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New Depot Formulation of LHRH Analogue Allows 12-Week Dosing

New Depot Formulation of LHRH Analogue Allows 12-Week Dosing

LAS VEGAS--A new, longer duration formulation of an LHRH (luteinizing
hormone releasing hormone) analogue for advanced prostate cancer
offers more convenient dosing and appears to be safe and effective.

Two randomized studies presented at the American Urological Association
annual meeting compared the new formulation, a 10.8 mg depot of
goserelin acetate (Zoladex), with the 3.6 mg depot of the same
agent.

At a poster session, Frans N.J. Debruyne, MD, University Hospital,
Nijmegen, the Netherlands, said that while the 3.6 mg depot requires
monthly visits to physician offices or clinics, the 10.8 mg depot
is replaced at 3 months, an interval coinciding perfectly with
the follow-up schedule of patients with metastatic prostate cancer.

In the two comparative studies presented by Dr. Debruyne, involving
a total of 160 patients with advanced prostate cancer, patients
received either a single 10.8 mg depot or three consecutive 3.6
mg depots over weeks 0 to 12. Subsequently, all patients received
three consecutive 10.8 mg depots over weeks 12 to 48.

Evaluations of the testosterone profiles of patients receiving
the different regimens revealed similar patterns. The expected
testosterone level rise in the first week was followed by rapid
declines to within the castrate range by day 21. Mean testosterone
levels in both studies during weeks 4 to 12 were 0.64 nmol/L and
0.69 nmol/L for the 10.8 mg and 3.6 mg depot groups, respectively
(P = .53).

Levels remained in the castrate range (0 to 2.50 nmol/L) throughout
the 48-week study period, Dr. Debruyne told Oncology News International.

Adverse events (mostly hot flushes) for patients receiving the
10.8 mg depot were comparable to those seen in the 3.6 mg depot
group. Also, the depot was well tolerated locally, with injection
site reactions reported for only 0.3% (2) of 614 administrations.

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