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Neuro-Oncology Working Group 01 Trial of Nimustine Plus Teniposide Versus
Nimustine Plus Cytarabine Chemotherapy in Addition to Involved-Field
Radiotherapy in the First-Line Treatment of Malignant Glioma
The Neuro-Oncology Working Group of the German Cancer Society
From the Neuro-Oncology Working Group of the German Cancer
Society, Germany. Address reprint requests to Michael Weller, MD, Department of Neurology,
University of Tübingen, Medical School, Hoppe-Seyler-Strasse 3, 72076 Tübingen,
Germany; e-mail: michael.weller@uni-tuebingen.de.
Purpose. The role of chemotherapy in the primary treatment of
malignant glioma remains controversial.
The results from the German-Austrian
Glioma trial (GAG, 1983 to 1988) demonstrated a survival benefit for
chemotherapy using carmustine (BCNU) plus teniposide (VM26) over BCNU
alone in addition to radiotherapy in patients with a Karnofsky
performance score (KPS) more than 60.
The Neuro-Oncology Working
Group (NOA) of the German Cancer Society therefore compared the
efficacy of nimustine (ACNU) plus VM26 and ACNU plus cytarabine
(Ara-C) chemotherapy in addition to standard radiotherapy in patients
with newly diagnosed malignant glioma. Patients and Methods.
From 1994 to 2000, 375 patients were
randomly assigned to receive radiotherapy and cycles of ACNU 90 mg/m2
intravenously (IV) on day 1 and VM26 60 mg/m2 IV on days 1 to
3 (n = 183), or ACNU 90 mg/m2 IV on day 1 and Ara-C 120 mg/m2
IV on days 1 to 3 (n = 179), in 6-week intervals.
Thirteen patients were
not eligible after central neuropathology review.
The remaining 362
patients had glioblastoma (n = 301) or anaplastic glioma (n = 61). Results.
Median survival and 2-year survival rates were 17.3
months and 25% for ACNU plus VM26, and 15.7 months and 29% for ACNU
plus Ara-C in glioblastoma, and 60 months and 88% for ACNU plus VM26
and 62.5 months and 72% for ACNU plus Ara-C in anaplastic glioma.
Multivariate analysis revealed no survival advantage for either arm
or for subpopulations defined by histology, age, or KPS.
Hematologic
toxicity was more prominent in the ACNU plus Ara-C arm. Conclusion.
The median survival times and 2-year survival rates
for patients with anaplastic glioma and glioblastoma achieved in
the NOA-01 trial compare favorably with historical trials and with
the Radiation Therapy Oncology Group database.
The toxicity profile
favors ACNU plus VM26 for further evaluation.
© 2003 American Society for Clinical Oncology
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