Kotake Masanori, Aoyama Toru, Munemoto Yoshinori, Doden Kenji, Kataoka Masato, Kobayashi Kenji, Nishimura Genichi, Fujita Hidehito, Nakamura Keishi, Takehara Akira, Tanaka Chihiro, Sakamoto Junichi, Nagata Naoki, Oba Koji, Kondo Ken
Department of Surgery, Kouseiren Takaoka Hospital, Takaoka, Toyama 933-8555, Japan.
Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Kanagawa 241-8515, Japan.
Oncol Lett. 2017 Feb;13(2):747-753. doi: 10.3892/ol.2016.5505. Epub 2016 Dec 14.
The current phase II study investigated the efficacy and safety of biweekly cetuximab combined with standard oxaliplatin-based chemotherapy [infusional 5-fluorouracil (5-FU), leucovorin, and oxaliplatin (FOLFOX-6)] in the first-line treatment of KRAS wild-type metastatic colorectal cancer (mCRC). Sixty patients with a median age of 64 years (range, 38-82 syears) received a biweekly intravenous infusion of cetuximab (500 mg/m on day 1) followed by FOLFOX-6 (2-hour oxaliplatin 85 mg/m infusion on day 1 in tandem with a 2-h leucovorin 200 mg/m infusion on days 1 and 2, and 5-FU as a 400 mg/m bolus followed by a 46-hour 2,400 mg/m infusion on days 1-3). Patient response rate was 70%, with 95% disease control rates. The median progression-free survival was 13.8 months. Thirteen patients (21.7%) were able to undergo resection of previously unresectable metastases, with the aim of curing them. The median follow-up was 22.7 months, and median overall survival was 31.0 months. Cetuximab did not increase FOLFOX-6 toxicity and was generally well tolerated. The results of the current study demonstrate that the combination of biweekly cetuximab with FOLFOX-6 was well tolerated and had a manageable safety profile for the first-line treatment of KRAS wild-type metastatic colorectal cancer. Efficacy was comparable to other treatment regimens. The results support the administration of biweekly cetuximab in combination with FOLFOX-6, which may be more convenient and provide treatment flexibility in this setting for patients with metastatic colorectal cancers.
当前的II期研究调查了每两周一次西妥昔单抗联合基于奥沙利铂的标准化疗方案[持续静脉输注5-氟尿嘧啶（5-FU）、亚叶酸钙和奥沙利铂（FOLFOX-6）]用于KRAS野生型转移性结直肠癌（mCRC）一线治疗的疗效和安全性。60例患者的中位年龄为64岁（范围38-82岁），接受每两周一次静脉输注西妥昔单抗（第1天500mg/m²），随后接受FOLFOX-6方案（第1天静脉输注奥沙利铂85mg/m²持续2小时，同时第1天和第2天静脉输注亚叶酸钙200mg/m²持续2小时，5-FU先给予400mg/m²推注，随后第1-3天持续静脉输注46小时共2400mg/m²）。患者缓解率为70%，疾病控制率为95%。中位无进展生存期为13.8个月。13例患者（21.7%）能够对先前不可切除的转移灶进行切除，目的是治愈。中位随访时间为22.7个月，中位总生存期为31.0个月。西妥昔单抗未增加FOLFOX-6的毒性，且总体耐受性良好。本研究结果表明，每两周一次西妥昔单抗联合FOLFOX-6耐受性良好，在KRAS野生型转移性结直肠癌一线治疗中具有可控的安全性。疗效与其他治疗方案相当。这些结果支持每两周一次西妥昔单抗联合FOLFOX-6的给药方案，在这种情况下，该方案可能更方便，为转移性结直肠癌患者提供治疗灵活性。
