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肿瘤治疗电场对日本新诊断胶质母细胞瘤患者生存的影响:一项多中心回顾性队列研究。

Impact of tumor-treating fields on the survival of Japanese patients with newly diagnosed glioblastoma: A multicenter, retrospective cohort study.

作者信息

Kanamori Masayuki, Tsuzuki Shunsuke, Shibahara Ichiyo, Saito Kuniaki, Shimoda Yoshiteru, Tanaka Kazuhiro, Yamaguchi Shigeru, Natsumeda Manabu, Matsutani Tomoo, Hanihara Mitsuto, Nakada Mitsutoshi, Kuroda Jun-Ichiro, Matsuda Masahide, Yoshimoto Koji, Yonezawa Ushio, Sonoda Yukihiko, Takano Koji, Yonezawa Hajime, Otani Yoshihiro, Nakahara Yukiko, Uchida Masashi, Nonaka Masahiro, Mineharu Yohei, Kitamura Yohei, Yamashita Shinji, Yamauchi Takahiro, Miyake Yohei, Deguchi Shoichi, Beppu Takaaki, Tamura Kaoru, Koizumi Shinichiro, Hirose Yuichi, Asano Kenichiro, Hiruta Ryo, Kinoshita Manabu, Miyake Keisuke, Nakayama Noriyuki, Inoue Akihiro, Ono Takahiro, Sasaki Takahiro, Akiyama Yukinori, Fukami Shinjiro, Yoshino Atsuo, Kawanishi Yu, Asanome Taku, Yamaguchi Takuhiro, Takahashi Masamichi, Yamasaki Fumiyuki, Arakawa Yoshiki, Narita Yoshitaka

机构信息

Department of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan.

Department of Neurosurgery, Tokyo Women's Medical University, Tokyo, Japan.

出版信息

Neurooncol Adv. 2024 Nov 28;6(1):vdae176. doi: 10.1093/noajnl/vdae176. eCollection 2024 Jan-Dec.

Abstract

BACKGROUND

The EF-14 clinical trial demonstrated the safety and efficacy of tumor-treating fields (TTFields) for newly diagnosed glioblastoma. This study aimed to clarify the current status, safety, and efficacy of TTFields in Japanese patients who meet the EF-14 inclusion criteria.

METHODS

This was a multicenter retrospective cohort study. Background, treatment, and outcome data of patients who satisfied the inclusion criteria of the EF-14 trial were collected from 45 institutions across Japan. The rate, determinants, and current status of TTField use, including its safety and efficacy in terms of progression and survival, were retrospectively investigated. This study was conducted in accordance with the STROBE checklist.

RESULTS

Among the 607 patients enrolled, 70 were excluded due to progressive disease during radiation and temozolomide therapy, age > 80 years old, and Karnofsky Performance Status score of <70. Among the remaining 537 patients, 210 (39%) underwent TTField treatment. Multivariate analysis revealed younger age and spouse as a caregiver as significant factors for TTField use. The compliance rate of TTField use exceeded 75% in 60% of patients, with a median TTField usage duration of 11 months. Skin disorders requiring medical treatment occurred in 56% of patients. Multivariate Cox proportional hazards analysis in the whole series and propensity score-matched analysis revealed that TTField use was not a prognostic factor for progression-free survival (PFS) or overall survival (OS).

CONCLUSIONS

TTField use did not have a substantial effect on either PFS or OS in Japanese patients with glioblastoma, despite compliance rates comparable to those observed in the EF-14.

摘要

背景

EF - 14临床试验证明了肿瘤治疗电场(TTFields)对新诊断的胶质母细胞瘤的安全性和有效性。本研究旨在阐明符合EF - 14纳入标准的日本患者中TTFields的现状、安全性和有效性。

方法

这是一项多中心回顾性队列研究。从日本各地的45家机构收集了符合EF - 14试验纳入标准的患者的背景、治疗和结局数据。回顾性调查了TTFields使用的发生率、决定因素和现状,包括其在疾病进展和生存方面的安全性和有效性。本研究按照STROBE清单进行。

结果

在纳入的607例患者中,70例因放疗和替莫唑胺治疗期间疾病进展、年龄>80岁以及卡诺夫斯基功能状态评分<70而被排除。在其余537例患者中,210例(39%)接受了TTFields治疗。多变量分析显示,年龄较小和配偶作为照顾者是TTFields使用的重要因素。60%的患者TTFields使用依从率超过75%,TTFields使用持续时间中位数为11个月。56%的患者出现需要药物治疗的皮肤疾病。对整个队列进行的多变量Cox比例风险分析和倾向评分匹配分析显示,使用TTFields不是无进展生存期(PFS)或总生存期(OS)的预后因素。

结论

尽管日本胶质母细胞瘤患者的TTFields使用依从率与EF - 14中观察到的相当,但对PFS或OS均无显著影响。

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