Bicalutamide monotherapy versus flutamide plus goserelin in prostate cancer: updated results of a multicentric trial.

Abstract

OBJECTIVES:

To compare the efficacy of bicalutamide monotherapy to maximal androgen blockade in advanced prostatic cancer.

PATIENTS AND METHODS:

Previously untreated patients with histologically proven stage C or D (American Urological Association Staging System) disease were randomly allocated to either bicalutamide (B) or goserelin plus flutamide (G+F). After disease progression, patients treated with B were assigned to castration. The primary endpoint for this trial was overall survival. Prostate cancer-specific survival and progression were included among secondary endpoints.

RESULTS:

In total 108 patients received B and 112 received G+F. At a median follow-up time of 54 months (range 1-89), 151 patients progressed and 113 died. There was no significant difference in the duration of either progression-free or overall survival. Hazards of progression, death and cancer-specific death, corrected by disease stage, tumor grade and baseline PSA level, showed that patients initially assigned to B had a higher risk of progression but a comparable risk of death and cancer-specific death with the exception of patients with G3 tumors who had an increased risk of death).

CONCLUSIONS:

In patients with well or moderately well differentiated tumors, B monotherapy followed by castration may offer the same survival chance as maximal androgen deprivation. In those patients it thus represents a reasonable choice that can avoid the side effects of androgen deprivation for considerable periods of time.

• Authors: Francesco Boccardo, Mario Barichello, Michele Battaglia, Giorgio Carmignani, Giancarlo Comeri, Valentino Ferraris, Sergio Lilliu, Franco Montefiore, Filippo Portoghese, Pietro Cortellini, Patrizio Rigatti, Enzo Usai, Alessandra Rubagotti, Italian Prostate Cancer Group
• Journal: European urology (Eur Urol) Vol. 42 Issue 5 Pg. 481-90 (Nov 2002) ISSN: 0302-2838 [Print] Switzerland
• PMID: 12429158 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anilides
• Antineoplastic Agents
• Nitriles
• Tosyl Compounds
• Goserelin
• Flutamide
• bicalutamide
• Prostate-Specific Antigen

Topics

• Aged
• Aged, 80 and over
• Anilides (therapeutic use)
• Antineoplastic Agents (therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Disease Progression
• Flutamide (administration & dosage)
• Goserelin (administration & dosage)
• Humans
• Male
• Middle Aged
• Nitriles
• Prostate-Specific Antigen
• Prostatic Neoplasms (drug therapy, pathology)
• Survival Analysis
• Tosyl Compounds
• Treatment Outcome