Beneficial effect of combination hormonal therapy administered prior and following external beam radiation therapy in localized prostate cancer
Beneficial effect of combination hormonal therapy administered prior and following external beam radiation therapy in localized prostate cancer
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DOI：
10.1016/s0360-3016(96)00513-5
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发表时间：
1997-01-15
影响因子：
7
通讯作者：
Labrie, F
中科院分区：
文献类型：
--
作者：
Laverdiere, J;Gomez, JL;Labrie, F
目的：本研究的目的是探讨与单独放疗相比，联合雄激素阻断治疗局限性前列腺癌是否在12个月和24个月时降低随访活检阳性率和血清PSA。这是一份中期分析报告。方法与材料：120例临床分期为B1-T2a、B2-T2b/T2c和C-T3/T4的前列腺腺癌患者进行前瞻性随机研究。经书面知情同意后，受试者被随机分配至单独外束放射治疗（EBRT）组（1组），EBRT前3个月的新辅助联合治疗（lhrh激动剂+氟他胺）组（2组），第三组在EBRT前3个月、期间和6个月后接受联合治疗。三组患者在年龄、疾病分期、肿瘤分级、预处理PSA水平等方面无显著差异。在EBRT结束12个月和24个月后进行对照经直肠超声（TRUS）引导下的针活检（无论是否存在TRUS异常，从最初的癌症部位取一个核心）。血清PSA测量在预定的访问中完成。结果：92例和68例患者分别在放疗结束后12个月和24个月接受了活检。第1组在12个月时有62%的对照患者发现残留肿瘤，而第2组和第3组分别只有30%和4%的患者发现残留肿瘤（p = 0.00005）。观察24个月后，1组、2组和3组分别有65%、28%和5%的患者显示癌症残留（p = 0.00001）。PSA测量也表明在12个月时三组之间存在差异（p < 0.0001），除了在24个月时，2组和3组之间的差异不再显著。结论：本临床试验的初步分析表明，单独接受放射治疗的患者在放射治疗结束后12个月和24个月的活检阳性率明显高于接受总抗雄激素阻断（TAB）和放射治疗的患者。在分析中位PSA血清水平时，我们发现在12个月时具有相同的优势，但是，在分析24个月时，PSA水平在2组和3组之间没有差异。(C) 1997爱思唯尔科学有限公司
Purpose: The aim of the present study is to investigate whether combined androgen blockade associated with radiation therapy for localized prostate cancer decreases at 12 and 24 months the rate of positive follow-up biopsies and serum PSA compared to radiation therapy alone. This is the report of an interim analysis.Methods and Materials: One hundred and twenty patients with clinical Stage B1-T2a, B2-T2b/T2c, and C-T3/T4, adenocarcinoma of the prostate were entered in a prospective randomized study. After written informed consent, the subjects were randomly allocated between external beam radiation therapy (EBRT) alone (group 1), 3 months of neoadjuvant combination therapy (LHRH-agonist + Flutamide) prior to EBRT (group 2), and a third group receiving combination therapy 3 months before, during, and 6 months after EBRT. There is no significant difference between the three groups concerning age, stage of disease, grade of tumor, and pretreatment PSA levels. Control transrectal ultrasound (TRUS)-guided needle biopsies (one core was taken from the initial cancer site regardless of the presence or absence of TRUS abnormalities) were done 12 and 24 months after the end of EBRT. Serum PSA measurements were done on schedule visits.Results: Ninety-two and 68 patients underwent biopsies at 12 and 24 months, respectively, after the end of radiation therapy. While 62 % of control patients at 12 months in Group 1 disclosed residual neoplasm, only 30 % and 4 % showed residual disease in groups 2 and 3, respectively (p = 0.00005). When looking at 24 months, 65, 28, and 5 % showed residual cancer for groups 1, 2, and 3, respectively (p = 0.00001). The PSA measurements indicate also at 12 months a difference between the three groups (p < 0.0001), except at 24 months, the difference between the group 2 and 3 is no longer significant.Conclusion: The preliminary analysis of this clinical trial indicates that patients treated with radiation therapy alone show a significantly higher rate of positive biopsies at 12 and 24 months after the end of radiation therapy as compared with those treated with total antiandrogen blockade (TAB) and radiation therapy. When analyzing the median PSA serum levels, we found the same advantage at 12 months, but, at the time of the analysis at 24 months, the PSA levels are not different between groups 2 and 3. (C) 1997 Elsevier Science Inc.