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Randomized phase II study of temozolomide (TMZ) with and without the matrix metalloprotease (MMP) inhibitor prinomastat in patients (pts) with glioblastoma multiforme (GBM) following best surgery and radiation therapy No significant difference between survival rate of pt treated with temodar + prinomastat vs temodar + placebo.


Posted on: 05/26/2002

Randomized phase II study of temozolomide (TMZ) with and without the matrix metalloprotease (MMP) inhibitor prinomastat in patients (pts) with glioblastoma multiforme (GBM) following best surgery and radiation therapy

VA Levin, S Phuphanich, M J Glantz, W P Mason, MD Groves, LD Recht, M Shaffrey, V Puduvalli, B Roeck, MH Zhang, M A Collier, M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; U Massachusetts, Boston, MA; Pencer Brain Tumor Ctr, Toronto, ON, Canada; U Virginia Health Sys, Charlottesville, VA; Pfizer Global Research and Development - La Jolla/Agouron Pharmaceuticals Inc, La Jolla, CA.

Prinomastat (AG3340) is a potent, selective MMP inhibitor. MMPs are a family of enzymes that degrade the extracellular matrix and facilitate tumor growth, invasion, metastasis, and neovascularization. MMP2 and 9 expression is upregulated in gliomas. Prinomastat administration inhibits tumor growth and prolongs survival in several murine glioma xenograft models. Between 4/00 and 8/01, 86 newly diagnosed GBM pts were randomized to daily prinomastat (25 mg BID orally) (n=43) or placebo (n=43), plus TMZ (200 mg/m2/d, d1-5, every 28 d) following surgery and RT. Median age (55 yr), KPS (90%), and extent of surgery were well-balanced between treatment groups. Chemotherapy-related adverse experiences were comparable between the two arms. The main prinomastat-related side-effect was moderate (grade 2) musculoskeletal toxicity (arthralgia, myalgia, joint stiffness and swelling), observed in 55% of prinomastat- and 20% of placebo-treated pts. Grade 2 toxicity lasting 3 wks was managed with prinomastat treatment rest and dose reduction. Median survival (12 vs 15 mo), progression-free survival (4.5 vs 6.3 mo), and 1-yr survival (44 vs 58%) did not differ significantly between the prinomastat- and placebo-treated groups. Prinomastat 25 mg BID can be safely administered with TMZ to pts with GBM following RT, but efficacy is not enhanced over TMZ alone.

Source: ASCO 2002 Annual Conference
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