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Clinical Therapy Trials - Other |
2a and 13-cis-retinoic acid with radiation treatment for high-grade glioma
Hoag Cancer Center, Newport Beach, CA 92658 (R.O.D., M.S., K.M., N.M.B.); Bloomington Hospital, Bloomington, IN 47402 (D.F.T., B.R.K., M.M.P.); Central Office of the Cancer Biotherapy Research Group Franklin, TN 37068 (C.K.C., C.D.)
3 Address correspondence and reprint requests to Robert O. Dillman, Medical Director, Hoag Cancer Center, One Hoag Drive, Building 41, Newport Beach, CA 92658.
Abstract
Interferon-
(IFN-) has been safely given concurrently with radiation
therapy (RT) in treating gliomas. As single agents, both IFN- and
cis-retinoic acid (CRA) have produced objective tumor regressions in
patients with recurrent gliomas. In vitro, IFN-2a and CRA enhance
radiation therapy effects on glioblastoma cells more than either agent alone.
This trial was conducted to determine the clinical effects of IFN-2a
and CRA when given concurrently with radiation therapy to patients with
high-grade glioma. Newly diagnosed patients with high-grade glioma received
IFN-2a at a dosage of 3 to 6 million IU s.c. 4 times a day for 3 days
per week and 1 mg/kg CRA by mouth 4 times a day for 5 days per week during the
delivery of partial brain radiation therapy at 180 cGy x 33 fractions
for 5 days per week for a total of 59.4 Gy during the 7-week period. Use of
the antiepileptic phenytoin was prohibited after observing that the
combination of IFN-2a, CRA, and phenytoin was associated with a high
rate of dermatologic toxicity not seen in a previous study with concurrent
IFN-2a and radiation therapy. Forty patients (26 men and 14 women) with
a median age of 60 (range, 19 to 81 years) were enrolled between August 1996
and October 1998. Histopathologic diagnoses were glioblastoma multiforme or
grade 4 anaplastic astrocytoma in 36 patients, and grade 3 anaplastic
astrocytoma in 4 patients. Only 4 patients (10%) underwent a gross total
resection of tumor prior to this therapy; 50% were asymptomatic when treatment
was initiated. The planned 7-week course of concurrent therapy was completed
by 75% of patients; 30% completed the 16-week course of IFN- and CRA
alone. At a median follow-up of 36 months, there were 37 deaths, with a median
overall survival of 9.3 months and a 1-year survival rate of 42%. There was no
improvement in survival compared with a similar group of 19 patients treated
with concurrent IFN-2a and radiation therapy in a previous trial. In
the highrisk group of patients in the present study, concurrent treatment with
IFN-2a, CRA, and RT was feasible, but was not associated with a better
outcome compared with a similar patient population treated with radiation
therapy and IFN-2a, or compared with radiation therapy alone in other
trials.
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