How effective is BCNU in recurrent glioblastoma in the modern era? A phase II trial.
BACKGROUND
The initial studies on nitrosoureas were performed >30 years ago. These drugs remain the standard chemotherapy for glioblastoma. However, because the criteria used to evaluate the activity of nitrosoureas in a neuro-oncologic setting have changed, new data on their activity are needed.


METHODS
The authors conducted a phase II study on 40 patients with recurrent glioblastoma following surgery and standard radiotherapy. They analyzed progression-free survival at 6 months (PFS-6), time to progression (TTP), response rate, and toxicity. Patients were treated with 80 mg/m2 carmustine on days 1 to 3, every 8 weeks for a maximum of six cycles.


RESULTS
Median TTP was 13.3 weeks (95% CI, 10.26 to 16.86 weeks), and PFS-6 was 17.5% (95% CI, 8.9 to 34.3). Response to chemotherapy, age < or =40 years, and performance status > or =90 were significant prognostic factors for TTP; however, with multivariate analysis, only response to chemotherapy was significant. The major side effects were reversible hematologic and long-lasting hepatic and pulmonary toxicity.


CONCLUSIONS
The activity of this BCNU regimen is comparable with that reported in the past and with the newest therapies, such as temozolomide. However, BCNU toxicity is high and recovery is slow, thus compromising the administration of further drugs in patients with progressive disease.
Brandes
A A
AA
Department of Medical Oncology, Azienda Ospedale-Università, Ospedale Busonera, Via Gattamelata 64, 35100 Padova, Italy. aabrandes@unipd.it
Tosoni
A
A
Amistà
P
P
Nicolardi
L
L
Grosso
D
D
Berti
F
F
Ermani
M
M
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy*; D002330:Carmustine / Q000009:adverse effects / Q000627:therapeutic use*; D056486:Chemical and Drug Induced Liver Injury; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy*; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008171:Lung Diseases / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy
D018906:Antineoplastic Agents, Alkylating; D002330:Carmustine