肺癌骨转移临床诊疗专家共识[1]

1、顾问组成员：（按姓名汉语拼音排序）顾问组成员：（按姓名汉语拼音排序）冯奉仪冯奉仪中国医学科学院肿瘤医院中国医学科学院肿瘤医院郭卫郭卫北京大学人民医院北京大学人民医院李龙芸李龙芸北京协和医院北京协和医院廖美琳廖美琳上海市胸科医院上海市胸科医院申文江申文江北京大学第一医院肿瘤中心北京大学第一医院肿瘤中心沈镇宙沈镇宙复旦大学肿瘤医院复旦大学肿瘤医院宋三泰宋三泰解放军解放军307307医院医院吴一龙吴一龙广东省人民医院广东省人民医院谢广茹谢广茹天津医科大学肿瘤医院天津医科大学肿瘤医院余子豪余子豪中国医学科学院肿瘤医院中国医学科学院肿瘤医院肺癌起草小组：（按姓名汉语拼音排序）肺癌起草小组：（按姓名汉语拼

2、音排序）李进李进复旦大学医学院肿瘤医院复旦大学医学院肿瘤医院陆舜陆舜上海市胸科医院上海市胸科医院秦叔逵秦叔逵八一医院全军肿瘤中心八一医院全军肿瘤中心王杰军王杰军第二军医大学上海长征医院第二军医大学上海长征医院张力张力中山大学肿瘤医院中山大学肿瘤医院支修益支修益首都医科大学肺癌诊疗中心首都医科大学肺癌诊疗中心周彩存周彩存上海市肺科医院肿瘤科上海市肺科医院肿瘤科周清华周清华四川大学华西医院肿瘤中心四川大学华西医院肿瘤中心1. 1. Mundy GR. Mechanisms of bone metastasis. Cancer. 1997;80:1546-1556. 2. 2. Coleman RE

3、. Skeletal complications of malignancy. Cancer. 1997;80:1588-1594. 3. 3. Ginsberg RJ, Vokes EE, Rosenzweig K. Non-small cell lung cancer. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds. Cancer: Principles & Practice of Oncology. 6th ed. Philadelphia: Lippincott Williams & Wilkins; 2001:925-983.随随机机化

4、化分分组组09 个月个月核心分析核心分析21 个月个月最终分析最终分析唑来膦酸唑来膦酸 4 mg + 每日口服维生素每日口服维生素 D 400 IU 和钙剂和钙剂 500 mg安慰剂安慰剂 +每日口服维生素每日口服维生素 D 400 IU 和钙剂和钙剂 500 mgn = 257n = 250 根据非小细胞肺癌（根据非小细胞肺癌（NSCLC）和其他实体肿瘤相比进行分层）和其他实体肿瘤相比进行分层n = 266唑来膦酸唑来膦酸 8mg +每日口服维生素每日口服维生素 D 400 IU 和钙剂和钙剂 500 mg1. 1. Rosen L, Gordon D, Tchekmedyian S, et

5、 al. 择泰significantly increased the median time to first skeletal related event (SRE) in patients with osteolytic bone metastases from non-small cell lung cancer (NSCLC) and other solid tumours (OST). JCO 2003;21:3150.随随机机化化分分组组09 个月个月核心分析核心分析21 个月个月最终分析最终分析唑来膦酸唑来膦酸 4 mg +每日口服维生素每日口服维生素 D 400 IU 和钙剂和

6、钙剂 500 mgn = 257安慰剂安慰剂+每日口服维生素每日口服维生素 D 400 IU 和钙剂和钙剂 500 mgn = 250 根据非小细胞肺癌（根据非小细胞肺癌（NSCLC）和其他实体肿瘤相比进行分层）和其他实体肿瘤相比进行分层1. 1. Rosen L, Gordon D, Tchekmedyian S, et al. 择泰significantly increased the median time to first skeletal related event (SRE) in patients with osteolytic bone metastases from non-

7、small cell lung cancer (NSCLC) and other solid tumours (OST). JCO 2003;21:3150.1. 1. Rosen L, Gordon D, Tchekmedyian S, et al. Zometa significantly increased the median time to first skeletal related event (SRE) in patients with osteolytic bone metastases from non-small cell lung cancer (NSCLC) and

8、other solid tumours (OST). Lung Cancer. 2001;34(suppl 1):67. Abstract.1. 1. Rosen L, Gordon D, Tchekmedyian S, et al. Zometa significantly increased the median time to first skeletal related event (SRE) in patients with osteolytic bone metastases from non-small cell lung cancer (NSCLC) and other sol

9、id tumours (OST). Lung Cancer. 2001;34(suppl 1):67. Abstract.1. 1. Rosen L, Gordon D, Tchekmedyian S, et al. Zometa significantly increased the median time to first skeletal related event (SRE) in patients with osteolytic bone metastases from non-small cell lung cancer (NSCLC) and other solid tumour

10、s (OST). Lung Cancer. 2001;34(suppl 1):67. Abstract.1. 1. Rosen L, Gordon D, Tchekmedyian S, et al. Zometa significantly increased the median time to first skeletal related event (SRE) in patients with osteolytic bone metastases from non-small cell lung cancer (NSCLC) and other solid tumours (OST).

11、Lung Cancer. 2001;34(suppl 1):67. Abstract.1. 1. Rosen L, Gordon D, Tchekmedyian S, et al. 择泰significantly increased the median time to first skeletal related event (SRE) in patients with osteolytic bone metastases from non-small cell lung cancer (NSCLC) and other solid tumours (OST). JCO 2003;21:31

12、50.1. 1. Rosen L, Gordon D, Tchekmedyian S, et al. Zometa significantly increased the median time to first skeletal related event (SRE) in patients with osteolytic bone metastases from non-small cell lung cancer (NSCLC) and other solid tumours (OST). Lung Cancer. 2001;34(suppl 1):67. Abstract.00.10.

13、P P=.039=.039ZOMETAZOMETA (zoledronic acid) 4 mg (zoledronic acid) 4 mgPlaceboPlaceboP P=.127=.12700.70.8ZOMETA 4 mgZOMETA 4 mgPlaceboPlacebo27Median,daysP valueZol 4 mg236 .009Placebo155唑来膦酸延迟唑来膦酸延迟SRE出现出现 2 monthsDays from start of treatmentPercent without even

14、tZol 42571074715117Placebo250803616116*Hypercalcemia of malignancy is included as a skeletal-related event. 81 daysIIIIII期临床研究期临床研究 011011骨相关事件骨相关事件28Zoledronic Acid Versus Placebo Multiple Event Analysis: Other Tumour Types*Hypercalcemia of malignancy is included as a skeletal-related event.RCC sub

15、set: Lipton A. Cancer. 2003;98:962-969.In favour of zoledronic acidIn favour of placeboP valueRisk ratio (zoledronic acid 4 mg versus placebo).003.016All patients NSCLC 00.81.82Riskreduction31%32%0.6930.675.01058%RCC0.418 = European registration = Global registrationRoss JR, et al

16、. Systemic review of role of bisphosphonates on skeletal morbidity in metas- tatic cancer. BMJ 2003; 327:46972Ross JR, et al. Systemic review of role of bisphosphonates on skeletal morbidity in metas- tatic cancer. BMJ 2003; 327:46972JCO 2001JCO 200135Pooled Protocols 036 and 037complete response ra

17、te: normalisation of corrected serum calcium 10.8 mg/dL ( 2.7 mmol/L)Complete responders, %*Denotes statistical significance versus pamidronate. Major P, et al. J Clin Oncol. 2001;19:558-567. 020406080100Day 0Day 4Day 7Day 10Zoledronic acid 4 mg (n = 86)Zoledronic acid 8 mg (n = 90)Pamidronate 90 mg

18、 (n = 99)83.3%P = .010*56%P = .021*88%P = .002*87%P = .015*82.6%P = .005*45%33%64%70%择泰择泰( (唑来膦酸唑来膦酸) ) 与帕米膦酸二钠治疗与帕米膦酸二钠治疗HCMHCM的疗效比较的疗效比较36 = Censored time. Zoledronic acid 4 mg versus Pam 90 mg, P .001; Zoledronic acid 8 mg versus Pamidronate 90 mg, P = .007.Proportion of patients without relapse00.81.0Zoledronic acid 4 mg median 30 daysZoledronic acid 8 mg median 40 daysPamidronate 90 mg me