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Abstract
This study aimed at improving the quality of life of patients with metastatic bladder cancer to bone through evaluation of the effect of zoledronic acid on skeletal related events( SRE ). SRE is a composite endpoint that includes pathological fractures, spinal cord compression, and the need for radiation or surgery to bone.
Between July 2005 and February 2007, forty patients with metastatic bladder cancer to bone were randomized to receive either zoledronic acid 4 mg or placebo.
Age of patients ranged from 42 to 70 years with a median value of 55 yaers.The median age was 55 &53 years for the placebo and bisphosphonates arms respectively.
Four patients ( 20 % ) in the placebo arm were females and 16 ( 80%) were males while 5 patients in the bisphpsphonates arm were females and 15 were males.
In the placebo arm,15 patients (75 %) had previous radical cystectomy and 5 patients (25 %) had only biopsy done for them .
In the bisphosphonates arm 17 patients (85%) had previous radical cystectomy and 3 patients (15%) were only biopsied.
In the placebo arm 12 patients( 60%) had transitional cell carcinoma,7 patients (35%) had squamous cell carcinoma and one patient (5%) had adenocarcinoma. In the bisphosphonates arm 13 patients (65%) had transitional cell carcinoma and 7 patients (35%) had squamous cell carcinoma.
In a median follow up of 6 months and a mean of 7.7±4.7 months , zoledronic acid had effectively reduced the mean skeletal related event rate from 2.05±1 in the placebo arm to 0.9±1 in the bisphosphonates arm .This means that zoledronic acid has led to 58 % reduction in the risk of developing skeletal related events.
The median time to first skeletal event was prolonged from 8 weeks in the placebo arm to 16 weeks in the bisphosphonates arm and this difference was statistically significant(p=0.0004).
Zoledronic acid had effectively reduced the mean pain score which was 2.95 in the bisphosphonate arm vs. 4.37 for the placebo arm.
This diferrence was statistically significant (p value = 0.015 ) .
The cumulative overall survival at six months for patients in the placebo arm was 25±9 % while in the bisphosphonates arm was 45±11 % .This difference in survival was statistically significant (p=0.02).
The overall survival rate at one year for patients in the placebo arm was 5±4% while in the bisphosphonates arm was 30±10% .This difference in survival was statistically significant (p=0.02) .
Five patients (25 %) in the placebo arm developed distant metastasis in sites other than bone and this was the same incidence for patients in the bisphosphonates arm