2017年St.Gallen国际晚期前列腺癌专家共识荟萃
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摘要
近年来,随着影像技术的发展、分子生物技术的进步和药物的研发,人们对晚期前列腺癌(advanced prostate cancer,APC)研究产生了许多新的问题和争议,尤其是针对循证医学证据不足的问题。2017年晚期前列腺癌国际专家共识会议(advanced prostate cancer consesus conference,APCCC)在欧洲小镇圣加仑(St.Gallen)召开,60多名专家基于循证医学证据,对APC临床诊疗领域热点问题通过讨论达成共识,并对有分歧的观点作出客观评价。10个有争议的问题达成共识:复发风险较高的局部APC治疗,寡转移性前列腺癌的治疗,去势敏感性与去势抵抗性前列腺癌的治疗,APC患者影像学检查,骨靶向治疗,血液及组织学检测与分子分型特征,基因咨询和基因检测,全身系统治疗的毒副作用,以及全球前列腺癌治疗药物的可获得性。本研究就各阶段前列腺癌的治疗以及个体化基因检测进行阐述,有望为APC的治疗提供理论指导。
In advanced prostate cancer(APC),successful drug development as well as advances in imaging and molecular characterisation have resulted in multiple areas where there is lack of evidence or low level of evidence.The Advanced Prostate Cancer Consensus Conference(APCCC)2017 was held at the town of St.Gallen,which was based on the evidence-based medicine and reached a consensus through discussion of the clinical diagnosis and treatment of APC by a panel of 60 international prostate cancer experts.Ten important areas of controversy in APC management were identified:high-risk localised and locally advanced prostate cancer;"oligometastatic"prostate cancer;castration-naive and castrationresistant prostate cancer;the role of imaging in APC;osteoclast-targeted therapy;molecular characterisation of blood and tissue;genetic counselling/testing;side effects of systemic treatment(s);global access to prostate cancer drugs.In this paper,we focused on the treatment of prostate cancer in various stages and individualized genetic testing and others.This article provided theoretical basis for the treatment of advanced prostate cancer.
In advanced prostate cancer(APC),successful drug development as well as advances in imaging and molecular characterisation have resulted in multiple areas where there is lack of evidence or low level of evidence.The Advanced Prostate Cancer Consensus Conference(APCCC)2017 was held at the town of St.Gallen,which was based on the evidence-based medicine and reached a consensus through discussion of the clinical diagnosis and treatment of APC by a panel of 60 international prostate cancer experts.Ten important areas of controversy in APC management were identified:high-risk localised and locally advanced prostate cancer;"oligometastatic"prostate cancer;castration-naive and castrationresistant prostate cancer;the role of imaging in APC;osteoclast-targeted therapy;molecular characterisation of blood and tissue;genetic counselling/testing;side effects of systemic treatment(s);global access to prostate cancer drugs.In this paper,we focused on the treatment of prostate cancer in various stages and individualized genetic testing and others.This article provided theoretical basis for the treatment of advanced prostate cancer.
引文
[1]Siegel RL,Miller KD,Jemal A.Cancer statistics,2016[J].CA Cancer J Clin,2016,66(1):7-30.
[2]Chen W,Zheng R,Baade PD,et al.Cancer statistics in China,2015[J].CA Cancer J Clin,2016,66(2):115-132.
[3]Cornford P,Bellmunt J,Bolla M,et al.EAU-ESTRO-SIOG guidelines on prostate cancer.PartⅡ:treatment of relapsing,metastatic,and castration-resistant prostate cancer[J].Eur Urol,2017,71(4):630-642.
[4]Diamond IR,Grant RC,Feldman BM,et al.Defining consensus:a systematic review recommends methodologic criteria for reporting of Delphi studies[J].J Clin Epidemiol,2014,67(4):4.
[5]Briganti A,Larcher A,Abdollah F,et al.Updated nomogram predicting lymph node invasion in patients with prostate cancer undergoing extended pelvic lymph node dissection:the essential importance of percentage of positive cores[J].Eur Urol,2012,61(3):480-487.
[6]Dell’Oglio P,Abdollah F,Suardi N,et al.External validation of the European association of urology recommendations for pelvic lymph node dissection in patients treated with robot-assisted radical prostatectomy[J].J Endourol,2014,28(4):416-423.
[7]Hinev AI,Anakievski D,Kolev NH,et al.Validation of nomograms predicting lymph node involvement in patients with prostate cancer undergoing extended pelvic lymph node dissection[J].Urol Int,2014,92(3):300-305.
[8]Briganti A,Wiegel T,Joniau S,et al.Early salvage radiation therapy does not compromise cancer control in patients with pT3N0prostate cancer after radical prostatectomy:results of a matchcontrolled multiinstitutional analysis[J].Eur Urol,2012,62(3):472-487.
[9]Carrie C,Hasbini A,de Laroche G,et al.Salvage radiotherapy with or without short-term hormone therapy for rising prostatespecific antigen concentration after radical prostatectomy(GETUGAFU 16):a randomised,multicentre,open-label phase3trial[J].Lancet Oncol,2016,17(6):747-756.
[10]Shipley WU,Seiferheld W,Lukka HR,et al.Radiation with or without antiandrogen therapy in recurrent prostate cancer[J].N Engl J Med,2017,376(5):417-428.
[11]James ND,Sydes MR,Clarke NW,et al.Addition of docetaxel,zoledronic acid,or both to first-line long-term hormone therapy in prostate cancer(STAMPEDE):survival results from an adaptive,multiarm,multistage,platform randomised controlled trial[J].Lancet,2016,387(10024):1163-1677.
[12]Sweeney CJ,Chen YH,Carducci M,et al.Chemohormonal therapy in metastatic hormone-sensitive prostate cancer[J].N Engl J Med,2015,373(8):737-746.
[13]Gravis G,Fizazi K,Joly F,et al.Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer(GETUG-AFU 15):a randomised,open-label,phase 3trial[J].Lancet Oncol,2013,14(2):149-158.
[14]Vale CL,Burdett S,Rydzewska LH,et al.Addition of docetaxel or bisphosphonates to standard of care in men with localised or metastatic,hormone-sensitive prostate cancer:a systematic review and meta-analyses of aggregate data[J].Lancet Oncol,2016,17(2):243-256.
[15]Badwe R,Hawaldar R,Nair N,et al.Locoregional treatment versus no treatment of the primary tumour in metastatic breast cancer:an open-label randomised controlled trial[J].Lancet Oncol,2015,16(3):1380-1388.
[16]Kantoff PW,Higano CS,Shore ND,et al.Sipuleucel-T immunotherapy for castration-resistant prostate cancer[J].N Engl J Med,2010,363(5):411-422.
[17]Ryan CJ,Smith MR,de Bono JS,et al.Abiraterone in metastatic prostate cancer without previous chemotherapy[J].N Engl J Med,2013,368(2):138-148.
[18]Beer TM,Armstrong AJ,Rathkopf DE,et al.Enzalutamide in metastatic prostate cancer before chemotherapy[J].N Engl J Med,2014,371(5):424-433.
[19]Tannock IF,de Wit R,Berry WR,et al.Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer[J].N Engl J Med,2004,351(15):1502-1512.
[20]Petrylak DP,Tangen CM,Hussain MH,et al.Docetaxel and estra-mustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer[J].N Engl J Med,2004,351(15):1513-1520.
[21]Parker C,Nilsson S,Heinrich D,et al.Alpha emitter radium-223and survival in metastatic prostate cancer[J].N Engl J Med,2013,369(3):213-223.
[22]de Bono JS,Logothetis CJ,Molina A,et al.Abiraterone and increased survival in metastatic prostate cancer[J].N Engl J Med,2011,364(21):1995-2005.
[23]de Bono JS,Oudard S,Ozguroglu M,et al.Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment:a randomised openlabel trial[J].Lancet,2010,376(974):1147-1154.
[24]Scher HI,Fizazi K,Saad F,et al.Increased survival with enzalutamide in prostate cancer after chemotherapy[J].N Engl J Med,2012,367(13):1187-1197.
[25]Beltran H,Tomlins S,Aparicio A,et al.Aggressive variants of castration-resistant prostate cancer[J].Clin Cancer Res,2014,20(11):2846-2850.
[26]Watson PA,Arora VK,Sawyers CL.Emerging mechanisms of resistance to androgen receptor inhibitors in prostate cancer[J].Nat Rev Cancer,2015,15(12):701-711.
[27]Fizazi K,Carducci M,Smith M,et al.Denosumab versus zoledronic acid for treatment of bone metastases in men with castrationresistant prostate cancer:a randomised,double-blind study[J].Lancet,2011,377(9768):813-822.
[28]Saad F.Zoledronic acid significantly reduces pathologic fractures in patients with advanced-stage prostate cancer metastatic to bone[J].Clin Prostate Cancer,2002,1(3):145-152.
[29]James ND,Pirrie SJ,Pope AM,et al.Clinical outcomes and survival following treatment of metastatic castrate-refractory prostate cancer with docetaxel alone or with strontium-89,zoledronic acid,or both:The TRAPEZE randomized clinical trial[J].JAMA Oncol,2016,2(4):493-499.
[30]Smith MR,Coleman RE,Klotz L,et al.Denosumab for the prevention of skeletal complications in metastatic castration-resistant prostate cancer:comparison of skeletal-related events and symptomatic skeletal events[J].Ann Oncol,2015,26(2):368-374.
[31]Parker C,Nilsson S,Heinrich D,et al.Alpha emitter radium-223and survival in metastatic prostate cancer[J].N Engl J Med,2013,369(3):213-223.
[32]Sartor O,Coleman R,Nilsson S,et al.Effect of radium-223dichloride on symptomatic skeletal events in patients with castration resistant prostate cancer and bone metastases:results from a phase 3,double-blind,randomised trial[J].Lancet Oncol,2014,15(7):738-746.
[33]Smith MR,Saad F,Coleman R,et al.Denosumab and bone-metastasis free survival in men with castration-resistant prostate cancer:results of a phase 3,randomised,placebo-controlled trial[J].Lancet,2012,379(9810):39-46.
[34]Smith MR,Halabi S,Ryan CJ,et al.Randomized controlled trial of early zoledronic acid in men with castration-sensitive prostate cancer and bone metastases:results of CALGB 90202(alliance)[J].J Clin Oncol,2014,32(11):1143-1150.
[35]Patel V,Kelleher M,Sproat C,et al.New cancer therapies and jaw necrosis[J].Br Dent J,2015,219(5):203-207.
[36]Saad F,Brown JE,Van Poznak C,et al.Incidence,risk factors,and outcomes of osteonecrosis of the jaw:integrated analysis from three blinded active-controlled phaseⅢtrials in cancer patients with bone metastases[J].Ann Oncol,2012,23(5):1341-1347.
[37]Beltran H,Prandi D,Mosquera JM,et al.Divergent clonal evolution of castration-resistant neuroendocrine prostate cancer[J].Nat Med,2016,22(3):298-305.
[38]Mu P,Zhang Z,Benelli M,et al.SOX2promotes lineage plasticity and antiandrogen resistance in TP53-and RB1-deficient prostate cancer[J].Science,2017,355(6320):84-88.
[39]Robinson D,Van Allen EM,Wu YM,et al.Integrative clinical genomics of advanced prostate cancer[J].Cell,2015,161(5):1215-1228.
[40]Mateo J,Carreira S,Sandhu S,et al.DNA-repair defects and olaparib in metastatic prostate cancer[J].N Engl J Med,2015,373(18):1697-1708.
[41]Ku SY,Rosario S,Wang Y,et al.Rb1and Trp53cooperate to suppress prostate cancer lineage plasticity,metastasis,and antiandrogen resistance[J].Science,2017,355(6320):78-83.
[42]Pritchard CC,Morrissey C,Kumar A,et al.Complex MSH2and MSH6 mutations in hypermutated microsatellite unstable advanced prostate cancer[J].Nat Commun,2014,5:4988.
[43]Aparicio AM,Shen L,Tapia EL,et al.Combined tumor suppressor defects characterize clinically defined aggressive variant prostate cancers[J].Clin Cancer Res,2016,22(6):1520-1530.
[44]Li Y,Donmez N,Sahinalp C,et al.SRRM4drives neuroendocrine transdifferentiation of prostate adenocarcinoma under androgen receptor pathway inhibition[J].Eur Urol,2017,71(1):68-78.
[45]Le DT,Uram JN,Wang H,et al.PD-1blockade in tumors with mismatch-repair deficiency[J].N Engl J Med,2015,372(26):2509-2520.
[46]Ahmed M,Eeles R.Germline genetic profiling in prostate cancer:latest developments and potential clinical applications[J].Future Sci OA,2016,2(1):FSO87.
[47]Narod SA,Neuhausen S,Vichodez G,et al.Rapid progression of prostate cancer in men with a BRCA2mutation[J].Br J Cancer,2008,99(2):371-374.
[48]Tryggvadottir L,Vidarsdottir L,Thorgeirsson T,et al.Prostate cancer progression and survival in BRCA2mutation carriers[J].J Natl Cancer Inst,2007,99(12):929-935.
[49]Castro E,Goh C,Olmos D,et al.Germline BRCA mutations are associated with higher risk of nodal involvement,distant metastasis,and poor survival outcomes in prostate cancer[J].J Clin Oncol,2013,31(14):1748-1757.
[50]Pritchard CC,Mateo J,Walsh MF,et al.Inherited DNA-repair gene mutations in men with metastatic prostate cancer[J].N Engl J Med,2016,375(5):443-453.
[2]Chen W,Zheng R,Baade PD,et al.Cancer statistics in China,2015[J].CA Cancer J Clin,2016,66(2):115-132.
[3]Cornford P,Bellmunt J,Bolla M,et al.EAU-ESTRO-SIOG guidelines on prostate cancer.PartⅡ:treatment of relapsing,metastatic,and castration-resistant prostate cancer[J].Eur Urol,2017,71(4):630-642.
[4]Diamond IR,Grant RC,Feldman BM,et al.Defining consensus:a systematic review recommends methodologic criteria for reporting of Delphi studies[J].J Clin Epidemiol,2014,67(4):4.
[5]Briganti A,Larcher A,Abdollah F,et al.Updated nomogram predicting lymph node invasion in patients with prostate cancer undergoing extended pelvic lymph node dissection:the essential importance of percentage of positive cores[J].Eur Urol,2012,61(3):480-487.
[6]Dell’Oglio P,Abdollah F,Suardi N,et al.External validation of the European association of urology recommendations for pelvic lymph node dissection in patients treated with robot-assisted radical prostatectomy[J].J Endourol,2014,28(4):416-423.
[7]Hinev AI,Anakievski D,Kolev NH,et al.Validation of nomograms predicting lymph node involvement in patients with prostate cancer undergoing extended pelvic lymph node dissection[J].Urol Int,2014,92(3):300-305.
[8]Briganti A,Wiegel T,Joniau S,et al.Early salvage radiation therapy does not compromise cancer control in patients with pT3N0prostate cancer after radical prostatectomy:results of a matchcontrolled multiinstitutional analysis[J].Eur Urol,2012,62(3):472-487.
[9]Carrie C,Hasbini A,de Laroche G,et al.Salvage radiotherapy with or without short-term hormone therapy for rising prostatespecific antigen concentration after radical prostatectomy(GETUGAFU 16):a randomised,multicentre,open-label phase3trial[J].Lancet Oncol,2016,17(6):747-756.
[10]Shipley WU,Seiferheld W,Lukka HR,et al.Radiation with or without antiandrogen therapy in recurrent prostate cancer[J].N Engl J Med,2017,376(5):417-428.
[11]James ND,Sydes MR,Clarke NW,et al.Addition of docetaxel,zoledronic acid,or both to first-line long-term hormone therapy in prostate cancer(STAMPEDE):survival results from an adaptive,multiarm,multistage,platform randomised controlled trial[J].Lancet,2016,387(10024):1163-1677.
[12]Sweeney CJ,Chen YH,Carducci M,et al.Chemohormonal therapy in metastatic hormone-sensitive prostate cancer[J].N Engl J Med,2015,373(8):737-746.
[13]Gravis G,Fizazi K,Joly F,et al.Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer(GETUG-AFU 15):a randomised,open-label,phase 3trial[J].Lancet Oncol,2013,14(2):149-158.
[14]Vale CL,Burdett S,Rydzewska LH,et al.Addition of docetaxel or bisphosphonates to standard of care in men with localised or metastatic,hormone-sensitive prostate cancer:a systematic review and meta-analyses of aggregate data[J].Lancet Oncol,2016,17(2):243-256.
[15]Badwe R,Hawaldar R,Nair N,et al.Locoregional treatment versus no treatment of the primary tumour in metastatic breast cancer:an open-label randomised controlled trial[J].Lancet Oncol,2015,16(3):1380-1388.
[16]Kantoff PW,Higano CS,Shore ND,et al.Sipuleucel-T immunotherapy for castration-resistant prostate cancer[J].N Engl J Med,2010,363(5):411-422.
[17]Ryan CJ,Smith MR,de Bono JS,et al.Abiraterone in metastatic prostate cancer without previous chemotherapy[J].N Engl J Med,2013,368(2):138-148.
[18]Beer TM,Armstrong AJ,Rathkopf DE,et al.Enzalutamide in metastatic prostate cancer before chemotherapy[J].N Engl J Med,2014,371(5):424-433.
[19]Tannock IF,de Wit R,Berry WR,et al.Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer[J].N Engl J Med,2004,351(15):1502-1512.
[20]Petrylak DP,Tangen CM,Hussain MH,et al.Docetaxel and estra-mustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer[J].N Engl J Med,2004,351(15):1513-1520.
[21]Parker C,Nilsson S,Heinrich D,et al.Alpha emitter radium-223and survival in metastatic prostate cancer[J].N Engl J Med,2013,369(3):213-223.
[22]de Bono JS,Logothetis CJ,Molina A,et al.Abiraterone and increased survival in metastatic prostate cancer[J].N Engl J Med,2011,364(21):1995-2005.
[23]de Bono JS,Oudard S,Ozguroglu M,et al.Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment:a randomised openlabel trial[J].Lancet,2010,376(974):1147-1154.
[24]Scher HI,Fizazi K,Saad F,et al.Increased survival with enzalutamide in prostate cancer after chemotherapy[J].N Engl J Med,2012,367(13):1187-1197.
[25]Beltran H,Tomlins S,Aparicio A,et al.Aggressive variants of castration-resistant prostate cancer[J].Clin Cancer Res,2014,20(11):2846-2850.
[26]Watson PA,Arora VK,Sawyers CL.Emerging mechanisms of resistance to androgen receptor inhibitors in prostate cancer[J].Nat Rev Cancer,2015,15(12):701-711.
[27]Fizazi K,Carducci M,Smith M,et al.Denosumab versus zoledronic acid for treatment of bone metastases in men with castrationresistant prostate cancer:a randomised,double-blind study[J].Lancet,2011,377(9768):813-822.
[28]Saad F.Zoledronic acid significantly reduces pathologic fractures in patients with advanced-stage prostate cancer metastatic to bone[J].Clin Prostate Cancer,2002,1(3):145-152.
[29]James ND,Pirrie SJ,Pope AM,et al.Clinical outcomes and survival following treatment of metastatic castrate-refractory prostate cancer with docetaxel alone or with strontium-89,zoledronic acid,or both:The TRAPEZE randomized clinical trial[J].JAMA Oncol,2016,2(4):493-499.
[30]Smith MR,Coleman RE,Klotz L,et al.Denosumab for the prevention of skeletal complications in metastatic castration-resistant prostate cancer:comparison of skeletal-related events and symptomatic skeletal events[J].Ann Oncol,2015,26(2):368-374.
[31]Parker C,Nilsson S,Heinrich D,et al.Alpha emitter radium-223and survival in metastatic prostate cancer[J].N Engl J Med,2013,369(3):213-223.
[32]Sartor O,Coleman R,Nilsson S,et al.Effect of radium-223dichloride on symptomatic skeletal events in patients with castration resistant prostate cancer and bone metastases:results from a phase 3,double-blind,randomised trial[J].Lancet Oncol,2014,15(7):738-746.
[33]Smith MR,Saad F,Coleman R,et al.Denosumab and bone-metastasis free survival in men with castration-resistant prostate cancer:results of a phase 3,randomised,placebo-controlled trial[J].Lancet,2012,379(9810):39-46.
[34]Smith MR,Halabi S,Ryan CJ,et al.Randomized controlled trial of early zoledronic acid in men with castration-sensitive prostate cancer and bone metastases:results of CALGB 90202(alliance)[J].J Clin Oncol,2014,32(11):1143-1150.
[35]Patel V,Kelleher M,Sproat C,et al.New cancer therapies and jaw necrosis[J].Br Dent J,2015,219(5):203-207.
[36]Saad F,Brown JE,Van Poznak C,et al.Incidence,risk factors,and outcomes of osteonecrosis of the jaw:integrated analysis from three blinded active-controlled phaseⅢtrials in cancer patients with bone metastases[J].Ann Oncol,2012,23(5):1341-1347.
[37]Beltran H,Prandi D,Mosquera JM,et al.Divergent clonal evolution of castration-resistant neuroendocrine prostate cancer[J].Nat Med,2016,22(3):298-305.
[38]Mu P,Zhang Z,Benelli M,et al.SOX2promotes lineage plasticity and antiandrogen resistance in TP53-and RB1-deficient prostate cancer[J].Science,2017,355(6320):84-88.
[39]Robinson D,Van Allen EM,Wu YM,et al.Integrative clinical genomics of advanced prostate cancer[J].Cell,2015,161(5):1215-1228.
[40]Mateo J,Carreira S,Sandhu S,et al.DNA-repair defects and olaparib in metastatic prostate cancer[J].N Engl J Med,2015,373(18):1697-1708.
[41]Ku SY,Rosario S,Wang Y,et al.Rb1and Trp53cooperate to suppress prostate cancer lineage plasticity,metastasis,and antiandrogen resistance[J].Science,2017,355(6320):78-83.
[42]Pritchard CC,Morrissey C,Kumar A,et al.Complex MSH2and MSH6 mutations in hypermutated microsatellite unstable advanced prostate cancer[J].Nat Commun,2014,5:4988.
[43]Aparicio AM,Shen L,Tapia EL,et al.Combined tumor suppressor defects characterize clinically defined aggressive variant prostate cancers[J].Clin Cancer Res,2016,22(6):1520-1530.
[44]Li Y,Donmez N,Sahinalp C,et al.SRRM4drives neuroendocrine transdifferentiation of prostate adenocarcinoma under androgen receptor pathway inhibition[J].Eur Urol,2017,71(1):68-78.
[45]Le DT,Uram JN,Wang H,et al.PD-1blockade in tumors with mismatch-repair deficiency[J].N Engl J Med,2015,372(26):2509-2520.
[46]Ahmed M,Eeles R.Germline genetic profiling in prostate cancer:latest developments and potential clinical applications[J].Future Sci OA,2016,2(1):FSO87.
[47]Narod SA,Neuhausen S,Vichodez G,et al.Rapid progression of prostate cancer in men with a BRCA2mutation[J].Br J Cancer,2008,99(2):371-374.
[48]Tryggvadottir L,Vidarsdottir L,Thorgeirsson T,et al.Prostate cancer progression and survival in BRCA2mutation carriers[J].J Natl Cancer Inst,2007,99(12):929-935.
[49]Castro E,Goh C,Olmos D,et al.Germline BRCA mutations are associated with higher risk of nodal involvement,distant metastasis,and poor survival outcomes in prostate cancer[J].J Clin Oncol,2013,31(14):1748-1757.
[50]Pritchard CC,Mateo J,Walsh MF,et al.Inherited DNA-repair gene mutations in men with metastatic prostate cancer[J].N Engl J Med,2016,375(5):443-453.