Safety & Efficacy

QUADRAMET® - A Predictable Safety Profile Helps Keep Treatment Options Open

Mild And Transient Myelosuppression
Incidence of Grade 3 and 4 toxicity was low in clinical trials.1

Toxicity grades

Toxicity grades based on National Cancer Institute criteria; for platelets these are: grade 1, lower limits of normal to 75,000/µL; grade 2, <75,000 to 50,000/µL; grade 3, <50,000 to 25,000/µL; grade 4,
<25,000/µL; for WBCs these are: grade 1, lower limits of normal to 3,000/µL; grade 2, <3,000 to 2,000/µL; grade 3, <2,000 to 1,000/µL; grade 4, <1,000/µL.5

Transient myelosuppression with QUADRAMET.3

Transient myelosuppression

  • WBC and platelet counts decreased consistently to nadirs of 40% to 50% of baseline within 3 to 5 weeks and tended to return to pretreatment levels by week 81, 3

"Recovery to PLT >75,000/mm3 and WBC >3,000/mm3 (toxicity grade 1 or less) by Week 8 occurred in 89.9% (160/178) of patients after an initial administration and 90.4% (66/73) after a second or greater administration." 4

Pain scores in placebo-controlled and multiple-dose studies2-4

Pain scores in placebo-controlled

Pain responses following multiple doses of QUADRAMET were similar to those in pivotal trials2-4

Mean Daily Opioid Analgesic Use Relative to Baseline2

opioid ratio

Patients in the placebo group increased their opioid consumption; patients in the 1.0 mCi/kg Quadramet group decreased their use of opioids.2

Patients who experience a reduction in pain may be encouraged to decrease their use of opioid analgesics.

REFERENCES:

  1. Quadramet® (Samarium Sm 153 Lexidronam Injection) prescribing information. April 2009.
  2. Serafini AN, Houston SJ, Resche I, et al. Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial. J Clin Oncol. 1998;16:1574-1581.
  3. 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.
  4. Sartor O, Reid RH, Bushnell DL, Quick DP, Ell PJ. Safety and efficacy of repeat administration of samarium Sm-153 lexidronam to patients with metastatic bone pain. Cancer. 2006; Dec 13: [Epub ahead of print].
  5. National Cancer Institute Common Terminology Criteria for Adverse Events v3.0 (CTCAE). August 9, 2006. Available at: http://ctep.cancer.gov/forms/CTCAEv3.pdf. Accessed December 6, 2006.