Palliative pamidronate treatment in patients with bone metastases from breast cancer

J Clin Oncol. 1993 Mar;11(3):491-8. doi: 10.1200/JCO.1993.11.3.491.


Purpose: An open, randomized study was performed to assess the effects of supportive pamidronate treatment on morbidity from bone metastases in breast cancer patients.

Patients and methods: Eighty-one pamidronate patients and 80 control patients were monitored for a median of 18 and 21 months, respectively, for events of skeletal morbidity and the radiologic course of metastatic bone disease. The oral pamidronate dose was 600 mg/d (high dose [HD]) during the earliest study years, then changed to 300 mg/d (low dose [LD]) because of gastrointestinal toxicity. Twenty-nine of 81 pamidronate (HD/LD) patients first received 600 mg/d and were then changed to 300 mg/d; 52 of 81 pamidronate LD patients received 300 mg/d throughout the study. Tumor treatment was unrestricted.

Results: An overall intent-to-treat analysis was performed. In the pamidronate group, the occurrence of hypercalcemia, severe bone pain, and symptomatic impending fractures decreased by 65%, 30%, and 50%, respectively; event-rates of systemic treatment and radiotherapy decreased by 35% (P < or = .02). The event-free period (EFP), radiologic course of disease, and survival did not improve. Subgroup analyses suggested a dose-dependent treatment effect. Compared with their controls, in pamidronate HD/LD patients, events occurred 60% to 90% less frequently (P < or = .03) and the EFP was prolonged (P = .002). In pamidronate LD patients, event-rates decreased by 15% to 45% (P < or = .04). Gastrointestinal toxicity of pamidronate caused a 23% drop-out rate, but other cancer-associated factors seemed to contribute to this toxicity.

Conclusion: Pamidronate treatment of breast cancer patients efficaciously reduced skeletal morbidity. The effect appeared to be dose-dependent. Further research on dose and mode of treatment is mandatory.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bone Neoplasms / drug therapy*
  • Bone Neoplasms / secondary
  • Breast Neoplasms / pathology*
  • Diphosphonates / administration & dosage
  • Diphosphonates / adverse effects
  • Diphosphonates / therapeutic use*
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Middle Aged
  • Multivariate Analysis
  • Palliative Care
  • Pamidronate
  • Quality of Life
  • Regression Analysis
  • Surveys and Questionnaires
  • Treatment Outcome


  • Diphosphonates
  • Pamidronate