Intravenous pamidronate disodium treatment of bone metastases in patients with breast cancer. A dose‐seeking study

Donna Glover, Alan Lipton, Alan Keller, Antonius A. Miller, Scott Browning, Robert J. Fram, Sebastian George, Kenneth Zelenakas, Richard S. Macerata, John J. Seaman

Research output: Contribution to journalArticle

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Abstract

Background. Treatment of the symptoms of bone metastases currently involves the use of narcotic medication, radiation therapy, or hormonal therapy. Pamidronate disodium, a bisphosphonate, may prove helpful in the palliative treatment of bone metastases in patients with breast cancer as demonstrated in this multicenter, dose‐ranging trial. Methods. Ambulatory female patients age 18 years or older with breast cancer metastatic to bone and a life expectancy of at least 3 months were eligible for the study. Bone metastases were confirmed by bone scan or bone survey within 6 months of enrollment. Sixty‐one patients were treated as outpatients and were randomized to receive one of four intravenous pamidronate regimens for 12 weeks: 30 mg administered every 2 weeks, 60 mg every 4 weeks, 60 mg every 2 weeks, or 90 mg every 4 weeks. The primary efficacy parameter for this study was pain score. The change from baseline in pain score was determined for each patient at each study visit and at endpoint, defined as the last postbaseline evaluation for each patient before or at week 12. Secondary efficacy variables included narcotic scores, urinary calcium/creatinine and hydroxyproline/creatinine ratios, serum osteocalcin and bone alkaline phosphatase concentrations, and bone lesion (radiologic) response. Results. At 3 months, the regimens of 60 mg every 4 weeks, 60 mg every 2 weeks, and 90 mg every 4 weeks resulted in significant reduction in bone pain beginning by week 6 of treatment. The regimen of 30 mg every 2 weeks was not effective. Narcotic use, as reflected by narcotic scores, did not parallel the pain scores, because there was little evidence of any effect for any of the treatment groups. Reduction in bone pain was accompanied by decreases in urinary calcium/creatinine and hydroxyproline/creatinine ratios, and bone alkaline phosphatase concentrations. Side effects of pamidronate were mild and transient. Radiographic changes consistent with healing of lytic lesions were observed in 15 patients (25%). Conclusion. Intravenous pamidronate is a well tolerated treatment that produced significant relief of bone pain in the majority of patients with metastatic breast cancer at the three highest doses tested.

Original languageEnglish (US)
Pages (from-to)2949-2955
Number of pages7
JournalCancer
Volume74
Issue number11
DOIs
StatePublished - Dec 1 1994

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pamidronate
Breast Neoplasms
Neoplasm Metastasis
Bone and Bones
Narcotics
Pain
Creatinine
Therapeutics
Hydroxyproline
Alkaline Phosphatase

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Glover, Donna ; Lipton, Alan ; Keller, Alan ; Miller, Antonius A. ; Browning, Scott ; Fram, Robert J. ; George, Sebastian ; Zelenakas, Kenneth ; Macerata, Richard S. ; Seaman, John J. / Intravenous pamidronate disodium treatment of bone metastases in patients with breast cancer. A dose‐seeking study. In: Cancer. 1994 ; Vol. 74, No. 11. pp. 2949-2955.
@article{66cbb305b5184438bb76224f4aa526f2,
title = "Intravenous pamidronate disodium treatment of bone metastases in patients with breast cancer. A dose‐seeking study",
abstract = "Background. Treatment of the symptoms of bone metastases currently involves the use of narcotic medication, radiation therapy, or hormonal therapy. Pamidronate disodium, a bisphosphonate, may prove helpful in the palliative treatment of bone metastases in patients with breast cancer as demonstrated in this multicenter, dose‐ranging trial. Methods. Ambulatory female patients age 18 years or older with breast cancer metastatic to bone and a life expectancy of at least 3 months were eligible for the study. Bone metastases were confirmed by bone scan or bone survey within 6 months of enrollment. Sixty‐one patients were treated as outpatients and were randomized to receive one of four intravenous pamidronate regimens for 12 weeks: 30 mg administered every 2 weeks, 60 mg every 4 weeks, 60 mg every 2 weeks, or 90 mg every 4 weeks. The primary efficacy parameter for this study was pain score. The change from baseline in pain score was determined for each patient at each study visit and at endpoint, defined as the last postbaseline evaluation for each patient before or at week 12. Secondary efficacy variables included narcotic scores, urinary calcium/creatinine and hydroxyproline/creatinine ratios, serum osteocalcin and bone alkaline phosphatase concentrations, and bone lesion (radiologic) response. Results. At 3 months, the regimens of 60 mg every 4 weeks, 60 mg every 2 weeks, and 90 mg every 4 weeks resulted in significant reduction in bone pain beginning by week 6 of treatment. The regimen of 30 mg every 2 weeks was not effective. Narcotic use, as reflected by narcotic scores, did not parallel the pain scores, because there was little evidence of any effect for any of the treatment groups. Reduction in bone pain was accompanied by decreases in urinary calcium/creatinine and hydroxyproline/creatinine ratios, and bone alkaline phosphatase concentrations. Side effects of pamidronate were mild and transient. Radiographic changes consistent with healing of lytic lesions were observed in 15 patients (25{\%}). Conclusion. Intravenous pamidronate is a well tolerated treatment that produced significant relief of bone pain in the majority of patients with metastatic breast cancer at the three highest doses tested.",
author = "Donna Glover and Alan Lipton and Alan Keller and Miller, {Antonius A.} and Scott Browning and Fram, {Robert J.} and Sebastian George and Kenneth Zelenakas and Macerata, {Richard S.} and Seaman, {John J.}",
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Glover, D, Lipton, A, Keller, A, Miller, AA, Browning, S, Fram, RJ, George, S, Zelenakas, K, Macerata, RS & Seaman, JJ 1994, 'Intravenous pamidronate disodium treatment of bone metastases in patients with breast cancer. A dose‐seeking study', Cancer, vol. 74, no. 11, pp. 2949-2955. https://doi.org/10.1002/1097-0142(19941201)74:11<2949::AID-CNCR2820741110>3.0.CO;2-Q

Intravenous pamidronate disodium treatment of bone metastases in patients with breast cancer. A dose‐seeking study. / Glover, Donna; Lipton, Alan; Keller, Alan; Miller, Antonius A.; Browning, Scott; Fram, Robert J.; George, Sebastian; Zelenakas, Kenneth; Macerata, Richard S.; Seaman, John J.

In: Cancer, Vol. 74, No. 11, 01.12.1994, p. 2949-2955.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Intravenous pamidronate disodium treatment of bone metastases in patients with breast cancer. A dose‐seeking study

AU - Glover, Donna

AU - Lipton, Alan

AU - Keller, Alan

AU - Miller, Antonius A.

AU - Browning, Scott

AU - Fram, Robert J.

AU - George, Sebastian

AU - Zelenakas, Kenneth

AU - Macerata, Richard S.

AU - Seaman, John J.

PY - 1994/12/1

Y1 - 1994/12/1

N2 - Background. Treatment of the symptoms of bone metastases currently involves the use of narcotic medication, radiation therapy, or hormonal therapy. Pamidronate disodium, a bisphosphonate, may prove helpful in the palliative treatment of bone metastases in patients with breast cancer as demonstrated in this multicenter, dose‐ranging trial. Methods. Ambulatory female patients age 18 years or older with breast cancer metastatic to bone and a life expectancy of at least 3 months were eligible for the study. Bone metastases were confirmed by bone scan or bone survey within 6 months of enrollment. Sixty‐one patients were treated as outpatients and were randomized to receive one of four intravenous pamidronate regimens for 12 weeks: 30 mg administered every 2 weeks, 60 mg every 4 weeks, 60 mg every 2 weeks, or 90 mg every 4 weeks. The primary efficacy parameter for this study was pain score. The change from baseline in pain score was determined for each patient at each study visit and at endpoint, defined as the last postbaseline evaluation for each patient before or at week 12. Secondary efficacy variables included narcotic scores, urinary calcium/creatinine and hydroxyproline/creatinine ratios, serum osteocalcin and bone alkaline phosphatase concentrations, and bone lesion (radiologic) response. Results. At 3 months, the regimens of 60 mg every 4 weeks, 60 mg every 2 weeks, and 90 mg every 4 weeks resulted in significant reduction in bone pain beginning by week 6 of treatment. The regimen of 30 mg every 2 weeks was not effective. Narcotic use, as reflected by narcotic scores, did not parallel the pain scores, because there was little evidence of any effect for any of the treatment groups. Reduction in bone pain was accompanied by decreases in urinary calcium/creatinine and hydroxyproline/creatinine ratios, and bone alkaline phosphatase concentrations. Side effects of pamidronate were mild and transient. Radiographic changes consistent with healing of lytic lesions were observed in 15 patients (25%). Conclusion. Intravenous pamidronate is a well tolerated treatment that produced significant relief of bone pain in the majority of patients with metastatic breast cancer at the three highest doses tested.

AB - Background. Treatment of the symptoms of bone metastases currently involves the use of narcotic medication, radiation therapy, or hormonal therapy. Pamidronate disodium, a bisphosphonate, may prove helpful in the palliative treatment of bone metastases in patients with breast cancer as demonstrated in this multicenter, dose‐ranging trial. Methods. Ambulatory female patients age 18 years or older with breast cancer metastatic to bone and a life expectancy of at least 3 months were eligible for the study. Bone metastases were confirmed by bone scan or bone survey within 6 months of enrollment. Sixty‐one patients were treated as outpatients and were randomized to receive one of four intravenous pamidronate regimens for 12 weeks: 30 mg administered every 2 weeks, 60 mg every 4 weeks, 60 mg every 2 weeks, or 90 mg every 4 weeks. The primary efficacy parameter for this study was pain score. The change from baseline in pain score was determined for each patient at each study visit and at endpoint, defined as the last postbaseline evaluation for each patient before or at week 12. Secondary efficacy variables included narcotic scores, urinary calcium/creatinine and hydroxyproline/creatinine ratios, serum osteocalcin and bone alkaline phosphatase concentrations, and bone lesion (radiologic) response. Results. At 3 months, the regimens of 60 mg every 4 weeks, 60 mg every 2 weeks, and 90 mg every 4 weeks resulted in significant reduction in bone pain beginning by week 6 of treatment. The regimen of 30 mg every 2 weeks was not effective. Narcotic use, as reflected by narcotic scores, did not parallel the pain scores, because there was little evidence of any effect for any of the treatment groups. Reduction in bone pain was accompanied by decreases in urinary calcium/creatinine and hydroxyproline/creatinine ratios, and bone alkaline phosphatase concentrations. Side effects of pamidronate were mild and transient. Radiographic changes consistent with healing of lytic lesions were observed in 15 patients (25%). Conclusion. Intravenous pamidronate is a well tolerated treatment that produced significant relief of bone pain in the majority of patients with metastatic breast cancer at the three highest doses tested.

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