A pilot study was performed administering
PCNU with
radiation therapy to treat patients with high-grade
astrocytomas and to explore the toxic effects of this
drug regimen.
PCNU at an initial dose of 110 mg/m2 i.v. was administered to 14 patients within 4 weeks after completion of
cranial irradiation. Courses were repeated every 6-8 weeks upon recovery from myelosuppression.
Radiation therapy consisted of 5,000 rad to the whole brain followed by an additional 1,500 rad to the
tumor site. Patients were followed by CT scan and neurologic examination. The median survival for the group was 80 weeks. Larger, randomized trials comparing
PCNU to other nitrosoureas will be needed to assess its value as adjuvant
therapy in patients with
malignant gliomas. Myelosuppression, particularly,
thrombocytopenia, was the main toxic effect in this study. Pulmonary infiltrates developed in 2 patients and was progressive and fatal in 1 patient after a total cumulative
PCNU dose of 850 mg/m2. Hepatic dysfunction with
hyperbilirubinemia also developed in 1 patient.
PCNU can produce pulmonary and hepatic toxicity similar to that reported for other nitrosoureas. Regular monitoring of pulmonary and hepatic function tests should be performed during treatment with
PCNU in future trials.