Gallium nitrate for acute treatment of cancer-related hypercalcemia: A randomized, double-blind comparison to calcitonin Journal Article


Authors: Warrell, R. P. Jr; Israel, R.; Frisone, M.; Snyder, T.; Gaynor, J. J.; Bockman, R. S.
Article Title: Gallium nitrate for acute treatment of cancer-related hypercalcemia: A randomized, double-blind comparison to calcitonin
Abstract: Study Objective: To determine whether gallium nitrate therapy is superior to maximally approved doses of calcitonin for acute control of cancer-related hypercalcemia. Design: Randomized, double-blind comparison of active treatments. Setting: Comprehensive cancer center. Patients: One hundred ninety-eight consecutive hypercalcemic events in 164 patients screened for entry. Eligibility criteria: hospitalization and intravenous hydration for at least 2 days; persistent elevated serum calcium levels of 2.99 mmol/L or greater (adjusted for serum albumin); serum creatinine levels of 221 μmol/L or less; no cytotoxic chemotherapy, radiation, or mithramycin within the preceding 7 days or during study; no concurrent use of aminoglycoside antibiotics; life expectancy greater than 4 weeks; lymphoma and parathyroid carcinoma excluded. Patients were stratified by histologic type of tumor (epidermoid or nonepidermoid). Fifty patients were randomized and treated. Interventions: Gallium nitrate 200 mg/m2 body surface area for 5 days by continuous intravenous infusion, or salmon calcitonin 8 IU/kg body weight every 6 hours for 5 days by intramuscular injection. Patients randomized to receive gallium nitrate received sham injections of saline to simulate calcitonin; patients randomized to receive calcitonin received 1000 mL 5%-dextrose solution to simulate gallium nitrate. Measurements and main results: All patients were evaluable. Eighteen of twenty-four patients who received gallium nitrate achieved normocalcemia compared with 8 of 26 patients who received calcitonin for an observed difference of 44% (95% confidence interval, 19% to 69%; P = 0.002). Median duration of normocalcemia before other cytotoxic or hypocalcemic therapy was 6 days for patients treated with gallium nitrate compared with 1 day for patients treated with calcitonin (P < 0.001). Median duration of normocalcemia regardless of intercurrent treatment and without adjustment for serum albumin was 11+days for patients treated with gallium nitrate and 2 days for patients treated with calcitonin (P < 0.01). Mean daily fluid intake and mean daily dose of furosemide were similar in both treatment groups. No additional benefit was seen in 9 patients randomized to receive calcitonin who incidentally received corticosteroids. Conclusions: Gallium nitrate therapy is highly effective and superior to maximally approved doses of calcitonin for acute control of cancer-related hypercalcemia.
Keywords: adult; controlled study; aged; human cell; major clinical study; calcitonin; hypercalcemia; intravenous drug administration; intramuscular drug administration; gallium nitrate; cancer; human; male; female; priority journal
Journal Title: Annals of Internal Medicine
Volume: 108
Issue: 5
ISSN: 0003-4819
Publisher: American College of Physicians  
Date Published: 1988-05-01
Start Page: 669
End Page: 674
Language: English
DOI: 10.7326/0003-4819-108-5-669
PUBMED: 3282463
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 6 August 2020 -- Source: Scopus
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  1. Raymond P Warrell
    175 Warrell
  2. Jeffrey J. Gaynor
    36 Gaynor
  3. Richard Bockman
    24 Bockman