Comparison of the Efficacy and Safety between Pamidronate Disodium and Zoledronic Acid in Treating Non-small-cell Lung Cancer Patients with Bone Metastasis_West China Medical Journal

Authors：

ZOU Bingwen , SONG Haixia , ZHANG Yu , ZHOU Lin , ZHU Jiang , LIU Yongmei , HUANG Meijuan , LI Lu ,  XU Yong

Department of Thoracic Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;

Corresponding author：

XU Yong, Email: zoubingwen@live.cn

Keywords：

非小细胞肺癌; 骨转移; 骨相关事件; 帕米膦酸二钠; 唑来膦酸

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【摘要】　目的　评价伴骨转移的非小细胞肺癌（non-small cell lung cancer，NSCLC）患者在接受帕米膦酸二钠和唑来膦酸治疗后的有效性和安全性。　方法　 2007年6月-2008年12月，74例伴骨转移的NSCLC，患者接受了双膦酸盐治疗，其中50例接受帕米膦酸二钠治疗，24例接受唑来膦酸治疗。帕米膦酸二钠90 mg，静脉滴注3 h，每4周重复1次；唑来膦酸4 mg，静脉滴注15 min，每4周重复1次。对可能影响其骨相关事件发生时间及生存率的各种临床﹑病理、治疗方法等因素进行分析，用Kaplan-Meier曲线及Log rank检验生存率差异，对不良反应的发生率等采用χ2检验。　结果　 18个月无骨相关事件生存率和总体生存率在帕米膦酸二钠及唑来膦酸组分别为19.3%、28.9%（P=0.253）和33.4%、38.2%（P=0.745），两组比较，差异均无统计学意义。两组患者不良反应中帕米膦酸二钠组8例（16.0%），唑来膦酸组6例（25.0%），两组比较差异无统计学意义（χ2=0.200，P=0.655）。7例患者用帕米膦酸二钠治疗失败后再用唑来膦酸治疗，其中位无骨相关事件生存时间为2个月（95%CI：0~4.6）。　结论　唑来膦酸和帕米膦酸二钠在缓解延迟骨相关事件发生时间疗效和不良反应发生率相当。用帕米膦酸二钠治疗失败后再用唑来膦酸可延缓骨相关事件发生时间。
【Abstract】　Objective　 To retrospectively evaluate the efficacy and safety of pamidronate disoclium and zoledronic acid in treating non-small-cell lung cancer (NSCLC) patients with bone metastasis.　Methods　 This study included 74 patients who were treated with bisphosphonate between June 2007 and December 2008. Fifty were treated with pamidronate disodium, and 24 with zoledronic acid. Pamidronate disodium was administered intravenously once for 3 hours every 4 weeks at a dose of 90 mg. Zoledronic acid was given intravenously once for 15 minutes every 4 weeks at a dose of 4 mg. Various clinical, pathological factors and treatment methods related to the occurring time of skeletal related events (SRE) and survival rate were analyzed. Kaplan-Meier curve and Log rank were adopted to detect the difference in survival rate between patients treated with different medicine, and we used χ2 test to discover the rate of adverse events of the patients.　Results　 Eighteen-month SRE-free survival and overall survival rate in the pamidronate disodium and zoledronic acid group were 19.3% vs. 28.9% (P=0.253), and 33.4% vs. 38.2% (P=0.745) respectively. There were 8 (8/50) cases of adverse events in the pamidronate disodium group, and 6 (6/24) in the zoledronic acid group (χ2=0.200, P=0.655). The SRE-free survival time for seven patients who were treated with zoledronic acid after pamidronate disodium failed was 2 months (95%CI: 0-4.6).　Conclusions　 Compared with zoledronic acid, pamidronate has equal efficacy in delaying SRE and incidence of adverse effects. Administering zoledronic acid after pamidronate failed can also delay the occurring time of SRE.

Citation： ZOU Bingwen,SONG Haixia,ZHANG Yu,ZHOU Lin,ZHU Jiang,LIU Yongmei,HUANG Meijuan,LI Lu,XU Yong. Comparison of the Efficacy and Safety between Pamidronate Disodium and Zoledronic Acid in Treating Non-small-cell Lung Cancer Patients with Bone Metastasis. West China Medical Journal, 2011, 26(2): 212-215. doi: Copy

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14.	Rosen LS, Gordon DH, Dugan W Jr, et al. Zoledronic acid is superior to pamidronate for the treatment of bone metastases in breast carcinoma patients with at least one osteolytic lesion[J]. Cancer, 2004, 100(1): 36-43.
15.	张力, 管忠震, 何友兼. 帕米膦酸二钠与氯甲膦酸二钠治疗晚期肿瘤骨转移的随机对照临床研究[J]. 癌症, 1997, 16(6): 430.
16.	Wong R, Wiffen PJ. Bisphosphonates for the relief of pain secondary to bone metastases[J]. Cochrane Database Syst Rev, 2002, (2): CD002068.
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1. 　Coleman RE. Skeletal complications of malignancy[J]. Cancer, 1997, 80(Suppl 8): 1588-1594.
2. 　Coleman RE. Bisphosphonates: clinical experience[J]. Oncologist, 2004, 9(Suppl 4): 14-27.
3. 　Coleman RE. Metastatic bone disease: clinical features, pathophysiology and treatment strategies[J]. Cancer Treat Rev, 2001, 27(3): 165-176.
4. 　Weinfurt KP, Li Y, Castel LD, et al. The impact of skeletal of life of patients with metastatic prostate cancer[J]. Ann Oncol, 2002, 13(Suppl 5): 180.
5. 　Major PP, Cook R. Efficacy of bisphosphonates in the management of skeletal complications of bone metastases and selection of clinical endpoints[J]. Am J Clin Oncol, 2002, 25(Suppl 1): 10-18.
6. 　Tyrrell CJ. Role of pamidronate in the management of bone metases from breast cancer[J]. Ann Oncol, 1994, 5(Suppl 7): 37.
7. 　Coxon FP, Rogers MJ. The role of prenylated small GTP binding proteins in regulation of osteoclast function[J]. Calcif Tissue Int, 2003, 72(1): 80-84.
8. 　Benford HL, McGowan NW, Helfich MH, et al. Visualization of bisphosphonate-induced caspase-3 active in apoptotic osteoclasts in vitro[J]. Bone, 2001, 28(5): 465-473.
9. 　Monkkonen H, Lehenkari PP, Kellinsalmi M, et al. A new mechanism of action for bisphosphonates appidedicated cytotoxicty of N-BPs[J]. Bone, 2004, 34(Suppl 1): S66-S67.
10. 　Rogers MJ. New insights in to the molecular mechanism of action of bisphospbonates[J]. Curr Pharm Des, 2003, 9(32): 2643-2658.
11. 　van Beek ER, Cohen LH, Leroy JM, et al. Different the mechanism of an tiresorptive action of nitrogen containing bisphosphonate[J]. Bone, 2003, 33(5): 805-811.
12. 　Coleman RE, Major P, Lipton A, et al. Predictive value of bone resorption and formation markers in cancer patients with bone metastases receiving the bisphosphonate zoledronic acid[J]. JCO, 2005, 23(22): 4925-4935.
13. 　邓坤, 王爱秋. 唑来膦酸联合化疗治疗肺癌骨转移的疗效观察[J]. 中国老年保健医学, 2009, 7(3): 33-34.
14. 　Rosen LS, Gordon DH, Dugan W Jr, et al. Zoledronic acid is superior to pamidronate for the treatment of bone metastases in breast carcinoma patients with at least one osteolytic lesion[J]. Cancer, 2004, 100(1): 36-43.
15. 　张力, 管忠震, 何友兼. 帕米膦酸二钠与氯甲膦酸二钠治疗晚期肿瘤骨转移的随机对照临床研究[J]. 癌症, 1997, 16(6): 430.
16. 　Wong R, Wiffen PJ. Bisphosphonates for the relief of pain secondary to bone metastases[J]. Cochrane Database Syst Rev, 2002, (2): CD002068.
17. 　李会齐, 李瑶. 帕米膦酸二钠治疗恶性肿瘤骨转移性骨痛疗效分析[J]. 临床和实验医学杂志, 2005, 4(4): 212-214.

West China Medical Journal

Comparison of the Efficacy and Safety between Pamidronate Disodium and Zoledronic Acid in Treating Non-small-cell Lung Cancer Patients with Bone Metastasis

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