Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: A double-blind placebo-controlled clinical trial

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, Katherine A. Harrison

Research output: Contribution to journalArticlepeer-review

367 Scopus citations


Purpose: To evaluate the effectiveness and safety of samarium-153 (153Sm) lexidronam (EDTMP) in a double-blind, placebo-controlled study. Portents 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.

Original languageEnglish (US)
Pages (from-to)1574-1581
Number of pages8
JournalJournal of Clinical Oncology
Issue number4
StatePublished - Apr 1998
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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