© Copyright 2008 by the Society for Neuro-Oncology
Received November 15, 2006
Accepted June 20, 2007
A pilot study: 131I-Antitenascin monoclonal antibody 81c6 to deliver a 44-Gy resection cavity boost
David A. Reardon 1*,
Michael R. Zalutsky 2,
Gamal Akabani 2,
R. Edward Coleman 2,
Allan H. Friedman 1,
James E. Herndon II 3,
Roger E. McLendon 4,
Charles N. Pegram 4,
Jennifer A. Quinn 5,
Jeremy N. Rich 5,
James J. Vredenburgh 5,
Annick Desjardins 6,
Sridharan Guruangan 1,
Susan Boulton 1,
Renee H. Raynor 1,
Jeanette M. Dowell 7,
Terence Z. Wong 2,
Xiao-Guang Zhao 8,
Henry S. Friedman 1,
Darell D. Bigner 4
1 Department of Surgery, Duke University Medical Center, Durham, NC, USA
2 Department of Radiology and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC, USA
3 Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA
4 Department of Pathology, Duke University Medical Center, Durham, NC, USA
5 Departments of Surgery and Medicine, Duke University Medical Center, Durham, NC, USA
6 Department of Medicine, Duke University Medical Center, Durham, NC, USA
7 Department of Radiation Therapy, Duke University Medical Center, Durham, NC, USA
8 Department of Radiology, Duke University Medical Center, Durham, NC, USA
* To whom correspondence should be addressed. E-mail: reard003{at}mc.duke.edu.
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Abstract |
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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
