• Moderate, predictable, and transient myelosuppression1

NEWS & PUBLICATIONS

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JUST PUBLISHED - QUADRAMET CLINICAL SAFETY UPDATES:

Phase I Study of Samarium - 153 Lexidronam With Docetaxel in Castration-Resistant Metastatic Prostate Cancer

-Morris MJ, et al. J Clin Oncol. May 20, 2009; Vol.27, No 15

Phase I Study of Concurrent Weekly Docetaxel and Repeated Samarium-153 Lexidronam in Patients With Castration-Resistant Metastatic Prostate Cancer

-Tu S, Mathew P, Wong FC, Jones D, Johnson MM, Logothetis CJ, Journal of Clinical Oncology 2009 May; JCO.2008.20.5393v1

Phase II Trial of Consolidation Docetaxel and Samarium-153 in Patients With Bone Metastases From Castration-Resistant Prostate Cancer

-Fizazi K, Beuzeboc P, Lumbroso J, Haddad V, Massard C, Gross-Goupil M, Di Palma M, et. al., Journal of Clinical Oncology 2009 May; 27:2429-2435

Quadramet Publications:

Samarium-153-lexidronam Complex for Treatment of Painful Bone Metastases in Hormone-Refractory Prostate Cancer (PDF 265KB)

- Sartor O, Reid RH, Hoskin PJ, et al. Urology. 2004;63:940-945

  • The results of this study demonstrated that Samarium-153-lexidronam (153Sm-lexidronam) is safe and effective for the relief of the pain of bone metastases in patients with hormone-refractory prostate cancer.

Safety and Efficacy of Repeat Administration of Samarium Sm-153 Lexidronam to Patients With Metastatic Bone Pain (PDF 191KB)

- Sartor O, Reid RH, Bushnell DL, et al. Cancer. 2007;109:637-643.

  • Repeated administration of Sm-153 is both efficacious and well tolerated in the treatment of bone pain and adverse events did not increase with repeat dosing of Sm-153.

Palliation of Pain Associated With Metastatic Bone Cancer Using Samarium-153 Lexidronam: A Double-Blind Placebo-Controlled Clinical Trial (PDF 193KB)

- Serafini AN, Houston SJ, Resch I, et al. J Clin Oncol. 1998;16:574-1581.

  • A single intravenous dose of 1.0 mCi/kg of 153Sm-EDTMP provided efficacy with relatively mild and reversible hematologic effects in patients with pain associated with bone metastases.

A Dose-Controlled Study of 153Sm-Ethylenediaminetetramethylenephosphonate (EDTMP) in the Treatment of Patients With Painful Bone Metastases (PDF 167KB)

- Resche I, Chatal J-F, Pecking A, et al. Eur J Cancer. 1997;33:1583-1591.

  • The 1.0 mCi/kg dose was found to be safe and effective for the treatment of painful bone metastases. Excellent efficacy and well-defined toxicity may make 153Sm-EDTMP appropriate for use in earlier stages of treatment of metastases.

Samarium for Osteoblastic Bone Metastases and Osteosarcoma (PDF 1MB)

- Anderson P. Expert Opin. Pharmacother. (2006) 7(11):1475-1486.

  • The data presented indicate that 153Sm-EDTMP in standard doses (0.5 - 2.5 mCi/kg) is an easy-to-administer cancer treatment that has high osteoblastic bone lesion uptake and a very favorable side-effect profile.

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REFERENCES:

  1. Sartor O, Reid RH, Hoskin PJ, et al. Samarium-153-Lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer. Urology. 2004;63:940-945.

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