Intermittent maximal androgen blockade in patients with metastatic prostate cancer: An EORTC feasibility study

被引:36
作者
Albrecht, W
Collette, L
Fava, C
Kariakine, OB
Whelan, P
Studer, UE
De Reiike, TM
Kil, PJ
Rea, LA
机构
[1] Rudolfstiftung, Dept Urol, A-1030 Vienna, Austria
[2] EORTC Data Ctr, Brussels, Belgium
[3] Osped Macchi, Varese, Italy
[4] MRRC, Obninsk, Russia
[5] St James, Leeds, W Yorkshire, England
[6] Univ Bern, Inselspital, CH-3010 Bern, Switzerland
[7] Univ Amsterdam, Acad Med Ctr, NL-1105 AZ Amsterdam, Netherlands
[8] St Elisabeth, Tilburg, Netherlands
关键词
intermittent therapy; prostate cancer;
D O I
10.1016/S0302-2838(03)00375-0
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
Objectives: In preparation of an intercontinental Phase III trial comparing continuous maximal androgen blockade (MAB) to intermittent androgen suppression (IAS) in untreated metastatic prostate cancer, a feasibility study on IAS was accomplished. Methods: 107 patients (median follow-up 92 weeks) were treated with MAB until a PSA nadir was reached. Nadir was defined as PSA below 20 ng/ml corresponding to PSA reduction by at least 80% of baseline value. Criteria for restarting treatment was PSA >20 ng/ml and PSA > nadir + 50%. Trials aim was to assess the likelihood that 80% of patients would reach a first nadir and that 80% of these would also reach a second nadir. Results: 51.4% of patients had some degree of pain at entry, 27.1% had >15 hot spots, 23.7% demonstrated obstruction. Only 17.8% had normal potency, 56.1% were totally impotent. One to seven cycles of treatment were given. 76.6% of patients reached a 1 st nadir after a median of 19 weeks of treatment, 84.1% of these started the 2nd cycle and 71% of them reached a 2nd nadir after a median of 13.6 weeks. Median time off-treatment was 14.3 and 16.0 weeks corresponding to 38.4% and 48.5% of the duration of each cycle. A similar proportion of patients was reported to be potent during follow-up compared to baseline. 32.7% of patients died during follow-up, 82.9% of prostate cancer. Conclusion: Around 75% of the patients achieved a nadir at each cycle. The concept of IAS seems to be feasible and warrants further investigation. (C) 2003 Elsevier B.V All rights reserved.
引用
收藏
页码:505 / 511
页数:7
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