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Phase
II Study of Chemotherapy with ACNU Plus Cisplatin Followed by Cranial
Irradiation in Patients with Newly Diagnosed Glioblastoma Multiforme
In
Sil Choi^, Se
Hoon Lee^, Tae-You Kim*, Sun Ha Paek*, Suzy
Kim+, Il Han Kim°, Dae Seog Heo^,Yung-Jue
Bang^, Dong Gyu Kim*, Hee-Won Jung*, Noe Kyeong
Kim^
^Department
of Internal Medicine, Seoul National University College of Medicine, Seoul,
Korea.
*Department of Neurosurgery, Seoul National University College of Medicine,
Seoul, Korea.
+Department of Therapeutic Radiology, Seoul National University College of
Medicine, Seoul, Korea.
°Department of Therapeutic Radiology, Cancer Research Institute, Seoul National
University College of Medicine, Seoul, Korea.
Purpose.
To evaluate the efficacy and toxicity of chemotherapy with ACNU
(1-(4-amino-2-methyl-5-pyrimidinyl)-methyl-(2-chloroethyl)-3-nitrosourea) plus
cisplatin followed by cranial irradiation in patients with newly diagnosed
glioblastoma multiforme.
Patients
and methods.
Between August 1999 and July 2001, previously untreated 30 patients with
histologically confirmed glioblastoma multiforme were treated.
Chemotherapy consisting of up to 2 cycles of 72 h
of continuous intravenous infusion of ACNU (40 mg/m2/day)
and cisplatin (40 mg/m2/d) was given
over a 6-week period.
Radiation was begun 6 weeks after the second cycle of chemotherapy.
Results.
Median age was 48 years (range 18–66 years) and
22 patients with residual measurable disease after surgery were eligible for
response analysis.
One (5%) had a complete response (CR), 36% partial response (PR), 14% stable
disease (SD), and 45% progressive disease (PD) after chemotherapy.
After additional radiation, 22% had CR, 22% PR, 16% SD, and 42% PD.
Grades III and IV leukopenia and thrombocytopenia occurred in 18 cycles (36%)
and 15 cycles (30%), respectively.
No fatal complications occurred. Median time to progression was 5.9 months (95%
CI 5.1–6.8 months) and median overall survival
was 14.9 months (95% CI 9.1–20.7 months).
Conclusions.
Preradiation chemotherapy with ACNU plus cisplatin is effective and feasible in
patients with glioblastoma multiforme.
Keywords:
glioblastoma,
chemotherapy, radiotherapy, phase II trial
Copyright ©
2002 Kluwer Academic Publishers, All rights reserved
Source: http://www.kluweronline.com/issn/0167-594X |