Abstract
e19558 Background: The primary objective was to assess pain course over time measured by a visual analog scale (VAS) for patients who reported pain and who did not have pain upon entry into the trial. The secondary objectives are time in chair, quality of life, and safety of ZOL administered with or without SREs. Methods: 72 patients from 5 Hungarian centre enrolled (12 dropouts), of which 38 patients had BC and 32 patients had PC. ZOL in 4 mg starting dose administered as intravenous infusions over a no less than 15-minute duration, every 3-4 weeks for a maximum of 6 infusions. Dose adjustments occurred according to creatinine clearance. The evaluations criteria used in the study are pain evaluated on VAS, quality of life (Functional Assessment of Cancer Therapy Scale – General (FACT-G) and time in infusion treatment chair. Results: The mean baseline pain score was 36.3 mm, 43,1mm for the BC subgroup and 28,7mm for the PC subgroup. At the end of the study the pain was found to be 16,0 mm and 20,7mm respectively. Analysis results confirm a significant reduction in pain from baseline during the treatment (p<0.0 5). The corresponding p-values for time of infusion at Visit 3 and Visit 5 are 0.699 and 0.273, respectively. A significant reduction in FACT-G total score from baseline is apparent during the treatment (p<0.05), primary cancer diagnosis and presence of SRE do not combine to influence the overall mean total score. During the study period 18 patients experienced adverse events. The rate and number of patients experienced adverse events are similar in both groups defined by primary cancer diagnosis. Conclusions: This study showed that treatment with ZOL appeared to be effective and safe to control pain in BC and PC patients with bone metastasis.
Published Version
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