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)

British Journal of Cancer

Volumn 95, Issue 9, 2006, Pages 1155-1160

  Brandes, A A ^a   Tosoni, A ^b   Cavallo, G ^a   Bertorelle, R ^b   Gioia, V ^c   Franceschi, E ^a   Biscuola, M ^b   Blatt, V ^b   Crino L ^d   Ermani, M ^e  

^a BELLARIA HOSPITAL   (Italy)

^b VENETO INSTITUTE OF ONCOLOGY IOV IRCCS   (Italy)

^c Azienda USL di Bologna   (Italy)

^d Hospital of Perugia   (Italy)

^e UNIVERSITY OF PADOVA   (Italy)

Author keywords

Clinical trials; Glioblastoma; MGMT; Prolonged temozolomide

Indexed keywords

METHYLATED DNA PROTEIN CYSTEINE METHYLTRANSFERASE; TEMOZOLOMIDE;

ADULT; AGED; ANEMIA; ARTICLE; CANCER GRADING; CANCER GROWTH; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; GLIOBLASTOMA; HERPES ZOSTER; HUMAN; LYMPHOCYTOPENIA; MALE; METHYLATION; NAUSEA; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RECURRENT CANCER; THROMBOCYTOPENIA; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION;

ADULT; AGED; ANEMIA; ANTINEOPLASTIC AGENTS, ALKYLATING; BRAIN NEOPLASMS; CONSTIPATION; DACARBAZINE; DISEASE PROGRESSION; DNA METHYLATION; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLIOBLASTOMA; HUMANS; LYMPHOPENIA; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; O(6)-METHYLGUANINE-DNA METHYLTRANSFERASE; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 33750432843     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6603376     Document Type: Article

References (30)

1. Brada M, Hoang-Xuan K, Rampling R, Dietrich PY, Dirix LY, Macdonald D, Heimans JJ, Zonnenberg BA, Bravo-Marques JM, Henriksson R, Stupp R, Yue N, Bruner J, Dugan M, Rao S, Zaknoen S (2001) Multicenter phase II trial of temozolomide in patients with glioblastoma multiforme at first relapse. Ann Oncol 12: 259-266
2. Brandes AA (2003) State-of-the-art treatment of high-grade brain tumors. Semin Oncol 30: 4-9
3. Brandes AA, Ermani M, Basso U, Paris MK, Lumachi F, Berti F, Amista P, Gardiman M, Iuzzolino P, Turazzi S, Monfardini S (2002) Temozolomide in patients with glioblastoma at second relapse after first line nitrosourea-procarbazine failure: a phase II study. Oncology 63: 38-41
4. Brock CS, Newlands ES, Wedge SR, Bower M, Evans H, Colquhoun I, Roddie M, Glaser M, Brampton MH, Rustin GJ (1998) Phase I trial of temozolomide using an extended continuous oral schedule. Cancer Res 58: 4363-4367
5. Chinot O, Barrié M, Cournède A, Dufor H, Figarella-Branger D, Braguer D, Peragut JC, Grisoli F (2005) Phase II study of temozolomide (TMZ) administered on a 7 days on-7days off regimen as primary treatment before radiotherapy (RT) in inoperable newly diagnosed glioblastoma multiforme (GBM). J Clin Oncol, ASCO Annual Meeting Proc 23(16S, Part I of II, June 1 Suppl): 1523
6. Denis L, Tolcher A, Figueroa J, Drengler R, Geyer C, Eckhardt S, Cutler D, Reyderman L, Von Hoff D, Rowinsky E (2000) Protracted daily administration of temozolomide is feasible: a phase I and pharmacokinetic - Pharmacodynamic Study. ASCO Proc 19(abs. n. 786)
7. 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: 9045-9051
8. 6-alkylguanine-DNA alkyltransferase analysis and response to Temodal in newly diagnosed malignant glioma. J Clin Oncol 16: 3851-3857
9. 6-benzylguanine for patients with recurrent or progressive malignant glioma. J Clin Oncol 18: 3522-3528
10. Gerson SL (2004) MGMT: its role in cancer aetiology and cancer therapeutics. Nat Rev Cancer 4: 296-307
11. 6- benzylguanine plus BCNU. Blood 88: 1649-1655
12. 6-methylguanine-DNA methyltransferase promoter methylation in glioblastoma patients treated with temozolomide. Clin Cancer Res 10: 1871-1874
13. Hegi ME, Diserens AC, Gorlia T, Hamou MF, de Tribolet N, Weller M, Kros JM, Hainfellner JA, Mason W, Mariani L, Bromberg JE, Hau P, Mirimanoff RO, Cairncross JG, Janzer RC, Stupp R (2005) MGMT gene silencing and benefit from temozolomide in glioblastoma. N Engl J Med 352: 997-1003
14. Herman JG, Graff JR, Myohanen S, Nelkin BD, Baylin SB (1996) Methylation-specific PCR: a novel PCR assay for methylation status of CpG islands. Proc Natl Acad Sci USA 93: 9821-9826
15. Kaplan E, Meier P (1958) Non parametric estimation for incomplete observation. J Am Stat Assoc 53: 457-481
16. Khan RB, Raizer JJ, Malkin MG, Bazylewicz KA, Abrey LE (2002) A phase II study of extended low-dose temozolomide in recurrent malignant gliomas. Neuro-oncol 4: 39-43
17. Kovacs JA, Masur H (2000) Prophylaxis against opportunistic infections in patients with human immunodeficiency virus infection. N Engl J Med 342: 1416-1429
18. Kurzen H, Schmitt S, Naher H, Mohler T (2003) Inhibition of angiogenesis by non-toxic doses of temozolomide. Anticancer Drugs 14: 515-522
19. Macdonald DR, Cascino TL, Schold Jr SC, Cairncross JG (1990) Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol 8: 1277-1280
20. Middleton MR, Lunn JM, Morris C, Rustin G, Wedge SR, Brampton MH, Lind MJ, Lee SM, Newell DR, Bleehen NM, Newlands ES, Calvert AH, Margison GP, Thatcher N (1998) O6-methylguanine-DNA methyltransferase in pretreatment tumour biopsies as a predictor of response to temozolomide in melanoma. Br J Cancer 78: 1199-1202
21. Palmisano WA, Divine KK, Saccomanno G, Gilliland FD, Baylin SB, Herman JG, Belinsky SA (2000) Predicting lung cancer by detecting aberrant promoter methylation in sputum. Cancer Res 60: 5954-5958
22. Paz MF, Yaya-Tur R, Rojas-Marcos I, Reynes G, Pollan M, Aguirre-Cruz L, Garcia-Lopez JL, Piquer J, Safont MJ, Balana C, Sanchez-Cespedes M, Garcia-Villanueva M, Arribas L, Esteller M (2004) CpG island hypermethylation of the DNA repair enzyme methyltransferase predicts response to temozolomide in primary gliomas. Clin Cancer Res 10: 4933-4938
23. Simon R (1989) Designs for efficient clinical trials. Oncology (Huntingt) 3: 43-49; discussion 51-53
24. Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO (2005) Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 352: 987-996
25. Su YB, Sohn S, Krown SE, Livingston PO, Wolchok JD, Quinn C, Williams L, Foster T, Sepkowitz KA, Chapman PB (2004) Selective CD4+ lymphopenia in melanoma patients treated with temozolomide: a toxicity with therapeutic implications. J Clin Oncol 22: 610-616
26. 6-alkylguanine-DNA alkyltransferase activity with protracted temozolomide schedules. Br J Cancer 88: 1004-1011
27. van Engeland M, Weijenberg MP, Roemen GM, Brink M, de Bruine AP, Goldbohm RA, van den Brandt PA, Baylin SB, de Goeij AF, Herman JG (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: 3133-3137
28. Wick W, Steinbach JP, Kuker WM, Dichgans J, Bamberg M, Weller M (2004) One week on/one week off: a novel active regimen of temozolomide for recurrent glioblastoma. Neurology 62: 2113-2115
29. Wick W, Weller M (2005) How lymphotoxic is dose-intensified temozolomide? The glioblastoma experience. J Clin Oncol 23: 4235-4236; author reply 4236
30. Yung WK, Albright RE, Olson J, Fredericks R, Fink K, Prados MD, Brada M, Spence A, Hohl RJ, Shapiro W, Glantz M, Greenberg H, Selker RG, Vick NA, Rampling R, Friedman H, Phillips P, Bruner J, Yue N, Osoba D, Zaknoen S, Levin VA (2000) A phase II study of temozolomide vs procarbazine in patients with glioblastoma multiforme at first relapse. Br J Cancer 83: 588-593