Journal
JOURNAL OF NEURO-ONCOLOGY
Volume 138, Issue 3, Pages 627-636Publisher
SPRINGER
DOI: 10.1007/s11060-018-2831-7
Keywords
Glioblastoma; Interferon-beta; Temozolomide; MGMT; RCT
Categories
Funding
- National Cancer Center Research and Development Fund [20S-4, 23-A-20, 26-A-4, 29-A-3]
- Health and Labour Science Research Grant [H20-19]
- ministry of Health, Labour and Welfare, Japan [H23-013]
- Grants-in-Aid for Scientific Research [15K10346, 15K10337, 16K10750] Funding Source: KAKEN
Ask authors/readers for more resources
This study explored the superiority of temozolomide (TMZ) + interferon beta (IFN beta) to standard TMZ as treatment for newly diagnosed glioblastoma (GBM) via randomized phase II screening 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(2), daily) followed by TMZ maintenance (100-200 mg/m(2)/day, days 1-5, every 4 weeks) for 2 years. Patients in the TMZ + IFN beta + RT arm intravenously received IFN beta (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). Between Apr 2010 and Jan 2012, 122 patients were randomized. The median OS with TMZ + RT and TMZ + IFN beta + 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 + IFN beta + 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%. TMZ + IFN beta + 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.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available