The efficacy and sequencing of a short course of androgen suppression on freedom from biochemical failure when administered with radiation therapy for T2-T3 prostate cancer
The efficacy and sequencing of a short course of androgen suppression on freedom from biochemical failure when administered with radiation therapy for T2-T3 prostate cancer
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DOI：
10.1097/01.ju.0000112979.97941.7f
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发表时间：
2004-03-01
影响因子：
6.6
通讯作者：
Harel, F
中科院分区：
文献类型：
--
作者：
Laverdière, J;Nabid, A;Harel, F
目的：评价雄激素抑制(AS)联合外照射(EBRT)治疗T2-T3前列腺癌的疗效和顺序。材料与方法：1990年至1999年，481例前列腺癌患者进入2个连续的前瞻性随机研究，其中研究1 161例，研究2 325例。符合条件的患者临床分期为T2-T3。在第一项研究中(L-101)，受试者被随机分为单纯EBRT(第1组)、EBRT加AS治疗3个月(第2组)、新辅助、伴随和辅助AS共10个月(第3组)。在第二项研究中(L-200)，我们分析了新辅助和伴随AS(总共5个月)与新辅助、伴随和短程辅助(总共10个月)的EBRT。在每项研究中，我们使用了当时的总AS(黄体生成素释放激素激动剂加抗雄激素)和标准剂量的放射治疗。患者的特征在年龄、分期、前列腺特异性抗原和Gleason评分方面得到了很好的平衡。根据温哥华规则，无生化疾病证据(BNED)被定义为终点。结果：在研究1中，中位随访5年的7年无生化生存率在第1至第3组分别为42%、66%和69%。BNED在组1和组2之间(p=0.009)和组1和组3之间(p=0.003)之间有显著差异，但在组2和组3之间无显著差异(p=0.60)。用COX比例风险模型进行多因素分析，Gleason评分(p=0.001)、PSA1.4(p=0.002)、1组与2组、1组与3组的HR分别为6.10(p=0.001)、1.40(p=0.002)、0.35(p=0.008)。在研究2中，4年后出生的比例为65%。第1组和第2组之间差异无统计学意义(p=0.55)。结论：研究1的分析显示，在局部T2-T3前列腺癌中，与单纯EBRT相比，使用短疗程的新辅助治疗是有好处的。此外，在每项研究中，在新佐剂1之后加入较短疗程的佐剂对这些患者没有更多的好处。
Purpose: We evaluated the benefits and sequencing of androgen suppression (AS) administered with external beam radiation therapy (EBRT) in T2-T3 prostate cancers.Materials and Methods: 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.Results: 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).Conclusions: 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.