肺癌骨转移临床诊疗专家共识

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

2、起草小组：（按姓名汉语拼音排序） 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;80:1546-1

3、556. 2. 2. Coleman RE. 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 2001:925-983. 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

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 mg n = 257 n = 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 mg 1. 1. Rosen L, Gordon D, Tchekmedyian S, et al. 择泰significantly increased the median

5、 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 和钙剂和钙剂 500 mg n = 257 安慰剂安慰剂 +每日口服维

6、生素每日口服维生素 D 400 IU 和钙剂和钙剂 500 mg n = 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-small cell lung cancer (NS

7、CLC) 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 other solid tumours (OST)

8、. 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). Lung C

9、ancer. 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). Lung Cancer. 2

10、001;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). Lung Cancer. 2001;34(s

11、uppl 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;21:3150. 1. 1. Rosen L, Go

12、rdon 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. 0 0.1 0.2 0.3 0.4 0.5 0.6

13、 0.7 0.8 P P=.039=.039 ZOMETAZOMETA (zoledronic acid) 4 mg (zoledronic acid) 4 mg PlaceboPlacebo P P=.127=.127 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 ZOMETA 4 mgZOMETA 4 mg PlaceboPlacebo 27 Median, daysP value Zol 4 mg236 .009 Placebo155 唑来膦酸延迟唑来膦酸延迟SRE出现出现 2 months Days from start of treatment Percent

14、without event Zol 42571074715117 Placebo250803616116 *Hypercalcemia of malignancy is included as a skeletal-related event. 81 days IIIIII期临床研究期临床研究 011011 骨相关事件骨相关事件 28 Zoledronic Acid Versus Placebo Multiple Event Analysis: Other Tumour Types *Hypercalcemia of malignancy is included as a skeletal-r

15、elated event. RCC subset: Lipton A. Cancer. 2003;98:962-969. In favour of zoledronic acidIn favour of placebo P value Risk ratio (zoledronic acid 4 mg versus placebo) .003 .016 All patients NSCLC 00.20.40.60.811.21.41.61.82 Risk reduction 31% 32% 0.693 0.675 .01058%RCC 0.418 = European registration

16、= Global registration Ross JR, et al. Systemic review of role of bisphosphonates on skeletal morbidity in metas- tatic cancer. BMJ 2003; 327:46972 Ross JR, et al. Systemic review of role of bisphosphonates on skeletal morbidity in metas- tatic cancer. BMJ 2003; 327:46972 JCO 2001JCO 2001 35 Pooled P

17、rotocols 036 and 037complete response rate: 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. 0 20 40 60 80 100 Day 0Day 4Day 7Day 10 Zoledronic acid 4 mg (n =

18、86) Zoledronic acid 8 mg (n = 90) Pamidronate 90 mg (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