1062: Bicalutamide 150 mg in Addition to Standard Care Significantly Improves Prostate Specific Antigen Progression-Free Survival in Patients with Early, Non-Metastatic Prostate Cancer: Median 5.4 Years' follow-up

PURPOSE Recently, we have shown that metastasis-free survival is a strong surrogate for overall survival (OS) in men with intermediate- and high-risk localized prostate cancer and can accelerate the evaluation of new (neo)adjuvant therapies. Event-free survival (EFS), an earlier prostate-specific antigen (PSA)–based composite end point, may further expedite trial completion. METHODS EFS was defined as the time from random assignment to the date of first evidence of disease recurrence, including biochemical failure, local or regional recurrence, distant metastasis, or death from any cause, or was censored at the date of last PSA assessment. Individual patient data from trials within the Intermediate Clinical Endpoints in Cancer of the Prostate–ICECaP–database with evaluable PSA and disease follow-up data were analyzed. We evaluated the surrogacy of EFS for OS using a 2-stage meta-analytic validation model by determining the correlation of EFS with OS (patient level) and the correlation of treatment effects (hazard ratios [HRs]) on both EFS and OS (trial level). A clinically relevant surrogacy was defined a priori as an R2 ≥ 0.7. RESULTS Data for 10,350 patients were analyzed from 15 radiation therapy–based trials enrolled from 1987 to 2011 with a median follow-up of 10 years. At the patient level, the correlation of EFS with OS was 0.43 (95% CI, 0.42 to 0.44) as measured by Kendall’s tau from a copula model. At the trial level, the R2 was 0.35 (95% CI, 0.01 to 0.60) from the weighted linear regression of log(HR)-OS on log(HR)-EFS. CONCLUSION EFS is a weak surrogate for OS and is not suitable for use as an intermediate clinical end point to substitute for OS to accelerate phase III (neo)adjuvant trials of prostate cancer therapies for primary radiation therapy–based trials.

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182 Bicalutamide (‘Casodex’) 150 mg as adjuvant to radiotherapy significantly improves progression-free survival in early non-metastatic prostate cancer: Results from the bicalutamide early prostate cancer programme after a median 5.4 years' follow-up

European Urology Supplements ◽

10.1016/s1569-9056(04)90183-2 ◽

2004 ◽

Vol 3 (2) ◽

pp. 48 ◽

Cited By ~ 2

Author(s):

D. McLeod ◽

P. Iversen ◽

W. See ◽

M. Wirth ◽

K. Carroll ◽

...

Keyword(s):

Prostate Cancer ◽

Metastatic Prostate Cancer ◽

Progression Free Survival ◽

Free Survival ◽

Early Prostate Cancer

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Efficacy of Combination Chemotherapy With Docetaxel, Estramustine and Carboplatin in Men With Castration-resistant Prostate Cancer

Cancer Diagnosis & Prognosis ◽

10.21873/cdp.10060 ◽

2021 ◽

Vol 1 (5) ◽

pp. 451-457

Author(s):

KATSUYA HIKITA ◽

MASASHI HONDA ◽

RYUTARO SHIMIZU ◽

SHOGO TERAOKA ◽

BUNYA KAWAMOTO ◽

...

Keyword(s):

Prostate Cancer ◽

Prostate Specific Antigen ◽

Cancer Progression ◽

Specific Antigen ◽

Treatment Protocol ◽

Area Under The Curve ◽

Progression Free Survival ◽

Castration Resistant Prostate Cancer ◽

Free Survival ◽

Castration Resistant

Background: The efficacy of docetaxel and carboplatin with oral estramustine was evaluated in patients with castration-resistant prostate cancer. Patients and Methods: Patients were treated with intravenous docetaxel at 30 mg/m2 on days 1, 8, 15, and 22 of a 28-day cycle. Intravenous carboplatin (area under the curve, 6 mg/ml/min) was administered on day 1. Patients received oral estramustine at 626.8 mg/day throughout the treatment protocol. Patients were evaluated for response, with treatment continued until cancer progression or onset of severe adverse events. Results: Twenty patients with castration-resistant prostate cancer were treated for a median of 3.5 cycles. Prostate-specific antigen decreased by more than 30% in 18 patients, including 14 patients with a decrease of more than 50%. Median overall survival was 11 months, prostate-specific antigen progression-free survival was 6.5 months, and radiographic progression-free survival was 7 months. Conclusion: Docetaxel and carboplatin with oral estramustine shows efficacy against castration-resistant prostate cancer.

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