多西他赛联合ADT治疗转移性去势敏感性前列腺癌的疗效及预后因素分析
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摘要
目的评价多西他赛联合雄激素剥夺疗法(ADT)治疗转移性去势敏感性前列腺癌(mHSPC)患者的疗效,并分析其预后影响因素。方法回顾性分析107例mHSPC患者的临床资料,所有患者均行多西他赛联合ADT治疗,观察终点为前列腺特异性抗原无进展生存期(PSA PFS)和影像学无进展生存期(rPFS)。采用Cox单因素和多因素回归分析患者PSA PFS和rPFS的相关预后影响因素。结果中位随访时间36月,13例患者死亡。中位PSA PFS 34.000(30.878～37.122)月,中位rPFS 33.000(30.031～35.969)月。单因素回归分析显示:初始血清PSA值、治疗7月时PSA最低值是否低于0.2 ng/dl、化疗周期数、患者体能状态评分(ECOG)、是否伴有内脏转移与患者的PSA FPS、rPFS显著相关。多因素回归分析显示:治疗7月时PSA最低值是否低于0.2 ng/dl以及是否伴有内脏转移与患者的PSA FPS、rPFS显著相关。结论多西他赛联合ADT治疗中国mHSPC患者疗效较好,治疗7月时PSA最低值是否低于0.2 ng/dl以及是否伴有内脏转移是患者PSA FPS、r PFS的独立预后因素。
Objective To assess the efficacy of docetaxel plus ADT on mHSPC patients and analyze the prognostic factors. Methods We retrospectively reviewed the clinical data of 107 mHSPC patients treated with docetaxel plus ADT. Co-primary end points were PSA PFS and rPFS. Univariable and multivariable Cox analyses were performed to determine prognostic factors for PSA PFS and rPFS. Results The median follow-up time was 36 months, and 13(12.1%) patients died. The median PSA PFS and rPFS were 34.000(30.878-37.122) and 33.000(30.031-35.969) months, respectively. Univariate analysis results showed that the serum PSA, PSA nadir at 7 th month(≤0.2 ng/dl vs. >0.2 ng/dl), number of chemotherapy cycles(≤6 vs.7-12), ECOG PS(0-1 vs. 2) and visceral disease(yes vs. no) were independent predictors for PSA PFS and rPFS. Multivariate analysis results showed that PSA nadir at 7 th month(≤0.2 ng/dl vs. >0.2 ng/dl) and visceral disease(yes vs. no) were independent predictors for PSA PFS and rPFS. Conclusion The effect of docetaxel plus ADT on patients with mHSPC in China is favorable. PSA nadir at 7 th month(≤0.2 ng/dl vs. >0.2 ng/dl)and visceral disease(yes vs. no) are independent predictors for PSA PFS and rPFS.
Objective To assess the efficacy of docetaxel plus ADT on mHSPC patients and analyze the prognostic factors. Methods We retrospectively reviewed the clinical data of 107 mHSPC patients treated with docetaxel plus ADT. Co-primary end points were PSA PFS and rPFS. Univariable and multivariable Cox analyses were performed to determine prognostic factors for PSA PFS and rPFS. Results The median follow-up time was 36 months, and 13(12.1%) patients died. The median PSA PFS and rPFS were 34.000(30.878-37.122) and 33.000(30.031-35.969) months, respectively. Univariate analysis results showed that the serum PSA, PSA nadir at 7 th month(≤0.2 ng/dl vs. >0.2 ng/dl), number of chemotherapy cycles(≤6 vs.7-12), ECOG PS(0-1 vs. 2) and visceral disease(yes vs. no) were independent predictors for PSA PFS and rPFS. Multivariate analysis results showed that PSA nadir at 7 th month(≤0.2 ng/dl vs. >0.2 ng/dl) and visceral disease(yes vs. no) were independent predictors for PSA PFS and rPFS. Conclusion The effect of docetaxel plus ADT on patients with mHSPC in China is favorable. PSA nadir at 7 th month(≤0.2 ng/dl vs. >0.2 ng/dl)and visceral disease(yes vs. no) are independent predictors for PSA PFS and rPFS.
引文
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[11]Vale CL,Burdett S,Rydzewska LHM,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):243-56.
[12]Cassinello J,Arranz Já,Piulats JM,et al.SEOM clinical guidelines for the treatment of metastatic prostate cancer(2017)[J].Clin Transl Oncol,2018,20(1):57-68.
[13]Chen W,Zheng R,Baade PD,et al.Cancer statistics in China,2015[J].CA Cancer J Clin,2016,66(2):115-32.
[14]Attard G,Parker C,Eeles RA,et al.Prostate cancer[J].Lancet,2016,387(10013):70-82.
[15]Chen R,Ren S,Chinese Prostate Cancer Consortium,et al.Prostate cancer in Asia:A collaborative report[J].Asian J Urol,2014,1(1):15-29.
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[17]Teoh JYC,Poon DMC,Lam D,et al.A Territory-wide,Multicenter,Age-and Prostate-specific Antigen-matched Study Comparing Chemohormonal Therapy and Hormonal Therapy Alone in Chinese Men With Metastatic Hormone-sensitive Prostate Cancer[J].Clin Genitourin Cancer,2019.17(1):e203-8.
[18]McNamara M,Sweeney C,Antonarakis ES,et al.The evolving landscape of metastatic hormone-sensitive prostate cancer:a critical review of the evidence for adding docetaxel or abiraterone to androgen deprivation[J].Prostate Cancer Prostatic Dis,2018,21(3):306-18.
[19]Gravis G,Boher JM,Joly F,et al.Androgen Deprivation Therapy(ADT)Plus Docetaxel Versus ADT Alone in Metastatic Non castrate Prostate Cancer:Impact of Metastatic Burden and Longterm Survival Analysis of the Randomized Phase 3 GETUG-AFU15 Trial[J].Eur Urol,2016,70(2):256-62.
[20]Alhanafy AM,Zanaty F,Ibrahem R,et al.Prognostic Factors for Hormone Sensitive Metastatic Prostate Cancer:Impact of Disease Volume[J].Asian Pac J Cancer Prev,2018,19(4):1113-8.
[21]Francini E,Gray KP,Xie W,et al.Time of metastatic disease presentation and volume of disease are prognostic for metastatic hormone sensitive prostate cancer(mHSPC)[J].Prostate,2018,78(12):889-95.
[22]Halabi S,Small EJ,Kantoff PW,et al.Prognostic model for predicting survival in men with hormone-refractory metastatic prostate cancer[J].J Clin Oncol,2003,21(7):1232-7.
[23]Nieder C,Haukland E,Pawinski A,et al.Seven-month prostatespecific antigen(PSA)is prognostic in patients with prostate cancer initially diagnosed with distant metastases[J].Med Oncol,2018,35(4):46.
[24]Francini E,Yip S,Ahmed S,et al.Clinical Outcomes of Firstline Abiraterone Acetate or Enzalutamide for Metastatic Castration-resistant Prostate Cancer After Androgen Deprivation Therapy+Docetaxel or ADT Alone for Metastatic Hormonesensitive Prostate Cancer[J].Clin Genitourin Cancer,2018,16(2):130-4.
[2]Siegel RL,Miller KD,Jemal A.Cancer statistics,2018[J].CACancer J Clin,2018,68(1):7-30.
[3]Corn PG,Agarwal N,Araujo JC,et al.Taxane-based Combination Therapies for Metastatic Prostate Cancer[J].Eur Urol Focus,2017.pii:S2405-4569(17)30265-1.
[4]Damodaran S,Kyriakopoulos CE,Jarrard DF.Newly Diagnosed Metastatic Prostate Cancer:Has the Paradigm Changed?[J].Urol Clin North Am,2017,44(4):611-21.
[5]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):1502-12.
[6]Xu L,Pachynski RK.Contemporary Management of the Newly Diagnosed Prostate Cancer Patient with Metastatic Disease at Presentation[J].Curr Urol Rep,2018,19(10):79.
[7]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 3 trial[J].Lancet Oncol,2013,14(2):149-58.
[8]Nevedomskaya E,Baumgart SJ,Haendler B.Recent Advances in Prostate Cancer Treatment and Drug Discovery[J].Int J Mol Sci,2018,19(5).pii:E1359.
[9]Sweeney CJ,Chen YH,Carducci M,et al.Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer[J].NEngl J Med,2015,373(8):737-46.
[10]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):1163-77.
[11]Vale CL,Burdett S,Rydzewska LHM,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):243-56.
[12]Cassinello J,Arranz Já,Piulats JM,et al.SEOM clinical guidelines for the treatment of metastatic prostate cancer(2017)[J].Clin Transl Oncol,2018,20(1):57-68.
[13]Chen W,Zheng R,Baade PD,et al.Cancer statistics in China,2015[J].CA Cancer J Clin,2016,66(2):115-32.
[14]Attard G,Parker C,Eeles RA,et al.Prostate cancer[J].Lancet,2016,387(10013):70-82.
[15]Chen R,Ren S,Chinese Prostate Cancer Consortium,et al.Prostate cancer in Asia:A collaborative report[J].Asian J Urol,2014,1(1):15-29.
[16]Teoh JY,Ng CF,Poon DM.Chemohormonal therapy for metastatic hormone-sensitive prostate cancer:An Asian perspective[J].Asia Pac J Clin Oncol,2018,14 Suppl 5:5-8.
[17]Teoh JYC,Poon DMC,Lam D,et al.A Territory-wide,Multicenter,Age-and Prostate-specific Antigen-matched Study Comparing Chemohormonal Therapy and Hormonal Therapy Alone in Chinese Men With Metastatic Hormone-sensitive Prostate Cancer[J].Clin Genitourin Cancer,2019.17(1):e203-8.
[18]McNamara M,Sweeney C,Antonarakis ES,et al.The evolving landscape of metastatic hormone-sensitive prostate cancer:a critical review of the evidence for adding docetaxel or abiraterone to androgen deprivation[J].Prostate Cancer Prostatic Dis,2018,21(3):306-18.
[19]Gravis G,Boher JM,Joly F,et al.Androgen Deprivation Therapy(ADT)Plus Docetaxel Versus ADT Alone in Metastatic Non castrate Prostate Cancer:Impact of Metastatic Burden and Longterm Survival Analysis of the Randomized Phase 3 GETUG-AFU15 Trial[J].Eur Urol,2016,70(2):256-62.
[20]Alhanafy AM,Zanaty F,Ibrahem R,et al.Prognostic Factors for Hormone Sensitive Metastatic Prostate Cancer:Impact of Disease Volume[J].Asian Pac J Cancer Prev,2018,19(4):1113-8.
[21]Francini E,Gray KP,Xie W,et al.Time of metastatic disease presentation and volume of disease are prognostic for metastatic hormone sensitive prostate cancer(mHSPC)[J].Prostate,2018,78(12):889-95.
[22]Halabi S,Small EJ,Kantoff PW,et al.Prognostic model for predicting survival in men with hormone-refractory metastatic prostate cancer[J].J Clin Oncol,2003,21(7):1232-7.
[23]Nieder C,Haukland E,Pawinski A,et al.Seven-month prostatespecific antigen(PSA)is prognostic in patients with prostate cancer initially diagnosed with distant metastases[J].Med Oncol,2018,35(4):46.
[24]Francini E,Yip S,Ahmed S,et al.Clinical Outcomes of Firstline Abiraterone Acetate or Enzalutamide for Metastatic Castration-resistant Prostate Cancer After Androgen Deprivation Therapy+Docetaxel or ADT Alone for Metastatic Hormonesensitive Prostate Cancer[J].Clin Genitourin Cancer,2018,16(2):130-4.