title: A pilot study: 131I-antitenascin monoclonal antibody 81c6 to deliver a 44-Gy resection cavity boost.
abstract: The purpose of this study was to determine the feasibility and assess the efficacy and toxicity, among newly diagnosed malignant glioma patients, of administering (131)I-labeled murine antitenascin monoclonal antibody 81C6 ((131)I-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 (131)I-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 (131)I-81C6. Our study regimen ((131)I-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.
authors.affiliation: Department of Surgery, Division of Neurosurgery, Duke University Medical Center, Durham, NC 27710, USA. reard003@mc.duke.edu
authors.forename: David A
authors.initials: DA
authors.lastname: Reardon
authors.forename: Michael R
authors.initials: MR
authors.lastname: Zalutsky
authors.forename: Gamal
authors.initials: G
authors.lastname: Akabani
authors.forename: R Edward
authors.initials: RE
authors.lastname: Coleman
authors.forename: Allan H
authors.initials: AH
authors.lastname: Friedman
authors.forename: James E
authors.initials: JE
authors.lastname: Herndon
authors.forename: Roger E
authors.initials: RE
authors.lastname: McLendon
authors.forename: Charles N
authors.initials: CN
authors.lastname: Pegram
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Quinn
authors.forename: Jeremy N
authors.initials: JN
authors.lastname: Rich
authors.forename: James J
authors.initials: JJ
authors.lastname: Vredenburgh
authors.forename: Annick
authors.initials: A
authors.lastname: Desjardins
authors.forename: Sridharan
authors.initials: S
authors.lastname: Guruangan
authors.forename: Susan
authors.initials: S
authors.lastname: Boulton
authors.forename: Renee H
authors.initials: RH
authors.lastname: Raynor
authors.forename: Jeanette M
authors.initials: JM
authors.lastname: Dowell
authors.forename: Terence Z
authors.initials: TZ
authors.lastname: Wong
authors.forename: Xiao-Guang
authors.initials: XG
authors.lastname: Zhao
authors.forename: Henry S
authors.initials: HS
authors.lastname: Friedman
authors.forename: Darell D
authors.initials: DD
authors.lastname: Bigner
mesh_terms: D000328:Adult; D000368:Aged; D000818:Animals; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001932:Brain Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy*; D002408:Catheters, Indwelling; D003131:Combined Modality Therapy; D005260:Female; D005910:Glioma / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy*; D006801:Humans; D015552:Injections, Intralesional; D007457:Iodine Radioisotopes / Q000008:administration & dosage*; D053208:Kaplan-Meier Estimate; D008297:Male; D051379:Mice; D008875:Middle Aged; D010865:Pilot Projects; D016499:Radioimmunotherapy / Q000379:methods*; D019063:Tenascin / Q000187:drug effects* / Q000276:immunology
chemical_list: D000911:Antibodies, Monoclonal; D007457:Iodine Radioisotopes; D019063:Tenascin