Department of Oncology, General Hospital of Eskilstuna, Eskilstuna, Sweden.
Oncologist. 2013;18(4):353-61. doi: 10.1634/theoncologist.2012-0261. Epub 2013 Feb 12.
The purpose of the study was to estimate the impact on survival and fracture rates of the use of zoledronic acid versus no use (or delayed use) in the adjuvant treatment of patients with early-stage (stages I-III) breast cancer.
We performed a systematic review and meta-analysis of randomized clinical trials. Trials were located through PubMed, ISI, Cochrane Library, and major cancer scientific meeting searches. All trials that randomized patients with primary breast cancer to undergo adjuvant treatment with zoledronic acid versus nonuse, placebo, or delayed use of zoledronic acid as treatment to individuals who develop osteoporosis were considered eligible. Standard meta-analytic procedures were used to analyze the study outcomes.
Fifteen studies were considered eligible and were further analyzed. The use of zoledronic acid resulted in a statistically significant better overall survival outcome (five studies, 6,414 patients; hazard ratio [HR], 0.81; 95% confidence interval [CI], 0.70-0.94). No significant differences were found for the disease-free survival outcome (seven studies, 7,541 patients; HR, 0.86; 95% CI, 0.70-1.06) or incidence of bone metastases (seven studies, 7,543 patients; odds ratio [OR], 0.94; 95% CI, 0.64-1.37). Treatment with zoledronic acid led to a significantly lower overall fracture rate (OR, 0.78; 95% CI, 0.63-0.96). Finally, the rate of osteonecrosis of the jaw was 0.52%.
Zoledronic acid as adjuvant therapy in breast cancer patients appears to not only reduce the fracture risk but also offer a survival benefit over placebo or no treatment.
本研究旨在评估在早期(I-III 期)乳腺癌的辅助治疗中使用唑来膦酸与不使用(或延迟使用)相比对生存和骨折率的影响。
我们对随机临床试验进行了系统评价和荟萃分析。通过 PubMed、ISI、Cochrane 图书馆和主要癌症科学会议检索来查找试验。所有将原发性乳腺癌患者随机分配至接受唑来膦酸辅助治疗与不使用、安慰剂或延迟使用唑来膦酸治疗骨质疏松症患者的试验均被认为符合条件。采用标准荟萃分析程序来分析研究结果。
有 15 项研究符合条件并进一步进行了分析。使用唑来膦酸可显著改善总体生存结局(5 项研究,6414 例患者;风险比[HR],0.81;95%置信区间[CI],0.70-0.94)。无病生存结局(7 项研究,7541 例患者;HR,0.86;95%CI,0.70-1.06)或骨转移发生率(7 项研究,7543 例患者;比值比[OR],0.94;95%CI,0.64-1.37)无显著差异。唑来膦酸治疗可显著降低总体骨折率(OR,0.78;95%CI,0.63-0.96)。最后,颌骨坏死发生率为 0.52%。
唑来膦酸作为乳腺癌患者的辅助治疗不仅可降低骨折风险,而且与安慰剂或不治疗相比具有生存获益。