Princess Margaret Hospital, Toronto, Canada.
Lancet. 2011 Dec 17;378(9809):2104-11. doi: 10.1016/S0140-6736(11)61095-7. Epub 2011 Nov 2.
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.
对于接受雄激素剥夺治疗（ADT）的局部晚期前列腺癌患者，添加放射治疗（RT）是否能改善整体存活率仍不清楚。我们旨在比较此类局部晚期前列腺癌患者的治疗结果。
纳入患者标准：局部晚期（T3 或 T4）前列腺癌（n=1057）；或局限性疾病（T2），同时伴有 PSA 浓度＞40ng/ml（n=119）或 PSA 浓度＞20ng/ml 且 Gleason 评分≥8（n=25），随机分配（在中央进行分层和动态最小化，不设盲）接受终生 ADT 和 RT（前列腺和精囊 65-69Gy，盆腔淋巴结 45Gy）。主要终点为整体存活率。此处呈现的结果是在最终分析的全部事件记录到三分之二时进行的中期分析。所有疗效分析均根据所有患者的数据进行意向治疗。该试验在 controlledtrials.com 上注册为 ISRCTN66312152，在 Clinicaltrials.gov 上注册为 NCT00002633。
1995 年至 2005 年期间，共随机分配 1205 名患者（ADT 组 602 名，ADT+RT 组 603 名）；中位随访时间为 6.0 年（IQR 4.4-8.0）。在分析时，共有 320 名患者死亡，ADT 组 175 名，ADT+RT 组 145 名。与 ADT 相比，RT 联合 ADT 可改善 7 年的整体存活率（74%，95%CI 70-78 比 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表明 RT 对晚期胃肠道毒性有轻微影响（直肠出血等级＞3，ADT 组 3 名患者（0.5%），ADT+RT 组 2 名患者（0.3%）；腹泻等级＞3，ADT 组 4 名患者（0.7%），ADT+RT 组 8 名患者（1.3%）；尿毒性等级＞3，ADT+RT 组 14 名患者（2.3%）。
应与所有局部晚期前列腺癌患者讨论联合治疗模式（ADT 和 RT）的获益。
加拿大癌症协会研究所以及美国国立癌症研究所和英国医学研究理事会。
