Abstract：
BACKGROUND: We previously reported that for men undergoing combined androgen deprivation therapy (ADT) and radiation therapy (RT) for prostate cancer, substitution of LHRH-agonists with 5-α- reductase inhibitors (5-ARIs) led to improved preservation of 6-month hormonal quality of life (hQOL). With longer term follow-up, we evaluated disease control.
METHODS: In this non-randomized trial, men with unfavorable intermediate or high-risk prostate cancer, aged ≥70 years or with Charlson Comorbidity Index ≥2, were treated with RT (78-79.2 Gy in 39-44 fractions) and either oral ADT (oADT; 5-ARI with antiandrogen) or standard of care ADT (SOC; leuprolide with antiandrogen) for up to 28 months. The primary endpoint was EPIC hQOL; secondary endpoints included biochemical control and survival as well as changes in cholesterol and hemoglobin levels.
RESULTS: Between 2011 and 2018, 70 men were enrolled (40 in oADT; 30 in SOC). Median follow-up was 65 months [IQR 36-94]. Five-year freedom from biochemical failure for oADT and SOC was 89% versus 86%, disease free survival was 62% versus 69%, cancer-specific survival was 100% versus 96%, and overall survival was 70% versus 81% (all P>.1). Testosterone (2 mo through 3 yr) and hemoglobin levels (2 mo through 2 yr) were higher, and cholesterol levels (1 yr) were lower in the oADT groups (all P < .05).
CONCLUSIONS: In this non-randomized study, men treated with combined RT and oADT had better preservation of hQOL and comparable 5-year disease outcomes to men treated with SOC. Eugonadal testosterone with this approach may yield measurable benefits in cholesterol and hemoglobin levels.
METHODS: In this non-randomized trial, men with unfavorable intermediate or high-risk prostate cancer, aged ≥70 years or with Charlson Comorbidity Index ≥2, were treated with RT (78-79.2 Gy in 39-44 fractions) and either oral ADT (oADT; 5-ARI with antiandrogen) or standard of care ADT (SOC; leuprolide with antiandrogen) for up to 28 months. The primary endpoint was EPIC hQOL; secondary endpoints included biochemical control and survival as well as changes in cholesterol and hemoglobin levels.
RESULTS: Between 2011 and 2018, 70 men were enrolled (40 in oADT; 30 in SOC). Median follow-up was 65 months [IQR 36-94]. Five-year freedom from biochemical failure for oADT and SOC was 89% versus 86%, disease free survival was 62% versus 69%, cancer-specific survival was 100% versus 96%, and overall survival was 70% versus 81% (all P>.1). Testosterone (2 mo through 3 yr) and hemoglobin levels (2 mo through 2 yr) were higher, and cholesterol levels (1 yr) were lower in the oADT groups (all P < .05).
CONCLUSIONS: In this non-randomized study, men treated with combined RT and oADT had better preservation of hQOL and comparable 5-year disease outcomes to men treated with SOC. Eugonadal testosterone with this approach may yield measurable benefits in cholesterol and hemoglobin levels.
摘要：
背景：我们以前报道过，对于接受联合雄激素剥夺治疗（ADT）和放射治疗（RT）治疗前列腺癌的男性，用5-α-还原酶抑制剂（5-ARIs）替代LHRH激动剂可改善6个月的激素生活质量（hQOL）。随着长期随访，我们评估了疾病控制。
方法：在这项非随机试验中，患有不利的中度或高风险前列腺癌的男性，年龄≥70岁或Charlson合并症指数≥2的患者接受RT(78-79.2Gy/39-44分)和口服ADT(oADT;5-ARI+抗雄激素)或标准治疗ADT(SOC;亮丙瑞林+抗雄激素)治疗长达28个月.主要终点是EPIChQOL；次要终点包括生化控制和生存率以及胆固醇和血红蛋白水平的变化。
结果：在2011年至2018年之间，招募了70名男性（oADT40名；SOC30名）。中位随访时间为65个月[IQR36-94]。oADT和SOC的五年生化失败发生率分别为89%和86%，无病生存率分别为62%和69%，癌症特异性生存率为100%对96%，总生存率分别为70%和81%（均P>1）。睾酮（2个月至3年）和血红蛋白水平（2个月至2年）较高，oADT组的胆固醇水平（1年）较低（均P<0.05）。
结论：在这项非随机研究中，与接受SOC治疗的男性相比,接受RT和oADT联合治疗的男性对hQOL的保留效果更好,且5年疾病结局具有可比性.使用这种方法的Euggonadal睾丸激素可能会在胆固醇和血红蛋白水平方面产生可测量的益处。
方法：在这项非随机试验中，患有不利的中度或高风险前列腺癌的男性，年龄≥70岁或Charlson合并症指数≥2的患者接受RT(78-79.2Gy/39-44分)和口服ADT(oADT;5-ARI+抗雄激素)或标准治疗ADT(SOC;亮丙瑞林+抗雄激素)治疗长达28个月.主要终点是EPIChQOL；次要终点包括生化控制和生存率以及胆固醇和血红蛋白水平的变化。
结果：在2011年至2018年之间，招募了70名男性（oADT40名；SOC30名）。中位随访时间为65个月[IQR36-94]。oADT和SOC的五年生化失败发生率分别为89%和86%，无病生存率分别为62%和69%，癌症特异性生存率为100%对96%，总生存率分别为70%和81%（均P>1）。睾酮（2个月至3年）和血红蛋白水平（2个月至2年）较高，oADT组的胆固醇水平（1年）较低（均P<0.05）。
结论：在这项非随机研究中，与接受SOC治疗的男性相比,接受RT和oADT联合治疗的男性对hQOL的保留效果更好,且5年疾病结局具有可比性.使用这种方法的Euggonadal睾丸激素可能会在胆固醇和血红蛋白水平方面产生可测量的益处。
