Bennouna Jaafar, Phelip Jean-Marc, André Thierry, Asselain Bernard, Ducreux Michel
Institut De Cancérologie De l'Ouest, Site René Gauducheau, Nantes, France.
Department of Gastroenterology, Centre Hospitalier Universitaire de Saint Etienne, Saint Etienne, France.
Clin Colorectal Cancer. 2017 Jun;16(2):129-140.e4. doi: 10.1016/j.clcc.2016.07.013. Epub 2016 Aug 9.
The CONCERT study (observational cohort study of patients with metastatic colorectal cancer initiating chemotherapy in combination with bevacizumab) aimed to describe patient characteristics, bevacizumab use, its efficacy in terms of progression-free survival (PFS) and overall survival (OS), and its safety in patients with metastatic colorectal cancer (mCRC) treated in daily medical practice.
CONCERT was an observational, prospective, multicenter, cohort study conducted in France. Patients with mCRC initiating bevacizumab combined with chemotherapy were included and followed up for ≤ 36 months.
Overall, 737 evaluable patients were assessed, and 71%, 21%, and 8% initiated bevacizumab as first-, second-, or third-line therapy or more, respectively. Their mean age was 64.5 years (range, 25-88 years), and 60% were men. Bevacizumab was mainly started at 5 mg/kg every 2 weeks (95%) and mostly combined with FOLFIRI (leucovorin, 5-fluorouracil, irinotecan; 68.0%) or FOLFOX (leucovorin, 5-fluorouracil, oxaliplatin; 22.0%). The median PFS was 10.4 months (95% confidence interval [CI], 9.6-11.3) in first-line, 8.5 months (95% CI, 7.0-9.2) in second-line, and 6.3 months (95% CI, 4.5-8.9) in third-line or beyond. The corresponding median OS was 25.3 months (95% CI, 21.5-28.6), 19.1 months (95% CI, 15.7-22.6), and 14.9 months (95% CI, 11.6-20.4). In first-line treatment, primary tumor resection and oxaliplatin-based chemotherapy were prognostic of a longer PFS. Eastern Cooperative Oncology Group performance status ≥ 2, > 1 metastatic sites, and intermediate or high risk using the Köhne prognostic index were associated with shorter PFS. The safety profile of bevacizumab combined with chemotherapy was comparable to that found by other observational studies of mCRC.
The efficacy and safety results of bevacizumab plus chemotherapy as first- and second-line treatment of mCRC in daily practice in the CONCERT observational, prospective study were in line with those from randomized clinical studies.
CONCERT研究（转移性结直肠癌患者启动化疗联合贝伐单抗的观察性队列研究）旨在描述在日常医疗实践中接受治疗的转移性结直肠癌（mCRC）患者的特征、贝伐单抗的使用情况、其在无进展生存期（PFS）和总生存期（OS）方面的疗效及其安全性。
CONCERT是一项在法国进行的观察性、前瞻性、多中心队列研究。纳入启动贝伐单抗联合化疗的mCRC患者，并随访≤36个月。
总体而言，评估了737例可评估患者，分别有71%、21%和8%的患者将贝伐单抗作为一线、二线或三线及以上治疗启动。他们的平均年龄为64.5岁（范围25 - 88岁），60%为男性。贝伐单抗主要起始剂量为每2周5mg/kg（95%），大多与FOLFIRI（亚叶酸钙、5-氟尿嘧啶、伊立替康；68.0%）或FOLFOX（亚叶酸钙、5-氟尿嘧啶、奥沙利铂；22.0%）联合使用。一线治疗的中位PFS为10.4个月（95%置信区间[CI]，9.6 - 11.3），二线治疗为8.5个月（95% CI，7.0 - 9.2），三线及以上治疗为6.3个月（95% CI，4.5 - 8.9）。相应的中位OS分别为25.3个月（95% CI，21.5 - 28.6）、19.1个月（95% CI，15.7 - 22.6）和14.9个月（95% CI，11.6 - 20.4）。在一线治疗中，原发肿瘤切除和基于奥沙利铂的化疗是PFS较长的预后因素。东部肿瘤协作组体能状态≥2、转移部位>1个以及使用Köhne预后指数为中或高风险与较短的PFS相关。贝伐单抗联合化疗的安全性与其他mCRC观察性研究的结果相当。
在CONCERT观察性前瞻性研究中，贝伐单抗加化疗作为mCRC一线和二线治疗在日常实践中的疗效和安全性结果与随机临床研究的结果一致。
