中高危前列腺癌放疗后雄激素剥夺治疗最佳持续时间的Meta分析
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摘要
目的:系统评价前列腺癌放射治疗后辅助雄激素剥夺治疗(androgen deprivation therapy,ADT)的最佳持续时间。方法:计算机检索CBM、CNKI、Wanfang、PubMed、EMbase、CochraneLibrary和Clinical Trials.gov等数据库,搜集有关中高危非转移性前列腺癌放射治疗后行长期和短期雄激素剥夺治疗的随机对照试验(randomized controlled trial,RCT),检索时限从建库——2018年11月5日。由2名研究者独立筛选文献、提取资料和评价纳入研究的质量后,采用RevMan 5.3软件进行Meta分析。结果 :共纳入8个RCT,包括6 165例患者。Meta分析结果显示,ADT长期治疗组总生存(overall survival,OS)率高于短期治疗组[风险比(hazard ratio,HR)=0.75,95%可信区间(con dence interval,CI)为0.63～0.89,P=0.0007];ADT长期治疗组无病生存(disease-freesurvival,DFS)率高于短期治疗组(HR=0.81,95%CI为0.70～0.94,P=0.007);ADT长期治疗组疾病特异性生存(disease-speci c survival,DSS)率高于短期治疗组(HR=0.83,95%CI为0.71～0.96,P=0.01);ADT长期治疗组局部进展(local progress,LP)率低于短期治疗组[相对危险度(relative risk,RR)=0.76,95%CI为0.59～0.97,P=0.03];ADT长期治疗组发生生化复发(biochemical failure,BF)率低于短期治疗组(RR=0.66,95%CI为0.52～0.83,P=0.000 4);ADT长期治疗组发生远处转移(distant metastasis,DM)率低于短期治疗组(RR=0.85,95%CI为0.74～0.96,P=0.01)。结论 :中高危前列腺癌放疗后ADT,长期治疗组在OS率、DFS率、DSS率、LP率、BF率和DM率等方面均相对优于短期治疗组。受纳入文献数量和质量的限制,上述结论尚待开展更高质量研究予以验证。
Objective: To systematically evaluate the optimal duration of adjuvant androgen deprivation therapy(ADT) after radiotherapy for prostate cancer.Methods: The CBM, CNKI, Wanfang, PubMed, EMbase, Cochrane Library, Clinical Trials.gov databases were searched by computer. The randomized controlled trial(RCT) on long-term and shortterm ADT for intermediate and high risk non-metastatic prostate cancer after radiotherapy were collected. The retrieval time was from the establishment of these databases to November 5, 2018. After independent screening literature, extracting data and evaluating the quality of the included studies, two researchers used RevMan 5.3 software for Meta-analysis.Results: A total of eight RCTs were selected, including 6 165 patients. Meta-analysis showed that the overall survival(OS) rate in longterm ADT group was higher than that in short-term treatment group [hazard ratio(HR) = 0.75, 95% confidence interval(CI): 0.63-0.89, P = 0.000 7]; the disease-free survival(DFS) rate in long-term ADT group was higher than that in short-term treatment group(HR = 0.81, 95% CI: 0.70-0.94, P = 0.007); the disease-specific survival(DSS) in long-term ADT group was higher than that in short-term treatment group(HR = 0.83, 95% CI : 0.71-0.96, P = 0.01); the local progress(LP) in long-term ADT group was lower than that in short-term treatment group [relative risk(RR) = 0.76, 95% CI : 0.59-0.97, P = 0.03]; the biochemical failure(BF) in long-term ADT group was lower than that in short-term treatment group(RR = 0.66, 95% CI : 0.52-0.83, P = 0.0004); the distant metastasis(DM) in long-term ADT group was lower than that in short-term treatment group(RR = 0.85, 95% CI : 0.74-0.96, P = 0.01).Conclusion: The long-term ADT treatment is superior to the shortterm treatment in OS rate, DFS rate, DSS rate, LP rate, BF rate and DM rate after radiotherapy for moderate and high risk prostate cancer. Due to the limitation of the quantity and quality of the included literatures, the above conclusion need to be verified by higher quality research.
Objective: To systematically evaluate the optimal duration of adjuvant androgen deprivation therapy(ADT) after radiotherapy for prostate cancer.Methods: The CBM, CNKI, Wanfang, PubMed, EMbase, Cochrane Library, Clinical Trials.gov databases were searched by computer. The randomized controlled trial(RCT) on long-term and shortterm ADT for intermediate and high risk non-metastatic prostate cancer after radiotherapy were collected. The retrieval time was from the establishment of these databases to November 5, 2018. After independent screening literature, extracting data and evaluating the quality of the included studies, two researchers used RevMan 5.3 software for Meta-analysis.Results: A total of eight RCTs were selected, including 6 165 patients. Meta-analysis showed that the overall survival(OS) rate in longterm ADT group was higher than that in short-term treatment group [hazard ratio(HR) = 0.75, 95% confidence interval(CI): 0.63-0.89, P = 0.000 7]; the disease-free survival(DFS) rate in long-term ADT group was higher than that in short-term treatment group(HR = 0.81, 95% CI: 0.70-0.94, P = 0.007); the disease-specific survival(DSS) in long-term ADT group was higher than that in short-term treatment group(HR = 0.83, 95% CI : 0.71-0.96, P = 0.01); the local progress(LP) in long-term ADT group was lower than that in short-term treatment group [relative risk(RR) = 0.76, 95% CI : 0.59-0.97, P = 0.03]; the biochemical failure(BF) in long-term ADT group was lower than that in short-term treatment group(RR = 0.66, 95% CI : 0.52-0.83, P = 0.0004); the distant metastasis(DM) in long-term ADT group was lower than that in short-term treatment group(RR = 0.85, 95% CI : 0.74-0.96, P = 0.01).Conclusion: The long-term ADT treatment is superior to the shortterm treatment in OS rate, DFS rate, DSS rate, LP rate, BF rate and DM rate after radiotherapy for moderate and high risk prostate cancer. Due to the limitation of the quantity and quality of the included literatures, the above conclusion need to be verified by higher quality research.
引文
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[3] ZAG ARS GK, JOHNSON DE,VONESCHENBACH AC, et al. Adjuvant estrogen following radiation therapy for stage C adenocarcinoma of the prostate:Long-term results of a prospective randomized study[J].Int J Radiat Oncol Biol Phys, 1 988,14(6):1085-1091.
[4] LAWTON CA, WINTER K, GRIGNON D,et aL. Androgen suppression plus radiation versus radiation alone for patients with stage D1/Pathologicnode-positive adenocarcinoma of the prostate:Updated results based on national prospective randomized trial Radiation Therapy Oncology Group 85-31[J]. J Clin Oncol, 2005,23(4):800-807.
[5] BOLLA M, VAN TIENHOVEN G,WARDE P, et al. External irradiation with or without long-term androgen suppression for prostate cancer with high metastatic risk:10-year results of an EORTC randomised study[J]. Lancet Oncol, 2010, 1 1(11):1066-1073.
[6] ROACH MI, BAE K, SPEIGHT J, et al.Short-term neoadjuvant androgen deprivation therapy and externalbeam radiotherapy for locally advanced prostate cancer:Long-term results of RTOG 8610[J]. J Clin Oncol,208, 6(4):585-591.
[7] SASSE AD, SASSE E, CARVALHO AM, et al.Androgenic suppression combined with radiotherapy for the treatment of prostate adenocarcinoma:a systematic review[J]. BMC Cancer, 2012, 1 2:54.
[8] SHELLEY MD, KUMAR S, WILT T, et al.A systematic review and meta-analysis of randomised trials of neo-adjuvant hormone therapy for localised and locally advanced prostate carcinomaU].Cancer Treat Rev, 2009, 35(1):9-17.
[9] MOTTET N, PENEAU M, MAZERON J, et al.Addition of radiotherapy to longterm androgen deprivation in locally advanced prostate cancer:an open randomised phase 3 trial[J].Eur Urol,2012,62(2):213-219.
[10] WARDE P, MASON M, DING K, et al.Combined androgen deprivation therapy and radiation therapy forlocally advanced prostate cancer:A randomised, phase 3 trial[J]. Lancet,2011,378(9809):2104-21 11.
[11] KEATING NL, O'MALLEY AJ,FREEDLAND SJ, et al. Diabetes and cardiovascular disease during androgen deprivation therapy:observational study of veterans with prostate cancer[J].J Natl Cancer Inst,2010, 102(1):39-46.
[12] 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 96.01randomised trial[J]. Lancet Oncol201 1, 12(5):451-459.
[13] CROOK J, LUDGATE C, MALONE S,et al.Final report of multicenter Canadian PhaseⅢrandomized trial of 3 versus 8 months of neoadjuvant androgen deprivation therapy before conventional-dose radiotherapy for clinically localized prostate cancer[J].Int J Radiat Oncol Biol Phys, 2009,73(2):327-333.
[14] HORWITZ EM, BAE K, HANKS GE, et al.Ten-year follow-up of radiation therapy oncology group protocol92-02:A phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer[J].J Clin Oncol, 2008, 26(1 5):2497-2504.
[15] BOLLA M,DE REIJKE TM,VAN TIENHOVEN G, et al. Duration of androgen suppression in the treatment of prostate cancer[J]. N Engl J Med, 2009, 360(24):2516-2527.
[16] BOLLA M. Re:High-risk prostate cancer treated with pelvic radiotherapy and 36 versus 18 months of androgen blockade:results of a phaseⅢrandomized study[abstract 3][J]. Eur Urol, 2013, 64(3):513.
[17]曾宪涛,包翠萍,曹世义,等.Meta分析系列之三:随机对照试验的质量评价工具[J].中国循证心血管医学杂志,2012,4(3):183-185.
[18] HORWITZ EM, BAE K, HANKS GE, et al.Ten-year follow-up of radiation therapy oncology group protocol 92-02:a phaseⅢtrial of the duration of elective androgen deprivation in locally advanced prostate cancer[J].J Clin Oncol, 2008, 26(1 5):2497-2504.
[19] LAWTON CAF,LIN X,HANKS GE,et al.Duration of androgen deprivation in locally advanced prostate cancer:long-term update of NRG Oncology RTOG 9202[J]. Int J Radiat Oncol Biol Phys, 2017, 98(2):296-303.
[20] 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 csancer[J]. Int J Radiat Oncol Biol Phys, 2011, 81(1):35-45.
[21] NABID A, CARRIER N, MARTIN AG, et al.Duration of androgen deprivation therapy in high-risk prostate cancer:a randomized phaseⅢtrial[J]. Eur Urol,2018, 74(4):432-441.
[22] BOLLA M, DE REIJKE TM, VAN TIENHOVEN G, et al. Duration of androgen suppression in the treatment of prostate cancer[J]. N Engl JMed, 2009, 360(24):2516-2527.
[23] ZAPATERO A, GUERRERO A,MALDONADO X, et al. High-dose radiotherapy with short-term or long-term androgen deprivation in localised prostate cancer(DARTO1/05GICOR):a randomised, controlled,phase 3 trial[J]. Lancet Oncol, 201 5,16(3):320-327.
[2] RESNICK MJ, KOYAMA T, FAN KH, et al.Long-term functional outcomes after treatment for localized prostate cancer[J]. N Engl J Med, 2013,368(5):436-445.
[3] ZAG ARS GK, JOHNSON DE,VONESCHENBACH AC, et al. Adjuvant estrogen following radiation therapy for stage C adenocarcinoma of the prostate:Long-term results of a prospective randomized study[J].Int J Radiat Oncol Biol Phys, 1 988,14(6):1085-1091.
[4] LAWTON CA, WINTER K, GRIGNON D,et aL. Androgen suppression plus radiation versus radiation alone for patients with stage D1/Pathologicnode-positive adenocarcinoma of the prostate:Updated results based on national prospective randomized trial Radiation Therapy Oncology Group 85-31[J]. J Clin Oncol, 2005,23(4):800-807.
[5] BOLLA M, VAN TIENHOVEN G,WARDE P, et al. External irradiation with or without long-term androgen suppression for prostate cancer with high metastatic risk:10-year results of an EORTC randomised study[J]. Lancet Oncol, 2010, 1 1(11):1066-1073.
[6] ROACH MI, BAE K, SPEIGHT J, et al.Short-term neoadjuvant androgen deprivation therapy and externalbeam radiotherapy for locally advanced prostate cancer:Long-term results of RTOG 8610[J]. J Clin Oncol,208, 6(4):585-591.
[7] SASSE AD, SASSE E, CARVALHO AM, et al.Androgenic suppression combined with radiotherapy for the treatment of prostate adenocarcinoma:a systematic review[J]. BMC Cancer, 2012, 1 2:54.
[8] SHELLEY MD, KUMAR S, WILT T, et al.A systematic review and meta-analysis of randomised trials of neo-adjuvant hormone therapy for localised and locally advanced prostate carcinomaU].Cancer Treat Rev, 2009, 35(1):9-17.
[9] MOTTET N, PENEAU M, MAZERON J, et al.Addition of radiotherapy to longterm androgen deprivation in locally advanced prostate cancer:an open randomised phase 3 trial[J].Eur Urol,2012,62(2):213-219.
[10] WARDE P, MASON M, DING K, et al.Combined androgen deprivation therapy and radiation therapy forlocally advanced prostate cancer:A randomised, phase 3 trial[J]. Lancet,2011,378(9809):2104-21 11.
[11] KEATING NL, O'MALLEY AJ,FREEDLAND SJ, et al. Diabetes and cardiovascular disease during androgen deprivation therapy:observational study of veterans with prostate cancer[J].J Natl Cancer Inst,2010, 102(1):39-46.
[12] 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 96.01randomised trial[J]. Lancet Oncol201 1, 12(5):451-459.
[13] CROOK J, LUDGATE C, MALONE S,et al.Final report of multicenter Canadian PhaseⅢrandomized trial of 3 versus 8 months of neoadjuvant androgen deprivation therapy before conventional-dose radiotherapy for clinically localized prostate cancer[J].Int J Radiat Oncol Biol Phys, 2009,73(2):327-333.
[14] HORWITZ EM, BAE K, HANKS GE, et al.Ten-year follow-up of radiation therapy oncology group protocol92-02:A phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer[J].J Clin Oncol, 2008, 26(1 5):2497-2504.
[15] BOLLA M,DE REIJKE TM,VAN TIENHOVEN G, et al. Duration of androgen suppression in the treatment of prostate cancer[J]. N Engl J Med, 2009, 360(24):2516-2527.
[16] BOLLA M. Re:High-risk prostate cancer treated with pelvic radiotherapy and 36 versus 18 months of androgen blockade:results of a phaseⅢrandomized study[abstract 3][J]. Eur Urol, 2013, 64(3):513.
[17]曾宪涛,包翠萍,曹世义,等.Meta分析系列之三:随机对照试验的质量评价工具[J].中国循证心血管医学杂志,2012,4(3):183-185.
[18] HORWITZ EM, BAE K, HANKS GE, et al.Ten-year follow-up of radiation therapy oncology group protocol 92-02:a phaseⅢtrial of the duration of elective androgen deprivation in locally advanced prostate cancer[J].J Clin Oncol, 2008, 26(1 5):2497-2504.
[19] LAWTON CAF,LIN X,HANKS GE,et al.Duration of androgen deprivation in locally advanced prostate cancer:long-term update of NRG Oncology RTOG 9202[J]. Int J Radiat Oncol Biol Phys, 2017, 98(2):296-303.
[20] 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 csancer[J]. Int J Radiat Oncol Biol Phys, 2011, 81(1):35-45.
[21] NABID A, CARRIER N, MARTIN AG, et al.Duration of androgen deprivation therapy in high-risk prostate cancer:a randomized phaseⅢtrial[J]. Eur Urol,2018, 74(4):432-441.
[22] BOLLA M, DE REIJKE TM, VAN TIENHOVEN G, et al. Duration of androgen suppression in the treatment of prostate cancer[J]. N Engl JMed, 2009, 360(24):2516-2527.
[23] ZAPATERO A, GUERRERO A,MALDONADO X, et al. High-dose radiotherapy with short-term or long-term androgen deprivation in localised prostate cancer(DARTO1/05GICOR):a randomised, controlled,phase 3 trial[J]. Lancet Oncol, 201 5,16(3):320-327.