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Temozolomide
and cisplatin for the treatment of glioblastoma: A phase II study
E.
Franceschi, L. Scopece, G. Cavallo, R. Degli Esposti, F. Spagnolli, S. Rimondini,
R. Conforti, E. Palmerini, S. Gori, L. Crino
Bellaria
Hospital, Bologna, Italy; Monteluce Hospital, Perugia, Italy
Prognosis
of glioblastoma (GBM) remains poor with a median survival of 10-12 months after
surgery and radiotherapy (RT).
Chemotherapy has shown limited activity and there is a large opportunity to
investigate new drugs and new regimens to improve results in malignant gliomas.
In recent years Temozolomide has shown activity in the treatment of GBMs as
single agent both in first and second line and cisplatin based chemotherapy has
been reported active in clinical trials in high grade gliomas.
On the basis of these considerations we designed a phase II study to investigate
activity and safety of the combination of TMZ/CDDP as primary chemotherapy in
patients with newly-diagnosed GBM, presenting with evaluable disease after
biopsy or partial resection.
Radiotherapy was planned at the end of induction chemotherpay.
Treatment consisted of TMZ 200 mg/mq/die days 1-5 and cisplatin (CDDP) 25 mg/mq/die
days 1-3 in a 28-day cycle, and was administered for 3-4 cycles before RT.
Primary endpoint were activity (in terms of progression free survival at 6
months and disease control rate) and toxicity; secondary end point was overall
survival (OS).
14 patients were included from june 2001 to december 2002; median age: 61 years;
median PS: 2.
Location was multifocal 3, multilobar 4, cerebellar 2, lobar/deep 5.
Surgery consisted of partial resection and biopsy.
9 patients were evaluable for response and toxicity.
Toxicity evaluated during 32 cycles included grade 3-4 toxicities:
trombocytopenia n 1; neutropenia n 1.
No neutropenic fever was found.
Peripheral neuropathy occurred in 0 pz.
Response after chemotherapy included PR 3/9, SD 0/9 and PD 6/9.
The median PFS was 4 months, PFS-6 was 33.3%.
Median survival was 9 months.
The trial accrual is still ongoing and final results will be presented at the
meeting.
© Copyright 2003
American Society of Clinical Oncology All rights
reserved worldwide
Source: http://www.asco.org/ac/1,1003,_12-002489-00_18-002003-00_19-00103697-00_29-00A,00.asp?cat=CNS+Tumors&parent=
Central+Nervous+System+Tumors&returnpid=2325&SubCat_ID=4 |
