Yusuke, Miyagishima, Takuto, Tsuji, Yasushi, Katagiri, Masaki, Nakamura, Michio, Sogabe, Susumu, Hatanaka, Kazuteru, Meguro, Takashi, Kobayashi, Tomoe, Ishiguro, Atsushi, Muto, Osamu, Shindo, Yoshiaki, Kotaka, Masahito, Ando, Takayuki, Takagi, Ryo, Sakamoto, Naoya, Sakata, Yu |
| المساهمون: |
Sanofi |
| المصدر: |
Frontiers in Oncology ; volume 12 ; ISSN 2234-943X |
| بيانات النشر: |
Frontiers Media SA |
| سنة النشر: |
2022 |
| المجموعة: |
Frontiers (Publisher - via CrossRef) |
| مصطلحات موضوعية: |
Cancer Research, Oncology |
| الوصف: |
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 ... |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
unknown |
| DOI: |
10.3389/fonc.2022.939425 |
| DOI: |
10.3389/fonc.2022.939425/full |
| الإتاحة: |
https://doi.org/10.3389/fonc.2022.939425Test |
| حقوق: |
https://creativecommons.org/licenses/by/4.0Test/ |
| رقم الانضمام: |
edsbas.85B8D6A1 |
| قاعدة البيانات: |
BASE |
