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Two phase II trials of temozolomide with interferon-alpha2b (pegylated and non-pegylated) in patients with recurrent glioblastoma multiforme.
- Source :
- British Journal of Cancer; 8/18/2009, Vol. 101 Issue 4, p615-620, 6p, 3 Charts, 1 Graph
- Publication Year :
- 2009
-
Abstract
- Background:Because of the poor outcomes for patients with recurrent glioblastoma multiforme (GBM), and some laboratory and clinical evidence of efficacy using interferon in GBM, we assessed the toxicity and efficacy of temozolomide (TMZ) combined with either short-acting (IFN) or long-acting (pegylated) interferon α2b (PEG) in two single-arm phase II studies, and compared the results to 6-month progression-free survival (PFS-6) data from historical controls.Methods:Two single-arm phase II studies were carried out in adults with GBM. Patients were treated with the standard regimen of TMZ (150–200 mg m<superscript>−2</superscript> per day × 5 days every month) combined with either 4 million units per m<superscript>2</superscript> subcutaneously (SQ) three times weekly of IFN or 0.5 μg kg<superscript>−1</superscript> SQ weekly of PEG. Physical exams and imaging evaluations were carried out every 8 weeks.Results:On the IFN study, 34 adults (74% men) were enrolled, and 29 adults (55% men) on the PEG study; median Karnofsky performance status was 80 and 90 for the IFN and PEG studies, respectively. Grade 3 or 4 toxicities were common, leucopoenia and thrombocytopoenia occurring in 35–38% and 18–21% of patients, respectively. Grade 3 or 4 fatigue occurred in 18% of patients on both studies. Lymphopoenia was infrequent. PFS-6 was 31% for 29 evaluable patients in the IFN study and 38% for 26 evaluable patients in the PEG study.Conclusion:In recurrent GBM patients, both studies of standard dose TMZ with either IFN or PEG showed improved efficacy when compared to historical controls, or reports using TMZ alone. Even though the TMZ+PEG study met criteria for further study, the results of both of these studies must be considered in light of the standard of care (TMZ plus radiotherapy) for newly diagnosed GBM, which has evolved since the inception of these studies. Despite the results of the current studies being eclipsed by the new GBM standard of care, these results can still inform the development of newer approaches for GBM, either in an earlier, upfront setting, or by extrapolation of the results and consideration of the use of PEG or IFN in conjunction with other antiglioma strategies.British Journal of Cancer (2009) 101, 615–620. doi:10.1038/sj.bjc.6605189 www.bjcancer.com [ABSTRACT FROM AUTHOR]
- Subjects :
- GLIOBLASTOMA multiforme
THERAPEUTIC use of interferons
CLINICAL drug trials
DRUG efficacy
THROMBOCYTOPENIA
LEUCOPENIA
PATIENTS
ANTINEOPLASTIC agents
BRAIN tumors
CANCER relapse
CLINICAL trials
COMPARATIVE studies
GLIOMAS
INTERFERONS
RESEARCH methodology
MEDICAL cooperation
POLYETHYLENE glycol
PROGNOSIS
PROTEINS
RECOMBINANT proteins
RESEARCH
EVALUATION research
TREATMENT effectiveness
KAPLAN-Meier estimator
KARNOFSKY Performance Status
DACARBAZINE
Subjects
Details
- Language :
- English
- ISSN :
- 00070920
- Volume :
- 101
- Issue :
- 4
- Database :
- Complementary Index
- Journal :
- British Journal of Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 43640002
- Full Text :
- https://doi.org/10.1038/sj.bjc.6605189