Pamidronate Reduces Skeletal Morbidity in Women With Advanced Breast Cancer and Lytic Bone Lesions: A Randomized, Placebo-Controlled Trial

Autor:	Kathleen Mellars, Stefan Glück, John F. Stewart, Dirk J. Reitsma, Gabriel N. Hortobagyi, Allan Lipton, Robert Knight, Ian Kennedy, Maika Heffernan, Richard Leff, Sean Costello, Joseph F. Simeone, John J. Seaman, Richard L. Theriault
Rok vydání:	1999
Předmět:	Cancer Research medicine.medical_specialty Performance status business.industry Placebo-controlled study Pamidronic acid Lytic Bone Lesion medicine.disease Placebo Surgery Breast cancer Oncology medicine Hormonal therapy medicine.symptom business Bone pain medicine.drug
Zdroj:	Journal of Clinical Oncology. 17:846-846
ISSN:	1527-7755 0732-183X
Popis:	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. Bone 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.
Databáze:	OpenAIRE
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