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Published in: Journal of Neuro-Oncology 2/2008

01-09-2008 | Clinical-patient studies

Temozolomide three weeks on and one week off as first line therapy for patients with recurrent or progressive low grade gliomas

Authors: A. Tosoni, E. Franceschi, M. Ermani, R. Bertorelle, L. Bonaldi, V. Blatt, Alba A. Brandes

Published in: Journal of Neuro-Oncology | Issue 2/2008

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Abstract

Background: Patients with recurrent or progressive low grade gliomas survive for a decade or more following diagnosis, and may be at a higher risk for treatment-related complications, such as cognitive impairment from radiotherapy. Purpose: The aim of the present study was to determine in patients with progressive or recurrent low grade gliomas, the response rate and toxicity incurred by a continued schedule of temozolomide chemotherapy administered before radiation therapy, and to explore correlations between response and survival with 1p/19q deletions and MGMT promoter methylation status. Methods: Progressive radio and chemotherapy naïve low grade glioma patients with O6-methyl-guanine-DNA-methyl-tranferase (MGMT) promoter status evaluation were considered eligible. Chemotherapy cycles consisted of temozolomide 75 mg/m2/daily for 21 days every 28 days for 12 cycles. Results: A total of 30 patients (median age 45 [range: 24.2–68.6] years) with a median KPS of 90 (range 60–90) were accrued. The overall response rate was 30% (9 partial responses); 17 patients (56.7%) had disease stabilization. Conclusion: The prolonged temozolomide schedule considered in the present study is followed by a high response rate; toxicity is acceptable. Further randomized trials should therefore be conducted to confirm the efficacy of this regimen as first-line therapy in patients with progressive low grade glioma.
Literature
1.
go back to reference CBTRUS, C.B.t.r.o.t.U.S. (2004) Primary brain tumors in the United States. Statistical report 1997–2001 CBTRUS, C.B.t.r.o.t.U.S. (2004) Primary brain tumors in the United States. Statistical report 1997–2001
2.
go back to reference Brandes AA, Tosoni A, Kortmann RD (2003) Guidelines for the management and treatment of low-grade gliomas. Forum (Genova) 13:4–17 Brandes AA, Tosoni A, Kortmann RD (2003) Guidelines for the management and treatment of low-grade gliomas. Forum (Genova) 13:4–17
3.
go back to reference Denny BJ, Wheelhouse RT, Stevens MF, Tsang LL, Slack JA (1994) NMR and molecular modeling investigation of the mechanism of activation of the antitumor drug temozolomide and its interaction with DNA. Biochemistry 33:9045–9051PubMedCrossRef Denny BJ, Wheelhouse RT, Stevens MF, Tsang LL, Slack JA (1994) NMR and molecular modeling investigation of the mechanism of activation of the antitumor drug temozolomide and its interaction with DNA. Biochemistry 33:9045–9051PubMedCrossRef
4.
go back to reference Tolcher AW, Gerson SL, Denis L et al (2003) Marked inactivation of O6-alkylguanine-DNA alkyltransferase activity with protracted temozolomide schedules. Br J Cancer 88:1004–1011PubMedCrossRef Tolcher AW, Gerson SL, Denis L et al (2003) Marked inactivation of O6-alkylguanine-DNA alkyltransferase activity with protracted temozolomide schedules. Br J Cancer 88:1004–1011PubMedCrossRef
5.
go back to reference Denis L, Tolcher A, Figueroa et al (2000) Protracted daily administration of temozolomide is feasible: a phase I and pharmacokinetic—pharmacodynamic study. In ASCO Proceedings, 2000 Annual Meeting, abstract number 786 Denis L, Tolcher A, Figueroa et al (2000) Protracted daily administration of temozolomide is feasible: a phase I and pharmacokinetic—pharmacodynamic study. In ASCO Proceedings, 2000 Annual Meeting, abstract number 786
6.
go back to reference Brandes AA, Tosoni A, Cavallo G et al (2006) Temozolomide 3 weeks on and 1 week off as first-line therapy for recurrent glioblastoma: phase II study from gruppo italiano cooperativo di neuro-oncologia (GICNO). Br J Cancer 95:1155–1160PubMedCrossRef Brandes AA, Tosoni A, Cavallo G et al (2006) Temozolomide 3 weeks on and 1 week off as first-line therapy for recurrent glioblastoma: phase II study from gruppo italiano cooperativo di neuro-oncologia (GICNO). Br J Cancer 95:1155–1160PubMedCrossRef
7.
go back to reference Tosoni A, Cavallo G, Ermani M et al (2006) Is protracted low-dose temozolomide feasible in glioma patients? Neurology 66:427–429PubMedCrossRef Tosoni A, Cavallo G, Ermani M et al (2006) Is protracted low-dose temozolomide feasible in glioma patients? Neurology 66:427–429PubMedCrossRef
8.
go back to reference Kovacs JA, Masur H (2000) Prophylaxis against opportunistic infections in patients with human immunodeficiency virus infection. N Engl J Med 342:1416–1429PubMedCrossRef Kovacs JA, Masur H (2000) Prophylaxis against opportunistic infections in patients with human immunodeficiency virus infection. N Engl J Med 342:1416–1429PubMedCrossRef
9.
go back to reference Macdonald DR, Cascino TL, Schold SC Jr, Cairncross JG (1990) Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol 8:1277–1280PubMed Macdonald DR, Cascino TL, Schold SC Jr, Cairncross JG (1990) Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol 8:1277–1280PubMed
10.
go back to reference Kaplan E, Meier P (1958) Non parametric estimation for incomplete observation. J Am Stat Assoc 53:457–481CrossRef Kaplan E, Meier P (1958) Non parametric estimation for incomplete observation. J Am Stat Assoc 53:457–481CrossRef
11.
go back to reference Palmisano WA, Divine KK, Saccomanno G et al (2000) Predicting lung cancer by detecting aberrant promoter methylation in sputum. Cancer Res 60:5954–5958PubMed Palmisano WA, Divine KK, Saccomanno G et al (2000) Predicting lung cancer by detecting aberrant promoter methylation in sputum. Cancer Res 60:5954–5958PubMed
12.
go back to reference van Engeland M, Weijenberg MP, Roemen GMJM et al (2003) Effects of dietary folate and alcohol intake on promoter methylation in sporadic colorectal cancer: the Netherlands cohort study on diet and cancer. Cancer Res 63:3133–3137PubMed van Engeland M, Weijenberg MP, Roemen GMJM et al (2003) Effects of dietary folate and alcohol intake on promoter methylation in sporadic colorectal cancer: the Netherlands cohort study on diet and cancer. Cancer Res 63:3133–3137PubMed
13.
go back to reference Simon R (1989) Designs for efficient clinical trials. Oncology (Huntingt) 3:43–49 discussion 51–43 Simon R (1989) Designs for efficient clinical trials. Oncology (Huntingt) 3:43–49 discussion 51–43
14.
go back to reference Brada M, Viviers L, Abson C et al (2003) Phase II study of primary temozolomide chemotherapy in patients with WHO grade II gliomas. Ann Oncol 14:1715–1721PubMedCrossRef Brada M, Viviers L, Abson C et al (2003) Phase II study of primary temozolomide chemotherapy in patients with WHO grade II gliomas. Ann Oncol 14:1715–1721PubMedCrossRef
15.
go back to reference Hoang-Xuan K, Capelle L, Kujas M et al (2004) Temozolomide as initial treatment for adults with low-grade oligodendrogliomas or oligoastrocytomas and correlation with chromosome 1p deletions. J Clin Oncol 22:3133–3138PubMedCrossRef Hoang-Xuan K, Capelle L, Kujas M et al (2004) Temozolomide as initial treatment for adults with low-grade oligodendrogliomas or oligoastrocytomas and correlation with chromosome 1p deletions. J Clin Oncol 22:3133–3138PubMedCrossRef
16.
go back to reference Pace A, Vidiri A, Galie E et al (2003) Temozolomide chemotherapy for progressive low-grade glioma: clinical benefits and radiological response. Ann Oncol 14:1722–1726PubMedCrossRef Pace A, Vidiri A, Galie E et al (2003) Temozolomide chemotherapy for progressive low-grade glioma: clinical benefits and radiological response. Ann Oncol 14:1722–1726PubMedCrossRef
17.
go back to reference Hoang-Xuan K, He J, Huguet S, Mokhtari K et al (2001) Molecular heterogeneity of oligodendrogliomas suggests alternative pathways in tumor progression. Neurology 57:1278–1281PubMed Hoang-Xuan K, He J, Huguet S, Mokhtari K et al (2001) Molecular heterogeneity of oligodendrogliomas suggests alternative pathways in tumor progression. Neurology 57:1278–1281PubMed
18.
go back to reference Quinn JA, Reardon DA, Friedman AH et al (2003) Phase II trial of temozolomide in patients with progressive low-grade glioma. J Clin Oncol 21:646–651PubMedCrossRef Quinn JA, Reardon DA, Friedman AH et al (2003) Phase II trial of temozolomide in patients with progressive low-grade glioma. J Clin Oncol 21:646–651PubMedCrossRef
19.
go back to reference Mariani L, Deiana G, Vassella E et al (2006) Loss of heterozygosity 1p36 and 19q13 is a prognostic factor for overall survival in patients with diffuse WHO grade 2 gliomas treated without chemotherapy. J Clin Oncol 24:4758–4763PubMedCrossRef Mariani L, Deiana G, Vassella E et al (2006) Loss of heterozygosity 1p36 and 19q13 is a prognostic factor for overall survival in patients with diffuse WHO grade 2 gliomas treated without chemotherapy. J Clin Oncol 24:4758–4763PubMedCrossRef
20.
go back to reference Kujas M, Lejeune J, Benouaich-Amiel A et al (2005) Chromosome 1p loss: a favorable prognostic factor in low-grade gliomas. Ann Neurol 58:322–326PubMedCrossRef Kujas M, Lejeune J, Benouaich-Amiel A et al (2005) Chromosome 1p loss: a favorable prognostic factor in low-grade gliomas. Ann Neurol 58:322–326PubMedCrossRef
21.
go back to reference Everhard S, Kaloshi G, Criniere E et al (2006) MGMT methylation: a marker of response to temozolomide in low-grade gliomas. Ann Neurol 60:740–743PubMedCrossRef Everhard S, Kaloshi G, Criniere E et al (2006) MGMT methylation: a marker of response to temozolomide in low-grade gliomas. Ann Neurol 60:740–743PubMedCrossRef
22.
go back to reference Komine C, Watanabe T, Katayama Y, Yoshino A, Yokoyama T, Fukushima T (2003) Promoter hypermethylation of the DNA repair gene O6-methylguanine-DNA methyltransferase is an independent predictor of shortened progression free survival in patients with low-grade diffuse astrocytomas. Brain Pathol 13:176–184PubMed Komine C, Watanabe T, Katayama Y, Yoshino A, Yokoyama T, Fukushima T (2003) Promoter hypermethylation of the DNA repair gene O6-methylguanine-DNA methyltransferase is an independent predictor of shortened progression free survival in patients with low-grade diffuse astrocytomas. Brain Pathol 13:176–184PubMed
Metadata
Title
Temozolomide three weeks on and one week off as first line therapy for patients with recurrent or progressive low grade gliomas
Authors
A. Tosoni
E. Franceschi
M. Ermani
R. Bertorelle
L. Bonaldi
V. Blatt
Alba A. Brandes
Publication date
01-09-2008
Publisher
Springer US
Published in
Journal of Neuro-Oncology / Issue 2/2008
Print ISSN: 0167-594X
Electronic ISSN: 1573-7373
DOI
https://doi.org/10.1007/s11060-008-9600-y

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