Treatment > Temozolomide Clinical Trials

Meeting Abstract

Temozolomide in First Line Treatment of Recurrent or Residual Malignant Brain Tumors

Alessandra Cassano, Raffaele Longo, Lucia Angelelli, Marco Ciaparrone, Michela Quirino, Giovanni Schinzari, Chiara Battelli, Michele Basso, Carmelo Pozzo, Carlo Barone

Oncologia Medica - Università Cattolica del Sacro Cuore, Rome, Italy

Background. First line treatment of brain tumors consists of surgery associated with radiotherapy and chemotherapy. 
CT prolongs time to progression and median survival time. 
Even with aggressive treatment using surgery, radiation and CT median survival is less than 1 year. 
Temozolomide (TMZ), a imidazotetrazine second-generation alkylating agent, is a new effective compound that enters the cerebrospinal fluid and has 100% oral bioavailability. 

Aim. The study evaluates the efficacy (with a primary end point of progression free survival) and safety of TMZ in patients with recurrent or residual malignant brain tumors. 

Patients and Methods. 22 pts were enrolled; the median age was 45,2 years. 
16 pts were male, 6 female. 
Histological subtypes were anaplastic astrocytomas (6 pts), glioblastoma multiforme (12) and oligodendroglioma (4). 
Patients were treated with TMZ (150-200 mg/mq daily, days 1-5, every 28 days). 
The median number of courses was 5.1. 

Results. All patients were evaluable for toxicity, 17 for response. 
Response assessment was established by RMN every 3 courses of treatment. 
4 pts had PR (23%), 7 SD (41%) and 6 PD (35%). 
No CR was observed. 
Median overall survival and median time to progression are not still reached. 
6 months survival rate was 78%. 
Adverse events were mild to moderate, with piastrinopenia occurring in 4 pts (18%), gastrointestinal side effects in 2 pts (9,1%) and hepatic toxicity in 1 pt (4,5%). 
Toxicity did not cause treatment interruption. 

Conclusion. TMZ is effective as a single agent in the treatment of malignant brain tumors with an accettable safety profile. 
Full results (including PFS) will be presented at the meeting. 

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