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A phase II trial of temozolomide and oral VP-16 for adults with recurrent malignant glioma

Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)


Posted on: 06/14/2003

39th ASCO Annual Meeting • Chicago, IL • May 31-June 3, 2003 (Abstract No. 447)

A phase II trial of temozolomide and oral VP-16 for adults with recurrent malignant glioma

D. Korones, M. Benita-Weiss, T. E. Coyle, P. Bushunow, L. Mechtler, H. S. Friedman

University of Rochester Medical Center, Rochester, NY; SUNY Health Science Center, Syracuse, NY; Rochester General Hospital, Rochester, NY; Dent Neurologic Institute, Buffalo, NY; Duke University Medical Center, Durham, NC

We conducted a phase I study of temozolomide and escalating doses of oral VP-16 for adults with recurrent malignant glioma, and established the maximum tolerated dose at temozolomide, 150 mg/m2/d, days 1-5, and oral VP-16, 50 mg/m2/d, days 1-12.

We then used this dose in a phase II trial for adults with progressive malignant glioma to determine response to this regimen and duration of progression-free survival (PFS).

Patients were enrolled from 5 centers and were eligible if they were > 18 years old, had a WHO performance status of < 2, and had MRI-documented evidence of progression of glioblastoma (GBM), gliosarcoma, anaplastic astrocytoma (AA), anaplastic oligoastrocytoma (AOA), or anaplastic oligodendroglioma (AO).

All patients received temozolomide 150 mg/m2/d, days 1-5, and oral VP-16, 50 mg/m2/d, days 1-12.

Clinical and radiographic response was assessed after every 2 cycles. Twenty-three patients have thus far been enrolled.

Their diagnoses include GBM (19), AA (2), and AOA (2).

The median WHO score was 1, and median age 54 years (range 32-71). Median follow-up is 4 months (1 to 14 months).

Eighteen (78%) were on enzyme-inducing anticonvulsants, and 20 (87%) were on dexamethasone.

Eighteen patients were enrolled at first recurrence, and 5 at second recurrence.

All 23 had received prior radiotherapy, and 16 (70%) had been treated with chemotherapy.

Of the 19 patients evaluable thus far for response, 3 had a partial response (PR), 1 had a minor response (MR), 11 had stable disease (SD), and 4 had progressive disease (PD).

Responses for the 15 evaluable patients with GBM included 2 with PR, 1 MR, 9 SD, and 3 with PD.

Responses for the 4 patients with anaplastic gliomas included 1 with PR, 2 SD, and 1 PD.

Progression-free survival at 6 months in the 16 patients evaluable is 44%. (67% for the 12 GBM patients.).

One patient had fever, neutropenia, and died of overwhelming gram-negative sepsis.

Four other patients had grade 3 or 4 hematotoxicity, but there were no other grade 3 or 4 drug-related toxicities.

In sum this combination oral chemotherapy regimen is well-tolerated, and demonstrates activity in patients with recurrent malignant glioma.

© Copyright 2003 American Society of Clinical Oncology All rights reserved worldwide Source:,1003,_12-002489-00_18-002003-00_19-00103385-00_29-00A,00.asp?cat=CNS+Tumors&parent= Central+Nervous+System+Tumors&returnpid=2325&SubCat_ID=4

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