瑞士和德國一項(xiàng)針對(duì)全球暢銷抗癌藥阿瓦斯汀的新研究顯示,,這種藥即不能延長乳腺癌患者的生命,也不能提高患者的生活質(zhì)量,。相關(guān)研究報(bào)告已發(fā)表在醫(yī)學(xué)雜志《科克倫圖書館》(The Cochrane Library)上,。
美國食品和藥物管理局曾在2008年通過簡易程序批準(zhǔn)阿瓦斯汀用于乳腺癌治療。但臨床試驗(yàn)顯示,,阿瓦斯汀并不能延長乳腺癌患者的生存期,,且具有明顯副作用,其中包括血壓升高,、易疲勞,、白細(xì)胞異常等。去年11月,,該局以不安全和無效為由吊銷阿瓦斯汀治療乳腺癌的許可,。目前阿瓦斯汀仍可用于治療肺癌、腎癌,、結(jié)腸癌和直腸癌等,。
美國等國的研究人員分析了7項(xiàng)針對(duì)4000多名轉(zhuǎn)移性乳腺癌患者展開的隨機(jī)對(duì)照試驗(yàn)。結(jié)果表明,,阿瓦斯汀不能延長患者的生存時(shí)間,。關(guān)于患者身體狀況和日常生活滿意度的調(diào)查也顯示,患者在服用阿瓦斯汀后,,相關(guān)情況沒有好轉(zhuǎn),。
阿瓦斯汀的化學(xué)名稱為“貝伐單抗”,是一種單克隆抗體類藥物,。其研發(fā)理論認(rèn)為,,該藥通過抑制血管內(nèi)皮生長因子來阻斷對(duì)腫瘤的血液供應(yīng),使腫瘤細(xì)胞無法在體內(nèi)擴(kuò)散,,并能使化療有效發(fā)揮作用,。(生物谷Bioon.com)
doi:10.1002/14651858.CD008941.pub2
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Vascular‐endothelial‐growth‐factor (VEGF) targeting therapies for endocrine refractory or resistant metastatic breast cancer
Wagner, Anna Dorothea; Thomssen, Christoph; Haerting, Johannes; Unverzagt, Susanne
Objectives To evaluate the benefits (in progression-free survival (PFS) and overall survival (OS)) and harms (toxicity) of VEGF-targeting therapies in patients with hormone-refractory or hormone-receptor negative metastatic breast cancer. Search methods Searches of CENTRAL, MEDLINE, EMBASE, the Cochrane Breast Cancer Group's Specialised Register, registers of ongoing trials and proceedings of conferences were conducted in January and September 2011, starting in 2000. Reference lists were scanned and members of the Cochrane Breast Cancer Group, experts and manufacturers of relevant drug were contacted to obtain further information. No language restrictions were applied. Selection criteria Randomised controlled trials (RCTs) to evaluate treatment benefit and non-randomised studies in the routine oncology practice setting to evaluate treatment harms. Data collection and analysis We performed data collection and analysis according to the published protocol. Individual patient data was sought but not provided. Therefore, the meta-analysis had to be based on published data. Summary statistics for the primary endpoint (PFS) were hazard ratios (HRs). Main results We identified seven RCTs, one register, and five ongoing trials from a total of 347 references. The published trials for VEGF-targeting drugs in MBC were limited to bevacizumab. Four trials, including a total of 2886 patients, were available for the comparison of first-line chemotherapy, with versus without bevacizumab. PFS (HR 0.67; 95% confidence interval (CI) 0.61 to 0.73) and response rate were significantly better for patients treated with bevacizumab, with moderate heterogeneity regarding the magnitude of the effect on PFS. For second-line chemotherapy, a smaller, but still significant benefit in terms of PFS could be demonstrated for patients treated with bevacizumab (HR 0.85; 95% CI 0.73 to 0.98), as well as a benefit in tumour response. However, OS did not differ significantly, neither in first- (HR 0.93; 95% CI 0.84 to 1.04), nor second-line therapy (HR 0.98; 95% CI 0.83 to 1.16). Quality of life (QoL) was evaluated in four trials but results were published for only two of these with no relevant impact. Subgroup analysis stated a significant greater benefit for patients with previous (taxane) chemotherapy and patients with hormone-receptor negative status. Regarding toxicity, data from RCTs and registry data were consistent and in line with the known toxicity profile of bevacizumab. While significantly higher rates of adverse events (AEs) grade III/IV (odds ratio (OR) 1.77; 95% CI 1.44 to 2.18) and serious adverse events (SAEs) (OR 1.41; 95% CI 1.13 to 1.75) were observed in patients treated with bevacizumab, rates of treatment-related deaths were lower in patients treated with bevacizumab (OR 0.60; 95% CI 0.36 to 0.99).