Journal article
Safety Analysis of Repeated High Doses of Samarium-153 Lexidronam in Men with Hormone-Naive Prostate Cancer Metastatic to Bone
Clinical genitourinary cancer, Vol.6(1), pp.40-45
2008
DOI: 10.3816/CGC.2008.n.007
PMID: 18501082
Abstract
The safety and tolerability of repetitive doses of the boneseeking radiopharmaceutical samarium-153 lexidronam (
153Sm- EDTMP) were investigated in men with hormone-naive prostate cancer metastatic to bone.
Within 30 days of initiating androgen deprivation, the first of 4 planned doses of
153Sm- EDTMP given every 12 weeks was administered. Growth factors were not permitted. The first cohort of 6 patients received
153Sm-EDTMP at 2 mCi/kg per dose; 3 patients completed all 4 doses and 3 received 3 doses.
There were 7 episodes of grade 3 neutropenia and 1 each of grade 3 and 4 thrombocytopenia. Of 6 patients in the second cohort who received
153Sm-EDTMP 2.5 mCi/kg per dose, only 1 received all 4 doses. Four events of grade 3 neutropenia and 2 events of grade 3 thrombocytopenia were reported. The 12-week dose schedule resulted in persistent low-grade thrombocytopenia and/or leukopenia, which prevented administration of all 4 planned doses. As a result, the dose of
153Sm-EDTMP was decreased to 2 mCi/kg for a total of 3 doses administered every 16 weeks. Five of 6 patients in this cohort received all 3 doses of
153Sm-EDTMP. There were 7 episodes of reversible grade 3 neutropenia. For all 18 patients on the study, there were no drug-related serious adverse events or grade 4 nonhemmatologic toxicities.
In men with hormone-naive prostate cancer metastatic to bone, the feasible dose and schedule for repreated doses of
153Sm-EDTMP is 2 mCi/kg given every 16 weeks for 3 doses.
Details
- Title: Subtitle
- Safety Analysis of Repeated High Doses of Samarium-153 Lexidronam in Men with Hormone-Naive Prostate Cancer Metastatic to Bone
- Creators
- Celestia S. Higano - University of Washington Medical CenterDonald P. Quick - Joe Arrington Cancer Research & Treatment Center, Lubbock, TXDavid Bushnell - Veterans Health AdministrationOliver Sartor - Dana-Farber Cancer Institute
- Resource Type
- Journal article
- Publication Details
- Clinical genitourinary cancer, Vol.6(1), pp.40-45
- Publisher
- Elsevier Inc
- DOI
- 10.3816/CGC.2008.n.007
- PMID
- 18501082
- ISSN
- 1558-7673
- eISSN
- 1938-0682
- Language
- English
- Date published
- 2008
- Academic Unit
- Radiology
- Record Identifier
- 9984318706702771
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