Laverdière Jacques, Nabid Abdenour, De Bedoya Luis Diaz, Ebacher Annie, Fortin Andre, Wang Chang Shu, Harel François
Department of Radiation Oncology, Centre Hospitalier Universitaire de Quebec, Laval University, Quebec, Canada.
J Urol. 2004 Mar;171(3):1137-40. doi: 10.1097/01.ju.0000112979.97941.7f.
We evaluated the benefits and sequencing of androgen suppression (AS) administered with external beam radiation therapy (EBRT) in T2-T3 prostate cancers.
Between 1990 and 1999, 481 patients were entered in 2 successive, prospective, randomized studies, including 161 in the study 1 and 325 in study 2. Eligible patients had clinical stages T2-T3 prostate cancer. In the first study (L-101) subjects were randomly allocated among EBRT alone (group 1), EBRT preceded by 3 months of AS (group 2), and neoadjuvant, concomitant and adjuvant AS for a total of 10 months (group 3). In the second study (L-200) we analyzed neoadjuvant and concomitant AS (total 5 months) vs neoadjuvant, concomitant and short course adjuvant (total 10 months) AS with EBRT. In each study we used a total AS (a luteinizing hormone-releasing hormone agonist plus an antiandrogen) and a standard dose of radiation therapy at that time. Patient characteristics were well balanced in regard to age, stage, prostate specific antigen and Gleason score. No biochemical evidence of disease (BNED) was defined as an end point according to the Vancouver rule.
In the study 1 at a median followup of 5 years 7-year biochemical-free survival rates were 42%, 66% and 69% in groups 1 to 3, respectively. BNED was significantly different between groups 1 and 2 (p = 0.009) and between groups 1 and 3 (p = 0.003) but not between groups 2 and 3 (p = 0.6). Multivariate analysis using a Cox proportional hazards model showed an HR of 6.1 for Gleason score (p = 0.001), 1.4 for PSA (p = 0.002), 0.5 for group 1 vs group 2 (p = 0.01) and 0.35 for group 1 vs group 3 (p = 0.008). In study 2 BNED at 4 years was 65%. There was no significant difference between arms 1 and 2 (p = 0.55).
The analysis of study 1 shows a benefit of using a short course of neoadjuvant AS with EBRT vs EBRT alone for localized T2-T3 prostate cancers. Moreover, in each study adding a short course of adjuvant AS after neoadjuvant 1 provided no more advantage in these patients.
我们评估了雄激素抑制（AS）联合外照射放疗（EBRT）治疗T2 - T3期前列腺癌的益处及序贯方案。
1990年至1999年期间，481例患者纳入两项连续的前瞻性随机研究，其中研究1有161例，研究2有325例。符合条件的患者为临床分期T2 - T3期前列腺癌。在第一项研究（L - 101）中，受试者被随机分配至单纯EBRT组（第1组）、先进行3个月AS再行EBRT组（第2组）以及新辅助、同步和辅助AS共10个月组（第3组）。在第二项研究（L - 200）中，我们分析了新辅助和同步AS（共5个月）与新辅助、同步及短程辅助AS（共10个月）联合EBRT的情况。每项研究中我们均使用了全雄激素抑制（一种促黄体激素释放激素激动剂加一种抗雄激素）及当时的标准放疗剂量。患者在年龄、分期、前列腺特异性抗原及Gleason评分方面特征均衡。根据温哥华标准，将无疾病生化证据（BNED）定义为终点。
在研究1中，中位随访5年时，第1至3组的7年无生化复发生存率分别为42%、66%和69%。第1组与第2组之间（p = 0.009）以及第1组与第3组之间（p = 0.003）BNED有显著差异，但第2组与第3组之间无显著差异（p = 0.6）。使用Cox比例风险模型进行的多因素分析显示，Gleason评分的HR为6.1（p = 0.001），PSA的HR为1.4（p = 0.002），第1组与第2组相比HR为0.5（p = 0.01），第1组与第3组相比HR为0.35（p = 0.008）。在研究2中，4年时的BNED为65%。第1组与第2组之间无显著差异（p = 0.55）。
研究1的分析表明，对于局限性T2 - T3期前列腺癌，与单纯EBRT相比，新辅助AS短程联合EBRT有益。此外，在每项研究中，新辅助1个月后加用短程辅助AS对这些患者并无更多益处。
