title: Phase II trial of pre-irradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligoastrocytomas: long term results of RTOG BR0131.
abstract: We report on the long-term results of a phase II study of pre-irradiation temozolomide followed by concurrent temozolomide and radiotherapy (RT) in patients with newly diagnosed anaplastic oligodendroglioma (AO) and mixed anaplastic oligoastrocytoma. Pre-RT temozolomide was given for up to 6 cycles. RT with concurrent temozolomide was administered to patients with less than a complete radiographic response. Forty eligible patients were entered and 32 completed protocol treatment. With a median follow-up time of 8.7 years (range 1.1-10.1), median progression-free survival (PFS) is 5.8 years (95 % CI 2.0, NR) and median overall survival (OS) has not been reached (5.9, NR). 1p/19q data are available in 37 cases; 23 tumors had codeletion while 14 tumors had no loss or loss of only 1p or 19q (non-codeleted). In codeleted patients, 9 patients have progressed and 4 have died; neither median PFS nor OS have been reached and two patients who received only pre-RT temozolomide and no RT have remained progression-free for over 7 years. 3-year PFS and 6-year OS are 78 % (95 % CI 61-95 %) and 83 % (95 % CI 67-98 %), respectively. Codeleted patients show a trend towards improved 6-year survival when compared to the codeleted procarbazine/CCNU/vincristrine (PCV) and RT cohort in RTOG 9402 (67 %, 95 % CI 55-79 %). For non-codeleted patients, median PFS and OS are 1.3 and 5.8 years, respectively. These updated results suggest that the regimen of dose intense, pre-RT temozolomide followed by concurrent RT/temozolomide has significant activity, particularly in patients with 1p/19q codeleted AOs and MAOs.
authors.affiliation: Cleveland Clinic Foundation, 9500 Euclid Avenue, ND40, Cleveland, OH, 44195, USA. vogelbm@ccf.org.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Vogelbaum
authors.affiliation: RTOG Statistical Center, 1818 Market Street, Suite 1600, Philadelphia, PA, 19103, USA.
authors.forename: Chen
authors.initials: C
authors.lastname: Hu
authors.affiliation: Cleveland Clinic Foundation, 9500 Euclid Avenue, ND40, Cleveland, OH, 44195, USA.
authors.forename: David M
authors.initials: DM
authors.lastname: Peereboom
authors.affiliation: University of Western Ontario London Regional Cancer Centre, 790 Commissioners Road East, London, ON, N6A 4L6, Canada.
authors.forename: David R
authors.initials: DR
authors.lastname: Macdonald
authors.affiliation: Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
authors.forename: Caterina
authors.initials: C
authors.lastname: Giannini
authors.affiliation: Cleveland Clinic Foundation, 9500 Euclid Avenue, ND40, Cleveland, OH, 44195, USA.
authors.forename: John H
authors.initials: JH
authors.lastname: Suh
authors.affiliation: Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
authors.forename: Robert B
authors.initials: RB
authors.lastname: Jenkins
authors.affiliation: Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
authors.forename: Nadia N
authors.initials: NN
authors.lastname: Laack
authors.affiliation: Arizona Oncology Services Foundation, PO Box 41700, Phoenix, AZ, 85080, USA.
authors.forename: David G
authors.initials: DG
authors.lastname: Brachman
authors.affiliation: University of Utah Health Science Center, 1950 Circle of Hope, Salt Lake City, UT, 84112, USA.
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Shrieve
authors.affiliation: McGill University, 1650 Cedar Avenue, Montreal, QC, H3G 1A4, Canada.
authors.forename: Luis
authors.initials: L
authors.lastname: Souhami
authors.affiliation: University of Maryland, 655 West Baltimore Street, Baltimore, MD, 21201-1559, USA.
authors.forename: Minesh P
authors.initials: MP
authors.lastname: Mehta
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000628:therapy*; D003606:Dacarbazine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009837:Oligodendroglioma / Q000628:therapy*; D011878:Radiotherapy / Q000379:methods*; D012189:Retrospective Studies; D000077204:Temozolomide; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide
keywords: 1p/19q loss of heterozygosity; MGMT; Oligodendroglioma; RTOG; Temozolomide