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

• Published in: Urology (Ridgewood, N.J.) Vol. 63; no. 5; pp. 940 - 945
• Main Authors: Sartor, Oliver, Reid, Robert H, Hoskin, Peter J, Quick, Donald P, Ell, Peter J, Coleman, Robert E, Kotler, Jon A, Freeman, Leonard M, Olivier, Pierre
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.05.2004; Elsevier Science
• Subjects: Aged; Aged, 80 and over; Biological and medical sciences; Bone Diseases - drug therapy; Bone Diseases - etiology; Bone Neoplasms - drug therapy; Bone Neoplasms - secondary; Double-Blind Method; Drug Combinations; Gynecology. Andrology. Obstetrics; Humans; Male; Male genital diseases; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; Organometallic Compounds - therapeutic use; Organophosphorus Compounds - therapeutic use; Pain - drug therapy; Pain - etiology; Pain Measurement; Prospective Studies; Prostatic Neoplasms; Radioisotopes - adverse effects; Radioisotopes - therapeutic use; Samarium - adverse effects; Samarium - therapeutic use; Tumors; Tumors of the urinary system; Urinary tract. Prostate gland; Hormone; Nephrology; Urinary system disease; Prostate disease; Malignant tumor; Metastasis; Complexes; Urology; Refractory; Pain; Treatment; Bone; Male genital diseases; Prostate cancer
• ISSN: 0090-4295; 1527-9995
• DOI: 10.1016/j.urology.2004.01.034

A Phase III randomized trial was designed to assess the effectiveness of samarium-153 ( 153Sm)-lexidronam for palliation of bone pain in patients with hormone-refractory prostate cancer. 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 ( 153Sm) versus nonradioactive ( 152Sm) lexidronam complexes. Patients were randomized (2:1) to the radioactive ( 153Sm) 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 153Sm-lexidronam in an open-label fashion. Pain was measured using validated patient-derived visual analog scales and pain descriptor scales. 153Sm-lexidronam had positive effects on measures of pain relief compared with placebo within 1 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 153Sm-lexidronam administration. The mean nadir white blood cell and platelet count (3 to 4 weeks after treatment) was 3800/μL and 127,000/μL, respectively. Counts recovered to baseline after approximately 8 weeks. No grade 4 decreases in either platelets or white bloods cells were documented. These findings demonstrate that 1 mCi/kg 153Sm-lexidronam is both safe and effective for the palliation of painful bone metastases in patients with hormone-refractory prostate cancer.