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For Healthcare
Professionals
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Efficacy Studies
A randomized, double-blind study evaluated Ganite efficacy versus calcitonin for acute
control of cancer-related hypercalcemia. Fifty patients met entry criteria, which included:
intravenous hydration for at least 2 days prior to entry, total albumin-adjusted serum calcium
level of ≥ 12.0 mg/dL, cancer diagnosis, and serum creatinine ≥ 2.5 mg/dL. Patients were
stratified according to epidermoid (squamous) or nonepidermoid histology. The primary endpoints
were normalization of serum calcium and duration of normocalcemia.
23
Ganite was administered as a continuous IV infusion at a dose of 200 mg/m2
daily for 5 days, and calcitonin was administered intramuscularly at a dose of 8 IU/kg every 6
hours for 5 days. Other hypocalcemic agents were not allowed. Intravenous fluids and furosemide
were administered at the discretion of the treating clinician. Corticosteroid therapy was allowed
at study entry if the dosage was stable or decreasing. A successful response was defined as a
single normal serum calcium value within 7 days after treatment administration.
The time-course of effect on serum calcium concentration (corrected for albumin) is summarized below:
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Change in Corrected Serum Calcium Concentration by Time From Initiation of Treatment
in a Randomized, Double-Blind Study Comparing Ganite and Calcitonin
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Mean Change in Serum Calcium Concentration (mg/dL)*
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Time Period† (hours)
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Ganite
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Calcitonin
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24
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-0.4
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-1.6‡
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48
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-0.9
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-1.4
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72
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-1.5
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-1.1
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96
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-2.9‡
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-1.1
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120
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-3.3‡
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-1.3
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*Change from baseline in serum calcium concentration (corrected for albumin).
†Time after initiation of therapy in hours.
‡Comparison between treatment groups (p<0.01).
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Elevated serum calcium concentration (corrected for albumin) was normalized in 75% (18 of 24)
of the patients receiving Ganite and in 27% (7 of 26) of the patients receiving
calcitonin (p=0.0016).
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92% of patients treated with Ganite had a decrease in serum calcium (corrected for
albumin) ≥ 2.0 mg/dL compared to 54% of patients treated with calcitonin (p = 0.004)
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In an open-label, non-randomized, dose-ranging study, there were no significant differences in
the proportion of patients responding to Ganite when considering either the presence or
absence of bone metastases, or whether the tumor histology was epidermoid or nonepidermoid.
24
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94% of patients receiving a 200 mg/m2/day dose of Ganite had a decrease in
serum calcium (corrected for albumin) ≥ 2.0 mg/dL; 90% of patients had a decrease of ≥
3.0 mg/dL
24
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Controlled studies have not been undertaken to evaluate the safety and effectiveness of
retreatment with Ganite
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