Safety and efficacy of repeat administration of samarium Sm-153 lexidronam to patients with metastatic bone pain.

Abstract

BACKGROUND:

Samarium Sm 153 lexidronam (Sm-153) is an effective and well-tolerated treatment for painful bone metastases. The purpose of the analysis was to assess the safety and efficacy of repeated doses of Sm-153 in patients with metastatic bone pain.

METHODS:

Data were collected prospectively for 202 patients administered 1.0 mCi/kg of Sm-153. Particular emphasis was placed on analysis of data from 55 patients receiving > or = 2 doses. Pain scores, adverse events, and hematologic parameters were assessed after each dose.

RESULTS:

Mild, transient suppression of platelets and white blood cell counts was the most common adverse event after treatment. Nadirs were approximately half of baseline at 4 weeks after dosing with recovery by Week 8 in 90% of patients. Temporary grade 3 thrombocytopenia occurred in 11%, 12%, and 17% of patients after the first, second, and third drug administration, respectively. Grade 3 leukopenia occurred in less than 7% of patients independent of the number of administrations. Significant decreases in pain scores (P < .001) were observed at Week 4 after each of the first 3 doses and maintained at Week 8 after the first 2 doses (P < .003) but not the third. Decreases in pain scores were observed in 70%, 63%, and 80% of patients, respectively, at Week 4 after the first 3 administrations.

CONCLUSIONS:

Repeated dosing of 1.0 mCi/kg of Sm-153 was both safe and effective and is a reasonable treatment option in patients whose bone pain responds and then recurs after an initial dose provided that adequate hematologic function is present at the time of drug administration.

• Authors: Oliver Sartor, Robert H Reid, David L Bushnell, Donald P Quick, Peter J Ell
• Journal: Cancer (Cancer) Vol. 109 Issue 3 Pg. 637-43 (Feb 01 2007) ISSN: 0008-543X [Print] United States
• PMID: 17167764 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: (c) 2007 American Cancer Society.

Chemical References

• Analgesics, Non-Narcotic
• Organometallic Compounds
• Organophosphorus Compounds
• Samarium
• samarium Sm-153 lexidronam

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Analgesics, Non-Narcotic (therapeutic use)
• Bone Neoplasms (drug therapy, secondary)
• Breast Neoplasms (drug therapy, pathology)
• Female
• Humans
• Lung Neoplasms (drug therapy, pathology)
• Male
• Middle Aged
• Organometallic Compounds (therapeutic use)
• Organophosphorus Compounds (therapeutic use)
• Pain (drug therapy)
• Pain Measurement
• Palliative Care
• Prospective Studies
• Prostatic Neoplasms (drug therapy, pathology)
• Safety
• Samarium (therapeutic use)