Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial

Details

Serval ID
serval:BIB_EA70FB692461
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial
Journal
Lancet
Author(s)
Bolla  M., Collette  L., Blank  L., Warde  P., Dubois  J. B., Mirimanoff  R. O., Storme  G., Bernier  J., Kuten  A., Sternberg  C., Mattelaer  J., Lopez Torecilla  J., Pfeffer  J. R., Lino Cutajar  C., Zurlo  A., Pierart  M.
ISSN
0140-6736 (Print)
Publication state
Published
Issued date
07/2002
Volume
360
Number
9327
Pages
103-6
Notes
Clinical Trial
Journal Article
Randomized Controlled Trial --- Old month value: Jul 13
Abstract
BACKGROUND: We did a randomised phase III trial comparing external irradiation alone and external irradiation combined with an analogue of luteinising-hormone releasing hormone (LHRH) to investigate the added value of long-term androgen suppression in locally advanced prostate cancer. METHODS: Between 1987 and 1995, 415 patients were randomly assigned radiotherapy alone or radiotherapy plus immediate androgen suppression. Eligible patients had T1-2 tumours of WHO grade 3 or T3-4 N0-1 M0 tumours; the median age of participants was 71 years (range 51-80). In both treatment groups, 50 Gy radiation was delivered to the pelvis over 5 weeks, and 20 Gy over 2 weeks as a prostatic boost. Goserelin (3.6 mg subcutaneously every 4 weeks) was started on the first day of irradiation and continued for 3 years; cyproterone acetate (150 mg orally) was given for 1 month starting 1 week before the first goserelin injection. The primary endpoint was clinical disease-free survival. Analyses were by intention to treat. FINDINGS: 412 patients had evaluable data, with median follow-up of 66 months (range 1-126). 5-year clinical disease-free survival was 40% (95% CI 32-48) in the radiotherapy-alone group and 74% (67-81) in the combined-treatment group (p=0.0001). 5-year overall survival was 62% (52-72) and 78% (72-84), respectively (p=0.0002) and 5-year specific survival 79% (72-86) and 94% (90-98). INTERPRETATION: Immediate androgen suppression with an LHRH analogue given during and for 3 years after external irradiation improves disease-free and overall survival of patients with locally advanced prostate cancer.
Keywords
Aged Aged, 80 and over Antineoplastic Agents, Hormonal/*therapeutic use Disease-Free Survival Goserelin/*therapeutic use Humans Male Middle Aged Prostatic Neoplasms/*drug therapy/pathology/radiotherapy Time Factors
Pubmed
Web of science
Create date
24/01/2008 17:12
Last modification date
20/08/2019 16:12
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