Treatment > Carmustine · Chemoresistance · Procarbazine

Meeting Abstract

Procarbazine Prior to and Concomitant with BCNU in Patients with Glioblastoma at First Relapse: a Phase II Study

Alba Ariela Brandes, Mario Ermani, Umberto Basso, Lara Maria Pasetto, Francesca Vastola, Franco Berti, Silvia Berlucchi, Pietro Amistà, Antonello Rotilio, Silvio Monfardini, 

Azienda ospedale-Università di Padova, Padova, ID, Italy

Purpose. A phase II study was conducted in patients (pts) with recurrent or progressive GBM after surgery and radiotherapy. 
Our aim was to investigate the response rate (RR), progression free survival at 6 months (PFS-6) and toxicity of a multidrug combination designed for reversing resistance to BCNU by depletion of the DNA repair enzyme AGT.

Methods. 58 pts were treated with procarbazine 100 mg/m2 on days 1 to 5, BCNU 80 mg/m2 on days 3 to 5 and vincristine 1.4 mg/m2 on day 3, every 8 weeks. 
The mean age was 45.3 years (18-64) and median KPS 80 (60-90). 
The median time from the end of radiotherapy and chemotherapy was 5.6 months (mo).

Results. All 58 pts were evaluable for response and PFS. 
We obtained 6 CR (10.3%; 95% Confidence interval (CI): 2.5-18.2%), 11 PR (19%; CI: 8.9-29%), 17 stable disease (SD) (29.3%; CI: 17.6-41%). 
The overall median time to progression was 4.8 mo (CI: 3.8-6.7 mo), 9.5 for CR, 11.6 for PR and 5.9 for SD. 
PFS-6 and PFS-12 were 42.3% (CI: 31.2-57.3%) and 15.4% (CI: 7.8-30.2%), respectively.

Toxicity. 137 cycles were administered, 14.5% delayed for a median of 2.7 weeks and 22% delivered at 75% of the dosage; 10 pts (17%) were withdrawn early due to toxicity. 
Neutropenia and thrombocytopenia were grade 3 in 8.6 and 17.2% of pts, respectively, and grade 4 in 5 and 12% of pts; hepatic and pulmonary toxicity was grade 3 in 2.2% and 8.6% of pts, respectively.

Conclusion. This regimen gave higher RR and PFS-6 than other new drugs, though at the price of a substantial toxicity.

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