放疗联合不同疗程激素治疗前列腺癌疗效和安全性的Meta分析_《中国循证医学杂志》

作者：

周支瑞 ¹ ,  朱小东 ¹ , 梁忠国 ¹ , 潘闻燕 ²

1. 广西医科大学附属肿瘤医院（南宁 530021）；2. 宁夏医科大学总医院（银川 75000）;

关键词：

前列腺癌放射治疗激素治疗 Meta分析系统评价随机对照试验

DOI：

10.7507/1672-2531.20120186

视频：

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摘要 全文 图表 视频 参考文献 施引文献 补充材料

目的　系统评价放疗联合短期与长期激素治疗前列腺癌的疗效和安全性。
方法　计算机检索EMbase、PubMed、Web of Science、CENTRAL、CBM，查找放疗联合短期与长期激素比较治疗前列腺癌的随机对照试验（RCT），检索时限均从建库至2012年8月。按照纳入/排除标准对纳入研究进行资料提取、方法学质量评价后，采用RevMan 5.1软件进行Meta分析，并使用GRADE系统评价证据质量和推荐等级。
结果　共纳入6个RCT，3 157例患者。Meta分析结果显示，放疗+短期激素治疗组与放疗+长期激素治疗组比较，在总生存率［RR=0.95，95%CI（0.91，1.00）］和无病生存率［RR=0.73，95%CI（0.46，1.13），P=0.16］方面，两组差异无统计学意义；但在无生化失败生存率［RR=0.81，95%CI（0.68，0.97）］、临床进展率［RR=1.61，95%CI（1.44，1.80）］和前列腺癌相关病死率［RR=1.44，95%CI（1.16，1.80）］方面，放疗+长期激素治疗组优于放疗+短期激素治疗组。基于GRADE系统的证据推荐等级评价结果显示：放疗+长期激素治疗组与放疗+短期激素治疗组比较，无生化失败率的证据水平为中级，推荐意为见弱推荐；无病生存率的证据水平为低级，推荐意见为弱推荐；总生存率的证据水平为高级，推荐意见为弱推荐；临床进展率和前列腺癌相关病死率的证据水平为高级，推荐意见为强推荐。
结论　目前有限证据支持延长激素治疗的时间可使局限期和局部晚期的前列腺癌患者，特别是较高Gleason评分的前列腺癌患者受益，但并不能提高患者总生存率和无病生存率。上述结论尚需更多高质量大样本RCT加以验证。

引用本文： 周支瑞,朱小东,梁忠国,潘闻燕. 放疗联合不同疗程激素治疗前列腺癌疗效和安全性的Meta分析. 中国循证医学杂志, 2012, 12(10): 1195-1202. doi: 10.7507/1672-2531.20120186 复制

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2.	Gronberg H. Prostate cancer epidemiology. Lancet, 2003, 361(9360): 859-864.
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4.	Wirth MP, See WA, McLeod DG, et al. Bicalutamide 150 mg in addition to standard care in patients with localized or locally advanced prostate cancer: Results from the second analysis of the early prostate cancer program at median followup of 5.4 years. Journal of Urology, 2004, 172(5): 1865-1870.
5.	D’Amico AV, Denham JW, Bolla M, et al. Short- vs. long-term androgen suppression plus external beam radiation therapy and survival in men of advanced age with node-negative high-risk adenocarcinoma of the prostate. Cancer, 2007, 109(10): 2004-2010.
6.	Denham JW, Steigler A, Lamb DS, et al. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. In: The Lancet Oncology, 2005, 6(11): 841-850.
7.	Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from: www.cochrane-handbook.org.
8.	Balshem H, Helfanda M, Schunemann HJ, 等. GRADE指南: Ⅲ. 证据质量分级. 中国循证医学杂志, 2011, 11(4): 451-455.
9.	Guyatt GH, Oxman AD, Kunz R, 等. GRADE: 从证据到推荐. 中国循证医学杂志, 2009, 9(3): 257-259.
10.	Guyatt GH, Oxman AD, Vist GE, 等. GRADE: 证据质量和推荐强度分级的共识. 中国循证医学杂志, 2009, 9(1): 8-11.
11.	曾宪涛, 冷卫东, 李胜, 等. 如何正确理解及使用GRADE系统. 中国循证医学杂志, 2011, 11(9): 985-990.
12.	曾宪涛, 田国祥, 牛玉明, 等. GRADEprofiler软件的使用简介. 中国循证心血管医学杂志, 2011, 3(5): 390-392.
13.	Armstrong J, Taylor J, Thirion P, et al. Preliminary results of a randomised trial comparing short vs. protracted neoadjuvant hormonal therapy (NHT) prior to radiation therapy (RT) of localized prostate cancer. (Irish Clinical Oncology Research Group Protocol # 97-01). Radiotherapy and Oncology, 2004, 73(3): 78.
14.	Armstrong JG, Gillham CM, Dunne MT, et al. A Randomized Trial (Irish Clinical Oncology Research Group 97-01) Comparing Short Versus Protracted Neoadjuvant Hormonal Therapy Before Radiotherapy for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys, 2010, 81(1): 35-45.
15.	Bolla M, De Reijke TM, Van Tienhoven G, et al. Duration of androgen suppression in the treatment of prostate cancer. New England Journal of Medicine, 2009, 360(24): 2516-2527.
16.	Crook J, Ludgate C, Malone S, et al. Report of a multicenter Canadian phase III randomized trial of 3 months vs. 8 months neoadjuvant androgen deprivation before standard-dose radiotherapy for clinically localized prostate cancer. In: International Journal of Radiation Oncology, Biology, Physics, 2004, 60(1): 15-23.
17.	Crook J, Ludgate C, Malone S, et al. Final report of multicenter Canadian Phase III randomized trial of 3 versus 8 months of neoadjuvant androgen deprivation therapy before conventional-dose radiotherapy for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys, 2009, 73(2): 327-333.
18.	Denham JW, Steigler A, Lamb DS, et al. Short-term neoadjuvant androgen deprivation and radiotherapy for locally advanced prostate cancer: 10-year data from the TROG 96.01 randomised trial. Lancet Oncol, 2011, 12(5): 451-459.
19.	Hanks GE, Pajak TF, Porter A, et al. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol, 2003, 21(21): 3972-3978.
20.	Horwitz EM, Bae K, Hanks GE, et al. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol, 2008, 26(15): 2497-2504.
21.	Lamb DS, Denham JW, Mameghan H, et al. Acceptability of short term neo-adjuvant androgen deprivation in patients with locally advanced prostate cancer. J of Euro Society for Therapeutic Radiology and Oncology, 2003, 68(3): 255-267.
22.	Laverdiere J, Nabid A, De Bedoya LD, et al. The efficacy and sequencing of a short course of androgen suppression on freedom from biochemical failure when administered with radiation therapy for T2-T3 prostate cancer. Journal of Urology, 2004, 171(3): 1137-1140.
23.	Zelefsky MJ. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: Results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. Urologic Oncology: Seminars and Original Investigations, 2006, 24(4): 376-377.
24.	Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys, 1995, 31(5): 1341-1346.
25.	Roach M, 3rd, Bae K, Speight J, et al. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol, 2008, 26(4): 585-591.
26.	Roach M, 3rd, DeSilvio M, Lawton C, et al. Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol, 2003, 21(10): 1904-1911.

1. Parkin DM, Bray F, Ferlay J, et al. Global cancer statistics, 2002. Ca-A Cancer Journal for Clinicians, 2005, 55(2): 74-108.
2. Gronberg H. Prostate cancer epidemiology. Lancet, 2003, 361(9360): 859-864.
3. Kumar S, Shelley M, Harrison C, et al. Neo-adjuvant and adjuvant hormone therapy for localised and locally advanced prostate cancer. Cochrane Database Syst Rev, 2006, 18(4): CD006019.
4. Wirth MP, See WA, McLeod DG, et al. Bicalutamide 150 mg in addition to standard care in patients with localized or locally advanced prostate cancer: Results from the second analysis of the early prostate cancer program at median followup of 5.4 years. Journal of Urology, 2004, 172(5): 1865-1870.
5. D’Amico AV, Denham JW, Bolla M, et al. Short- vs. long-term androgen suppression plus external beam radiation therapy and survival in men of advanced age with node-negative high-risk adenocarcinoma of the prostate. Cancer, 2007, 109(10): 2004-2010.
6. Denham JW, Steigler A, Lamb DS, et al. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. In: The Lancet Oncology, 2005, 6(11): 841-850.
7. Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from: www.cochrane-handbook.org.
8. Balshem H, Helfanda M, Schunemann HJ, 等. GRADE指南: Ⅲ. 证据质量分级. 中国循证医学杂志, 2011, 11(4): 451-455.
9. Guyatt GH, Oxman AD, Kunz R, 等. GRADE: 从证据到推荐. 中国循证医学杂志, 2009, 9(3): 257-259.
10. Guyatt GH, Oxman AD, Vist GE, 等. GRADE: 证据质量和推荐强度分级的共识. 中国循证医学杂志, 2009, 9(1): 8-11.
11. 曾宪涛, 冷卫东, 李胜, 等. 如何正确理解及使用GRADE系统. 中国循证医学杂志, 2011, 11(9): 985-990.
12. 曾宪涛, 田国祥, 牛玉明, 等. GRADEprofiler软件的使用简介. 中国循证心血管医学杂志, 2011, 3(5): 390-392.
13. Armstrong J, Taylor J, Thirion P, et al. Preliminary results of a randomised trial comparing short vs. protracted neoadjuvant hormonal therapy (NHT) prior to radiation therapy (RT) of localized prostate cancer. (Irish Clinical Oncology Research Group Protocol # 97-01). Radiotherapy and Oncology, 2004, 73(3): 78.
14. Armstrong JG, Gillham CM, Dunne MT, et al. A Randomized Trial (Irish Clinical Oncology Research Group 97-01) Comparing Short Versus Protracted Neoadjuvant Hormonal Therapy Before Radiotherapy for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys, 2010, 81(1): 35-45.
15. Bolla M, De Reijke TM, Van Tienhoven G, et al. Duration of androgen suppression in the treatment of prostate cancer. New England Journal of Medicine, 2009, 360(24): 2516-2527.
16. Crook J, Ludgate C, Malone S, et al. Report of a multicenter Canadian phase III randomized trial of 3 months vs. 8 months neoadjuvant androgen deprivation before standard-dose radiotherapy for clinically localized prostate cancer. In: International Journal of Radiation Oncology, Biology, Physics, 2004, 60(1): 15-23.
17. Crook J, Ludgate C, Malone S, et al. Final report of multicenter Canadian Phase III randomized trial of 3 versus 8 months of neoadjuvant androgen deprivation therapy before conventional-dose radiotherapy for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys, 2009, 73(2): 327-333.
18. Denham JW, Steigler A, Lamb DS, et al. Short-term neoadjuvant androgen deprivation and radiotherapy for locally advanced prostate cancer: 10-year data from the TROG 96.01 randomised trial. Lancet Oncol, 2011, 12(5): 451-459.
19. Hanks GE, Pajak TF, Porter A, et al. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol, 2003, 21(21): 3972-3978.
20. Horwitz EM, Bae K, Hanks GE, et al. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol, 2008, 26(15): 2497-2504.
21. Lamb DS, Denham JW, Mameghan H, et al. Acceptability of short term neo-adjuvant androgen deprivation in patients with locally advanced prostate cancer. J of Euro Society for Therapeutic Radiology and Oncology, 2003, 68(3): 255-267.
22. Laverdiere J, Nabid A, De Bedoya LD, et al. The efficacy and sequencing of a short course of androgen suppression on freedom from biochemical failure when administered with radiation therapy for T2-T3 prostate cancer. Journal of Urology, 2004, 171(3): 1137-1140.
23. Zelefsky MJ. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: Results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. Urologic Oncology: Seminars and Original Investigations, 2006, 24(4): 376-377.
24. Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys, 1995, 31(5): 1341-1346.
25. Roach M, 3rd, Bae K, Speight J, et al. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol, 2008, 26(4): 585-591.
26. Roach M, 3rd, DeSilvio M, Lawton C, et al. Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol, 2003, 21(10): 1904-1911.

《中国循证医学杂志》

放疗联合不同疗程激素治疗前列腺癌疗效和安全性的Meta分析

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《中国循证医学杂志》

放疗联合不同疗程激素治疗前列腺癌疗效和安全性的Meta分析

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