Casas F, Henríquez I, Bejar A, Maldonado X, Alvarez A, González-Sansegundo C, Boladeras A, Ferrer F, Hervás A, Herruzo I, Caro M, Rodriguez I, Ferrer C
Radiation Oncology Department, Hospital Clínic, Villarroel 170, 08036, Barcelona, Spain.
Radiation Oncology Department, Hospital Sant Joan, Reus, Spain.
Clin Transl Oncol. 2017 Mar;19(3):373-378. doi: 10.1007/s12094-016-1538-5. Epub 2016 Oct 21.
We compared biochemical control and quality of life with intermittent (6 months) versus continuous (36 months) androgen deprivation therapy (ADT) in a non-inferiority randomized phase 3 trial in patients with biochemical failure (BF) after external beam radical radiotherapy (EBRT).
Patients were stratified according to the Gleason score (GS) and were classified as low risk with a GS < 6 and 7 (3 + 4) and high risk with a GS of 7 (4 + 3) and >7. Patients were followed with PSA determinations and quality-of-life assessments (QLQ C-30 and QLQ PR-25) every 6 months for a period of 3 years. BF after radiation was defined as a PSA level of nadir +2 ng/ml. Disease progression (DP) after ADT was defined as PSA ≥4 ng/ml (BF) and/or metastases.
Seventy-seven patients were included in this multicenter phase 3 trial from 2005 to 2009. Thirty-eight and 39 patients were included in the intermittent and continuous groups, respectively. The median follow-up for both groups was 48 months (40-68). DP after ADT in the intermittent group was seen in three patients (distant metastases in one patient) versus 0 in the continuous group. The QLQ-C30 and QLQ PR-25 scores did not show any statistically difference between the two ADT groups.
No significant differences were seen in DP and QLQ between intermittent (6 months) and continuous (36 months) ADT in patients with BF after EBRT.
在一项非劣效性随机3期试验中，我们比较了间断性（6个月）与持续性（36个月）雄激素剥夺治疗（ADT）对接受体外束放射治疗（EBRT）后出现生化复发（BF）的患者的生化控制情况及生活质量。
根据 Gleason评分（GS）对患者进行分层，GS＜6和7（3 + 4）为低风险，GS为7（4 + 3）及＞7为高风险。每6个月对患者进行PSA测定及生活质量评估（QLQ C - 30和QLQ PR - 25），为期3年。放疗后生化复发定义为PSA最低点水平 + 2 ng/ml。ADT后疾病进展（DP）定义为PSA≥4 ng/ml（生化复发）和/或转移。
2005年至2009年，77例患者纳入了这项多中心3期试验。间断组和持续组分别纳入38例和39例患者。两组的中位随访时间均为48个月（40 - 68个月）。间断组ADT后有3例出现疾病进展（1例远处转移），而持续组为0例。两个ADT组的QLQ - C30和QLQ PR - 25评分无统计学差异。
对于接受EBRT后出现生化复发的患者，间断性（6个月）与持续性（36个月）ADT在疾病进展和生活质量方面无显著差异。
