放療聯合不同療程激素治療前列腺癌療效和安全性的Meta分析_《中國循證醫學雜志》

作者：

周支瑞 ¹ ,  朱小東 ¹ , 梁忠國 ¹ , 潘聞燕 ²

1. 廣西醫科大學附屬腫瘤醫院（南寧 530021）；2. 寧夏醫科大學總醫院（銀川 75000）;

關鍵詞：

前列腺癌放射治療激素治療 Meta分析系統評價隨機對照試驗

DOI：

10.7507/1672-2531.20120186

視頻：

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目的　系統評價放療聯合短期與長期激素治療前列腺癌的療效和安全性。
方法　計算機檢索EMbase、PubMed、Web of Science、CENTRAL、CBM，查找放療聯合短期與長期激素比較治療前列腺癌的隨機對照試驗（RCT），檢索時限均從建庫至2012年8月。按照納入/排除標準對納入研究進行資料提取、方法學質量評價后，采用RevMan 5.1軟件進行Meta分析，并使用GRADE系統評價證據質量和推薦等級。
結果　共納入6個RCT，3 157例患者。Meta分析結果顯示，放療+短期激素治療組與放療+長期激素治療組比較，在總生存率［RR=0.95，95%CI（0.91，1.00）］和無病生存率［RR=0.73，95%CI（0.46，1.13），P=0.16］方面，兩組差異無統計學意義；但在無生化失敗生存率［RR=0.81，95%CI（0.68，0.97）］、臨床進展率［RR=1.61，95%CI（1.44，1.80）］和前列腺癌相關病死率［RR=1.44，95%CI（1.16，1.80）］方面，放療+長期激素治療組優于放療+短期激素治療組。基于GRADE系統的證據推薦等級評價結果顯示：放療+長期激素治療組與放療+短期激素治療組比較，無生化失敗率的證據水平為中級，推薦意為見弱推薦；無病生存率的證據水平為低級，推薦意見為弱推薦；總生存率的證據水平為高級，推薦意見為弱推薦；臨床進展率和前列腺癌相關病死率的證據水平為高級，推薦意見為強推薦。
結論　目前有限證據支持延長激素治療的時間可使局限期和局部晚期的前列腺癌患者，特別是較高Gleason評分的前列腺癌患者受益，但并不能提高患者總生存率和無病生存率。上述結論尚需更多高質量大樣本RCT加以驗證。

引用本文： 周支瑞,朱小東,梁忠國,潘聞燕. 放療聯合不同療程激素治療前列腺癌療效和安全性的Meta分析. 中國循證醫學雜志, 2012, 12(10): 1195-1202. doi: 10.7507/1672-2531.20120186 復制

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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.
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8.	Balshem H, Helfanda M, Schunemann HJ, 等. GRADE指南: Ⅲ. 證據質量分級. 中國循證醫學雜志, 2011, 11(4): 451-455.
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11.	曾憲濤, 冷衛東, 李勝, 等. 如何正確理解及使用GRADE系統. 中國循證醫學雜志, 2011, 11(9): 985-990.
12.	曾憲濤, 田國祥, 牛玉明, 等. GRADEprofiler軟件的使用簡介. 中國循證心血管醫學雜志, 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. 證據質量分級. 中國循證醫學雜志, 2011, 11(4): 451-455.
9. Guyatt GH, Oxman AD, Kunz R, 等. GRADE: 從證據到推薦. 中國循證醫學雜志, 2009, 9(3): 257-259.
10. Guyatt GH, Oxman AD, Vist GE, 等. GRADE: 證據質量和推薦強度分級的共識. 中國循證醫學雜志, 2009, 9(1): 8-11.
11. 曾憲濤, 冷衛東, 李勝, 等. 如何正確理解及使用GRADE系統. 中國循證醫學雜志, 2011, 11(9): 985-990.
12. 曾憲濤, 田國祥, 牛玉明, 等. GRADEprofiler軟件的使用簡介. 中國循證心血管醫學雜志, 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.

《中國循證醫學雜志》

放療聯合不同療程激素治療前列腺癌療效和安全性的Meta分析

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《中國循證醫學雜志》

放療聯合不同療程激素治療前列腺癌療效和安全性的Meta分析

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