Duration of Androgen Suppression in the Treatment of Prostate Cancer

被引：753

作者：

Bolla, Michel ^{[1
]}

de Reijke, Theodorus M. ^{[2
]}

Van Tienhoven, Geertjan ^{[2
]}

Van den Bergh, Alphonsus C. M. ^{[3
]}

Oddens, Jorg ^{[4
]}

Poortmans, Philip M. P. ^{[5
]}

Gez, Eliahu ^{[8
]}

Kil, Paul ^{[6
]}

Akdas, Atif ^{[9
]}

Soete, Guy

Kariakine, Oleg

Van der Steen-Banasik, Elsbietha M. ^{[7
]}

Musat, Elena

Pierart, Marianne

Mauer, Murielle E.

Collette, Laurence

机构：

[1] CHR Univ Grenoble, Grenoble, France

[2] Univ Amsterdam, Acad Med Ctr, NL-1105 AZ Amsterdam, Netherlands

[3] Univ Groningen, Med Ctr, Groningen, Netherlands

[4] Jeroen Bosch Medictr, Shertogenbosch, Netherlands

[5] Doctor Bernard Verbeeten Inst, Tilburg, Netherlands

[6] Sint Elisabeth Ziekenhuis, Tilburg, Netherlands

[7] Arnhems RadioTherapeut Inst, Arnhem, Netherlands

[8] Rambam Med Ctr, Haifa, Israel

[9] Marmara Univ Hosp, Istanbul, Turkey

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2009年 / 360卷 / 24期

关键词：

QUALITY-OF-LIFE; PHASE-III; DEPRIVATION THERAPY; RADIATION-THERAPY; RADIOTHERAPY; ADJUVANT; TRIAL; IRRADIATION; MANAGEMENT; OUTCOMES;

D O I：

10.1056/NEJMoa0810095

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND The combination of radiotherapy plus long-term medical suppression of androgens (>= 2 years) improves overall survival in patients with locally advanced prostate cancer. We compared the use of radiotherapy plus short-term androgen suppression with the use of radiotherapy plus long-term androgen suppression in the treatment of locally advanced prostate cancer. METHODS We randomly assigned patients with locally advanced prostate cancer who had received external-beam radiotherapy plus 6 months of androgen suppression to two groups, one to receive no further treatment (short-term suppression) and the other to receive 2.5 years of further treatment with a luteinizing hormone-releasing hormone agonist (long-term suppression). An outcome of noninferiority of short-term androgen suppression as compared with long-term suppression required a hazard ratio of more than 1.35 for overall survival, with a one-sided alpha level of 0.05. An interim analysis showed futility, and the results are presented with an adjusted one-sided alpha level of 0.0429. RESULTS A total of 1113 men were registered, of whom 970 were randomly assigned, 483 to short-term suppression and 487 to long-term suppression. After a median follow-up of 6.4 years, 132 patients in the short-term group and 98 in the long-term group had died; the number of deaths due to prostate cancer was 47 in the short-term group and 29 in the long-term group. The 5-year overall mortality for short-term and long-term suppression was 19.0% and 15.2%, respectively; the observed hazard ratio was 1.42 (upper 95.71% confidence limit, 1.79; P=0.65 for noninferiority). Adverse events in both groups included fatigue, diminished sexual function, and hot flushes. CONCLUSIONS The combination of radiotherapy plus 6 months of androgen suppression provides inferior survival as compared with radiotherapy plus 3 years of androgen suppression in the treatment of locally advanced prostate cancer. (ClinicalTrials.gov number, NCT00003026.)

引用

页码：2516 / 2527

页数：12

共 32 条

[31]

*UN INT CONTR CANC, 1992, UICC TNM CLASS MAL T

[32] Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial [J].

Widmark, Anders ;

Klepp, Olbjorn ;

Solberg, Arne ;

Damber, Jan-Erik ;

Angelsen, Anders ;

Fransson, Per ;

Lund, Jo-Asmund ;

Tasdemir, Ilker ;

Hoyer, Morten ;

Wiklund, Fredrik ;

Fossa, Sophie D. .

LANCET, 2009, 373 (9660) :301-308

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