Mirhadi Amin J, Zhang Qiang, Hanks Gerald E, Lepor Herbert, Grignon David J, Peters Christopher A, Rosenthal Seth A, Zeitzer Kenneth, Radwan John S, Lawton Colleen, Parliament Matthew B, Reznik Robert S, Sandler Howard M
Cedars-Sinai Medical Center, Los Angeles, California.
NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
Int J Radiat Oncol Biol Phys. 2017 Mar 1;97(3):511-515. doi: 10.1016/j.ijrobp.2016.11.002. Epub 2016 Nov 8.
NRG Oncology RTOG 9202 was a randomized trial testing long-term adjuvant androgen deprivation (LTAD) versus initial androgen deprivation only (STAD) with external beam radiation therapy (RT) in mostly high-risk and some intermediate-risk prostate cancer patients. RTOG 9408 found an overall survival (OS) advantage in patients with cT1b-T2b disease and prostate-specific antigen (PSA) <20 ng/mL, with benefit observed mostly among intermediate-risk patients. It was still unknown whether intermediate-risk patients would experience an additional survival benefit with LTAD; thus, we performed a secondary analysis to explore whether LTAD had any incremental benefit beyond STAD among the intermediate-risk subset of RTOG 9202. The study endpoints were OS, disease-specific survival (DSS), and PSA failure (PSAF).
An analysis was performed for all patients enrolled in RTOG 9202 defined as intermediate-risk (cT2 disease, PSA<10 ng/mL, and Gleason score = 7 or cT2 disease, PSA 10-20 ng/mL, and Gleason score <7). This review yielded 133 patients: 74 (STAD) and 59 (LTAD). The Kaplan-Meier method was used to estimate OS; the cumulative incidence approach was used to estimate DSS and PSAF. A 2-sided test was used, with significance level defined to be .05.
With over 11 years of median follow-up, 39 STAD patients were alive and 33 LTAD patients were alive. There was no difference in OS (10-year estimates, 61% STAD vs 65% LTAD; P=.53), DSS (10-year DSS, 96% vs 97%; P=.72), or PSAF (10-year PSAF, 53% vs 55%; P=.99) between groups.
LTAD did not confer a benefit in terms of OS, DSS, or PSAF rates in the intermediate-risk subset in this study. Whereas the subset was relatively small, treatment assignment was randomly applied, and a trend in favor of LTAD would have been of interest. Given the small number of disease-specific deaths observed and lack of benefit with respect to our endpoints, this secondary analysis does not suggest that exploration of longer hormonal therapy is worth testing in the intermediate-risk prostate cancer subset.
NRG肿瘤学组的RTOG 9202是一项随机试验，在大多数高危和部分中危前列腺癌患者中，比较长期辅助雄激素剥夺疗法（LTAD）与仅初始雄激素剥夺疗法（STAD）联合外照射放疗（RT）的疗效。RTOG 9408研究发现，cT1b-T2b期且前列腺特异性抗原（PSA）<20 ng/mL的患者总生存期（OS）有优势，且主要在中危患者中观察到获益。尚不清楚中危患者接受LTAD是否会有额外的生存获益；因此，我们进行了一项二次分析，以探讨在RTOG 9202的中危亚组中，LTAD是否比STAD有任何额外的益处。研究终点为OS、疾病特异性生存期（DSS）和PSA失败（PSAF）。
对所有纳入RTOG 9202且被定义为中危（cT2期疾病、PSA<10 ng/mL且Gleason评分 = 7或cT2期疾病、PSA 10 - 20 ng/mL且Gleason评分<7）的患者进行分析。该综述共纳入133例患者：74例（STAD组）和59例（LTAD组）。采用Kaplan-Meier法估计OS；采用累积发病率法估计DSS和PSAF。采用双侧检验，显著性水平设定为0.05。
中位随访超过11年，STAD组有39例患者存活，LTAD组有33例患者存活。两组之间在OS（10年估计值，STAD组为61%，LTAD组为65%；P = 0.53）、DSS（10年DSS，分别为96%和97%；P = 0.72）或PSAF（10年PSAF，分别为53%和55%；P = 0.99）方面均无差异。
在本研究的中危亚组中，LTAD在OS、DSS或PSAF率方面未显示出获益。尽管该亚组相对较小，但治疗分配是随机的，若有支持LTAD的趋势则会很有意义。鉴于观察到的疾病特异性死亡病例数较少且在我们的研究终点方面未显示出获益，这项二次分析并不表明在中危前列腺癌亚组中探索更长疗程的激素治疗值得进行试验。
