Abstract | OBJECTIVE: PATIENTS AND METHODS: In all, 8113 patients with localized (T1-2, N0/Nx) or locally advanced (T3-4, any N; or any T, N+) prostate cancer (all M0) were enrolled in three complementary, double-blind, placebo-controlled trials. Patients were randomized to receive standard care plus either oral bicalutamide 150 mg once-daily or oral placebo. Primary endpoints were progression-free survival (PFS) and overall survival (OS). Data were collated from individual trials and evaluated in a combined analysis. RESULTS: Overall, at a median follow-up of 9.7 years, bicalutamide significantly improved PFS (hazard ratio 0.85, 95% confidence interval 0.79-0.91; P= 0.001). Compared with placebo there was no difference in OS (hazard ratio 1.01, P= 0.77). Patients who derived benefit from bicalutamide in terms of PFS were those with locally advanced disease, with OS significantly favouring bicalutamide in patients with locally advanced disease undergoing radiotherapy (P= 0.031). Patients with localized disease showed no clinically or statistically significant improvements in PFS; there was a survival trend in favour of placebo in patients with localized disease undergoing watchful waiting (P= 0.054). The overall tolerability of bicalutamide was consistent with previous analyses, with breast pain (73.7%) and gynaecomastia (68.8%) the most frequently reported adverse events in patients randomized to bicalutamide. CONCLUSIONS:
Bicalutamide 150 mg, either as monotherapy or adjuvant to standard care, improved PFS in patients with locally advanced prostate cancer, but not in patients with localized disease. A pre-planned subset analysis showed a benefit for OS in patients with locally advanced disease undergoing radiotherapy. Bicalutamide 150 mg might represent an alternative for patients with locally advanced prostate cancer considering androgen-deprivation therapy.
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Authors | Peter Iversen, David G McLeod, William A See, Thomas Morris, Jon Armstrong, Manfred P Wirth, Casodex Early Prostate Cancer Trialists' Group |
Journal | BJU international
(BJU Int)
Vol. 105
Issue 8
Pg. 1074-81
(Apr 2010)
ISSN: 1464-410X [Electronic] England |
PMID | 22129214
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | [PETER IVERSEN], [MANFRED P. WIRTH], ASTRAZENECA, [US FEDERAL GOVERNMENT] 2010. JOURNAL COMPILATION © 2010 BJU INTERNATIONAL. |
Chemical References |
- Androgen Antagonists
- Anilides
- Antineoplastic Agents
- Nitriles
- Tosyl Compounds
- bicalutamide
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Topics |
- Adult
- Aged
- Androgen Antagonists
(administration & dosage, adverse effects)
- Anilides
(administration & dosage, adverse effects)
- Antineoplastic Agents
(administration & dosage, adverse effects)
- Disease-Free Survival
- Double-Blind Method
- Drug Administration Schedule
- Follow-Up Studies
- Humans
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Nitriles
(administration & dosage, adverse effects)
- Prostatic Neoplasms
(drug therapy)
- Tosyl Compounds
(administration & dosage, adverse effects)
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