标准化疗药物中添加贝伐单抗能改善妇科肿瘤患者无进展生存期-来自欧洲肿瘤医学会

【原文】：
 
     Adding Bevacizumab to Standard Chemo Improves Progression-Free Survival in Patients With Gynaecological Cancers: Presented at ESMO
                                                                     By Chris Berrie
　　MILAN, Italy -- October 14, 2010 -- Addition of concurrent and maintenance bevacizumab to standard carboplatin plus paclitaxel provides significant improvement to progression-free survival (PFS) in patients with newly diagnosed epithelial ovarian, primary peritoneal, or fallopian tube cancer, researchers said here at the 35th European Society for Medical Oncology (ESMO) Congress.
　　Tim Perren, MD, Medical Oncology, St. James" Institute of Oncology, St. James" University Hospital, Leeds, United Kingdom, presented results here on October 11.
　　Ovarian cancer remains a challenge, as despite good response to surgery and platinum-based chemotherapy, more than 50％ of the women will eventually die from their disease.
　　As angiogenesis is known to have a central role in progression of ovarian cancer, the present study was designed to investigate the use of bevacizumab in this setting.
For the study, patients with histologically confirmed ovarian, primary peritoneal or fallopian tube cancer, with poor surgical debulking received 6 cycles of carboplatin (area under the curve 6) and paclitaxel 175 mg/m2 every 3 weeks, combined with either placebo (n = 764) or 6 cycles of bevacizumab 7.5 mg/kg every 3 weeks (n = 764).
　　The triple combination group then continued bevacizumab treatment for a further 12 cycles of maintenance, without carboplatin and paclitaxel.
The primary endpoint was progression-free survival (PFS), with disease progression defined according to Response Evaluation Criteria in Solid Tumours (RECIST). Secondary endpoints were overall survival, response rate, and toxicity.
　　At median follow-up of 19.4 months, PFS was 19.0 months for patients receiving bevacizumab versus 17.3 months for patients receiving placebo.
　　However, the PFS curves converged following crossing of the median. "This means that the hazards are not proportional, and the conventional statistical endpoints that we use for describing outcome data in clinical trials, assumes underlying poportionality of the risks," Dr. Perren explained. Thus the hazard ratio (HR) needs to be considered with caution: 0.81 (95％ confidence interval [CI], 0.70-0.94; P =.0041).
　　For their preliminary analysis of overall survival, Dr. Perren said there were "slightly less deaths in the research arm than the control arm, and the trend is in the right direction, but we should say no more." The addition of bevacizumab provided a HR of 0.81 (P =.098).
　　For toxicities, these paralleled those already recognised for bevacizumab and were generally mild. Grade >=2 hypertension was seen in 18.3％ of patients, the level at which additional antihypertensive medication is required.

{NextPage}【译文】：

　　在标准化疗药物中添加贝伐单抗能改善妇科肿瘤患者无进展生存期-来自欧洲肿瘤医学会

　　2010年10月14日，意大利米兰，在第35届欧洲肿瘤医学会大会上有研究者表明：在标准化疗药物卡波铂及紫杉醇中同时添加维持剂量的贝伐单抗，对新诊断出患有上皮性卵巢癌、原发性输卵管癌的患者来说有很重要的意义，因为能够很好的改善无进展生存期。
　　英国利兹市圣.詹姆斯大学医院，圣.詹姆斯肿瘤研究所肿瘤医务部的蒂姆.佩伦，在10月11日同样也这一结论。
　　卵巢癌仍然是一个挑战，虽然它对手术及以铂类物质为主的化疗的反应还是好的，但是仍有超过50％的妇女最终死于他们所患的这种疾病。
　　如同所知道的血管再生术对卵巢癌的发展过程有非常重要作用一样。目前的研究主要是对贝伐单抗在这一机制中的作用进行研究。
　　对于这个研究，那些在组织学上确认患有卵巢癌，原发性输卵管癌的患者，不手术而给予6个周期的卡波铂（在曲线6下的区域）并每三个月给予紫杉醇175mg/m2，同时联合给764例安慰剂或是每三个月给予贝伐单抗7.5mg/kg。
　　这三种药物共同使用的联合疗法在接下来的12个周期中只选择继续使用贝伐单抗，而不再添加卡波铂和紫杉醇。
　　根据实体瘤疗效评价标准中对疾病分级定义，首先考虑的是无进展生存期。其次是总体的生存率、有效率及毒性。
　　在19.4个月的研究过程中，使用贝伐单抗组的无进展生存期为19个月，而安慰剂组的无进展生存期为17.3个月。
　　然而不管怎样， PFS曲线在穿过中点后会逐渐趋向于一点，“这就意味着，这个风险并不是成比例的，并且我们通常在临床试验中所用来描述结果的统计学数据，这些假设也是建立在相应的风险上的。”佩伦博士解释道。因此，风险比例需要很谨慎的被确认：0.81。
对她们总体生存率的初步研究，佩伦博士说：“研究组的死亡率略微低于控制组，并且这种趋势正向良好的方向发展，但是目前我们不能多说些什么。”只有在风险比例在0.81的条件下才能添加贝伐单抗。
　　毒性方面，作为我们已经认识的贝伐单抗来说，二组非常的相似并且都很温和。18.3％的病人曾出现不低于2级的高血压，这时候需要同时添加抗高血压的药物。