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JCOG0911 INTEGRA study: a randomized screening phase II trial of interferonβ plus temozolomide in comparison with temozolomide alone for newly diagnosed glioblastoma.
- Source :
-
Journal of neuro-oncology [J Neurooncol] 2018 Jul; Vol. 138 (3), pp. 627-636. Date of Electronic Publication: 2018 Mar 20. - Publication Year :
- 2018
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Abstract
- Purpose: This study explored the superiority of temozolomide (TMZ) + interferonβ (IFNβ) to standard TMZ as treatment for newly diagnosed glioblastoma (GBM) via randomized phase II screening design.<br />Experimental Design: Eligibility criteria included histologically proven GBM, with 50% of the tumor located in supratentorial areas, without involvement of the optic, olfactory nerves, and pituitary gland and without multiple lesions and dissemination. Patients in the TMZ + radiotherapy (RT) arm received RT (2.0 Gy/fr/day, 30 fr) with TMZ (75 mg/m <superscript>2</superscript> , daily) followed by TMZ maintenance (100-200 mg/m <superscript>2</superscript> /day, days 1-5, every 4 weeks) for 2 years. Patients in the TMZ + IFNβ + RT arm intravenously received IFNβ (3 MU/body, alternative days during RT and day 1, every 4 weeks during maintenance period) and TMZ + RT. The primary endpoint was overall survival (OS). The planned sample size was 120 (one-sided alpha 0.2; power 0.8).<br />Results: Between Apr 2010 and Jan 2012, 122 patients were randomized. The median OS with TMZ + RT and TMZ + IFNβ + RT was 20.3 and 24.0 months (HR 1.00, 95% CI 0.65-1.55; one-sided log rank P = 0.51). The median progression-free survival times were 10.1 and 8.5 months (HR 1.25, 95% CI 0.85-1.84). The incidence of neutropenia with the TMZ + RT and the TMZ + IFNβ + RT (grade 3-4, CTCAE version 3.0) was 12.7 versus 20.7% during concomitant period and was 3.6 versus 9.3% during maintenance period. The incidence of lymphopenia was 54.0 versus 63.8% and 34.5 versus 41.9%.<br />Conclusions: TMZ + IFNβ + RT is not considered as a candidate for the following phase III trial, and TMZ + RT remained to be a most promising treatment. This trial was registered with the UMIN Clinical Trials Registry: UMIN000003466.
- Subjects :
- Administration, Intravenous
Adult
Aged
Antineoplastic Agents adverse effects
Brain Neoplasms mortality
Chemoradiotherapy
Female
Glioblastoma mortality
Humans
Interferon-beta adverse effects
Male
Middle Aged
Survival Analysis
Temozolomide adverse effects
Treatment Outcome
Young Adult
Antineoplastic Agents therapeutic use
Brain Neoplasms therapy
Glioblastoma therapy
Interferon-beta therapeutic use
Temozolomide therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1573-7373
- Volume :
- 138
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Journal of neuro-oncology
- Publication Type :
- Academic Journal
- Accession number :
- 29557060
- Full Text :
- https://doi.org/10.1007/s11060-018-2831-7