Multiple myeloma (MM) is an incurable disease with a poor survival, which has not been affected even by high-dose chemotherapy. This systematic review was performed to assess the efficacy and safety of the novel agent bortezomib for patients with previously untreated MM. We systematically searched biomedical literature databases and identified randomized controlled trials (RCTs) comparing bortezomib with placebo, no bortezomib, or other active agents for patients with previously untreated MM. Overall survival (OS), reported as hazard ratio (HR) with 95% confidence interval (CI), was the primary outcome measure. The secondary outcomes included time to progression (TTP), progression-free survival (PFS), and response rates. Five RCTs involving 2,728 patients were included. Three trials compared bortezomib with no bortezomib, and two compared bortezomib with other active agents (vincristine ± adriamycin-based chemotherapy). All included RCTs had methodological shortcomings, including no or unclear allocation concealment and blinding. Compared with no bortezomib or vincristine-based chemotherapy, the bortezomib-based regimen significantly improved the OS of patients with previously untreated MM. HR was 0.71 (95% CI 0.55-0.93) and 0.77 (95% CI 0.60-0.99), respectively. However, when compared with the vincristine + adriamycin-based regimen, the OS was similar (HR = 0.87, 95% CI 0.57-1.33). TTP, PFS, and response rates were also improved in patients receiving bortezomib-based regimen. However, the risk of peripheral neuropathy was found to be significantly higher. In summary, bortezomib appears to improve survival and response rates of patients with previously untreated MM in spite of higher risk of peripheral neuropathy.

译文

:多发性骨髓瘤(MM)是一种无法治愈的疾病,其生存率很低,即使进行大剂量化疗也没有受到影响。进行了这项系统的评估,以评估新型药物硼替佐米对先前未经治疗的MM患者的疗效和安全性。我们系统地搜索了生物医学文献数据库,并确定了将硼替佐米与安慰剂,无硼替佐米或其他活性药物用于以前未经治疗的MM患者进行比较的随机对照试验(RCT)。总体生存期(OS)以危险比(HR)表示,置信区间(CI)为95%,是主要的结局指标。次要结果包括进展时间(TTP),无进展生存期(PFS)和缓解率。纳入了5项RCT,涉及2,728例患者。三项试验比较了硼替佐米与无硼替佐米,两项试验将硼替佐米与其他活性剂(以长春新碱±阿霉素为基础的化疗)进行比较。所有纳入的RCT都有方法上的缺陷,包括没有或不清楚的分配隐藏和盲目性。与不使用硼替佐米或长春新碱为基础的化疗相比,基于硼替佐米的方案显着改善了先前未经治疗的MM患者的OS。 HR分别为0.71(95%CI 0.55-0.93)和0.77(95%CI 0.60-0.99)。但是,与基于长春新碱阿霉素的方案相比,OS相似(HR = 0.87,95%CI 0.57-1.33)。接受基于硼替佐米的治疗方案的患者的TTP,PFS和反应率也得到改善。然而,发现周围神经病的风险明显更高。总之,尽管周围神经病变的风险较高,但硼替佐米似乎可以改善先前未经治疗的MM患者的存活率和反应率。

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