Muro Kei, Itabashi Michio, Hashida Hiroki, Masuishi Toshiki, Bando Hiroyuki, Denda Tadamichi, Yamanaka Takeharu, Ohashi Yasuo, Sugihara Kenichi
Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, Tokyo, Japan.
Jpn J Clin Oncol. 2019 Apr 1;49(4):339-346. doi: 10.1093/jjco/hyy189.
We aimed to clarify the clinical practice and outcomes of first-line cetuximab-containing chemotherapy in patients with metastatic colorectal cancer. Efficacy and safety were evaluated in each group classified by the European Society for Medical Oncology Guidelines 2012.
This prospective observational study included patients with previously untreated metastatic colorectal cancer from 158 centers in Japan who started first-line cetuximab-containing chemotherapy from January 2012 to June 2013 and were followed for up to 3 years. The resection rates after chemotherapy were calculated and the overall survival was estimated using the Kaplan-Meier method for Group 1 (G1, potentially resectable), Group 2 (G2, not resectable and tumor-related symptoms) and Group 3 (G3, not resectable and asymptomatic).
Of 578 patients, 562 were classified into G1 (n = 165), G2 (n = 224) or G3 (n = 173). The resection rate of any site was higher in G1 (57.0%) than in G2 (11.2%) and G3 (11.6%). G1, G2 and G3 showed median overall survivals (95% confidence interval) of 45.9 (38.1-not available), 16.7 (14.5-18.8) and 30.6 (23.2-34.8) months, respectively (P < 0.0001). The common tumor-related symptoms in G2 were pain, fatigue and anorexia, from which 31.7, 22.2 and 14.8% of the patients suffered at baseline.
The expected efficacy and safety of first-line cetuximab-containing chemotherapy were demonstrated in patients with metastatic colorectal cancer under clinical practice in Japan.
UMIN000007275.
我们旨在阐明含西妥昔单抗一线化疗在转移性结直肠癌患者中的临床实践及疗效。依据2012年欧洲医学肿瘤学会指南对各亚组的疗效和安全性进行评估。
这项前瞻性观察性研究纳入了来自日本158个中心的既往未经治疗的转移性结直肠癌患者，这些患者于2012年1月至2013年6月开始含西妥昔单抗的一线化疗，并随访长达3年。计算化疗后的切除率，并采用Kaplan-Meier法对第1组（G1组，潜在可切除）、第2组（G2组，不可切除且有肿瘤相关症状）和第3组（G3组，不可切除且无症状）估计总生存期。
578例患者中，562例被分为G1组（n = 165）、G2组（n = 224）或G3组（n = 173）。G1组任何部位的切除率（57.0%）高于G2组（11.2%）和G3组（11.6%）。G1组、G2组和G3组的中位总生存期（95%置信区间）分别为45.9（38.1 - 未获得）、16.7（14.5 - 18.8）和30.6（23.2 - 34.8）个月（P < 0.0001）。G2组常见的肿瘤相关症状为疼痛、乏力和厌食，基线时分别有31.7%、22.2%和14.8%的患者出现这些症状。
在日本的临床实践中，含西妥昔单抗一线化疗在转移性结直肠癌患者中展现出了预期的疗效和安全性。
UMIN000007275
