Randomized trials have demonstrated
Gliadel improves survival for appropriately selected patients with newly diagnosed
malignant glioma. As only limited information is available to guide the management of patients who have
Gliadel controlled-release
BCNU wafers implanted in the cranial resection cavity prior to
radiotherapy (RT), this retrospective review was conducted to describe
clinical course, toxicity, and pathologic findings after this
therapy for newly diagnosed
malignant glioma. Forty-six consecutive patients receiving
Gliadel (3.8%
BCNU impregnated wafers) followed by
radiotherapy for newly diagnosed
malignant glioma at Johns Hopkins Hospital from 1990 to August 1999 were identified, although one was lost to follow up and is excluded. Patients were evaluated for postoperative
infection, pathology at reoperation, and survival. Twenty-eight patients received
radiotherapy at Johns Hopkins and these patients are also evaluable for toxicity experienced during and one month after completion of RT. The median age of all patients is 57 years. Eighty-nine percent had
glioblastoma, and median follow-up of surviving
glioblastoma patients is 16.8 (12-20) months. Postoperative
infection or need for reoperation within 30 days was uncommon after
Gliadel placement. Full-dose
radiotherapy was tolerable after
Gliadel implantation. Five patients (19%) developed
neurologic symptoms during
radiotherapy responding to increased
steroids and/or
anticonvulsants, whereas an additional 8 of 27 (30%) developed
neurologic symptoms during
dexamethasone taper that responded to increases in
dexamethasone dose. At one month after RT, 58% of patients were still on
dexamethasone despite attempted taper. Fifteen of 45 patients, 33% underwent reoperation or biopsy for a new local contrast-enhancing lesion. In five of 15 (33%) the reoperation revealed
necrosis or treatment effect without active
tumor. Two of five patients with treatment/effect
necrosis has a third surgery 2.9 and 3.2 months after the initial reoperation, and treatment effect/
necrosis without
tumor was demonstrated in both cases. The Kaplan-Meier median survival for all the
glioblastoma patients is 12.8 (95% CI 9.6, 15.9) months. For
glioblastoma patients under 55 years old, median survival is 15.9 (95% CI 13.5, too few events) months whereas for older patients it is 9.6 (7.7, 14.4) months. We conclude that
Gliadel followed by full-dose standard
radiotherapy is acutely well tolerated, although, close supervision should be emphasized during
dexamethasone taper. Median survival in excess of one year suggests that there are not complications that result in overall premature death. The finding of
necrosis/treatment effect was noted in five of 45 (11%) of all patients and five of 15 (33%) of those undergoing reoperation. Therefore, the possibility of
necrosis/treatment effect should be considered for each patient with radiographic findings suspicious for local recurrence.