Safety and Pain Palliation of Zoledronic Acid in Patients with Breast Cancer, Prostate Cancer, or Multiple Myeloma Who Previously Received Bisphosphonate Therapy

Abstract

An open-label study conducted in community centers assessed the safety of zoledronic acid 4 mg intravenously over 15 minutes every 3–4 weeks as treatment of bone metastases in patients with multiple myeloma, breast cancer, or prostate cancer with and without previous bisphosphonate exposure. Adverse events (AEs), pain, and quality-of-life (QOL) scores were recorded, and serum creatinine (SCr) levels were measured before each infusion. Of 638 patients, 415 patients (65%) had received prior bisphosphonate therapy. Fatigue, nausea, and arthralgia were the most frequent AEs. Nausea was more common in bisphosphonate-naïve patients. SCr levels increased notably in 6.6% of patients: 7.7% of patients who received prior bisphosphonate therapy and 4.5% of bisphosphonate-naïve patients. Treatment was delayed because of SCr-level increases in 1.4% of patients with prior bisphosphonate exposure and 0.4% of bisphosphonate-naïve patients. SCr-level increases and treatment delays did not correlate with duration of prior bisphosphonate therapy. There was a trend towards more treatment discontinuations in patients with prior bisphosphonate exposure compared with bisphosphonate-naïve patients. Pain scores decreased from baseline; total QOL scores remained constant. The results of this study suggest that, with proper SCr-level monitoring, cancer patients with bone metastases who have previously received intravenous bisphosphonate treatment can be safely converted to zoledronic acid therapy.