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Phase II trial of BCNU, temozolamide (TMZ) plus intraarterial cisplatin (CDDP) in unresectable or recurrent high grade glioma Preliminary data suggest that this chemotherapy combination is active and well tolerated.


Posted on: 05/26/2002

Phase II trial of BCNU, temozolamide (TMZ) plus intraarterial cisplatin (CDDP) in unresectable or recurrent high grade glioma

Maria Gonzalez Cao, Javier Aristu, Marta Santisteban, Jose M Ordonez, Jose M Aramendia, Ignacio Bilbao, Oscar Fernandez, Salvador Martin Algarra, Clinica Universitaria de Navarra, Pamplona, Spain.

Objective: To evaluate the efficacy and tolerance of BCNU, TMZ and intraarterial CDDP in high grade glioma after biopsy or partial resection.

Patients and Methods: Treatment consisted on BCNU 100mg iv day (d)1, CDDP 50 mg/m2 ia d1 plus TMZ 150 mg/m2 oral d1-5, every 28 d. Response was assessed by MRI. It was allowed 3D-conformal radiotherapy (RT) and/or stereotactic RT plus concomitant chemotherapy (CBDCA AUC5 weekly plus TMZ 50 mg/m2 daily ) over maximal response to chemotherapy.

Results: Data from the first 19 patients (pts) included are presented. Male/female ratio was 12/7, GBM/AA: 14/5, Biopsy/ partial resection: 5/14. Median age was 44 years (range 27 to 69), median karnofsky index was 70% (range 50% to 90%). There were 9 cases relapsed after prior surgery and/or RT, and the other ten pts were poor prognostic class patients (4, 1, 4 and 1 pt were RTOG prognostic groups VI, V, IV and III, respectively). Three pts received prior chemotherapy. After chemotherapy 12 pts were treated with RT. Median number of cycles of chemotherapy administered per pt was 4 (range 1 to 10). Toxicity GIII-IV was: neutropenia 1 pt, thrombocytopenia 3 pts. One pt had pneumonia without neutropenia. There were 3 cases of transient acute neurotoxicity after intraarterial infusion: 2 pts headache and one pt quadrantanopia. The partial response rate was 42% (8 pts; 95% IC, 20.3 to 66.5); seven additional pts (37%) had stable disease, and four (21%) progressed. After a median follow-up time of 18 months (m), the median overall survival and TTP were 10 m (95%CI: 8;12) and 6 m (95%CI: 4;8) respectively. One-year overall and progression free survival were 32% and 22% respectively.

Conclusions: Our preliminary data suggest that this chemotherapy combination is active and well tolerated in this group of patients with unfavourable prognostic factors.

Source: ASCO 2002 Annual Conference
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