Uemura Mamoru, Kim Ho Min, Hata Tsuyoshi, Sakata Kazuya, Okuyama Masaki, Takemoto Hiroyoshi, Fujii Hitoshi, Fukuzaki Takayuki, Morita Tetsushi, Hata Taishi, Takemasa Ichiro, Satoh Taroh, Mizushima Tsunekazu, Doki Yuichiro, Mori Maski
Department of Surgery, National Hospital Organization, Osaka National Hospital, Osaka 540-0006, Japan; Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka 565-0871, Japan.
Department of Surgery, Osaka Rosai Hospital, Osaka 591-8025, Japan; Department of Surgery, Rinku General Medical Center, Osaka 598-8577, Japan.
Mol Clin Oncol. 2016 Aug;5(2):375-379. doi: 10.3892/mco.2016.938. Epub 2016 Jun 17.
Colorectal cancer (CRC) is one of the most commonly occurring cancers worldwide. A burgeoning number of studies have demonstrated that the addition of cetuximab to another standard first-line regimen markedly improves the outcome of CRC treatment. However, at present, the efficacy and safety of cetuximab-based combination chemotherapy has not been well described in Japan. The aim of the present study was to evaluate the efficacy and safety of first-line chemotherapies that included cetuximab for patients with advanced or metastatic Kirsten rat sarcoma viral oncogene homolog () wild-type CRC in Japan. This prospective multicenter observational study was conducted at 13 affiliated medical institutions. A total of 64 patients were enrolled between 2010 and 2013. The patients met the following criteria for eligibility: i) histologically confirmed, advanced or metastatic wild-type CRC; and ii) cetuximab-based chemotherapies administered as a first-line treatment. First-line cetuximab-based treatments were administered as follows: 29 patients (45.3%) received a combination of infusional fluorouracil, leucovorin and oxaliplatin; 14 patients (21.9%) received a combination of capecitabine and oxaliplatin; and 10 patients (15.6%) received a combination of infusional fluorouracil, leucovorin and irinotecan. The overall response rate (including complete plus partial responses) was 50% (32/64 patients). Initially, 48 lesions were diagnosed as unresectable. Among those, 13 lesions (27.1%) were converted to a resectable status following cetuximab-based combination chemotherapy treatments. The median overall survival time and the progression-free survival time were 1,189 and 359 days, respectively. The most frequent grade 3/4 adverse event was neutropenia, which occurred in 20.3% of the patients. The incidence of grade 3/4 skin toxicity was 17.2% (11/64 patients). Cetuximab-based therapies may represent a promising first-line regimen for patients with advanced or metastatic wild-type CRC in Japan. In addition, this combination was associated with a low incidence of serious toxicities.
结直肠癌（CRC）是全球最常见的癌症之一。越来越多的研究表明，在另一种标准一线治疗方案中添加西妥昔单抗可显著改善CRC治疗效果。然而，目前在日本，基于西妥昔单抗的联合化疗的疗效和安全性尚未得到充分描述。本研究的目的是评估在日本，一线化疗联合西妥昔单抗治疗晚期或转移性Kirsten大鼠肉瘤病毒癌基因同源物（）野生型CRC患者的疗效和安全性。这项前瞻性多中心观察性研究在13家附属医院进行。2010年至2013年期间共纳入64例患者。患者符合以下入选标准：i）组织学确诊为晚期或转移性野生型CRC；ii）一线治疗采用基于西妥昔单抗的化疗。基于西妥昔单抗的一线治疗方案如下：29例患者（45.3%）接受氟尿嘧啶持续静脉输注、亚叶酸钙和奥沙利铂联合治疗；14例患者（21.9%）接受卡培他滨和奥沙利铂联合治疗；10例患者（15.6%）接受氟尿嘧啶持续静脉输注、亚叶酸钙和伊立替康联合治疗。总缓解率（包括完全缓解和部分缓解）为50%（32/64例患者）。最初，48个病灶被诊断为不可切除。其中，13个病灶（27.1%）在基于西妥昔单抗的联合化疗治疗后转变为可切除状态。中位总生存时间和无进展生存时间分别为1189天和359天。最常见的3/4级不良事件是中性粒细胞减少，发生率为20.3%。3/4级皮肤毒性的发生率为17.2%（11/64例患者）。基于西妥昔单抗的治疗方案可能是日本晚期或转移性野生型CRC患者有前景的一线治疗方案。此外，这种联合治疗的严重毒性发生率较低。
