Breast cancer and bone metastases: diphosphonate reduced pain and hypercalcaemia

Clinical bottom line (level 1b)

  1. Patients with breast cancer and bone metastases who took diphosphonate compared with placebo required less analgesia (NNT = 1 at 9 months) ; and fewer needed radiotherapy (NNT = 2 at 9 years) .
  2. Fewer developed new bone metastases (NNT = 2 at 9 months) .
Elomaa et al: Lancet 1983; ( 1 ): 146-148
Expires October 2003

The study

Single-blinded ?concealed randomised trial without intention-to-treat
Setting: university hospital, Finland

34 patients (aged 34 to 69; mean 51, 100% female) with breast cancer, multiple bone metastases and a normal calcium
Control Group: (n = 17, 17 analysed): placebo
Experimental Group: (n = 17, 17 analysed): diphosphonate: 1.6 to 3.2 g/ day for 3 to 9 months
All patients continued receiving regular cancer therapy (typically tamoxifen +/- chemotherapy)
100% followed for 9 months

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NN T
(95% CI)
reduction in analgesia used 9 months 3
(17.6%)		 15
(88.2%)		 400%
(76% to 1300%)		 70.6%
(46.9% to 94.3%)		 1
(1 to 2)
radiotherapy 9 months 10
(58.8%)		 3
(17.6%)		 70%
(10% to 90%)		 41.2%
(11.6% to 70.8%)		 2
(1 to 9)
hypercalcaemia 9 months 4
(23.5%)		 1
(5.9%)		 75%
(-100% to 97%)		 0.176%
(-0.054% to 0.407%)		 6
(NNT = 2 to infinity;
NNH = 18 to infinity)
new bone metastases 9 months 11
(64.7%)		 3
(17.6%)		 73%
(19% to 91%)		 47.1%
(18.0% to 76.1%)		 2
(1 to 6)

Comments

  1. 4 patients died in placebo group (all from hypercalcaemia). No patients died in disphosphonate group

Citation

  1. Elomaa I, et al: long-term controlled trial with diphosphonate in patients with osteolytic bone metastases. Lancet 1983; ( 1 ): 146-148
Search Terms: hypercalc* in Cochrane
Contributor: Chris Ball, October 2001
Reviewer:

Clinical Question.
Patient breast cancer, bony metastases
Intervention or Exposure diphosphonate
Comparison placebo
Outcome pain, new metastases, radiotherapy.