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Phase I/IIa trial of fractionated radiotherapy, temozolomide, and autologous formalin-fixed tumor vaccine for newly diagnosed glioblastoma

Authors: Eiichi Ishikawa, M.D., Ph.D., Yoshihiro Muragaki, M.D., Ph.D., Tetsuya Yamamoto, M.D., Ph.D., Takashi Maruyama, M.D., Ph.D., Koji Tsuboi, M.D., Ph.D., Soko Ikuta, Ph.D., Koichi Hashimoto, Ph.D., Youji Uemae, Ph.D., Takeshi Ishihara, M.Sc., Masahide Matsuda, M.D., Ph.D., Masao Matsutani, M.D., Ph.D., Katsuyuki Karasawa, M.D., Ph.D., Yoichi Nakazato, M.D., Ph.D., Tatsuya Abe, M.D., Ph.D., Tadao Ohno, Ph.D., and Akira Matsumura, M.D., Ph.D.

Journal: Journal of Neurosurgery 2014 Sep;121(3):543-53. doi: 10.3171/2014.5.JNS132392. Epub 2014 Jul 4.

Abstract:
Object Temozolomide (TMZ) may enhance antitumor immunity in patients with glioblastoma multiforme (GBM). In this paper the authors report on a prospective Phase I/IIa clinical trial of fractionated radiotherapy (FRT) concomitant with TMZ therapy, followed by treatment with autologous formalin-fixed tumor vaccine (AFTV) and TMZ maintenance in patients with newly diagnosed GBM.
Methods Twenty-four patients (age 16-75 years, Karnofsky Performance Scale score ≥ 60% before initiation of FRT) with newly diagnosed GBM received a total dose of 60 Gy of FRT with daily concurrent TMZ. After a 4-week interval, the patients received 3 AFTV injections and the first course of TMZ maintenance chemotherapy for 5 days, followed by multiple courses of TMZ for 5 days in each 28-day cycle.
Results This treatment regimen was well tolerated by all patients. The percentage of patients with progression-free survival (PFS) ≥ 24 months was 33%. The median PFS, median overall survival (OS), and the actuarial 2- and 3-year survival rates of the 24 patients were 8.2 months, 22.2 months, 47%, and 38%, respectively. The median PFS in patients with a delayed-type hypersensitivity (DTH) response after the third AFTV injection (DTH-2) of 10 mm or larger surpassed the median length of follow-up for progression-free patients (29.5 months), which was significantly greater than the median PFS in patients with a smaller DTH-2 response.
Conclusions The treatment regimen was well tolerated and resulted in favorable PFS and OS for newly diagnosed GBM patients. Clinical trial registration no.: UMIN000001426 (UMIN clinical trials registry, Japan).