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

• 荒川, 芳輝

  Department of Neurosurgery, Kyoto University Graduate School of Medicine

• ,

• 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)

書誌事項

タイトル別名

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

抄録

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.

収録刊行物

• Journal of neuro-oncology

  Journal of neuro-oncology 138 (3), 627-636, 2018-07

  Springer Nature

キーワード

• Glioblastoma
• Interferon-beta
• Temozolomide
• MGMT
• RCT

詳細情報

• CRID: 1050282810837021440
• NII論文ID: 120006491921
• ISSN: 0167594X
• ISSN: 15737373
• DOI: 10.1007/s11060-018-2831-7
• HANDLE: 2433/232946
• Web Site: http://link.springer.com/article/10.1007/s11060-018-2831-7/fulltext.html
• Web Site: http://link.springer.com/content/pdf/10.1007/s11060-018-2831-7.pdf
• 本文言語コード: en
• 資料種別: journal article
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