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

Oliver Sartor, Robert H. Reid, Peter J. Hoskin, Donald P. Quick, Peter J. Ell, Robert E. Coleman, Jon A. Kotler, Leonard M. Freeman, Pierre Olivier

Research output: Contribution to journalArticle

251 Citations (Scopus)

Abstract

Objectives 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. 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 (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. Results 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. Conclusions 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.

Original languageEnglish (US)
Pages (from-to)940-945
Number of pages6
JournalUrology
Volume63
Issue number5
DOIs
StatePublished - May 2004
Externally publishedYes

Fingerprint

Prostatic Neoplasms
Hormones
Neoplasm Metastasis
Bone and Bones
Pain
Placebos
Therapeutics
Bone Neoplasms
Pain Measurement
Platelet Count
Leukocyte Count
Opioid Analgesics
Analgesics
Leukocytes
Blood Platelets
Bone Marrow
samarium ethylenediaminetetramethylenephosphonate

ASJC Scopus subject areas

  • Urology

Cite this

Sartor, O., Reid, R. H., Hoskin, P. J., Quick, D. P., Ell, P. J., Coleman, R. E., ... Olivier, P. (2004). Samarium-153-lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer. Urology, 63(5), 940-945. https://doi.org/10.1016/j.urology.2004.01.034

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

In: Urology, Vol. 63, No. 5, 05.2004, p. 940-945.

Research output: Contribution to journalArticle

Sartor, O, Reid, RH, Hoskin, PJ, Quick, DP, Ell, PJ, Coleman, RE, Kotler, JA, Freeman, LM & Olivier, P 2004, 'Samarium-153-lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer', Urology, vol. 63, no. 5, pp. 940-945. https://doi.org/10.1016/j.urology.2004.01.034
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. / Samarium-153-lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer. In: Urology. 2004 ; Vol. 63, No. 5. pp. 940-945.
@article{c11d9ec31e4a4d5eb1a2853be62a4d38,
title = "Samarium-153-lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer",
abstract = "Objectives 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. 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 (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. Results 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. Conclusions 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.",
author = "Oliver Sartor and Reid, {Robert H.} and Hoskin, {Peter J.} and Quick, {Donald P.} and Ell, {Peter J.} and Coleman, {Robert E.} and Kotler, {Jon A.} and Freeman, {Leonard M.} and Pierre Olivier",
year = "2004",
month = "5",
doi = "10.1016/j.urology.2004.01.034",
language = "English (US)",
volume = "63",
pages = "940--945",
journal = "Urology",
issn = "0090-4295",
publisher = "Elsevier Inc.",
number = "5",

}

TY - JOUR

T1 - Samarium-153-lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer

AU - Sartor, Oliver

AU - Reid, Robert H.

AU - Hoskin, Peter J.

AU - Quick, Donald P.

AU - Ell, Peter J.

AU - Coleman, Robert E.

AU - Kotler, Jon A.

AU - Freeman, Leonard M.

AU - Olivier, Pierre

PY - 2004/5

Y1 - 2004/5

N2 - Objectives 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. 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 (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. Results 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. Conclusions 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.

AB - Objectives 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. 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 (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. Results 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. Conclusions 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.

UR - http://www.scopus.com/inward/record.url?scp=2342509633&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=2342509633&partnerID=8YFLogxK

U2 - 10.1016/j.urology.2004.01.034

DO - 10.1016/j.urology.2004.01.034

M3 - Article

VL - 63

SP - 940

EP - 945

JO - Urology

JF - Urology

SN - 0090-4295

IS - 5

ER -