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This Article Full Text Full Text (PDF) All Versions of this Article: 10/2/182    most recent 15228517-2007-053v1 Alert me when this article is cited Alert me if a correction is posted Citation Map Services Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Google Scholar Articles by Reardon, D. A. Articles by Bigner, D. D. PubMed PubMed Citation

A pilot study: ¹³¹I-Antitenascin monoclonal antibody 81c6 to deliver a 44-Gy resection cavity boost

Departments of Surgery (D.A.R., A.H.F., J.A.Q., J.N.R., J.J.V., S.G., S.B., R.H.R., H.S.F.), Medicine (J.A.Q., J.N.R., J.J.V., A.D.), Pathology (R.E.M., C.N.P., D.D.B.), Radiation Therapy (J.M.D.), Radiology (X.-G.Z.), Radiology and Cancer Center Biostatistics (M.R.Z., G.A., R.E.C., T.Z.W.), Biostatistics and Bioinformatics (J.E.H.), Duke University Medical Center, Durham, NC, USA

Address correspondence to David A. Reardon, M.D., Department of Surgery, Division of Neurosurgery, Duke University Medical Center, Box 3624, Durham, NC 27710, USA (reard003{at}mc.duke.edu).

The purpose of this study was to determine the feasibility and assess the efficacy and toxicity, among newly diagnosed malignant glioma patients, of administering ¹³¹I-labeled murine antitenascin monoclonal antibody 81C6 (¹³¹I-81C6) into a surgically created resection cavity (SCRC) to achieve a patient-specific, 44-Gy boost to the 2-cm SCRC margin. A radioactivity dose of ¹³¹I-81C6 calculated to achieve a 44-Gy boost to the SCRC was administered, followed by conventional external beam radiotherapy (XRT) and chemotherapy. Twenty-one patients were enrolled in the study: 16 with glioblastoma multiforme (GBM) and 5 with anaplastic astrocytoma. Twenty patients received the targeted 44-Gy boost (±10%) to the SCRC. Attributable toxicity was mild and limited to reversible grade 3 neutropenia or thrombocytopenia (n = 3; 14%), CNS wound infections (n = 3; 14%), and headache (n = 2; 10%). With a median follow-up of 151 weeks, median overall survival times for all patients and those with GBM are 96.6 and 90.6 weeks, respectively; 87% of GBM patients are alive at 1 year. It is feasible to consistently achieve a 44-Gy boost dose to the SCRC margin with patient-specific dosing of ¹³¹I-81C6. Our study regimen (¹³¹I-81C6 + XRT + temozolomide) was well tolerated and had encouraging survival. To determine if selection of good-prognosis patients affects outcome associated with this approach, the U.S. Food and Drug Administration has approved a trial randomizing newly diagnosed GBM patients to either our study regimen or standard XRT plus temozolomide.

Key Words: glioblastoma multiforme • malignant glioma • monoclonal antibody • radioimmunotherapy