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Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 5033
© 2008 American Society of Clinical Oncology
A controlled prospective randomized placebo-controlled trial of Zoledronic acid in bony metastatic bladder cancer patients
M. S. Zaghloul,
R. Boutrus,
H. El-Hosieny,
Y. A-Kader,
I. El-Attar and
M. Nazmy
NCI Cairo University, Cairo, Egypt
5033
Background: Bisphosphonates decreased the skeletal-related events (SRE) in metastatic breast cancer and multiple myeloma patients. Zoledronic acid succeeded in lowering SRE in metastatic bronchial and urologic cancer patients including prostate and renal cancer patients. Methods: Forty bony metastatic bladder cancer patients were treated with palliative radiotherapy. One week later, they were randomized into 2 arms. Arm 1(placebo) received 250 ml N saline over 15 minutes infusion and arm 2 (Zoledronic acid ) received 4 mg. Zoledronic acid was dissolved in the same amount of N saline and given in the same schedule for 6 months Results: Randomized patients were evenly distributed between the 2 arms with no statistical differences. Patients were followed up for a period of 58 to 756 days with a median of 183 days. All patients tolerated treatment nicely. None of the patients developed generalized bony pain, GIT, eye symptoms or local reaction at site of injection. Three patients in Zoledronic arm developed hypocalcaemia. Five patients in arm 1 and 7 patients in arm 2 developed mild elevated s. creatinine with no statistical difference. The mean SRE had reduced from 2.05 ± 1 in the placebo arm to 0.9± 0.9 in Zoledranic acid arm (P=0.001). Nine patients (45%) in zoledronic arm did not experience any new SRE compared to 2 (10%) in the placebo arm (p=0.011). The median time to first SRE was prolonged from 56 days in the placebo arm to 115 days in Zoledronic arm (0.0004). Zoledronic acid reduced the mean pain score from 4.37 in the placebo arm to 2.95 in treatment arm (P=0.015). The mean score was continuously better in Zoledronic patients than placebo patients. Multiple event analysis of SRE revealed that Zoledronic acid decreased the hazard by 58% with a hazard ratio of 0.413 P value of 0.008. The one-year overall survival rate was 30±10%in Zoledronic arm compared to 5± 4% in the placebo arm (0.02). No significant difference was noticed in distant metastasis (other than bone) in the 2 arms. Conclusions: Zoledronic acid decreased the SRE in bladder cancer patients. It improved the one-year overall survival rate of patients having bony metastasis either due to its antitumor effect or through improving patients’ quality of life via decreasing SRE.
No significant financial relationships to disclose.
Abstract presentation from the 2008 ASCO Annual Meeting
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