Radiological Associates of Sacramento, Sacramento, CA 95816, USA.
N Engl J Med. 2011 Jul 14;365(2):107-18. doi: 10.1056/NEJMoa1012348.
It is not known whether short-term androgen-deprivation therapy (ADT) before and during radiotherapy improves cancer control and overall survival among patients with early, localized prostate adenocarcinoma.
From 1994 through 2001, we randomly assigned 1979 eligible patients with stage T1b, T1c, T2a, or T2b prostate adenocarcinoma and a prostate-specific antigen (PSA) level of 20 ng per milliliter or less to radiotherapy alone (992 patients) or radiotherapy with 4 months of total androgen suppression starting 2 months before radiotherapy (radiotherapy plus short-term ADT, 987 patients). The primary end point was overall survival. Secondary end points included disease-specific mortality, distant metastases, biochemical failure (an increasing level of PSA), and the rate of positive findings on repeat prostate biopsy at 2 years.
The median follow-up period was 9.1 years. The 10-year rate of overall survival was 62% among patients receiving radiotherapy plus short-term ADT (the combined-therapy group), as compared with 57% among patients receiving radiotherapy alone (hazard ratio for death with radiotherapy alone, 1.17; P=0.03). The addition of short-term ADT was associated with a decrease in the 10-year disease-specific mortality from 8% to 4% (hazard ratio for radiotherapy alone, 1.87; P=0.001). Biochemical failure, distant metastases, and the rate of positive findings on repeat prostate biopsy at 2 years were significantly improved with radiotherapy plus short-term ADT. Acute and late radiation-induced toxic effects were similar in the two groups. The incidence of grade 3 or higher hormone-related toxic effects was less than 5%. Reanalysis according to risk showed reductions in overall and disease-specific mortality primarily among intermediate-risk patients, with no significant reductions among low-risk patients.
Among patients with stage T1b, T1c, T2a, or T2b prostate adenocarcinoma and a PSA level of 20 ng per milliliter or less, the use of short-term ADT for 4 months before and during radiotherapy was associated with significantly decreased disease-specific mortality and increased overall survival. According to post hoc risk analysis, the benefit was mainly seen in intermediate-risk, but not low-risk, men. (Funded by the National Cancer Institute; RTOG 94-08 ClinicalTrials.gov number, NCT00002597.).
目前尚不清楚在放疗前和放疗期间进行短期雄激素剥夺疗法（ADT）是否能改善早期局限性前列腺腺癌患者的癌症控制和总生存率。
1994 年至 2001 年，我们将 1979 名符合条件的 T1b、T1c、T2a 或 T2b 期前列腺腺癌患者和 PSA 水平<20ng/ml 的患者随机分为单纯放疗组（992 例）或放疗加 4 个月全雄激素抑制组（987 例），后者的雄激素抑制治疗从放疗前 2 个月开始。主要终点是总生存率。次要终点包括疾病特异性死亡率、远处转移、生化失败（PSA 水平升高）以及 2 年时重复前列腺活检的阳性发现率。
中位随访时间为 9.1 年。接受放疗加短期 ADT 治疗的患者 10 年总生存率为 62%（联合治疗组），而接受单纯放疗的患者为 57%（单纯放疗组死亡风险比，1.17；P=0.03）。短期 ADT 的加入可使 10 年疾病特异性死亡率从 8%降至 4%（单纯放疗组风险比，1.87；P=0.001）。生化失败、远处转移和 2 年时重复前列腺活检的阳性发现率均显著改善。两组的急性和迟发性放射诱导毒性作用相似。3 级或更高级别的激素相关毒性作用发生率<5%。根据风险的重新分析，总死亡率和疾病特异性死亡率的降低主要发生在中危患者，而低危患者则没有显著降低。
对于 PSA 水平<20ng/ml 的 T1b、T1c、T2a 或 T2b 期前列腺腺癌患者，在放疗前和放疗期间使用 4 个月的短期 ADT 治疗与疾病特异性死亡率显著降低和总生存率提高相关。根据事后风险分析，该获益主要见于中危患者，但在低危患者中则不明显。（由美国国立癌症研究所资助；RTOG 94-08 临床试验.gov 编号，NCT00002597。）
