Safety update of a long-term follow-up of `Casodex' (Bicalutamide) 150 mg monotherapy vs castration
Kaisary, A.V. Iversen, P. Tyrell, C.J. Anderson, J.B. Van Poppel, Hendrik Chamberlain, M. Tammela, T. #
BJU international vol:86 issue:S3 pages:56-56
SIU edition:25 location:Singapore date:29 October - 2 November 2000
Introduction and objective
Two multicenter, parallel group studies have compared `Casodex' (bicalutamide) 150 mg monotherapy with
castration in 480 patients with locally advanced (MO) prostate cancer and 805 patients with metastatic (M1) disease. The MO patients have been followed up for a median of 6.3 years and the M1 patients for a median of 1.9 years. We present here the safety analysis of these longterm data.
Patients with T3/4 prostate cancer were randomized to
receive `Casodex` 150 mg/day or castration (bilateral orchiectomy or `Zoladex' [goserelin acetate} 3.6mg every 28 days). The studies were of an identical design, allowing the data to be pooled.
Safety data were available for 160 MO patients receiving
castration and 314 patients receiving `Casodex' 150 mg. The highest incidences of adverse events were the pharmacological side effects of hot flushes in the castration group (80/160 [50.0%] patients compared with
41/314 [13.1%] patients in the `Casodex' 150mg group), and breast pain (126/314 [40.1%] patients) and gynaecomastia (155/314 [49.4%] patients) in the `Casodex' 150 mg group. The incidences were low and profiles were similar. The incidence of withdrawals due to drug-related adverse events in the `Casodex' 150mg group was low (4.1%). Of these
withdrawals only four (1.3%) were due to breast pain and/or
gynaecomastia. Similar results were obtained when data from M0 and M1 patients were combined.
In a 6.3-year follow-up of M0 patients and in a 1.9-year
follow-up with M1 patients, `Casodex' 150mg monotherapy was well tolerated.
`Casodex' and `Zoladex' are trademarks, the property of the AstraZeneca group of companies.