Department of Oncology, McGill University Health Centre, Royal Victoria Hospital, Montreal, QC.
Curr Oncol. 2013 Oct;20(5):247-51. doi: 10.3747/co.20.1370.
Before its regulatory approval in Canada, bevacizumab to treat patients with colorectal cancer (crc) was accessed through the Bevacizumab Expanded Access Trial and a special-access program at the Jewish General Hospital. We retrospectively evaluated patient outcomes in that large cohort.
All patients (n = 196) had metastatic crc, were bevacizumab-naïve, and received bevacizumab in combination with chemotherapy at the Jewish General Hospital between 2004 and 2009. We collected patient demographics and clinical characteristics; relevant medical history, disease stage and tumour pathology at diagnosis; type, duration, and line of therapy; grades 3 and 4 adverse events (aes), time to disease progression (ttp), and overall survival (os) from diagnosis.
Median follow-up was 36.0 months. Median ttp was 8.0 months [95% confidence interval (ci): 7.0 to 9.0 months). Median os was 41.0 months (95% ci: 36.0 to 47.0 months). Of the 40 grades 3 and 4 bevacizumab-related aes experienced by 38 patients (19.4%), the most common were thrombocytopenia (n = 17), deep-vein thrombosis (n = 6), pulmonary embolism (n = 4), and hypertension (n = 3).
In an expanded access setting, our data reflect the efficacy and safety of bevacizumab-based therapy in the controlled post-registration clinical trial setting.
在加拿大获得监管批准之前，贝伐单抗（bevacizumab）用于治疗结直肠癌（CRC）患者是通过 Bevacizumab 扩大准入试验和犹太综合医院的特殊准入计划获得的。我们回顾性地评估了该大型队列中的患者结局。
所有患者（n=196）均患有转移性 CRC，为贝伐单抗初治患者，并于 2004 年至 2009 年在犹太综合医院接受贝伐单抗联合化疗。我们收集了患者的人口统计学和临床特征；相关的病史、诊断时的疾病分期和肿瘤病理学；治疗类型、持续时间和线数；3 级和 4 级不良事件（AE）、疾病进展时间（ttp）和从诊断开始的总生存期（OS）。
中位随访时间为 36.0 个月。中位 ttp 为 8.0 个月[95%置信区间（CI）：7.0 至 9.0 个月）。中位 OS 为 41.0 个月（95%CI：36.0 至 47.0 个月）。在 38 名患者（19.4%）中经历了 40 例 3 级和 4 级与贝伐单抗相关的 AE，其中最常见的是血小板减少症（n=17）、深静脉血栓形成（n=6）、肺栓塞（n=4）和高血压（n=3）。
在扩大准入的情况下，我们的数据反映了贝伐单抗为基础的治疗在注册后临床试验中的疗效和安全性。
