© 2004 by Society
© 2004 by the Society forNeuro-Oncology
Suramin and radiotherapy in newly diagnosed glioblastoma: Phase 2 NABTTCNS Consortium study
The Sidney Kimmel Comprehensive Cancer Center at JohnsHopkins, Baltimore, MD 21231 (J.J.L., S.A.G., K.A.C); Department of Hematology and Oncology, Wake ForestUniversity Baptist Medical Center, Winston-Salem, NC 27157 (G.J.L.); Brain Tumor Center, Massachusetts General Hospital, Boston,MA 02114 (F.H.H.); and Department of Neuro-Oncology,The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030(M.R.G.); USA
2 Address correspondence to John Laterra, c/o The NABTT CNS Consortium, G87Cancer Research Building, 1650 Orleans Street, Baltimore, MD 21231, USA(jfisher{at}jhmi.edu).
| Abstract |
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Suramin is a polysulfonated naphthylurea that inhibits the function ofgrowth factors and growth factor receptors implicated in glioma progression,angiogenesis, and radioresistance. The safety and benefits of combininginhibitors of angiogenesis and growth factors with cytotoxic therapies inpatients with neoplasms of the central nervous system remain unclear. Theobjectives of this phase 2 study were to determine the safety of administeringsuramin with standard cranial radiotherapy (RT) and to estimate survival usingthis approach in patients with newly diagnosed glioblastoma multiforme (GBM).Fifty-five patients with newly diagnosed GBM (Karnofsky performance status
60) were enrolled in this multicenter phase 2 study. Patients receivedsuramin by a conventional intermittent fixed-dosing regimen for 1 week priorto and during cranial RT (60 Gy in 30 fractions, weeks 2-7). Patients withstable or responsive disease at week 18 received an additional 4 weeks ofsuramin (weeks 19-22). The median survival for suramin-treated patients was11.6 months, with 1-year and 18-month survival rates of 49% (95% confidenceinterval [CI], 36%-62%) and 18% (95% CI, 8%-28%), respectively. Overall, 55%of the patients (30/55) had greater than grade 2 toxicity at least possiblyrelated to suramin therapy. Two patients died of possibly related neurologicevents (i.e., stroke, elevated intracranial pressure). Otherwise, toxicitieswere generally transient and self-limited. Administration of suramin using anintermittent fixed-dosing regimen during cranial RT was generally welltolerated. However, overall survival is not significantly improved whencompared with the New Approaches to Brain Tumor Therapy GBM database or othercomparable patient populations.
Received April 14, 2003; Accepted July 25, 2003
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