がん免疫療法 - 自家がんワクチン

　このほど、脳腫瘍に対する自家がんワクチンの効果についてASCO2010（シカゴ、6月4-8日開催）で以下の発表が行われます。

　ご存知のように、ASCOの年次総会は参加者が3万人を超えるというマンモス学会で、全世界からがん臨床医が参集します。会場のマコーミックプレースは東京ビッグサイトの約3倍もの広さがあります。

　この年次総会への発表申し込み演題数も膨大な上、採択率は50％程度という厳しさです。ASCOへの発表は、それが企業ならば株価にストレートに反映されるほど、影響力も大きいとされています。

　今回発表の第1著者は、東京女子医大（先端工学外科学・脳神経外科）村垣善浩先生です。共著者の一人として弊社がASCOで発表するのは、2007年（Ref.1）以来です。

　読者の皆様には、ASCO2010に先駆けて今回の発表内容をご紹介します。

PhaseI/IIa trial of autologous formalin-fixed tumor vaccine for newly diagnosed glioblastoma.

Y. Muragaki, T. Maruyama, H. Iseki, K. Tsuboi, A. Matsumura, T. Yamamoto, M. Matsutani, K. Karasawa, Y. Nakazato, T. Ohno;

Faculty of Advanced Techno-Surgery, Tokyo Women's Medical University, Tokyo, Japan; Dept. of Neurosurgery, Tokyo Women's Medical University, Tokyo, Japan; Graduate School of Comprehensive Human Science, University of Tsukuba, Tsukuba, Japan; Dep.of Neurosurgery, University of Tsukuba, Tsukuba, Japan; Saitama Medical University International Medical Center, Hidaka, Japan; Tokyo Metropolitan Komagome Hospital, Tokyo, Japan; Department of Human Pathology, Gunma University, Maebashi, Japan; Cell-Medcn Inc, Tsukuba, Japan

Abstract Text:

Background: Autologous formalin-fixed tumor vaccine (AFTV) has been shown to have a potential role in effective adjuvant therapy for hepatocellular carcinoma and recurrent malignant glioma. We tried to determine the efficacy and safety of AFTV concomitant with radiation for newly diagnosed GBM patients from two institutions. Methods: Patients with supratentorial GBM who underwent debulking surgery were eligible. The AFTV was injected intradermally 3 times, with 7 days between injections, starting when the cumulative radiation dose reached 32 - 36 Gy. Results: A total of 24 patients were treated. Two patients were excluded by the radiation protocol or by the patient's consent. Although grade 1 dermal toxicity was observed at the injected sites in all patients, no grade 2 or higher hematologic or other toxicity was observed. The trial met the prospectively-defined primary endpoints, with 21.4 months median survival time (range 6.1 to 42 months), 40.0% 2-year survival, and 7.6 months median progression-free survival time (PFS, range 2.2 to 25.6 months). The PFS of the patients with greater delayed type hypersensitivity (DTH) reaction (13.9 months) was statistically longer (p<0.01) than that of the patients with weaker DTH reaction (4.3 months). Conclusions: The AFTV immunotherapy concomitant with radiation is a safe treatment for patients with newly diagnosed GBM and seems to have a positive effect on the PFS. Additional testing of AFTV in combination regimens is warranted.

Reference

1. Koji Tsuboi, Eiichi Ishikawa, Tetsuya Yamamoto, Ai Muroi,
Shingo Takano, Takao Enomoto, Akira Matsumura and Tadao Ohno:
A clinical trial of autologous formalin-fixed tumor vaccine
for glioblastoma multiforme patients.
Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings
Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 2085.