Cartenì Giacomo, Bordonaro Roberto, Giotta Francesco, Lorusso Vito, Scalone Simona, Vinaccia Vincenza, Rondena Roberta, Amadori Dino
AORNA Cardarelli, Napoli, Italy.
Oncologist. 2006 Jul-Aug;11(7):841-8. doi: 10.1634/theoncologist.11-7-841.
This study evaluated the efficacy and safety of zoledronic acid in breast cancer patients with newly diagnosed bone metastases.
Patients diagnosed with bone metastases < or = 6 weeks prior to first visit were enrolled. Zoledronic acid (4 mg) was administered via a 15-minute infusion every 3 or 4 weeks for 12 infusions. Skeletal-related events (SREs) were defined as pathologic bone fractures, spinal cord compression, surgery to bone, radiation therapy to bone, and hypercalcemia of malignancy. Primary efficacy end points were the proportion of patients with at least one SRE and the time to first SRE. Secondary end points included pain, analgesic use, and quality of life.
Among 312 patients enrolled, 30% experienced at least one SRE during the 12-month study, and 22% experienced only one SRE. The median time to first SRE was not reached in the intent-to-treat population. Mean pain and analgesic scores declined from baseline, and quality-of-life scores remained stable to study end. The most frequently reported adverse events, regardless of relationship to study drug, were pyrexia (22%) and bone pain (10%). Serum creatinine levels did not significantly increase from baseline throughout the study.
Breast cancer patients with newly diagnosed bone metastases who were treated with zoledronic acid had a low incidence of SREs compared with patients who received placebo in randomized phase III trials, and pain was decreased from baseline. This study demonstrated the favorable risk:benefit ratio of zoledronic acid for the prevention of skeletal complications.
本研究评估了唑来膦酸在新诊断为骨转移的乳腺癌患者中的疗效和安全性。
纳入首次就诊前6周内诊断为骨转移的患者。唑来膦酸（4毫克）每3或4周通过15分钟静脉输注给药，共输注12次。骨相关事件（SREs）定义为病理性骨折、脊髓压迫、骨手术、骨放疗和恶性肿瘤高钙血症。主要疗效终点为至少发生一次SRE的患者比例和首次发生SRE的时间。次要终点包括疼痛、镇痛药物使用和生活质量。
在纳入的312例患者中，30%在12个月的研究期间至少经历一次SRE，22%仅经历一次SRE。在意向性治疗人群中，未达到首次发生SRE的中位时间。平均疼痛和镇痛评分较基线下降，生活质量评分至研究结束时保持稳定。无论与研究药物有无关系，最常报告的不良事件为发热（22%）和骨痛（10%）。在整个研究过程中，血清肌酐水平较基线无显著升高。
与随机III期试验中接受安慰剂治疗的患者相比，接受唑来膦酸治疗的新诊断为骨转移的乳腺癌患者SREs发生率较低，且疼痛较基线减轻。本研究证明了唑来膦酸在预防骨骼并发症方面具有良好的风险效益比。
