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Long‐term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma
Author(s) -
Rosen Lee S.,
Gordon David,
Kaminski Mary,
Howell Anthony,
Belch Andrew,
Mackey John,
Apffelstaedt Justus,
Hussein Mohamad A.,
Coleman Robert E.,
Reitsma Dirk J.,
Chen BeeLian,
Seaman John J.
Publication year - 2003
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.11701
Subject(s) - zoledronic acid , medicine , bisphosphonate , adverse effect , bone pain , pathologic fracture , multiple myeloma , surgery , urology , osteoporosis
BACKGROUND The goal of the current study was to compare the long‐term (25‐month) safety and efficacy of zoledronic acid with pamidronate in patients with bone lesions secondary to advanced breast carcinoma or multiple myeloma. METHODS Patients ( n = 1648) were randomized to receive 4 mg or 8 mg (reduced to 4 mg) zoledronic acid as a 15‐minute infusion or to receive 90 mg pamidronate as a 2‐hour infusion every 3–4 weeks for 24 months. The primary endpoint was the proportion of patients with at least 1 skeletal‐related event (SRE), defined as pathologic fracture, spinal cord compression, radiation therapy, or surgery to bone. Secondary analyses included time to first SRE, skeletal morbidity rate, and multiple‐event analysis. Hypercalcemia of malignancy (HCM) was included as an SRE in some secondary analyses. RESULTS After 25 months of follow‐up, zoledronic acid reduced the overall proportion of patients with an SRE and reduced the skeletal morbidity rate similar to pamidronate. Compared with pamidronate, zoledronic acid (4 mg) reduced the overall risk of developing skeletal complications (including HCM) by an additional 16% ( P = 0.030). In patients with breast carcinoma, zoledronic acid (4 mg) was significantly more effective than pamidronate, reducing the risk of SREs by an additional 20% ( P = 0.025) compared with pamidronate and by an additional 30% in patients receiving hormonal therapy ( P = 0.009). Zoledronic acid (4 mg) and pamidronate were tolerated equally well. The most common adverse events included bone pain, nausea, and fatigue. CONCLUSIONS Long‐term follow‐up data confirm that zoledronic acid was more effective than pamidronate in reducing the risk of skeletal complications in patients with bone metastases from breast carcinoma and was of similar efficacy in patients with multiple myeloma. Cancer 2003. © 2003 American Cancer Society. DOI 10.1002/cncr.11701