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1、前列腺癌 ASCO,1,1. 多西他赛：E3805 (CHAARTED)与STAMPEDE 2.生化复发的挽救治疗：GETUG-AFU16 3.转移性前列腺癌间断或持续雄激素剥夺治疗的长期结果 4. PAS升高前列腺癌ADT干预时机：2个期随机临床试验联合分析,主要内容,2,1. 多西他赛：E3805 (CHAARTED)与STAMPEDE 2.生化复发的挽救治疗：GETUG-AFU16 3.转移性前列腺癌间断或持续雄激素剥夺治疗的长期结果 4. PAS升高前列腺癌ADT干预时机：2个期随机临床试验联合分析,主要内容,3,E3805 (CHAARTED)：研究设计,Sweeney C, et
2、al. 2014 ASCO Abstract LBA2.,4,E3805 (CHAARTED)：主要入组标准,转移性前列腺癌 既往抗雄治疗，限于： 随机前12天或辅助治疗24个月或完成后12个月内无进展 ECOG PS 0-2 足够肝肾、骨髓、心脏、肺与神经功能 适合接受多西他赛 既往未接受多西他赛治疗,Sweeney C, et al. 2014 ASCO Abstract LBA2.,5,E3805 (CHAARTED)：OS (主要终点),延长13.6个月 降低死亡风险39%,Sweeney C, et al. 2014 ASCO Abstract LBA2.,6,E3805 (CHAA
3、RTED)： 开始治疗时不同转移性疾病程度的OS,延长17个月 降低死亡风险40%,Sweeney C, et al. 2014 ASCO Abstract LBA2.,高肿瘤负荷：内脏转移，和/或4个骨转移(至少1个越过盆腔和脊柱),7,8,E3805 (CHAARTED)： 去势治疗联合多西他赛在所有亚组中均获益,Sweeney C, et al. 2014 ASCO Abstract LBA2.,Slide 1,Presented By Nicholas James at 2015 ASCO Annual Meeting,9,Rationale for study agents,Pres
4、ented By Nicholas James at 2015 ASCO Annual Meeting,研究药物选择依据：多系紫杉醇：可以延长去势抵抗转移性前列腺癌生存期；老年人也有较好的耐受性唑来膦酸：降低去势抵抗转移性前列腺癌骨相关事件的发生系列研究把唑来膦酸作为预防转移的药物 联合治疗：体外有证据支持二者有协调作用预期二者联合耐受性良好,10,Inclusion criteria,Presented By Nicholas James at 2015 ASCO Annual Meeting,未经 ADT 治疗的新诊断转移性前列腺癌患者,11,Outcome measures,Presen
5、ted By Nicholas James at 2015 ASCO Annual Meeting,主要终点：OS次要终点：FFS(Failure-free survival）毒性、生活质量、骨相关事件、经济影响FFS：PSA失败、局部失败、淋巴结失败、远处转移、前列腺癌死亡PSA失败：PAS下降小于50%；如PSA下降大于50%：24周内最低值+50%和大于4ng/ml,12,Docetaxel & ZA comparisons: patients,Presented By Nicholas James at 2015 ASCO Annual Meeting,13,Accrual,Prese
6、nted By Nicholas James at 2015 ASCO Annual Meeting,按 2：1：1：1 分成 4 个治疗组：标准治疗（ 3 年 ADT局部放疗）标准治疗 + 多西他赛（6 周期）标准治疗 + 唑来膦酸（2 年）标准治疗 + 多西他赛 + 唑来膦酸多西他赛给药方案是 3 周一次 75 mg/m2+ 强的松每日 10 mg 为一个周期，持续 6 个周期。唑来膦酸的给药方案是每 3 周一次 4 mg，6 周期后每 4 周一次，持续 2 年。,14,Zoledronic acid: Failure-free survival,Presented By Nicholas
7、 James at 2015 ASCO Annual Meeting,15,Zoledronic acid: Survival,Presented By Nicholas James at 2015 ASCO Annual Meeting,唑来膦酸组生存差异不具统计学意义,16,Docetaxel: Failure-free survival,Presented By Nicholas James at 2015 ASCO Annual Meeting,17,Docetaxel: Survival,Presented By Nicholas James at 2015 ASCO Annual
8、Meeting,多西他赛组总生存延长 10 个月,18,Zoledronic acid + docetaxel: Failure-free survival,Presented By Nicholas James at 2015 ASCO Annual Meeting,19,Zoledronic acid + docetaxel: Survival,Presented By Nicholas James at 2015 ASCO Annual Meeting,多西他赛 + 唑来膦酸组生存改善与多西他赛组相似,20,Treatment effect by metastatic status: F
9、FS,Presented By Nicholas James at 2015 ASCO Annual Meeting,M1亚组分析,21,Treatment effect by metastatic status: Overall survival,Presented By Nicholas James at 2015 ASCO Annual Meeting,M1亚组分析,22,Docetaxel: Survival M1 Patients,Presented By Nicholas James at 2015 ASCO Annual Meeting,转移的亚组延长 22 个月,M1亚组分析,
10、23,Grade 3+ adverse events ever reported,Presented By Nicholas James at 2015 ASCO Annual Meeting,毒副反应,24,Grade 3+ adverse events ever reported,Presented By Nicholas James at 2015 ASCO Annual Meeting,毒副反应,25,Grade 3+ adverse events at 1 year,Presented By Nicholas James at 2015 ASCO Annual Meeting,毒副反
11、应,26,Conclusions,Presented By Nicholas James at 2015 ASCO Annual Meeting,结论多西他赛可以改善未用过激素治疗的前列腺癌病人的生存唑来膦酸不能改善生存两药联合改善生存，但未超过单独加用多西他赛多臂、多阶段临床试验是有实践意义的多西他赛可以考虑用于新诊断转移性前列腺癌的常规治疗可以考虑用于高危非转移性前列腺癌（是基于亚组分析：可以延长无失败生存时间FFS）,27,1. 多西他赛：E3805 (CHAARTED)与STAMPEDE 2.生化复发的挽救治疗：GETUG-AFU16 3.转移性前列腺癌间断或持续雄激素剥夺治疗的长期结
12、果 4. PAS升高前列腺癌ADT干预时机：2个期随机临床试验联合分析,主要内容,28,GETUG-AFU 16 Interest of short androgen deprivation therapy (ADT) combined with radiotherapy (RT) as salvage treatment for biological relapse (BR) after radical prostatectomy (RP) Results of the GETUG-AFU 16 phase III randomized trial,Presented By Christia
13、n Carrie at 2015 ASCO Annual Meeting,短期去势联合放疗作为挽救治疗根治术后生化复发前列腺癌的疗效影响：GETUG-AFU16 期随机临床试验,29,Background and objective,Presented By Christian Carrie at 2015 ASCO Annual Meeting,背景：约1/3的前列腺癌根治术后8年内会出现复发：表现PSA升高，但无临床或影像学证据，最终出现远处转移挽救性放疗是仅有生化复发（PSA）病人的标准治疗，可使35%的病人5年内不会再出现生化复发并且推迟长期雄激素抑制时间回顾性资料也提示：短期去势联合
14、放疗可以改善高危复发病人的预后研究目的：观察去势联合放疗与单纯放疗对前列腺癌根治术后生化复发5年PFS的疗效,30,Study endpoints,Presented By Christian Carrie at 2015 ASCO Annual Meeting,研究终点 主要终点：PFS：从随机化开始到生化或临床进展，或死亡 次要终点：OS急性和最终毒性（TTCAE V3.0）生活质量,31,Study design,Presented By Christian Carrie at 2015 ASCO Annual Meeting,32,Main inclusion criteria,Pre
15、sented By Christian Carrie at 2015 ASCO Annual Meeting,主要入组标准前列腺腺癌，分期：pT2、T3、T4（膀胱颈受侵），根治性前列腺切除术后（RP）pN0/pNXRP术后至少6个月PSA正常无临床或影像学进展证据PSA0.2ng/ml或PSA2ng/ml必须从最低点起间隔2个月以上连续检测2次，可认为是生化复发PS2分之前未行ADT治疗,33,Recruitment and follow-up,Presented By Christian Carrie at 2015 ASCO Annual Meeting,入组与随访,34,Baselin
16、e characteristics,Presented By Christian Carrie at 2015 ASCO Annual Meeting,35,Results Treatment administration,Presented By Christian Carrie at 2015 ASCO Annual Meeting,结果：治疗情况放疗738病人接受了放疗705（96%）3D RT 33（4%）IMRT前列腺床的中位剂量66Gy/7周15%病人接受盆腔淋巴结放疗ADT（戈舍瑞林：10.8mg）3个病人未接受第一次注射（1人拒绝、2人遗漏）15个病人（4%）未接受第二次注射10人拒绝、2人遗漏、2人因为毒性、1人原因不清楚,36,Acute toxicities (CTC-AE v3),Presented By Christian Carrie at 2015 ASCO Annual Meeting,潮红和出汗(大于3度),37,Late toxicities (CTC-AE v3),Presented By Christian Carrie at 2015 ASCO Annual Meeting,
