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NEJM:阿瓦斯汀不能显著延长卵巢癌患者生存期

  1. 阿瓦斯汀

来源:新华网 2012-11-18 10:43

最新一期美国《新英格兰医学杂志》刊登的两项研究报告显示,瑞士罗氏公司生产的抗癌药阿瓦斯汀不能显著延长卵巢癌患者的生存期。 这两项研究分别由英国和美国研究人员完成。在第一项研究中,分析人员跟踪研究了1500多名晚期卵巢癌患者的病情。她们均接受标准化疗,其中半数在化疗后服用阿瓦斯汀。结果显示,服用阿瓦斯汀只能使患者肿瘤的生长延缓一个半月。

最新一期美国《新英格兰医学杂志》刊登的两项研究报告显示,瑞士罗氏公司生产的抗癌药阿瓦斯汀不能显著延长卵巢癌患者的生存期。

这两项研究分别由英国和美国研究人员完成。在第一项研究中,分析人员跟踪研究了1500多名晚期卵巢癌患者的病情。她们均接受标准化疗,其中半数在化疗后服用阿瓦斯汀。结果显示,服用阿瓦斯汀只能使患者肿瘤的生长延缓一个半月。

第二项研究涉及1800多名晚期卵巢癌患者,其中部分人接受了化疗和高剂量阿瓦斯汀的联合治疗,其他人接受化疗和安慰剂治疗。结果显示,前一组患者肿瘤恶化的时间仅比后一组晚不到4个月。

两项研究均显示,尽管阿瓦斯汀能稍微延缓肿瘤恶化时间,但对患者生存期却无明显效果。此外,服用阿瓦斯汀的这些患者出现了多种不良反应:两名女性分别死于两种并发症——脑出血和肠穿孔,另外还有很多患者出现高血压症状。

罗氏公司此前称,阿瓦斯汀能通过抑制血管内皮生长因子来阻断肿瘤血液供应,使肿瘤无法在体内扩散,并能使化疗发挥效果。作为罗氏公司最畅销的抗癌药物之一,阿瓦斯汀在2009年的销售额达到59亿美元。

美国食品和药物管理局在今年11月以不安全和无效为由,决定吊销阿瓦斯汀治疗乳腺癌的许可。不过,它仍可用于治疗肺癌、肾癌、结肠癌和直肠癌。罗氏公司目前尚未计划在美国申请用阿瓦斯汀治疗卵巢癌。(生物谷Bioon.com)

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A Phase 3 Trial of Bevacizumab in Ovarian Cancer

Timothy J. Perren, M.D., Ann Marie Swart, M.D., Jacobus Pfisterer, M.D., Jonathan A. Ledermann, M.D., Eric Pujade-Lauraine, M.D., Gunnar Kristensen, M.D., Mark S. Carey, M.D., Philip Beale, M.D., Andrés Cervantes, M.D., Christian Kurzeder, M.D., Andreas du Bois, M.D., Jalid Sehouli, M.D., Rainer Kimmig, M.D., Anne St?hle, M.D., Fiona Collinson, M.D., Sharadah Essapen, M.D., Charlie Gourley, M.D., Alain Lortholary, M.D., Frédéric Selle, M.D., Mansoor R. Mirza, M.D., Arto Leminen, M.D., Marie Plante, M.D., Dan Stark, M.D., Wendi Qian, Ph.D., Mahesh K.B. Parmar, Ph.D., and Amit M. Oza, M.D. for the ICON7 Investigators

BACKGROUND

Angiogenesis plays a role in the biology of ovarian cancer. We examined the effect of bevacizumab, the vascular endothelial growth factor inhibitor, on survival in women with this disease.

METHODS

We randomly assigned women with ovarian cancer to carboplatin (area under the curve, 5 or 6) and paclitaxel (175 mg per square meter of body-surface area), given every 3 weeks for 6 cycles, or to this regimen plus bevacizumab (7.5 mg per kilogram of body weight), given concurrently every 3 weeks for 5 or 6 cycles and continued for 12 additional cycles or until progression of disease. Outcome measures included progression-free survival, first analyzed per protocol and then updated, and interim overall survival.

RESULTS

A total of 1528 women from 11 countries were randomly assigned to one of the two treatment regimens. Their median age was 57 years; 90% had epithelial ovarian cancer, 69% had a serous histologic type, 9% had high-risk early-stage disease, 30% were at high risk for progression, and 70% had stage IIIC or IV ovarian cancer. Progression-free survival (restricted mean) at 36 months was 20.3 months with standard therapy, as compared with 21.8 months with standard therapy plus bevacizumab (hazard ratio for progression or death with bevacizumab added, 0.81; 95% confidence interval, 0.70 to 0.94; P=0.004 by the log-rank test). Nonproportional hazards were detected (i.e., the treatment effect was not consistent over time on the hazard function scale) (P<0.001), with a maximum effect at 12 months, coinciding with the end of planned bevacizumab treatment and diminishing by 24 months. Bevacizumab was associated with more toxic effects (most often hypertension of grade 2 or higher) (18%, vs. 2% with chemotherapy alone). In the updated analyses, progression-free survival (restricted mean) at 42 months was 22.4 months without bevacizumab versus 24.1 months with bevacizumab (P=0.04 by log-rank test); in patients at high risk for progression, the benefit was greater with bevacizumab than without it, with progression-free survival (restricted mean) at 42 months of 14.5 months with standard therapy alone and 18.1 months with bevacizumab added, with respective median overall survival of 28.8 and 36.6 months.

CONCLUSIONS

Bevacizumab improved progression-free survival in women with ovarian cancer. The benefits with respect to both progression-free and overall survival were greater among those at high risk for disease progression.

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