A randomized double-blind study of gallium nitrate compared with etidronate for acute control of cancer-related hypercalcemia Journal Article


Authors: Warrell, R. P. Jr; Murphy, W. K.; Schulman, P.; O'Dwyer, P. J.; Heller, G.
Article Title: A randomized double-blind study of gallium nitrate compared with etidronate for acute control of cancer-related hypercalcemia
Abstract: Hypercalcemia is a major source of morbidity and mortality in patients with cancer. Gallium nitrate and the bisphosphonate, etidronate, are new agents that have recently become available for treatment of this disorder. To directly compare therapeutic effectiveness, we conducted a randomized, double-blind, multicenter study of gallium nitrate compared with etidronate for acute control of cancer-related hypercalcemia. Gallium nitrate was administered by continuous intravenous (IV) infusion at a dose of 200 mg/m2/d. Etidronate was administered as a 4-hour IV infusion at a dose of 7.5 mg/kg. Both drugs were given daily for 5 consecutive days. Eligible patients had persistent moderate-to-severe hypercalcemia (total serum calcium [corrected for serum albumin] ≥ 12.0 mg/dL) after 2 days of hospitalization and IV hydration. Seventy-one patients were randomized and treated. Twenty-eight of 34 patients (82%) who received gallium nitrate achieved normocalcemia compared with 16 of 37 patients (43%) who received etidronate (P < .001). Patients who received etidronate required significantly greater amounts of IV fluids (P = .04) and more hypocalcemic drug treatment (P < .05) during the poststudy period than patients who received gallium nitrate. Kaplan-Meier analysis showed a significantly longer median duration of normocalcemia for patients treated with gallium nitrate (8 days v 0 days, P = .0005). A significantly higher proportion of patients treated with gallium nitrate developed asymptomatic hypophosphatemia compared with patients treated with etidronate (97% v 43%, P < .001). We conclude that gallium nitrate is highly effective and superior to etidronate for acute control of moderate-to-severe cancer-related hypercalcemia. © 1991 by American Society of Clinical Oncology.
Keywords: adult; controlled study; aged; major clinical study; hypophosphatemia; conference paper; cancer patient; comparative study; neoplasms; calcium; creatinine; hypercalcemia; regression analysis; double-blind method; analysis of variance; infusions, intravenous; phosphates; intravenous drug administration; middle age; gallium; etidronic acid; gallium nitrate; human; male; female; priority journal; support, non-u.s. gov't; support, u.s. gov't, p.h.s.
Journal Title: Journal of Clinical Oncology
Volume: 9
Issue: 8
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1991-08-01
Start Page: 1467
End Page: 1475
Language: English
DOI: 10.1200/jco.1991.9.8.1467
PUBMED: 1906532
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 27 September 2019 -- Source: Scopus
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  1. Glenn Heller
    399 Heller
  2. Raymond P Warrell
    175 Warrell