Treatment > Cisplatin · Temozolomide Clinical Trials

Meeting Abstract

First line chemotherapy with cisplatin plus fractionated temozolomide (bid) in recurrent glioblastoma (GBM)

Mario Ermani, Alba A Brandes, Lara M Pasetto, Umberto Basso, Michele Reni, Sergio Turazzi, Silvia Berlucchi, Paolo Iuzzolino, Giampietro Pinna, Renato Scienza, Silvio Monfardini

Azienda Ospedale-Universita, Padova, Italy; Istituto San Raffaele, Milano, Italy; Azienda Ospedale-Universita, Verona, Italy

Background. Cisplatin (DDP) and temozolomide (TMZ) showed a synergistic effect in glioma cell lines, and a bid regimen of TMZ administration achieved strong inhibition of AGT with high response rates (RR) in high grade gliomas. 

Objectives. Evaluate progression free survival at 6 months (PFS-6), RR and toxicity of the association of DDP and bid TMZ for five days in a multicenter phase II trial. 

Methods. Chemonaive patients (pts) with GBM recurring or progressing after surgery and standard radiotherapy were eligible. 
Chemotherapy regimen consisted in DDP 75 mg/m² on day 1, TMZ 130 mg/m² bolus followed by nine doses of 70 mg/m² every 12 hours, every 4 weeks. 
In the absence of hematological toxicity, TMZ was escalated to 1,000 mg/m² in five days. 
Response was assessed according to McDonald’s criteria. 

Results. From February to November 2001, 23 pts (12 men) were enrolled, median age was 51 years (range 27-59). 
After a median observation of 5.6 months, 20 pts were evaluable for toxicity, and 18 for response. 
We obtained 4 PR (22%), and 8 (44%) stabilizations of disease (SD). 
Median time to progression (TTP) was 5.9 months, with a PFS-6 of 33%. 
A total of 72 cycles was delivered, on average 3.1 per pt. 
Hematological toxicity was: G4 neutropenia in 1 pt (5%), G3 thrombocytopenia in 3 (15%), and G3 anemia in 1 (5%). Nausea and vomiting were G1-2 in 3 pts (15%), and constipation G1-2 in 3 (17%). 
Peripheral neurological toxicity was observed in one pt (5%); 3 pts discontinued DDP, one because of G3 tinnitus, one for pulmonary embolism, and one for acute cholecystitis. 

Conclusions. This new regimen of DDP plus bid TMZ is effective in chemonaive recurrent GBM, with acceptable toxicity.

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