Premium
A phase III study of radiation therapy plus carmustine with or without recombinant interferon‐α in the treatment of patients with newly diagnosed high‐grade glioma
Author(s) -
Buckner Jan C.,
Schomberg Paula J.,
McGinnis William L.,
Cascino Terrence L.,
Scheithauer Bernd W.,
O'Fallon Judith R.,
Morton Roscoe F.,
Kuross Steven A.,
Mailliard James A.,
Hatfield Alan K.,
Cole John T.,
Steen Preston D.,
Bernath Albert M.
Publication year - 2001
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(20010715)92:2<420::aid-cncr1338>3.0.co;2-3
Subject(s) - medicine , carmustine , anaplastic astrocytoma , glioma , radiation therapy , gliosarcoma , performance status , oncology , proportional hazards model , surgery , astrocytoma , chemotherapy , cancer research , etoposide
BACKGROUND The current study was conducted to determine whether the addition of interferon‐α (IFN‐α) to treatment with radiation therapy and carmustine (BCNU) improves time to disease progression or overall survival in patients with high‐grade glioma. METHODS Patients with anaplastic astrocytoma, anaplastic oligoastrocytoma, glioblastoma multiforme, or gliosarcoma received radiation therapy plus BCNU as initial therapy. Subsequently, patients without tumor progression at the completion of radiation therapy were stratified by age, extent of surgery, tumor grade and histology, Eastern Cooperative Oncology Group performance status, and treating institution, and then were randomly assigned to receive either BCNU alone (200 mg/m 2 on Day 1) or BCNU (150 mg/m 2 on Day 3) plus IFN—α (12 million U/m 2 on Days 1–3, Weeks 1, 3, and 5) every 7 weeks for a maximum of 6 cycles. RESULTS Of the 383 patients enrolled in the study, 275 eligible patients were randomized. There was no significant difference with regard to time to disease progression or overall survival between the two groups. Patients receiving IFN‐α experienced more fever, chills, myalgias, and neurocortical symptoms including somnolence, confusion, and exacerbation of neurologic deficits. Cox multivariate regression models confirmed known favorable prognostic variables including younger age, Grade 3 tumor (according to World Health Organization criteria), and greater extent of surgery. Cox and classification and regression tree analysis models also demonstrated that a normal baseline Folstein mini‐mental status examination (MMSE) score was associated with better prognosis. CONCLUSIONS IFN‐α does not appear to improve time to disease progression or overall survival in patients with high‐grade glioma and appears to add significantly to toxicity. The baseline MMSE score may serve as an independent prognostic factor and warrants further investigation. Cancer 2001;92:420–33. © 2001 American Cancer Society.