Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial

被引：505

作者：

Warde, Padraig ^{[1
]}

Mason, Malcolm ^{[3
]}

Ding, Keyue ^{[4
]}

Kirkbride, Peter ^{[6
]}

Brundage, Michael ^{[5
]}

Cowan, Richard ^{[10
]}

Gospodarowicz, Mary ^{[1
]}

Sanders, Karen ^{[11
]}

Kostashuk, Edmund ^{[7
]}

Swanson, Greg ^{[8
]}

Barber, Jim ^{[2
]}

Hiltz, Andrea ^{[4
]}

Parmar, Mahesh K. B. ^{[11
]}

Sathya, Jinka ^{[9
]}

Anderson, John ^{[6
]}

Hayter, Charles ^{[13
]}

Hetherington, John ^{[12
]}

Sydes, Matthew R. ^{[11
]}

Parulekar, Wendy ^{[4
]}

机构：

[1] Princess Margaret Hosp, Toronto, ON M4X 1K9, Canada

[2] Velindre Hosp, Cardiff, S Glam, Wales

[3] Cardiff Univ, Sch Med, Cardiff, S Glam, Wales

[4] NCIC CTG, Kingston, ON, Canada

[5] Kingston Reg Canc Ctr, Kingston, ON, Canada

[6] Weston Pk Hosp, Sheffield, S Yorkshire, England

[7] Fraser Valley Canc Ctr, Surrey, BC, Canada

[8] Univ Texas Hlth Sci Ctr San Antonio, San Antonio, TX 78229 USA

[9] Dr H Bliss Murphy Canc Clin, St John, NF, Canada

[10] Christie Hosp, Manchester, Lancs, England

[11] MRC, Clin Trials Unit, London, England

[12] Castle Hill Hosp, Kingston Upon Hull, N Humberside, England

[13] Carlo Fidani Canc Ctr, Mississauga, ON, Canada

来源：

LANCET | 2011年 / 378卷 / 9809期

基金：

英国医学研究理事会;

关键词：

QUALITY-OF-LIFE; FUNCTIONAL ASSESSMENT; CLINICAL-TRIALS; HIGH-RISK; RADIOTHERAPY; SUPPRESSION; DURATION;

D O I：

10.1016/S0140-6736(11)61095-7

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

Background Whether the addition of radiation therapy (RT) improves overall survival in men with locally advanced prostate cancer managed with androgen deprivation therapy (ADT) is unclear. Our aim was to compare outcomes in such patients with locally advanced prostate cancer. Methods Patients with: locally advanced (T3 or T4) prostate cancer (n=1057); or organ-confined disease (T2) with either a prostate-specific antigen (PSA) concentration more than 40 ng/mL (n=119) or PSA concentration more than 20 ng/mL and a Gleason score of 8 or higher (n=25), were randomly assigned (done centrally with stratification and dynamic minimisation, not masked) to receive lifelong ADT and RT (65-69 Gy to the prostate and seminal vesicles, 45 Gy to the pelvic nodes). The primary endpoint was overall survival. The results presented here are of an interim analysis planned for when two-thirds of the events for the final analysis were recorded. All efficacy analyses were done by intention to treat and were based on data from all patients. This trial is registered at controlledtrials.com as ISRCTN24991896 and Clinicaltrials.gov as NCT00002633. Results Between 1995 and 2005, 1205 patients were randomly assigned (602 in the ADT only group and 603 in the ADT and RT group); median follow-up was 6.0 years (IQR 4.4-8.0). At the time of analysis, a total of 320 patients had died, 175 in the ADT only group and 145 in the ADT and RT group. The addition of RT to ADT improved overall survival at 7 years (74%, 95% CI 70-78 vs 66%, 60-70; hazard ratio [HR] 0.77, 95% CI 0.61-0.98, p=0.033). Both toxicity and health-related quality-of-life results showed a small effect of RT on late gastrointestinal toxicity (rectal bleeding grade >3, three patients (0.5%) in the ADT only group, two (0.3%) in the ADT and RT group; diarrhoea grade >3, four patients (0.7%) vs eight (1.3%); urinary toxicity grade >3, 14 patients (2.3%) in both groups). Interpretation The benefits of combined modality treatment-ADT and RT-should be discussed with all patients with locally advanced prostate cancer.

引用

页码：2104 / 2111

页数：8

共 27 条

[1]

THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER QLQ-C30 - A QUALITY-OF-LIFE INSTRUMENT FOR USE IN INTERNATIONAL CLINICAL-TRIALS IN ONCOLOGY [J].