Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing 100021, China.
Chin Med J (Engl). 2012 Mar;125(5):764-9.
Three randomised trials have demonstrated that combining bevacizumab with first-line chemotherapy significantly improves progression-free survival versus chemotherapy alone in HER2-negative locally recurrent/metastatic breast cancer (LR/mBC). However, data from Chinese populations are limited and possible differences between ethnic and geographic populations are unknown. This study was conducted to determine whether there are differences in safety and efficacy in patients with HER2-negative LR/mRC between Chinese and Western populations after they receive first-line bevacizumab combined with taxane-based therapy.
In the single-arm, open-label, Avastin Therapy for Advanced Breast Cancer (ATHENA) study (NCT00448591), patients with HER2-negative LR/mBC received first-line bevacizumab (investigator's choice of 10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) combined with taxane-based therapy. The primary endpoint was safety profile and the secondary is time to progression (TTP). A subpopulation analysis was conducted to assess safety and efficacy in Chinese patients.
Of 2264 patients treated in ATHENA, 202 were enrolled in China. Bevacizumab was combined with docetaxel in 90% of Chinese patients and paclitaxel in 10%. The most common grade 3/4 adverse events were diarrhoea (in 5.0% of patients) and hypertension (in 2.5% of patients). Grade 3/4 proteinuria occurred in 0.5%. After median follow-up of 17.6 months and events in 56% of patients, median TTP was 9.0 months (95%CI, 8.4-11.1). Overall survival data were immature.
We found no evidence of increased bevacizumab-related toxicity or reduced efficacy in Chinese LR/mBC patients receiving first-line bevacizumab-taxane therapy compared with predominantly Western populations. The safety profile was generally similar to previously reported LR/mBC trials. Subtle differences may be attributable to different lifestyle and cardiovascular risk factors in Chinese patients compared with the overall population. It appears reasonable to extrapolate findings from bevacizumab-based randomised trials to Chinese populations.
三项随机试验表明，与单独化疗相比，贝伐珠单抗联合一线化疗可显著改善 HER2 阴性局部复发性/转移性乳腺癌（LR/mBC）患者的无进展生存期。然而，来自中国人群的数据有限，且不同种族和地理人群之间可能存在差异。本研究旨在确定在中国人群中，与西方人群相比，接受一线贝伐珠单抗联合紫杉烷类治疗的 HER2 阴性 LR/mRC 患者的安全性和疗效是否存在差异。
在单臂、开放标签的 Avastin Therapy for Advanced Breast Cancer（ATHENA）研究（NCT00448591）中，HER2 阴性 LR/mBC 患者接受一线贝伐珠单抗（研究者选择 10 mg/kg，每 2 周 1 次或 15 mg/kg，每 3 周 1 次）联合紫杉烷类治疗。主要终点为安全性谱，次要终点为无进展生存期（TTP）。进行了亚人群分析，以评估中国患者的安全性和疗效。
在 ATHENA 中接受治疗的 2264 例患者中，有 202 例在中国入组。贝伐珠单抗联合多西他赛治疗的患者占 90%，联合紫杉醇治疗的患者占 10%。最常见的 3/4 级不良事件为腹泻（5.0%的患者）和高血压（2.5%的患者）。3/4 级蛋白尿发生率为 0.5%。中位随访 17.6 个月后，56%的患者发生事件，中位 TTP 为 9.0 个月（95%CI，8.4-11.1）。总生存数据不成熟。
我们发现，与主要为西方人群相比，接受一线贝伐珠单抗-紫杉烷治疗的中国 LR/mBC 患者并未出现贝伐珠单抗相关毒性增加或疗效降低的证据。安全性谱与先前报道的 LR/mBC 试验大致相似。与总体人群相比，中国患者的生活方式和心血管危险因素可能存在细微差异，这可能导致了安全性谱的差异。从基于贝伐珠单抗的随机试验推断出的结果外推至中国人群似乎是合理的。
