Long-term prevention of skeletal complications of metastatic breast cancer with pamidronate

Gabriel N. Hortobagyi, Richard L. Theriault, Allan Lipton, Lester Porter, Douglas Blayney, Clive Sinoff, Helen Wheeler, Joseph F. Simeone, John J. Seaman, Robert D. Knight, Maika Heffernan, Kathleen Mellars, Dirk J. Reitsma

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Abstract

Purpose Pamidronate, an aminobisphosphonate, has been shown to lower the risk of skeletal complications associated with lytic bone lesions for up to 1 year in women with stage IV breast cancer who received chemotherapy. We studied the long-term effectiveness and safety of continued treatment with intravenous pamidronate infusions for up to 2 years. Patients and Methods: Three hundred eight-two women with metastatic breast cancer and lytic bone lesions who received chemotherapy were randomly assigned to receive either 90 mg of pamidronate or placebo intravenously every 3 to 4 weeks in this double- blind, multicenter, parallel-group trial. Patients were evaluated monthly for 2 years for skeletal complications, which included pathologic fractures, need for radiation or surgery to treat bone complications, spinal cord compression, and hypercalcemia. Bone pain, analgesic use, bone biochemical markers, performance status, quality of life, radiologic response in bone, and survival were also evaluated. Results: As in the first, year of treatment, the proportion of patients with any skeletal complications was significantly less for the pamidronate than the placebo group of 15, 18, 21, and 24 months (P<.001). The proportions of patients with any pathologic fracture (ie, vertebral and nonvertebral fractures), need for radiation or surgery to treat bone complications, and hypercalcemia were also statistically less for the pamidronate than the placebo group. The median time to the first skeletal complication was 13.9 months in the pamidronate- treated women and 7.0 months in the placebo group (P<.001). Long-term treatment did not result in any unexpected adverse events. Survival did not differ between the two groups. Conclusion: The risk for osteolytic bone lesion complications in metastatic breast cancer was significantly decreased with monthly infusions of 90 mg of pamidronate, and this effect was maintained for at least 2 years. Pamidronate is a useful adjunct to standard chemotherapy in the palliative treatment of metastatic breast cancer.

Original languageEnglish (US)
Pages (from-to)2038-2044
Number of pages7
JournalJournal of Clinical Oncology
Volume16
Issue number6
DOIs
StatePublished - Jan 1 1998

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pamidronate
Breast Neoplasms
Bone and Bones
Placebos
Spontaneous Fractures
Hypercalcemia
Drug Therapy
Radiation
Bone Neoplasms
Spinal Cord Compression
Survival
Palliative Care
Intravenous Infusions

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Hortobagyi, G. N., Theriault, R. L., Lipton, A., Porter, L., Blayney, D., Sinoff, C., ... Reitsma, D. J. (1998). Long-term prevention of skeletal complications of metastatic breast cancer with pamidronate. Journal of Clinical Oncology, 16(6), 2038-2044. https://doi.org/10.1200/JCO.1998.16.6.2038
Hortobagyi, Gabriel N. ; Theriault, Richard L. ; Lipton, Allan ; Porter, Lester ; Blayney, Douglas ; Sinoff, Clive ; Wheeler, Helen ; Simeone, Joseph F. ; Seaman, John J. ; Knight, Robert D. ; Heffernan, Maika ; Mellars, Kathleen ; Reitsma, Dirk J. / Long-term prevention of skeletal complications of metastatic breast cancer with pamidronate. In: Journal of Clinical Oncology. 1998 ; Vol. 16, No. 6. pp. 2038-2044.
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abstract = "Purpose Pamidronate, an aminobisphosphonate, has been shown to lower the risk of skeletal complications associated with lytic bone lesions for up to 1 year in women with stage IV breast cancer who received chemotherapy. We studied the long-term effectiveness and safety of continued treatment with intravenous pamidronate infusions for up to 2 years. Patients and Methods: Three hundred eight-two women with metastatic breast cancer and lytic bone lesions who received chemotherapy were randomly assigned to receive either 90 mg of pamidronate or placebo intravenously every 3 to 4 weeks in this double- blind, multicenter, parallel-group trial. Patients were evaluated monthly for 2 years for skeletal complications, which included pathologic fractures, need for radiation or surgery to treat bone complications, spinal cord compression, and hypercalcemia. Bone pain, analgesic use, bone biochemical markers, performance status, quality of life, radiologic response in bone, and survival were also evaluated. Results: As in the first, year of treatment, the proportion of patients with any skeletal complications was significantly less for the pamidronate than the placebo group of 15, 18, 21, and 24 months (P<.001). The proportions of patients with any pathologic fracture (ie, vertebral and nonvertebral fractures), need for radiation or surgery to treat bone complications, and hypercalcemia were also statistically less for the pamidronate than the placebo group. The median time to the first skeletal complication was 13.9 months in the pamidronate- treated women and 7.0 months in the placebo group (P<.001). Long-term treatment did not result in any unexpected adverse events. Survival did not differ between the two groups. Conclusion: The risk for osteolytic bone lesion complications in metastatic breast cancer was significantly decreased with monthly infusions of 90 mg of pamidronate, and this effect was maintained for at least 2 years. Pamidronate is a useful adjunct to standard chemotherapy in the palliative treatment of metastatic breast cancer.",
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Hortobagyi, GN, Theriault, RL, Lipton, A, Porter, L, Blayney, D, Sinoff, C, Wheeler, H, Simeone, JF, Seaman, JJ, Knight, RD, Heffernan, M, Mellars, K & Reitsma, DJ 1998, 'Long-term prevention of skeletal complications of metastatic breast cancer with pamidronate', Journal of Clinical Oncology, vol. 16, no. 6, pp. 2038-2044. https://doi.org/10.1200/JCO.1998.16.6.2038

Long-term prevention of skeletal complications of metastatic breast cancer with pamidronate. / Hortobagyi, Gabriel N.; Theriault, Richard L.; Lipton, Allan; Porter, Lester; Blayney, Douglas; Sinoff, Clive; Wheeler, Helen; Simeone, Joseph F.; Seaman, John J.; Knight, Robert D.; Heffernan, Maika; Mellars, Kathleen; Reitsma, Dirk J.

In: Journal of Clinical Oncology, Vol. 16, No. 6, 01.01.1998, p. 2038-2044.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Long-term prevention of skeletal complications of metastatic breast cancer with pamidronate

AU - Hortobagyi, Gabriel N.

AU - Theriault, Richard L.

AU - Lipton, Allan

AU - Porter, Lester

AU - Blayney, Douglas

AU - Sinoff, Clive

AU - Wheeler, Helen

AU - Simeone, Joseph F.

AU - Seaman, John J.

AU - Knight, Robert D.

AU - Heffernan, Maika

AU - Mellars, Kathleen

AU - Reitsma, Dirk J.

PY - 1998/1/1

Y1 - 1998/1/1

N2 - Purpose Pamidronate, an aminobisphosphonate, has been shown to lower the risk of skeletal complications associated with lytic bone lesions for up to 1 year in women with stage IV breast cancer who received chemotherapy. We studied the long-term effectiveness and safety of continued treatment with intravenous pamidronate infusions for up to 2 years. Patients and Methods: Three hundred eight-two women with metastatic breast cancer and lytic bone lesions who received chemotherapy were randomly assigned to receive either 90 mg of pamidronate or placebo intravenously every 3 to 4 weeks in this double- blind, multicenter, parallel-group trial. Patients were evaluated monthly for 2 years for skeletal complications, which included pathologic fractures, need for radiation or surgery to treat bone complications, spinal cord compression, and hypercalcemia. Bone pain, analgesic use, bone biochemical markers, performance status, quality of life, radiologic response in bone, and survival were also evaluated. Results: As in the first, year of treatment, the proportion of patients with any skeletal complications was significantly less for the pamidronate than the placebo group of 15, 18, 21, and 24 months (P<.001). The proportions of patients with any pathologic fracture (ie, vertebral and nonvertebral fractures), need for radiation or surgery to treat bone complications, and hypercalcemia were also statistically less for the pamidronate than the placebo group. The median time to the first skeletal complication was 13.9 months in the pamidronate- treated women and 7.0 months in the placebo group (P<.001). Long-term treatment did not result in any unexpected adverse events. Survival did not differ between the two groups. Conclusion: The risk for osteolytic bone lesion complications in metastatic breast cancer was significantly decreased with monthly infusions of 90 mg of pamidronate, and this effect was maintained for at least 2 years. Pamidronate is a useful adjunct to standard chemotherapy in the palliative treatment of metastatic breast cancer.

AB - Purpose Pamidronate, an aminobisphosphonate, has been shown to lower the risk of skeletal complications associated with lytic bone lesions for up to 1 year in women with stage IV breast cancer who received chemotherapy. We studied the long-term effectiveness and safety of continued treatment with intravenous pamidronate infusions for up to 2 years. Patients and Methods: Three hundred eight-two women with metastatic breast cancer and lytic bone lesions who received chemotherapy were randomly assigned to receive either 90 mg of pamidronate or placebo intravenously every 3 to 4 weeks in this double- blind, multicenter, parallel-group trial. Patients were evaluated monthly for 2 years for skeletal complications, which included pathologic fractures, need for radiation or surgery to treat bone complications, spinal cord compression, and hypercalcemia. Bone pain, analgesic use, bone biochemical markers, performance status, quality of life, radiologic response in bone, and survival were also evaluated. Results: As in the first, year of treatment, the proportion of patients with any skeletal complications was significantly less for the pamidronate than the placebo group of 15, 18, 21, and 24 months (P<.001). The proportions of patients with any pathologic fracture (ie, vertebral and nonvertebral fractures), need for radiation or surgery to treat bone complications, and hypercalcemia were also statistically less for the pamidronate than the placebo group. The median time to the first skeletal complication was 13.9 months in the pamidronate- treated women and 7.0 months in the placebo group (P<.001). Long-term treatment did not result in any unexpected adverse events. Survival did not differ between the two groups. Conclusion: The risk for osteolytic bone lesion complications in metastatic breast cancer was significantly decreased with monthly infusions of 90 mg of pamidronate, and this effect was maintained for at least 2 years. Pamidronate is a useful adjunct to standard chemotherapy in the palliative treatment of metastatic breast cancer.

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