Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions: A randomized, placebo-controlled trial

Richard L. Theriault, Allan Lipton, Gabriel N. Hortobagyi, Richard Leff, Stefan Glück, John F. Stewart, Sean Costello, Ian Kennedy, Joseph Simeone, John J. Seaman, Robert D. Knight, Kathleen Mellars, Maika Heffernan, Dirk J. Reitsma

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Abstract

Purpose: To assess whether pamidronate can reduce the frequency of skeletal morbidity in women with lytic bone metastases from breast cancer treated with hormone therapy. Patients and Methods: Three hundred seventy- two women with breast cancer who had at least one lytic bone lesion and who were receiving hormonal therapy were randomized to receive 90 mg of pamidronate or placebo as a 2-hour intravenous infusion given in double- blind fashion every 4 weeks for 24 cycles. Patients were evaluated for skeletal complications: pathologic fractures, spinal cord compression, irradiation of or surgery on bone, or hypercalcemia. The skeletal morbidity rate (the ratio of the number of skeletal complications to the time on trial) was the primary efficacy variable. Bane pain, use of analgesics, quality of life, performance status, bone tumor response, and biochemical parameters were also evaluated. Results: One hundred eighty-two patients who received pamidronate and 189 who received placebo were assessable. The skeletal morbidity rate was significantly reduced at 12, 18, and 24 cycles in patients treated with 90 mg of pamidronate (P = .028, .023, and .008, respectively). At 24 cycles, the proportion of patients having had any skeletal complication was 56% in the pamidronate group and 67% in the placebo group (P = .027). The time to the first skeletal complication was longer for patients receiving pamidronate than for those given placebo (P = .049). There was no statistical difference in survival or in objective bone response rate. Pamidronate was well tolerated. Conclusion: Treatment with 90 mg of pamidronate as a 2-hour intravenous infusion every 4 weeks in addition to hormonal therapy significantly reduces skeletal morbidity from osteolytic metastases.

Original languageEnglish
Pages (from-to)846-854
Number of pages9
JournalJournal of Clinical Oncology
Volume17
Issue number3
StatePublished - Mar 1 1999
Externally publishedYes

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pamidronate
Bone Neoplasms
Randomized Controlled Trials
Placebos
Breast Neoplasms
Morbidity
Bone and Bones
Intravenous Infusions
Neoplasm Metastasis
Spontaneous Fractures
Spinal Cord Compression
Hypercalcemia
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Theriault, R. L., Lipton, A., Hortobagyi, G. N., Leff, R., Glück, S., Stewart, J. F., ... Reitsma, D. J. (1999). Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions: A randomized, placebo-controlled trial. Journal of Clinical Oncology, 17(3), 846-854.

Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions : A randomized, placebo-controlled trial. / Theriault, Richard L.; Lipton, Allan; Hortobagyi, Gabriel N.; Leff, Richard; Glück, Stefan; Stewart, John F.; Costello, Sean; Kennedy, Ian; Simeone, Joseph; Seaman, John J.; Knight, Robert D.; Mellars, Kathleen; Heffernan, Maika; Reitsma, Dirk J.

In: Journal of Clinical Oncology, Vol. 17, No. 3, 01.03.1999, p. 846-854.

Research output: Contribution to journalArticle

Theriault, RL, Lipton, A, Hortobagyi, GN, Leff, R, Glück, S, Stewart, JF, Costello, S, Kennedy, I, Simeone, J, Seaman, JJ, Knight, RD, Mellars, K, Heffernan, M & Reitsma, DJ 1999, 'Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions: A randomized, placebo-controlled trial', Journal of Clinical Oncology, vol. 17, no. 3, pp. 846-854.
Theriault, Richard L. ; Lipton, Allan ; Hortobagyi, Gabriel N. ; Leff, Richard ; Glück, Stefan ; Stewart, John F. ; Costello, Sean ; Kennedy, Ian ; Simeone, Joseph ; Seaman, John J. ; Knight, Robert D. ; Mellars, Kathleen ; Heffernan, Maika ; Reitsma, Dirk J. / Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions : A randomized, placebo-controlled trial. In: Journal of Clinical Oncology. 1999 ; Vol. 17, No. 3. pp. 846-854.
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abstract = "Purpose: To assess whether pamidronate can reduce the frequency of skeletal morbidity in women with lytic bone metastases from breast cancer treated with hormone therapy. Patients and Methods: Three hundred seventy- two women with breast cancer who had at least one lytic bone lesion and who were receiving hormonal therapy were randomized to receive 90 mg of pamidronate or placebo as a 2-hour intravenous infusion given in double- blind fashion every 4 weeks for 24 cycles. Patients were evaluated for skeletal complications: pathologic fractures, spinal cord compression, irradiation of or surgery on bone, or hypercalcemia. The skeletal morbidity rate (the ratio of the number of skeletal complications to the time on trial) was the primary efficacy variable. Bane pain, use of analgesics, quality of life, performance status, bone tumor response, and biochemical parameters were also evaluated. Results: One hundred eighty-two patients who received pamidronate and 189 who received placebo were assessable. The skeletal morbidity rate was significantly reduced at 12, 18, and 24 cycles in patients treated with 90 mg of pamidronate (P = .028, .023, and .008, respectively). At 24 cycles, the proportion of patients having had any skeletal complication was 56{\%} in the pamidronate group and 67{\%} in the placebo group (P = .027). The time to the first skeletal complication was longer for patients receiving pamidronate than for those given placebo (P = .049). There was no statistical difference in survival or in objective bone response rate. Pamidronate was well tolerated. Conclusion: Treatment with 90 mg of pamidronate as a 2-hour intravenous infusion every 4 weeks in addition to hormonal therapy significantly reduces skeletal morbidity from osteolytic metastases.",
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T1 - Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions

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AU - Theriault, Richard L.

AU - Lipton, Allan

AU - Hortobagyi, Gabriel N.

AU - Leff, Richard

AU - Glück, Stefan

AU - Stewart, John F.

AU - Costello, Sean

AU - Kennedy, Ian

AU - Simeone, Joseph

AU - Seaman, John J.

AU - Knight, Robert D.

AU - Mellars, Kathleen

AU - Heffernan, Maika

AU - Reitsma, Dirk J.

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N2 - Purpose: To assess whether pamidronate can reduce the frequency of skeletal morbidity in women with lytic bone metastases from breast cancer treated with hormone therapy. Patients and Methods: Three hundred seventy- two women with breast cancer who had at least one lytic bone lesion and who were receiving hormonal therapy were randomized to receive 90 mg of pamidronate or placebo as a 2-hour intravenous infusion given in double- blind fashion every 4 weeks for 24 cycles. Patients were evaluated for skeletal complications: pathologic fractures, spinal cord compression, irradiation of or surgery on bone, or hypercalcemia. The skeletal morbidity rate (the ratio of the number of skeletal complications to the time on trial) was the primary efficacy variable. Bane pain, use of analgesics, quality of life, performance status, bone tumor response, and biochemical parameters were also evaluated. Results: One hundred eighty-two patients who received pamidronate and 189 who received placebo were assessable. The skeletal morbidity rate was significantly reduced at 12, 18, and 24 cycles in patients treated with 90 mg of pamidronate (P = .028, .023, and .008, respectively). At 24 cycles, the proportion of patients having had any skeletal complication was 56% in the pamidronate group and 67% in the placebo group (P = .027). The time to the first skeletal complication was longer for patients receiving pamidronate than for those given placebo (P = .049). There was no statistical difference in survival or in objective bone response rate. Pamidronate was well tolerated. Conclusion: Treatment with 90 mg of pamidronate as a 2-hour intravenous infusion every 4 weeks in addition to hormonal therapy significantly reduces skeletal morbidity from osteolytic metastases.

AB - Purpose: To assess whether pamidronate can reduce the frequency of skeletal morbidity in women with lytic bone metastases from breast cancer treated with hormone therapy. Patients and Methods: Three hundred seventy- two women with breast cancer who had at least one lytic bone lesion and who were receiving hormonal therapy were randomized to receive 90 mg of pamidronate or placebo as a 2-hour intravenous infusion given in double- blind fashion every 4 weeks for 24 cycles. Patients were evaluated for skeletal complications: pathologic fractures, spinal cord compression, irradiation of or surgery on bone, or hypercalcemia. The skeletal morbidity rate (the ratio of the number of skeletal complications to the time on trial) was the primary efficacy variable. Bane pain, use of analgesics, quality of life, performance status, bone tumor response, and biochemical parameters were also evaluated. Results: One hundred eighty-two patients who received pamidronate and 189 who received placebo were assessable. The skeletal morbidity rate was significantly reduced at 12, 18, and 24 cycles in patients treated with 90 mg of pamidronate (P = .028, .023, and .008, respectively). At 24 cycles, the proportion of patients having had any skeletal complication was 56% in the pamidronate group and 67% in the placebo group (P = .027). The time to the first skeletal complication was longer for patients receiving pamidronate than for those given placebo (P = .049). There was no statistical difference in survival or in objective bone response rate. Pamidronate was well tolerated. Conclusion: Treatment with 90 mg of pamidronate as a 2-hour intravenous infusion every 4 weeks in addition to hormonal therapy significantly reduces skeletal morbidity from osteolytic metastases.

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