A prospective, multicenter, open-label clinical evaluation of the effect of zoledronic acid (Zometa 4mg I.V. on pain and quality of life in breast cancer, multiple myeloma and prostate cancer patients with cancer-related bone lesions.

Introduction: Bone metastasis is a frequent problem occurring in cancer patients. It is the third most common organ side of metastasis after lung and liver. In about 70 percent of breast and prostate cancer, 40 percent of lung cancer and 70 percent-95 percent of multiple myeloma, bone metastasis has been reported. Bone metastasis is associated with severe, oftentimes Intractable pain compromising quality of life

Bisphosphonates have slowly emerged as a leading therapeutic intervention for the treatment and prevention of skeletal complications of malignancy. The effect of zoledronic acid (Zometa), a third generation bisphosphonate, was investigated in patients with bone metastases from breast cancer, multiple myeloma, and prostate cancer. Zoledronic acid, by inhibiting octeoclastic bone resorption, is expected to stabilize overall pain during application of the drug despite disease progression

Objective: A prospective, open-label, multicenter study was conducted to evaluate the effect of zoledronic acid on pain, quality of life, and safety in breast cancer, multiple myeloma, and prostate cancer patients with bone metastases

Materials and Methods: Seventy patients with advanced tumor and metastatic bone disease from multiple myeloma, breast and prostate cancer received zoledronic acid 4mg as a 15-minute infusion every three to four weeks for a maximum of six infusions. Pain assessment using a visual analog scale (VAS) and quality of life was assessed using FACT-G questionnaires. Calcium and creatinine levels to assess renal function were done

Results: Zoledronic acid treatment significantly reduced bone pain scores, beginning at week 3 with mean pain scores declining from 2.36 at baseline (Week 0) to 1.94 at week 3 (p=0.0359); further declining with continuation of treatment to mean pain score of 0.98 at the end of study (p0.0001) with 74.6 percent of patients with slight to no pain

The mean quality of life scores using the FACT-G instrument increased from 79.2 at screening to 83.8 at week 15 (p0.0347)

A significant decrease in calcium levels was recorded in week 3, which increased in subsequent weeks to levels not significantly lower than baseline. No significant change in creatinine levels was observed. Serious adverse events were attributed to progression of malignancy and chemotherapy, except in 3 percent of cases who developed fever and 1.5 percent each with hypocalcemia, fatigue and diarrhea which may possibly be attributed to zoledronic acid

Conclusion: Zoledronic acid significantly decreased pain levels and considerably improved quality of life in patients with bone metastasis from multiple myeloma, breast and prostate cancer. The drug is safe and with minimal side effects. (Author)