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For enrollment in the trial, patients must have moderate to severe pain -- a score of 4 out of 10 on the Brief Pain Inventory in the previous 24-hour period, and have pain despite previous surgery, radiation, chemotherapy or combinations of these treatments. About 21% of the patients, however, had neither chemotherapy nor radiation upon entry into the study. Patients with spinal cord metastases were excluded. "The iceball that is generated by the cryosurgery covered the entire metastasis and can be seen very easily with computer-assisted tomography monitoring," Dr. Callstrom demonstrated. Upon entry into the study the average pain score was 7.5 -- an indicator of severe pain. That score was reduced an average of 3 points within 4 weeks (P <.0001), Dr. Callstrom said. "A reduction of 2 points is considered clinically meaningful," he noted. The pain reduction was also significant at 8 weeks, decreasing about another point, and was sustained at least as long as 24 weeks. The study also evaluated quality of life status, looking at the effect of pain on activities of daily living. The improvement in quality of life reached statistical significance at 4 weeks (P =.0005) and at 8 weeks (P =.0007), he said. The interference scores were 5 out of 10 prior to the minimally invasive cryoablation procedure and decreased to between 1 and 2 after the treatment. In the follow-up period there have been no major or minor complications reported, he said. The trial is being expanded into a multicenter study. Dr. Callstrom said his study is being supported by Endocare of Irvine, California. [Presentation title: Percutaneous Cryotherapy Treatment of Painful Metastatic Disease Involving Bone: Ongoing Clinical Trial. Abstract SSA02-07] [/list]
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