PS2 Late breaking Adding bicalutamide 150mg to standard care for localised or locally advanced prostate cancer: results from the largest hormonal therapy trial ever conducted in prostate cancer patients, at over 7 years' follow up

2005 ◽  
Vol 3 (4) ◽  
pp. 2 ◽  
Keyword(s):  
Prostate Cancer ◽  
Cancer Patients ◽  
Hormonal Therapy ◽  
Standard Care ◽  
Advanced Prostate Cancer ◽  
Locally Advanced ◽  
Locally Advanced Prostate Cancer ◽  
Therapy Trial

Delaying metastatic disease progression in locally advanced disease − Results from the Early Prostate Cancer program at a median follow-up of 7.4 years

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4629-4629 ◽  
Author(s):  
M. P. Wirth ◽  
W. A. See ◽  
D. G. McLeod ◽  
P. Iversen ◽  
T. Morris ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Standard Care ◽  
Advanced Prostate Cancer ◽  
Bone Scan ◽  
Advanced Disease ◽  
Locally Advanced ◽  
Distant Metastases ◽  
Locally Advanced Prostate Cancer ◽  
Locally Advanced Disease

4629 Background: Progression of prostate cancer to bone metastases impacts seriously on patients (pts)’ quality of life and increases treatment costs. The 3rd analysis of the Early Prostate Cancer (EPC) program revealed that bicalutamide (CASODEX) 150 mg plus standard care (radiotherapy [RT], radical prostatectomy [RP] or watchful waiting [WW]) significantly improved progression-free survival (PFS) vs standard care alone in locally advanced disease. Adjuvant bicalutamide 150 mg also improved overall survival for RT pts with locally advanced disease. Here, we report an exploratory analysis of the effect of bicalutamide on delaying bone metastases in pts with locally advanced disease in the EPC program. Methods: The EPC program comprises 3 trials in which pts (n = 8113) were randomized to standard care plus bicalutamide 150 mg or placebo. This exploratory analysis included only pts with locally advanced disease (T3–4, any N; or any T, N+; bicalutamide n = 1367, placebo n = 1315). Distant metastases were assessed by bone scan. Metastatic PFS was defined as time from randomization to either first bone scan-confirmed progression or death in the absence of bone-scan data. A Cox proportional hazards regression model was used for the WW and adjuvant subgroups; each was analyzed separately with covariates for trial, treatment, prior therapy, baseline prostate-specific antigen level, and tumor grade. Results: At 7.4 years’ median follow-up, bicalutamide significantly improved metastatic PFS vs placebo (hazard ratio [HR] 0.64, p < 0.001 for WW; HR 0.77, p = 0.005 for RT/RP; table). The most common adverse events were gynecomastia and breast pain. Conclusion: Addition of bicalutamide 150 mg to standard care significantly reduced the risk of distant metastases in locally advanced prostate cancer, irrespective of standard care. Both the efficacy and tolerability of treatment must be considered, and therefore, bicalutamide is an option for men with locally advanced prostate cancer. [Table: see text] [Table: see text]

Intergroup randomized phase III study of androgen deprivation therapy (ADT) plus radiation therapy (RT) in locally advanced prostate cancer (CaP) (NCIC-CTG, SWOG, MRC-UK, INT: T94-0110; NCT00002633).

2010 ◽  
Vol 28 (18_suppl) ◽  
pp. CRA4504-CRA4504 ◽  
Author(s):  
P. R. Warde ◽  
M. D. Mason ◽  
M. R. Sydes ◽  
M. K. Gospodarowicz ◽  
G. P. Swanson ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Advanced Prostate Cancer ◽  
Locally Advanced ◽  
Phase Iii ◽  
Disease Specific Survival ◽  
Locally Advanced Prostate Cancer ◽  
Combined Modality ◽  
Disease Specific

CRA4504 Background: The impact of radiotherapy on overall survival (OS) in men with locally advanced CaP is unclear. The SPCG-7 trial recently showed a benefit to RT for CaP specific mortality. Our primary objective was to assess the effect of RT on OS when added to lifelong ADT in men with locally advanced CaP. Methods: Patients with T3/T4 (1057) or T2, PSA > 40 μ g/l (119) or T2 PSA > 20 μ g/l and Gleason ≥ 8 (25) and N0 /NX, M0 prostate adenocarcinoma were randomized to lifelong ADT (bilateral orchiectomy or LHRH agonist) with or without RT (65-69 Gy to prostate ± seminal vesicles with or without 45Gy to pelvic nodes). The primary endpoint was OS and secondary endpoints included disease specific survival (DSS), time to disease progression and quality of life. Results: 1205 patients were randomized from 1995 to 2005, 602 to ADT and 603 to ADT+RT (well balanced with respect to baseline characteristics). A protocol specified second interim analysis on OS was performed in Aug 2009 (data cut-off Dec 31 2008). The DSMC recommended release of the results to the Trial Committee for publication. The median follow-up is 6.0 years and 320 patients have died (175 ADT and 145 ADT+RT). 10% of patients had no follow-up data beyond 2006. The addition of RT to ADT significantly reduced the risk of death (hazard ratio [HR] 0.77, 95% CI 0.61-0.98, p=0.033). 140 patients died of disease and/or treatment (89 on ADT and 51 on ADT+RT) The disease specific survival HR was 0.57 (95% CI 0.41-0.81, p=0.001) favoring ADT+RT. The 10 year cumulative disease specific death rates were estimated at 15% with ADT+ RT and 23% with ADT alone. Grade ≥2 late GI toxicity rates were similar in both arms (proctitis, 1.3% ADT alone, 1.8% ADT+RT). Conclusions: The trial results indicate a substantial overall survival and disease specific survival benefit for the combined modality approach (ADT+RT) in the management of patients with locally advanced prostate cancer with no significant increase in late treatment toxicity. In view of this data combined modality therapy (ADT+RT) should be the standard treatment approach for these patients. Supported by NCI-US Grant #5U10CA077202-12, CCSRI Grant #15469. No significant financial relationships to disclose.

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