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Samarium-153-lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer

Sartor, O; Reid, RH; Hoskin, PJ; Quick, DP; Ell, PJ; Coleman, RE; Kotler, JA; ... Quadrament 424Sm10-11 Study Grp, ; + view all (2004) Samarium-153-lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer. UROLOGY , 63 (5) 940 - 945. 10.1016/j.urology.2004.01.034.

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Abstract

Objectives. A Phase III randomized trial was designed to assess the effectiveness of samarium-153 (Sm-153)-lexidronam for palliation of bone pain in patients with hormone-refractory prostate cancer.Methods. A total of 152 men with hormone-refractory prostate cancer and painful bone metastases were enrolled in a prospective, randomized, double-blind trial comparing radioactive ((SM)-S-153) versus nonradioactive (Sm-152) lexidronam complexes. Patients were randomized (2:1) to the radioactive (Sm-153) agent. Patient diaries recording daily pain and analgesic use were completed during a planned 16-week evaluation period. Nonresponders were informed of the treatment received after 4 weeks of treatment and, if initially treated with placebo, were allowed to receive Sm-153-lexidronam in an open-label fashion. Pain was measured using validated patient-derived visual analog scales and pain descriptor scales.Results. Sm-153-lexidronam had positive effects on measures of pain relief compared with placebo within I to 2 weeks. Reductions in opioid use were recorded at weeks 3 and 4. Because nonresponders were unblinded at week 4, statistical comparisons between the arms beyond week 4 were not possible. Mild, transient bone marrow suppression was the only adverse event associated with S-153 m-lexidronam administration. The mean nadir white blood cell and platelet count (3 to 4 weeks after treatment) was 3800/muL and 127,000/muL, respectively. Counts recovered to baseline after approximately 8 weeks. No grade 4 decreases in either platelets or white bloods cells were documented.Conclusions. These findings demonstrate that 1 mCi/kg S-153 m-lexidronam is both safe and effective for the palliation of painful bone metastases in patients with hormone-refractory prostate cancer. (C) 2004 Elsevier Inc.

Type: Article
Title: Samarium-153-lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer
DOI: 10.1016/j.urology.2004.01.034
Keywords: SAMARIUM-153-EDTMP, TRIAL, EDTMP
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > Research Department of Oncology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Metabolism and Experi Therapeutics
URI: http://discovery.ucl.ac.uk/id/eprint/100166
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