肺癌骨轉(zhuǎn)移臨床診療專家共識[1]

1、顧問組成員：（按姓名漢語拼音排序）顧問組成員：（按姓名漢語拼音排序）馮奉儀馮奉儀中國醫(yī)學(xué)科學(xué)院腫瘤醫(yī)院中國醫(yī)學(xué)科學(xué)院腫瘤醫(yī)院郭衛(wèi)郭衛(wèi)北京大學(xué)人民醫(yī)院北京大學(xué)人民醫(yī)院李龍蕓李龍蕓北京協(xié)和醫(yī)院北京協(xié)和醫(yī)院廖美琳廖美琳上海市胸科醫(yī)院上海市胸科醫(yī)院申文江申文江北京大學(xué)第一醫(yī)院腫瘤中心北京大學(xué)第一醫(yī)院腫瘤中心沈鎮(zhèn)宙沈鎮(zhèn)宙復(fù)旦大學(xué)腫瘤醫(yī)院復(fù)旦大學(xué)腫瘤醫(yī)院宋三泰宋三泰解放軍解放軍307307醫(yī)院醫(yī)院吳一龍吳一龍廣東省人民醫(yī)院廣東省人民醫(yī)院謝廣茹謝廣茹天津醫(yī)科大學(xué)腫瘤醫(yī)院天津醫(yī)科大學(xué)腫瘤醫(yī)院余子豪余子豪中國醫(yī)學(xué)科學(xué)院腫瘤醫(yī)院中國醫(yī)學(xué)科學(xué)院腫瘤醫(yī)院肺癌起草小組：（按姓名漢語拼音排序）肺癌起草小組：（按姓名漢語拼

2、音排序）李進李進復(fù)旦大學(xué)醫(yī)學(xué)院腫瘤醫(yī)院復(fù)旦大學(xué)醫(yī)學(xué)院腫瘤醫(yī)院陸舜陸舜上海市胸科醫(yī)院上海市胸科醫(yī)院秦叔逵秦叔逵八一醫(yī)院全軍腫瘤中心八一醫(yī)院全軍腫瘤中心王杰軍王杰軍第二軍醫(yī)大學(xué)上海長征醫(yī)院第二軍醫(yī)大學(xué)上海長征醫(yī)院張力張力中山大學(xué)腫瘤醫(yī)院中山大學(xué)腫瘤醫(yī)院支修益支修益首都醫(yī)科大學(xué)肺癌診療中心首都醫(yī)科大學(xué)肺癌診療中心周彩存周彩存上海市肺科醫(yī)院腫瘤科上海市肺科醫(yī)院腫瘤科周清華周清華四川大學(xué)華西醫(yī)院腫瘤中心四川大學(xué)華西醫(yī)院腫瘤中心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; 2001:925-9

4、83.隨隨機機化化分分組組09 個月個月核心分析核心分析21 個月個月最終分析最終分析唑來膦酸唑來膦酸 4 mg + 每日口服維生素每日口服維生素 D 400 IU 和鈣劑和鈣劑 500 mg安慰劑安慰劑 +每日口服維生素每日口服維生素 D 400 IU 和鈣劑和鈣劑 500 mgn = 257n = 250 根據(jù)非小細(xì)胞肺癌（根據(jù)非小細(xì)胞肺癌（NSCLC）和其他實體腫瘤相比進行分層）和其他實體腫瘤相比進行分層n = 266唑來膦酸唑來膦酸 8mg +每日口服維生素每日口服維生素 D 400 IU 和鈣劑和鈣劑 500 mg1. 1. Rosen L, Gordon D, Tchekmedyi

5、an S, et al. 擇泰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.隨隨機機化化分分組組09 個月個月核心分析核心分析21 個月個月最終分析最終分析唑來膦酸唑來膦酸 4 mg +每日口服維生素每日口服維生素 D 400

6、 IU 和鈣劑和鈣劑 500 mgn = 257安慰劑安慰劑+每日口服維生素每日口服維生素 D 400 IU 和鈣劑和鈣劑 500 mgn = 250 根據(jù)非小細(xì)胞肺癌（根據(jù)非小細(xì)胞肺癌（NSCLC）和其他實體腫瘤相比進行分層）和其他實體腫瘤相比進行分層1. 1. Rosen L, Gordon D, Tchekmedyian S, et al. 擇泰significantly increased the median time to first skeletal related event (SRE) in patients with osteolytic bone metastases f

7、rom non-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 (NSC

8、LC) and 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 o

9、ther 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 soli

10、d 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 tumours

11、 (OST). Lung Cancer. 2001;34(suppl 1):67. Abstract.1. 1. Rosen L, Gordon D, Tchekmedyian S, et al. 擇泰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 20

12、03;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). Lung Cancer. 2001;34(suppl 1):67. Abstrac

13、t.00.70.8P 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唑來膦酸延遲唑來膦酸延遲SRE出現(xiàn)出現(xiàn) 2 monthsDays from start of treatmentPercent with

14、out eventZol 42571074715117Placebo250803616116*Hypercalcemia of malignancy is included as a skeletal-related event. 81 daysIIIIII期臨床研究期臨床研究 011011骨相關(guān)事件骨相關(guān)事件28Zoledronic Acid Versus Placebo Multiple Event Analysis: Other Tumour Types*Hypercalcemia of malignancy is included as a skeletal-related event

15、.RCC subset: 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 J

16、R, et al. 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 res

17、ponse 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. 020406080100Day 0Day 4Day 7Day 10Zoledronic acid 4 mg (n = 86)Zoledronic acid 8 mg (n = 90)Pamidrona

18、te 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%擇泰擇泰( (唑來膦酸唑來膦酸) ) 與帕米膦酸二鈉治療與帕米膦酸二鈉治療HCMHCM的療效比較的療效比較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 m