Hypercalcaemia: gallium nitrate was more effective than etidronate.

Clinical bottom line (level 1b)

  1. Patients with cancer-related hypercalcaemia who are given gallium nitrate were more likely to have normocalcaemia, than those given etidronate (NNT = 3 at unknown) .
  2. Patients given gallium nitrate were more likely to suffer hypophosphataemia than those given etidronate (NNH = 2 at unknown) .
Warrell et al: Journal of Clinical Oncology 1991; 9 (8): 1467-1475
Expires January 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: general hospital, USA

71 patients (aged range 41 to 79 years; median 59, 55% male) hospitalised with moderate to severe hypercalcaemia (total serum calcium = 12.0 mg/dL), with a histological diagnosis of cancer

Excluded if
  • serum creatinine >2.5 mg/dL
  • cytotoxic chemotherapy, mithramycin (plicamycin) or radiation within preceding seven days
  • concomitant aminoglycoside therapy
  • life expectancy <4 weeks
  • parathyroid carcinoma
  • malignant lymphoma


  • Note:
  • Patients were stratified according to histologic type of tumour and by Karnofsky performance status ( = 40 or <40).


  • Control Group: (n = 37, 37 analysed): etidronate 7.5 mg/kg diluted in 250 mL of normal saline and administered as an iv infusion over 4 hours daily for 5 days.
    Experimental Group: (n = 34, 34 analysed): gallium nitrate (200 mg/m ² /d) diluted in 1,000 cc 5% dextrose solution and administered as a continuous iv infusion daily for 5 days
    Hydration with or without diuretics for at least two days preceding entry. Patients also received placebo in regimens identical to the treatment that they were not receiving to maintain blindness.
    100% followed for ?

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)
    ARR
    (95% CI)
    NNT
    (95% CI)
    normocalcaemia unknown 16
    (43.24%)
    28
    (82.35%)
    69%
    (32% to 86%)
    39.11%
    (18.64% to 59.58%)
    3
    (2 to 5)
    hypophosphataemia after the study unknown 15
    (40.5%)
    30
    (88.2%)
    -118%
    (-228% to -45.0%)
    -47.7%
    (-66.87% to -28.52%)
    -2
    (-4 to -1)

    Citation

    1. Warrell RP, Murphy WK, Schulman P, et al: A randomized double-blind study of Gallium Nitrate compared with Etidronate for acute control of cancer-related hypercalcaemia. Journal of Clinical Oncology 1991; 9 (8): 1467-1475
    Contributor: Clare Wotton and Musab Hayatli, January 2000
    Reviewer:

    Clinical Question.
    Patient cancer-related hypercalcaemia
    Intervention or Exposure gallium nitrate
    Comparison etidronate
    Outcome normocalcaemia