Low-dose gallium nitrate for prevention of osteolysis in myeloma: Results of a pilot randomized study Journal Article


Authors: Warrell, R. P. Jr; Lovett, D.; Dilmanian, F. A.; Schneider, R.; Heelan, R. T.
Article Title: Low-dose gallium nitrate for prevention of osteolysis in myeloma: Results of a pilot randomized study
Abstract: Purpose: Since osteolysis is a major cause of morbidity in myeloma, we conducted a pilot study to evaluate whether the addition of gallium nitrate to standard antimyeloma treatment could preserve or increase bone mass in patients with osteolytic disease. Methods: Patients stabilized on cytotoxic therapy were randomized to treatment with gallium nitrate for 6 months, or to observation only for the first 6 months followed by gallium nitrate treatment during the subsequent 6 months. Gallium nitrate was administered in monthly cycles by daily subcutaneous injections (30 mg/ m2d) for 2 weeks, followed by 2 weeks with no therapy, supplemented by an intravenous infusion (100 mg/m2/ d) for 5 days every other month. Results: Paired 6-month comparisons were available for seven observation periods and 13 gallium nitrate treatment periods. Total-body calcium assessed by delayed-gamma neutron activation (DGNA) decreased in four of seven patients during observation, but increased in nine of 13 patients during gallium nitrate treatment; the mean difference in total-body calcium (TBCa) between the two groups at 6 months was 3%. Median regional bone density assessed by dual-photon absorp tiometry (DPA) declined by 1.4% in patients under observation (range, + 6.7% to -18.3%), but was unchanged during gallium nitrate treatment (median change, 0%; range, -10.5% to + 14.4%). The group mean vertebral fracture index assessed by lateral spine x-rays decreased by 27% during observation compared with 2% during gallium nitrate treatment. Mean body height decreased by 0.57 inches in the observation group and .06 inches in the gallium nitrate group. Patient self-assessment of bone pain showed that seven of 12 gallium nitrate-treated patients rated themselves as experiencing major reductions in bone pain, compared with zero of seven patients who were observed. One episode of hypercalcemia occurred in a patient under observation. Conclusion: Adjuvant treatment with low-dose gallium nitrate attenuates the rate of bone loss in myeloma and may be useful for ameliorating the consequences of skeletal morbidity in patients with cancer-related osteolysis. © 1993 by American Society of Clinical Oncology.
Keywords: adult; aged; osteolysis; multiple myeloma; calcium; kidney failure; bone density; pilot projects; bone mass; pain assessment; intravenous drug administration; myeloma; bone atrophy; middle age; gallium; subcutaneous drug administration; gallium nitrate; human; male; female; priority journal; article; support, u.s. gov't, p.h.s.; support, u.s. gov't, non-p.h.s.
Journal Title: Journal of Clinical Oncology
Volume: 11
Issue: 12
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1993-12-01
Start Page: 2443
End Page: 2450
Language: English
DOI: 10.1200/jco.1993.11.12.2443
PUBMED: 8246033
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 1 March 2019 -- Source: Scopus
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  1. Robert T Heelan
    140 Heelan
  2. Raymond P Warrell
    175 Warrell