Phase II study of chemotherapy with ACNU plus cisplatin followed by cranial irradiation in patients with newly diagnosed glioblastoma multiforme.
OBJECTIVE
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.


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 gliobiastoma multiforme.
Choi
In Sil
IS
Department of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Lee
Se Hoon
SH
Kim
Tae-You
TY
Bang
Jae Seug
JS
Paek
Sun Ha
SH
Kim
Suzy
S
Kim
Il Han
IH
Heo
Dae Seog
DS
Bang
Yung-Jue
YJ
Kim
Dong Gyu
DG
Jung
Hee-Won
HW
Kim
Noe Kyeong
NK
D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D015376:Nimustine / Q000008:administration & dosage* / Q000009:adverse effects; D016019:Survival Analysis
D000970:Antineoplastic Agents; D015376:Nimustine; D002945:Cisplatin