Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial.
Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial.
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DOI：
10.1016/s0140-6736(11)61095-7
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发表时间：
2011-12-17
期刊：
影响因子：
168.9
通讯作者：
Parulekar, Wendy
中科院分区：
文献类型：
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作者：
Warde, Padraig;Mason, Malcolm;Ding, Keyue;Kirkbride, Peter;Brundage, Michael;Cowan, Richard;Gospodarowicz, Mary;Sanders, Karen;Kostashuk, Edmund;Swanson, Greg;Barber, Jim;Hiltz, Andrea;Parmar, Mahesh K. B.;Sathya, Jinka;Anderson, John;Hayter, Charles;Hetherington, John;Sydes, Matthew R.;Parulekar, Wendy
目前尚不清楚放射治疗（RT）是否能提高局部晚期前列腺癌患者接受雄激素剥夺治疗（ADT）的总生存率。我们的目的是比较这些局部晚期前列腺癌患者的预后。局部晚期（T3或T4）前列腺癌患者（n=1057）；前列腺特异性抗原（PSA）浓度大于40 ng/mL （n=119）或PSA浓度大于20 ng/mL且Gleason评分为8或更高（n=25）的器官局限性疾病（T2）被随机分配（分层和动态最小化，不掩盖）接受终身ADT和RT（前列腺和精囊65-69 Gy，盆腔淋巴结45 Gy）。主要终点是总生存期。这里提出的结果是一个中期分析计划，当三分之二的事件为最终分析记录。所有的疗效分析都是根据治疗意向和所有患者的数据进行的。该试验在controlledtrials.com注册为ISRCTN24991896， Clinicaltrials.gov注册为NCT00002633。1995年至2005年间，1205名患者被随机分配（仅ADT组602名，ADT和RT组603名）；中位随访时间为6.0年（IQR为4.4 ~ 8.0）。在分析时，共有320例患者死亡，其中仅ADT组175例，ADT和RT组145例。在ADT基础上加用RT可改善7年总生存率（74%,95% CI 70-78 vs 66%, 60-70；风险比[HR] 0.77, 95% CI 0.61 - 0.98, p= 0.033）。毒性和健康相关生活质量结果均显示，RT对晚期胃肠道毒性的影响很小(直肠出血等级为bb0.3，仅ADT组有3例（0.5%），ADT和RT组有2例（0.3%）；腹泻等级为>.3,4例（0.7%）vs 8例（1.3%）；尿毒性分级为>，两组共3,14例（2.3%）。应与所有局部晚期前列腺癌患者讨论adt和rt联合治疗的益处。加拿大癌症协会研究所、美国国家癌症研究所和英国医学研究委员会。
Whether the addition of radiation therapy (RT) improves overall survival in men with locally advanced prostate cancer managed with androgen deprivation therapy (ADT) is unclear. Our aim was to compare outcomes in such patients with locally advanced prostate cancer. Patients with: locally advanced (T3 or T4) prostate cancer (n=1057); or organ-confined disease (T2) with either a prostate-specific antigen (PSA) concentration more than 40 ng/mL (n=119) or PSA concentration more than 20 ng/mL and a Gleason score of 8 or higher (n=25), were randomly assigned (done centrally with stratification and dynamic minimisation, not masked) to receive lifelong ADT and RT (65–69 Gy to the prostate and seminal vesicles, 45 Gy to the pelvic nodes). The primary endpoint was overall survival. The results presented here are of an interim analysis planned for when two-thirds of the events for the final analysis were recorded. All efficacy analyses were done by intention to treat and were based on data from all patients. This trial is registered at controlledtrials.com as ISRCTN24991896 and Clinicaltrials.gov as NCT00002633. Between 1995 and 2005, 1205 patients were randomly assigned (602 in the ADT only group and 603 in the ADT and RT group); median follow-up was 6·0 years (IQR 4·4–8·0). At the time of analysis, a total of 320 patients had died, 175 in the ADT only group and 145 in the ADT and RT group. The addition of RT to ADT improved overall survival at 7 years (74%, 95% CI 70–78 vs 66%, 60–70; hazard ratio [HR] 0·77, 95% CI 0·61–0·98, p=0·033). Both toxicity and health-related quality-of-life results showed a small effect of RT on late gastrointestinal toxicity (rectal bleeding grade >3, three patients (0·5%) in the ADT only group, two (0·3%) in the ADT and RT group; diarrhoea grade >3, four patients (0·7%) vs eight (1·3%); urinary toxicity grade >3, 14 patients (2·3%) in both groups). The benefits of combined modality treatment—ADT and RT—should be discussed with all patients with locally advanced prostate cancer. Canadian Cancer Society Research Institute, US National Cancer Institute, and UK Medical Research Council.