Department of Pharmacy, Guangdong Medical College, China.
Department of Pharmacy, Guangdong Medical College, China.
Eur J Cancer. 2013 Jun;49(9):2086-92. doi: 10.1016/j.ejca.2013.01.021. Epub 2013 Feb 26.
The aim of this study was to evaluate the effectiveness of clodronate in the adjuvant therapy of early breast cancer on patient survival.
We performed a literature search to identify studies that investigated the effects of clodronate treatment on early breast cancer. Random and fixed-effect meta-analytical models were used where indicated and between-study heterogeneity was assessed. The primary study end-points were overall survival. Secondary end-points were bone metastasis-free survival and non-skeletal metastasis (mainly visceral metastases) free survival.
Four randomised controlled trials met the inclusion criteria. Risk ratio (95% confidence interval (CI)) of overall survival was 0.84 (0.56-1.26); risk ratio (95% CI) of bone metastasis-free survival was 0.77 (0.58-1.02); risk ratio (95% CI) of non-bone metastasis-free survival was 0.89 (0.61-1.30). Outcomes after sensitivity analysis were: risk ratio (95% CI) of overall survival was 0.71 (0.52-0.96); risk ratio (95% CI) of bone metastasis-free survival was 0.70 (0.56-0.86); risk ratio (95% CI) of non-bone metastasis-free survival was 0.76 (0.64-0.92).
Compared with the control arm, adjuvant treatment with clodronate may improve the overall survival, bone metastasis-free survival and non-bone metastasis-free (mainly visceral metastases) survival in patients with early breast cancer. However, further meta-analyses involving all known randomised trials with analysis of sub-groups by age or menopausal status, accessing original trial data, should be performed.
本研究旨在评估氯膦酸酯在早期乳腺癌辅助治疗中的疗效及其对患者生存的影响。
我们进行了文献检索,以确定研究氯膦酸酯治疗对早期乳腺癌影响的研究。在有指示的情况下,使用随机和固定效应荟萃分析模型,并评估研究间的异质性。主要研究终点是总生存率。次要终点是无骨转移生存率和无非骨骼转移(主要是内脏转移)生存率。
四项随机对照试验符合纳入标准。总生存率的风险比(95%置信区间(CI))为 0.84(0.56-1.26);无骨转移生存率的风险比(95%CI)为 0.77(0.58-1.02);无非骨骼转移生存率的风险比(95%CI)为 0.89(0.61-1.30)。敏感性分析后的结果为:总生存率的风险比(95%CI)为 0.71(0.52-0.96);无骨转移生存率的风险比(95%CI)为 0.70(0.56-0.86);无非骨骼转移生存率的风险比(95%CI)为 0.76(0.64-0.92)。
与对照组相比,早期乳腺癌患者接受氯膦酸酯辅助治疗可能会提高总生存率、无骨转移生存率和无非骨骼转移(主要是内脏转移)生存率。然而,应该进行进一步的荟萃分析,包括所有已知的随机试验,并按年龄或绝经状态进行亚组分析,获取原始试验数据。