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To: John Hensley who wrote (7172)	4/6/1998 12:26:00 PM
From: John Mattessich	Respond to of 8116

Here's the Journal of Oncology abstract on Quad : jcojournal.org Palliation of Pain Associated With Metastatic Bone Cancer Using Samarium-153 Lexidronam: A Double-Blind Placebo-Controlled Clinical Trial By Aldo N. Serafini, Stephen J. Houston, Isabelle Resche, Donald P. Quick, Frank M. Grund, Peter J. Ell, Alain Bertrand, Frederick R. Ahmann, Eduardo Orihuela, Robert H. Reid, Richard A. Lerski, B. David Collier, James H. McKillop, Gary L. Purnell, Alain P. Pecking, F. Deaver Thomas, and Katherine A. Harrison Purpose: To evaluate the effectiveness and safety of samarium-153 (153Sm) lexidronam (EDTMP) in a double-blind, placebo-controlled study. Patients and Methods: Patients with painful bone metastases secondary to a variety of primary malignancies were randomized to receive 153Sm-EDTMP 0.5 or 1.0 mCi/kg, or placebo. Treatment was unblinded for patients who did not respond by week 4, with those who had received placebo eligible to receive 1.0 mCi/kg of active drug in an open-label manner. Patient and physician evaluations were used to assess pain relief, as was concurrent change in opioid analgesia. Results: One hundred eighteen patients were enrolled onto the study. Patients who received 1.0 mCi/kg of active drug had significant reductions in pain during each of the first 4 weeks in both patient-rated and physician-rated evaluations. Pain relief was observed in 62% to 72% of those who received the 1.0-mCi/kg dose during the first 4 weeks, with marked or complete relief noted in 31% by week 4. Persistence of pain relief was seen through week 16 in 43% of patients who received 1.0 mCi/kg, of active drug. A significant correlation (P = .01) was observed between reductions in opioid analgesic use and pain scores only for those patients who received 1.0 mCi/kg 153Sm-EDTMP. Bone marrow suppression was mild, reversible, and not associated with grade 4 toxicity. Conclusion: A single dose of 1.0 mCi/kg of 153Sm-EDTMP provided relief from pain associated with bone metastases. Pain relief was observed within 1 week of administration and persisted until at least week 16 in the majority of patients who responded. J Clin Oncol 16:1574-1581. Address reprint requests to Aldo N. Serafini, MD, Professor of Radiology and Medicine, Sylvester Comprehensive Cancer Center, Box 016960, Miami, FL 33101. c 1998 by American Society of Clinical Oncology.