Observational study of first-line chemotherapy including cetuximab in patients with metastatic colorectal cancer: CORAL trial.
Observational study of first-line chemotherapy including cetuximab in patients with metastatic colorectal cancer: CORAL trial.
复制标题
转移性结直肠癌患者一线化疗（包括西妥昔单抗）的观察性研究：CORAL 试验。
DOI：
10.1093/jjco/hyy189
复制
发表时间：
2019
期刊：
影响因子：
--
通讯作者：
Sugihara K.
中科院分区：
文献类型：
--
作者：
Muro K;Itabashi M;Hashida H;Masuishi T;Bando H;Denda T;Yamanaka T;Ohashi Y;Sugihara K.
目的探讨含西妥昔单抗一线化疗方案治疗转移性结直肠癌的临床效果。根据2012年欧洲医学肿瘤学会指南对每组患者的疗效和安全性进行评估。方法这项前瞻性观察性研究包括来自日本158个中心的未经治疗的转移性结直肠癌患者，他们于2012年1月至2013年6月开始接受含西妥昔单抗的一线化疗，并进行了长达3年的随访。结果578例患者中，562例分为G1组(165例)、G2组(224例)和G3组(173例)。G1组各部位的切除率(57.0%)均高于G2组(11.2%)和G3组(11.6%)。G1、G2和G3的中位总生存期(95%可信区间)分别为45.9(38.1-不可用)、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、乏力和食欲不振，分别有31.7%、22.2%和14.8%的患者出现疼痛、乏力和食欲不振。结论西妥昔单抗一线化疗在日本临床实践中对转移性结直肠癌患者具有预期的疗效和安全性。
ObjectiveWe 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.MethodsThis 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).ResultsOf 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.ConclusionsThe expected efficacy and safety of first-line cetuximab-containing chemotherapy were demonstrated in patients with metastatic colorectal cancer under clinical practice in Japan.Registered clinical trial numbersUMIN000007275