Zoledronic acid versus pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: A phase III, double-blind, comparative trial
Date
2001
Authors
Rosen L.S.
Gordon D.
Kaminski M.
Howell A.
Belch A.
Mackey J.
Apffelstaedt J.
Hussein M.
Coleman R.E.
Reitsma D.J.
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
PURPOSE: Zoledronic acid, a new and more potent bisphosphonate, was compared with pamidronate, the current standard treatment for patients with osteolytic or mixed bone metastases/lesions. PATIENTS AND METHODS: A total of 1648 patients with either Durie-Salmon stage III multiple myeloma or advanced breast cancer and at least one bone lesion were randomly assigned to treatment with either 4 or 8 mg of zoledronic acid via 15-minute intravenous infusion or 90 mg of pamidronate via 2-hour intravenous infusion every 3 to 4 weeks for 12 months. The primary efficacy endpoint was the proportion of patients experiencing at least one skeletal-related event over 13 months. RESULTS: The proportion of patients with at least one skeletal-related event was similar in all treatment groups. Median time to the first skeletal-related event was approximately 1 year in each treatment group. The skeletal morbidity rate was slightly lower in patients treated with zoledronic acid than in those treated with pamidronate, and zoledronic acid (4 mg) significantly decreased the incidence and event rate for radiation therapy to bone, both overall and in breast cancer patients receiving hormonal therapy. Pain scores decreased in all treatment groups in the presence of stable or decreased analgesic use. Zoledronic acid (4 mg) and pamidronate were equally well tolerated; the most common adverse events were bone pain, nausea, fatigue, and fever and < 5% of serious adverse events were related to the study drug. The incidence of renal impairment among patients treated with 4 mg of zoledronic acid via 15-minute infusion was similar to that among patients treated with pamidronate. CONCLUSIONS: Zoledronic acid (4 mg) via 15-minute intravenous infusion was as effective and well tolerated as 90 mg of pamidronate in the treatment of osteolytic and mixed bone metastases/lesions in patients with advanced breast cancer or multiple myeloma. Copyright © 2001 Jones and Bartlett Publishers, Inc.
Description
Keywords
analgesic agent, antineoplastic agent, calcium, hormone, multivitamin, pamidronic acid, zoledronic acid, bisphosphonic acid derivative, imidazole derivative, adult, alopecia, anemia, anorexia, arthralgia, article, bone metastasis, bone pain, breast cancer, cancer hormone therapy, cancer pain, cancer radiotherapy, cancer staging, clinical trial, constipation, controlled clinical trial, controlled study, coughing, diarrhea, double blind procedure, drug efficacy, drug megadose, drug safety, drug tolerability, dyspnea, fatigue, female, fever, headache, human, incidence, kidney disease, leg edema, major clinical study, male, morbidity, multicenter study, multiple myeloma, muscle weakness, myalgia, nausea, osteolysis, pain assessment, phase 3 clinical trial, priority journal, randomized controlled trial, vomiting, bone tumor, breast tumor, comparative study, metastasis, middle aged, pathology, Antineoplastic Agents, Bone Neoplasms, Breast Neoplasms, Diphosphonates, Double-Blind Method, Female, Humans, Imidazoles, Male, Middle Aged, Multicenter Studies, Multiple Myeloma
Citation
Cancer Journal
7
5
7
5