JCOG0911 INTEGRA study: a randomized screening phase II trial of interferonβ plus temozolomide in comparison with temozolomide alone for newly diagnosed glioblastoma

Autor: Wakabayashi, Toshihiko, Natsume, Atsushi, Mizusawa, Junki, Katayama, Hiroshi, Fukuda, Haruhiko, Sumi, Minako, Nishikawa, Ryo, Narita, Yoshitaka, Muragaki, Yoshihiro, Maruyama, Takashi, Ito, Tamio, Beppu, Takaaki, Nakamura, Hideo, Kayama, Takamasa, Sato, Shinya, Nagane, Motoo, Mishima, Kazuhiko, Nakasu, Yoko, Kurisu, Kaoru, Yamasaki, Fumiyuki, Sugiyama, Kazuhiko, Onishi, Takanori, Iwadate, Yasuo, Terasaki, Mizuhiko, Kobayashi, Hiroyuki, Matsumura, Akira, Ishikawa, Eiichi, Sasaki, Hikaru, Mukasa, Akitake, Matsuo, Takayuki, Hirano, Hirofumi, Kumabe, Toshihiro, Shinoura, Nobusada, Hashimoto, Naoya, Aoki, Tomokazu, Asai, Akio, Abe, Tatsuya, Yoshino, Atsuo, Arakawa, Yoshiki, Asano, Kenichiro, Yoshimoto, Koji, Shibui, Soichiro, Members of Japan Clinical Oncology Group Brain Tumor Study Group (JCOG-BTSG)
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Zdroj: Journal of neuro-oncology. 138(3):627-636
ISSN: 0167-594X
Popis: 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.
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/m², daily) followed by TMZ maintenance (100–200 mg/m²/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).
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%.
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.
Databáze: OpenAIRE
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