HER2 Support Group Forums - View Single Post - ~Quadramet Question~Lani, Rich, Becky...anyone??

Rich66 · 06-23-2009, 09:19 AM

1: Cancer. 2007 Feb 1;109(3):637-43.

Links

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

Sartor O, Reid RH, Bushnell DL, Quick DP, Ell PJ.
Lank Center for Genitourinary Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA. oliver_sartor@dfci.harvard.edu
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. (c) 2007 American Cancer Society.
PMID: 17167764 [PubMed - indexed for MEDLINE]

Maybe less relevant:
1: Int J Radiat Biol. 2009 May;85(5):448-53.

Links

Bone marrow recovery following use of systemic (153)Sm-lexidronam and (89)Sr-chloride for bone pain palliation after myelosuppressive therapy.

Papatheofanis FJ, Najib MM.
Department of Radiology, Rebecca and John Moores UCSD Comprehensive Cancer Center, University of California, San Diego, USA.
PURPOSE: Using plasma flt3 ((FMS (Friend murine strain))-like tyrosine kinase 3)-ligand cytokine (FL) as a biomarker, the purpose of this study was to determine whether patients receiving palliative radionuclide treatment following chemotherapy experienced enhanced myelosuppression. MATERIALS AND METHODS: A total of 48 patients with solid tumors who failed multi-agent chemotherapy were investigated; they previously received 1-3 cycles of combination chemotherapy over 4-10 months. Patients were divided into four cohorts including 10 patients with early stage solid tumors prior to chemotherapy induction (naive group), 10 patients with (non-metastatic) malignancy actively undergoing chemotherapy without radionuclide follow-up (chemotherapy-alone group), 13 patients who underwent standard (1.0 mCi/kg) dose (153)Sm ((153)samarium)-lexidronam therapy following chemotherapy ((153)Sm group), and 15 patients who underwent standard (4 mCi) dose (89)Sr ((89)strontium)-chloride therapy following chemotherapy ((89)Sr group). Plasma FL was measured using a quantitative sandwich enzyme immunoassay and CBC (complete blood count), measuring WBC (white blood cell) and PLT (platelet), was performed. RESULTS: Plasma FL concentration demonstrated a gradual decrease after chemotherapy. In patients who received (153)Sm within two weeks of completing chemotherapy, there is a distinguishable spike in FL concentration at approximately three weeks after dose administration, which precedes a decrease in WBC and PLT counts. On the other hand, a spike in FL levels in patients who received (89)Sr therapy is noted at approximately 10 weeks (p < 0.034). CONCLUSIONS: Increases in FL concentration associated with (153)Sm-lexidronam therapy following combination chemotherapy occurred earlier and returned to control levels more rapidly than did those in patients similarly treated with (89)Sr. These differences might be associated with the shorter decay half-life and lower particle emission energies of (153)Sm.
PMID: 19437245 [PubMed - in process]

Googling around, can't find anything noting brain side effects other than those inherent to anesthesia.
FWIW, a consent form for quadramet administration that mentions anesthesia:
http://www.virginia.edu/uvaprint/HSC/pdf/041172.pdf

06-23-2009, 09:19 AM	#2
Rich66 Senior Member Join Date: Feb 2008 Location: South East Wisconsin Posts: 3,431	1: Cancer. 2007 Feb 1;109(3):637-43. Links Safety and efficacy of repeat administration of samarium Sm-153 lexidronam to patients with metastatic bone pain. Sartor O, Reid RH, Bushnell DL, Quick DP, Ell PJ. Lank Center for Genitourinary Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA. oliver_sartor@dfci.harvard.edu 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. (c) 2007 American Cancer Society. PMID: 17167764 [PubMed - indexed for MEDLINE] Maybe less relevant: 1: Int J Radiat Biol. 2009 May;85(5):448-53. Links Bone marrow recovery following use of systemic (153)Sm-lexidronam and (89)Sr-chloride for bone pain palliation after myelosuppressive therapy. Papatheofanis FJ, Najib MM. Department of Radiology, Rebecca and John Moores UCSD Comprehensive Cancer Center, University of California, San Diego, USA. PURPOSE: Using plasma flt3 ((FMS (Friend murine strain))-like tyrosine kinase 3)-ligand cytokine (FL) as a biomarker, the purpose of this study was to determine whether patients receiving palliative radionuclide treatment following chemotherapy experienced enhanced myelosuppression. MATERIALS AND METHODS: A total of 48 patients with solid tumors who failed multi-agent chemotherapy were investigated; they previously received 1-3 cycles of combination chemotherapy over 4-10 months. Patients were divided into four cohorts including 10 patients with early stage solid tumors prior to chemotherapy induction (naive group), 10 patients with (non-metastatic) malignancy actively undergoing chemotherapy without radionuclide follow-up (chemotherapy-alone group), 13 patients who underwent standard (1.0 mCi/kg) dose (153)Sm ((153)samarium)-lexidronam therapy following chemotherapy ((153)Sm group), and 15 patients who underwent standard (4 mCi) dose (89)Sr ((89)strontium)-chloride therapy following chemotherapy ((89)Sr group). Plasma FL was measured using a quantitative sandwich enzyme immunoassay and CBC (complete blood count), measuring WBC (white blood cell) and PLT (platelet), was performed. RESULTS: Plasma FL concentration demonstrated a gradual decrease after chemotherapy. In patients who received (153)Sm within two weeks of completing chemotherapy, there is a distinguishable spike in FL concentration at approximately three weeks after dose administration, which precedes a decrease in WBC and PLT counts. On the other hand, a spike in FL levels in patients who received (89)Sr therapy is noted at approximately 10 weeks (p < 0.034). CONCLUSIONS: Increases in FL concentration associated with (153)Sm-lexidronam therapy following combination chemotherapy occurred earlier and returned to control levels more rapidly than did those in patients similarly treated with (89)Sr. These differences might be associated with the shorter decay half-life and lower particle emission energies of (153)Sm. PMID: 19437245 [PubMed - in process] Googling around, can't find anything noting brain side effects other than those inherent to anesthesia. FWIW, a consent form for quadramet administration that mentions anesthesia: http://www.virginia.edu/uvaprint/HSC/pdf/041172.pdf