Zoledronic acid is superior to pamidronate in the treatment of hypercalcemia of malignancy: A pooled analysis of two randomized, controlled clinical trials
P. Major et al., Zoledronic acid is superior to pamidronate in the treatment of hypercalcemia of malignancy: A pooled analysis of two randomized, controlled clinical trials, J CL ONCOL, 19(2), 2001, pp. 558-567
Purpose: Two identical, concurrent, parallel, multicenter, randomized, doub
le-blind, double-dummy trials were conducted to compare the efficacy and sa
fety of zoledronic acid and pamidronate for treating hypercalcemia of malig
nancy (HCM).
Patients and Methods: Patients with moderate to severe HCM (corrected serum
calcium [CSC] greater than or equal to 3.00 mmol/L [12.0 mg/dL]) were trea
ted with a single dose of zoledronic acid (4 or 8 mg) via 5-minute infusion
or pamidronate (90 mg) via 2-hour infusion. A protocol-specified pooled an
alysis of the two parallel trials was performed. Clinical end points includ
ed rate of complete response by day 10, response duration, and time to rela
pse.
Results: Two hundred eighty-seven patients were randomized and evaluated fo
r safety,. 275 were evaluated for efficacy. Both doses of zoledronic acid w
ere superior to pamidronate in the treatment of HCM. The complete response
rates by day 10 were 88.4% (P =.002), 86.7% (P =.015), and 69.7% for zoledr
onic acid 4 mg and 8 mg and pamidronate 90 mg, respectively. Normalization
of CSC occurred by day 4 in approximately 50% of patients treated with zole
dronic acid and in only 33.3% of the pamidronate-treated patients. The medi
an duration of complete response favored zoledronic acid 4 and 8 mg over pa
midronate 90 mg with response durations of 32, 43, and 18 days, respectivel
y.
Conclusion: Zoledronic acid is superior to pamidronate; 4 mg is the dose re
commended for initial treatment of HCM and 8 mg for relapsed or refractory
hypercalcemia. J Clin Oncol 19:558-567. (C) 2001 by American Society of Cli
nical Oncology.