Top

Published in:

01-03-2009 | Clinical study - patient study

A multi-institutional phase II study on second-line Fotemustine chemotherapy in recurrent glioblastoma

Authors: Maria Grazia Fabrini, Giovanni Silvano, Ivan Lolli, Franco Perrone, Annarita Marsella, Valerio Scotti, Luca Cionini

Published in: Journal of Neuro-Oncology | Issue 1/2009

Abstract

The present study aims to assess the feasibility and the effectiveness of a second-line Fotemustine chemotherapy in patients with recurrent Glioblastoma after standard primary treatment. Between 2005 and 2007, 50 patients with relapsed malignant glioma (median age = 56.8 years; median KPS = 90) underwent a second-line chemotherapy with Fotemustine. Selected patients were previously treated with a standard 60 Gy Radiotherapy course and Temozolomide Chemotherapy. Patients were stratified into classes according to the prognostic Recursive Partition Analysis. Endpoints of the study were Progression Free Survival at 6 months, duration of Objective Response and Stabilization, Overall Survival and toxicity. At analysis, 36 patients were dead and 14 were alive. Median follow-up from primary diagnosis was 26.6 months. The Efficacy control of the disease was 62%. PFS was 6.1 months; PFS-6 was 52% and median overall survival from primary diagnosis was 24.5 months, with few manageable haematological toxicities. Fotemustine was safe and effective as second-line chemotherapy in recurrent glioblastoma.

Legler JM, Ries LA, Smith MA et al (1999) Cancer surveillance series [corrected]: brain and other central nervous system cancers: recent trends in incidence and mortality. J Natl Cancer Inst 91:1382–1390. doi:10.1093/jnci/91.16.1382 PubMedCrossRef

Levin VA, Leibel SA, Gutin PH (2001) Neoplasms of the central nervous system. In: DeVita VT Jr, Hellman S, Rosenberg SA (eds) Cancer: principles and practice of oncology, 6th edn. Lippincott Williams & Wilkins, Philadelphia, Pa, pp 2100–2160

Stupp R, Mason WP, van den Bent MJ et al (2005) Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 352(10):987–996. doi:10.1056/NEJMoa043330 PubMedCrossRef

DeAngelis LM (2005) Chemotherapy for brain tumors—a new beginning. N Engl J Med 352(10):1036–1038. doi:10.1056/NEJMe058010 PubMedCrossRef

Taphoorn MJ, Stupp R, Coens C et al (2005) Health-related quality of life in patients with glioblastoma: a randomised controlled trial. Lancet Oncol 6(12):937–944. doi:10.1016/S1470-2045(05)70432-0 PubMedCrossRef

Keles GE, Anderson B, Berger MS (1999) The effect of extent of resection on time to tumor progression and survival in patients with glioblastoma multiforme of the cerebral hemisphere. Surg Neurol 52:371–379. doi:10.1016/S0090-3019(99)00103-2 PubMedCrossRef

Kowalczuk A, Macdonald RL, Amidei C et al (1997) Quantitative imaging study of extent of surgical resection and prognosis of malignant astrocytomas. Neurosurgery 41:1028–1038. doi:10.1097/00006123-199711000-00004 PubMedCrossRef

Lacroix M, Abi-Said D, Fourney DR et al (2001) A multivariate analysis of 416 patients with glioblastoma multiforme: prognosis, extentof resection, and survival. J Neurosurg 95:190–198PubMedCrossRef

Stupp R, Mason WP, Van Den Bent MJ, et al (2004) Concomitant and adjuvant temozolomide and radiotherapy for newly diagnosed glioblastoma multiforme (GBM). Conclusive results of a randomized phase III trial by the EORTC Brain and RT Groups and NCIC Clinical Trials Group [Abstract]. J Clin Oncol, ASCO Annual Meeting Proceedings (Post-Meeting Edition), vol 22, No 14S (July 15 Supplement) 2

10.

Nieder C, Adam M, Molls M et al (2006) Therapeutic options for recurrent high-grade glioma in adult patients: recent advances. Crit Rev Oncol Hematol 60(3):181–193. doi:10.1016/j.critrevonc.2006.06.007 PubMedCrossRef

11.

Brem H, Piantadosi S, Burger PC et al (1995) Placebo-controlled trial of safety and efficacy of intraoperative controlled delivery by biodegradable polymers of chemotherapy for recurrent gliomas. Lancet 345:1008–1012. doi:10.1016/S0140-6736(95)90755-6 PubMedCrossRef

12.

Pinsker M, Lumenta C (2001) Experience with reoperation on recurrent glioblastoma multiforme. Zentralbl Neurochir 62:43–47. doi:10.1055/s-2002-19477 PubMedCrossRef

13.

Olivi A, Grossman SA, Tatter S et al (2003) Dose escalation of carmustine in surgically implanted polymers in patients with recurrent malignant glioma: a new approaches to brain tumor therapy CNS consortium trial. J Clin Oncol 21:1845–1849. doi:10.1200/JCO.2003.09.041 PubMedCrossRef

14.

Franceschi E, Omuro AM, Lassman AB et al (2005) Salvage temozolomide for prior temozolomide responders. Cancer 104(11):2473–2476. doi:10.1002/cncr.21564 PubMedCrossRef

15.

Kong DS, Lee JI, Kim WS et al (2006) A pilot study of metronomic temozolomide treatment in patients with recurrent temozolomide-refractory glioblastoma. Oncol Rep 16(5):1117–1121PubMed

16.

Chamberlain MC, Tsao-Wei DD (2004) Salvage chemotherapy with cyclophosphamide for recurrent, temozolomide-refractory glioblastoma multiforme. Cancer 15, 100(6):1213–1220CrossRef

17.

Brandes AA, Tosoni A, Basso U et al (2004) Second-line chemotherapy with irinotecan plus carmustine in glioblastoma recurrent or progressive after first-line temozolomide chemotherapy: a phase II study of the Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO). J Clin Oncol 22(23):4779–4786. doi:10.1200/JCO.2004.06.181 Erratum in: J Clin Oncol 2005 23. 1:248PubMedCrossRef

18.

Fine HA, Wen PY, Maher EA et al (2003) Phase II trial of thalidomide and carmustine for patients with recurrent high-grade gliomas. J Clin Oncol 21(12):2299–2304. doi:10.1200/JCO.2003.08.045 PubMedCrossRef

19.

Kayat D, Lokiec F, Bizzarri JP et al (1987) Phase I clinical study of the new amino acid-linked nirtrosourea, S 10036, administered in a weekly schedule. Cancer Res 47:6782–6785

20.

Kleeberg UR, Engel E, Israels P et al (1995) Palliative therapy of melanoma patients with fotemustine. Inverse relationship between tumour load and treatment effectiveness. A multicentre phase II trial of the EORTC-Melanoma Cooperative Group (MCG). Melanoma Res 5(3):195–200. doi:10.1097/00008390-199506000-00009 PubMedCrossRef

21.

Silvani A, Lamperti E, Gaviani P et al (2008) Salvage chemotherapy with procarbazine and fotemustine combination in the treatment of temozolomide treated recurrent glioblastoma patients. J Neurooncol 87(2):143–151. doi:10.1007/s11060-007-9427-y PubMedCrossRef

22.

Therasse P, Arbuck SG, Eisenhauer EA et al (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92(3):205–216. doi:10.1093/jnci/92.3.205 PubMedCrossRef

23.

Macdonald DR, Cascino TL, Schold SC Jr et al (1990) Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol 8:1277–1280PubMed

24.

Kaplan EL, Meier P (1958) Non-parametric estimation from incomplete observations. J Am Stat Assoc 53:457–481. doi:10.2307/2281868 CrossRef

25.

Curran WJ, Scott JB, Horton JS et al (1993) Recursive partition analysis of prognostic factors in three radiation therapy and oncology group malignant glioma trials. J Natl Cancer Inst 85:704–710. doi:10.1093/jnci/85.9.704 PubMedCrossRef

26.

Lai A, Filka E, McGibbon B et al (2008) Phase II pilot study of bevacizumab in combination with temozolomide and regional radiation therapy for up-front treatment of patients with newly diagnosed glioblastoma multiforme: interim analysis of safety and tolerability. Int J Radiat Oncol Biol Phys 71(5):1372–1380. doi:10.1016/j.ijrobp.2007.11.068 PubMed

27.

Ali SA, McHayleh WM, Ahmad A et al (2008) Bevacizumab and irinotecan therapy in glioblastoma multiforme: a series of 13 cases. J Neurosurg 109(2):268–272. doi:10.3171/JNS/2008/109/8/0268 PubMedCrossRef

28.

Bokstein F, Shpigel S, Blumenthal DT (2008) Treatment with bevacizumab and irinotecan for recurrent high-grade glial tumors. Cancer 112(10):2267–2273. doi:10.1002/cncr.23401 PubMedCrossRef

29.

Norden AD, Young GS, Setayesh K (2008) Bevacizumab for recurrent malignant gliomas: efficacy, toxicity, and patterns of recurrence. Neurology 70(10):779–787. doi:10.1212/01.wnl.0000304121.57857.38 PubMedCrossRef

30.

Fazeny-Dorner B et al (2003) Second-line chemotherapy with dacarbazine and fotemustine in nitrosourea-pretreated patients with recurrent glioblastoma multiforme. Anticancer Drugs 14:437–442. doi:10.1097/00001813-200307000-00008 PubMedCrossRef

31.

Frenay M, Giroux B, Khoury S et al (1991) Phase II study of fotemustine in recurrent sopratentorial malignant gliomas. Eur J Cancer 27(7):852–856PubMed

32.

Scoccianti S, Detti B, Iannalfi A et al (2008) Second-line chemotherapy with fotemustine in temozolomide-pretreated patients with relapsing glioblastoma: a single institutional experience. Anti-Cancer Drug 19:6613–6620

Title: A multi-institutional phase II study on second-line Fotemustine chemotherapy in recurrent glioblastoma
Authors: Maria Grazia Fabrini
Giovanni Silvano
Ivan Lolli
Franco Perrone
Annarita Marsella
Valerio Scotti
Luca Cionini
Publication date: 01-03-2009
Publisher: Springer US
Published in: Journal of Neuro-Oncology / Issue 1/2009
Print ISSN: 0167-594X
Electronic ISSN: 1573-7373
DOI: https://doi.org/10.1007/s11060-008-9739-6

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

A multi-institutional phase II study on second-line Fotemustine chemotherapy in recurrent glioblastoma

Abstract

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 1/2009

Cognition before and after chemotherapy alone in children with chiasmatic-hypothalamic tumors

ACNU-based chemotherapy for recurrent glioma in the temozolomide era

Clinical epidemiology for childhood primary central nervous system tumors

A pilot study of everolimus and gefitinib in the treatment of recurrent glioblastoma (GBM)

Rosai-Dorfman disease manifesting as intracranial and intraorbital lesion

Long-term survival in primary CNS lymphoma treated by high-dose methotrexate monochemotherapy: role of STAT6 activation as prognostic determinant