Pilepich M V, Winter K, John M J, Mesic J B, Sause W, Rubin P, Lawton C, Machtay M, Grignon D
Department of Radiation Oncology, Ann Arbor Regional CCOP, Ann Arbor, MI, USA.
Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1243-52. doi: 10.1016/s0360-3016(01)01579-6.
To test the hypothesis that androgen ablation before and during radiotherapy for locally advanced carcinoma of the prostate may, by reducing tumor bulk and enhancing tumor cell kill, improve locoregional control and ultimately survival.
The study was conducted from 1987 to 1991. Eligible patients were those with bulky tumors (T2--T4) with or without pelvic lymph node involvement and without evidence of distant metastases. They were randomized to receive goserelin, 3.6 mg every 4 weeks; and flutamide, 250 mg t.i.d. for 2 months before radiation therapy and during radiation therapy (Arm I), or radiation therapy alone (Arm II). Of 471 randomized patients, 456 were evaluable: 226 on Arm I and 230 on Arm II.
As of November 1999, the median follow-up has reached 6.7 years for all patients and 8.6 years for alive patients. At 8 years, androgen ablation has been associated with an improvement in local control (42% vs. 30%, p = 0.016), reduction in the incidence of distant metastases (34% vs. 45%, p = 0.04), disease-free survival (33% vs. 21%, p = 0.004), biochemical disease-free survival = PSA <1.5 (24% vs. 10%, p < 0.0001), and cause-specific mortality (23% vs. 31%, p = 0.05). However, subset analysis indicates that the beneficial effect of short-term androgen ablation appears preferentially in patients with Gleason score 2--6. In that population, there is a highly significant improvement in all endpoints, including survival (70% vs. 52%, p = 0.015). In patients with Gleason 7--10 tumors, the regimen has not resulted in a significant enhancement in either locoregional control or survival.
In patients with Gleason score 2--6 carcinoma of the prostate, a short course of androgen ablation administered before and during radiotherapy has been associated with a highly significant improvement in local control, reduction in disease progression, and overall survival.
验证以下假说：对于局部晚期前列腺癌患者，在放疗前及放疗期间进行雄激素剥夺治疗，通过减小肿瘤体积和增强肿瘤细胞杀伤作用，可改善局部区域控制并最终提高生存率。
本研究于1987年至1991年进行。符合条件的患者为患有体积较大肿瘤（T2 - T4）、伴有或不伴有盆腔淋巴结受累且无远处转移证据的患者。他们被随机分为两组，一组接受戈舍瑞林治疗，每4周注射3.6毫克；以及氟他胺治疗，放疗前及放疗期间每日3次，每次250毫克，持续2个月（第一组），另一组仅接受放疗（第二组）。在471名随机分组的患者中，456名可进行评估：第一组226名，第二组230名。
截至1999年11月，所有患者的中位随访时间已达6.7年，存活患者的中位随访时间为8.6年。在8年时，雄激素剥夺治疗与局部控制改善相关（42%对30%，p = 0.016），远处转移发生率降低（34%对45%，p = 0.04），无病生存率提高（33%对21%，p = 0.004），生化无病生存率（前列腺特异抗原<1.5）提高（24%对10%，p < 0.0001），以及特定病因死亡率降低（23%对31%，p = 0.05）。然而，亚组分析表明，短期雄激素剥夺治疗的有益效果似乎在Gleason评分2 - 6的患者中更为明显。在该人群中，所有终点指标均有高度显著改善，包括生存率（70%对52%，p = 0.015）。在Gleason评分7 - 10的肿瘤患者中，该治疗方案在局部区域控制或生存率方面均未带来显著提高。
对于Gleason评分2 - 6的前列腺癌患者，在放疗前及放疗期间进行短期雄激素剥夺治疗与局部控制的高度显著改善、疾病进展的减少以及总体生存率的提高相关。
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