Journal of Clinical Oncology, Vol 16, 1574-1581, Copyright © 1998 by American Society of Clinical Oncology
Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial
AN Serafini, SJ Houston, I Resche, DP Quick, FM Grund, PJ Ell, A Bertrand, FR Ahmann, E Orihuela, RH Reid, RA Lerski, BD Collier, JH McKillop, GL Purnell, AP Pecking, FD Thomas and KA Harrison
University of Miami, FL, USA.
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.O-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.
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