Wednesday, December 30, 2009
WEDNESDAY, Dec. 30 (HealthDay News) -- Figitumumab -- a fully human IgG2 monoclonal antibody -- appears safe for use in sarcoma, with observable anti-tumor activity, according to research published online Dec. 24 in The Lancet Oncology.
David Olmos, M.D., of the Institute of Cancer Research in Sutton, U.K., and colleagues analyzed data from 29 patients with sarcoma -- largely Ewing's sarcoma -- aged 9 years and older in a phase 1 dose-escalation study. Patients received intravenous figitumumab at the maximum feasible dose of 20 milligrams per kilogram every three to four weeks until disease progression or excessive toxicity.
The researchers found that grade 3 adverse events included deep venous thrombosis, vomiting, and back pain in one patient each. One patient had a grade 4 elevated concentration of uric acid; another patient had grade 3 or 4 increases in aspartate aminotransferase, gammaglutamyltransferase, and alanine aminotransferase. Two patients with Ewing's sarcoma had complete or partial responses, and another eight had disease stabilization for at least four months.
"In conclusion, our results show that figitumumab can be safe for both adult and pediatric sarcoma patients, and has single-agent anti-tumor activity in different sarcoma subtypes, including Ewing's sarcoma. Phase 2 studies of figitumumab and other anti-IGF-R agents in Ewing's sarcoma and other sarcoma subtypes are now completing accrual and rational combinations with other treatments are also being pursued," the authors write.
The study was funded by Pfizer, which employs several of the co-authors. Three other co-authors also reported financial associations with Pfizer.
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