Efficacy and safety of carmustine wafers, followed by radiation, temozolomide, and bevacizumab therapy, for newly diagnosed glioblastoma with maximal resection.

Autor: Kanamori M; Department of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan. mkanamori@med.tohoku.ac.jp., Shibahara I; Department of Neurosurgery, Kitasato University School of Medicine, Sagamihara, Japan., Shimoda Y; Department of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan., Akiyama Y; Department of Neurosurgery, Sapporo Medical University School of Medicine, Sapporo, Japan., Beppu T; Department of Neurosurgery, Iwate Medical University, Shiwa, Japan., Ohba S; Department of Neurosurgery, Fujita Health University, Toyoake, Japan., Enomoto T; Department of Neurosurgery, Fukuoka University, Fukuoka, Japan., Ono T; Department of Neurosurgery, Akita University Graduate School of Medicine, Akita, Japan., Mitobe Y; Department of Neurosurgery, Faculty of Medicine, Yamagata University, Yamagata, Japan., Hanihara M; Department of Neurosurgery, Graduate School of Medicine, University of Yamanashi, Yamanashi, Japan., Mineharu Y; Department of Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan., Ishida J; Department of Neurological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan., Asano K; Department of Neurosurgery, Hirosaki University Graduate School of Medicine, Hirosaki, Japan., Yoshida Y; Department of Neurosurgery, St. Marianna University School of Medicine, Kawasaki, Japan., Natsumeda M; Department of Neurosurgery, Niigata University Brain Research Institute, Niigata, Japan., Nomura S; Department of Neurosurgery, Yamaguchi University School of Medicine, Ube, Japan., Abe T; Department of Neurosurgery, Faculty of Medicine, Saga University, Saga, Japan., Yonezawa H; Department of Neurosurgery, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan., Katakura R; Department of Neurosurgery, Miyagi Cancer Center, Natori, Japan., Shibui S; Department of Neurosurgery, Teikyo University Hospital, Kawasaki, Japan., Kuroiwa T; Department of Neurosurgery, Osaka Medical and Pharmaceutical University, Takatsuki, Japan., Suzuki H; Department of Pathology and Laboratory Medicine, National Hospital Organization Sendai Medical Center, Miyagi, Japan., Takei H; Department of Pathology and Laboratory Medicine, University of Texas, Houston, USA., Matsushita H; Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan., Saito R; Department of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan.; Department of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan., Arakawa Y; Department of Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan., Sonoda Y; Department of Neurosurgery, Faculty of Medicine, Yamagata University, Yamagata, Japan., Hirose Y; Department of Neurosurgery, Fujita Health University, Toyoake, Japan., Kumabe T; Department of Neurosurgery, Kitasato University School of Medicine, Sagamihara, Japan., Yamaguchi T; Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan., Endo H; Department of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan., Tominaga T; Department of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan.
Jazyk: angličtina
Zdroj: International journal of clinical oncology [Int J Clin Oncol] 2024 Nov 11. Date of Electronic Publication: 2024 Nov 11.
DOI: 10.1007/s10147-024-02650-9
Abstrakt: Background: To improve the outcome in newly diagnosed glioblastoma patients with maximal resection, we aimed to evaluate the efficacy and safety of implantation of carmustine wafers (CWs), radiation concomitant with temozolomide and bevacizumab, and maintenance chemotherapy with six cycles of temozolomide and bevacizumab.
Method: This prospective phase II study enrolled glioblastoma patients considered candidates for complete resection (> 90%) of a contrast-enhanced lesion. The CWs were intraoperatively implanted into the resection cavity after achieving maximal resection. Patients without a measurable contrast-enhanced lesion on magnetic resonance imaging within 48 h after resection received concomitant radiotherapy and chemotherapy with temozolomide and bevacizumab, followed by maintenance treatment with up to six cycles of temozolomide and bevacizumab. The primary endpoint was the 2-year overall survival rate in glioblastoma patients with protocol treatment.
Results: From October 2015 to April 2018, we obtained consent for the first registration from 70 patients across 17 institutions in Japan, and 49 patients were treated according to the protocol. We evaluated the safety in 49 patients who were part of the second registration and the efficacy in 45 glioblastoma patients treated according to the protocol. The profile of hematological and most of the non-hematological adverse effects was similar to that in previous studies, but stroke occurred in 12% of cases (6/49 patients). The estimated 2-year overall survival rate was 51.3%.
Conclusion: Implantation of CWs, followed by concomitant radiation, temozolomide, and bevacizumab, and six cycles of temozolomide and bevacizumab may offer some benefit to survival in Japanese glioblastoma patients with maximal resection.
Trial Id: jRCTs021180007.
Competing Interests: Declarations Conflict of interest Masayuki Kanamori received a grant from Eisai Co. Ltd., and lecture honoraria from Eisai Co. Ltd. and Novocure Co. Ltd. Ichiyo Shibahara received lecture honoraria from Eisai Co. Ltd. and Novocure Co. Ltd. Yoshiteru Shimoda received a grant from Eisai Co. Ltd. Shigeo Ohba received lecture honoraria from Eisai Co. Ltd., and Novocure Co. Ltd. Toshiyuki Enomoto received lecture honoraria from Eisai Co. Ltd. and Novocure Co. Ltd. Mitsuto Hanihara received lecture honoraria from Eisai Co. Ltd. Yohei Mineharu received lecture honoraria from Eisai Co. Ltd., and Novocure Co. Ltd. Joji Ishida received lecture honoraria from Eisai Co. Ltd. Kenichiro Asano received lecture honoraria from Eisai Co. Ltd. Yasuyuki Yoshida received lecture honoraria from Eisai Co. Ltd. Manabu Natsumeda received lecture honoraria from Chugai Pharmaceutical Co., Ltd., Eisai Co. Ltd., and Novocure Co. Ltd., and support for travel for the conference from Eisai Co. Ltd., and Novocure Co. Ltd. Tatsuya Abe received grant from Chugai Pharmaceutical Co., Ltd. and lecture honoraria from Chugai Pharmaceutical Co., Ltd. and Novocure Co. Ltd. Hajime Yonezawa received lecture honoraria from Chugai Pharmaceutical Co., Ltd., Eisai Co. Ltd., and Novocure Co. Ltd. Soichiro Shibui received lecture honoraria from Chugai Pharmaceutical Co., Ltd. Ryuta Saito received lecture honoraria from Eisai Co. Ltd. and Novocure Co. Ltd. Yoshiki Arakawa received grant from Chugai Pharmaceutical Co., Ltd. and Eisai Co. Ltd. and lecture honoraria from Chugai Pharmaceutical Co., Ltd., Eisai Co. Ltd., Nippon Kayaku. and Novocure Co. Ltd. Yukihiko Sonoda received lecture honoraria from Chugai Pharmaceutical Co., Ltd., Eisai Co. Ltd., and Novocure Co. Ltd. Yuichi Hirose received a grant from Eisai Co. Ltd. and honoraria from Chugai Pharmaceutical Co., Ltd., Eisai Co. Ltd., and Novocure Co. Ltd. Toshihiro Kumabe received lecture honoraria and travel support from Chugai Pharmaceutical Co., Ltd., Eisai Co. Ltd., and Novocure Co. Ltd. Hidenori Endo received a grant from Eisai Co. Ltd. Teiji Tominaga received a grant from Eisai Co. Ltd. and honoraria from Chugai Pharmaceutical Co., Ltd., Eisai Co. Ltd., Nippon Kayaku, MSD, and Novocure Co. Ltd.Yukinori Akiyama, Takaaki Beppu, Yuta Mitobe, Takahiro Ono, Sadahiro Nomura, Ryuichi Katakura, Toshihiko Kuroiwa, Hiroyoshi Suzuki, Hidehiro Takei, and Haruo Matsushita have no conflict of interest. Ethical approval The study was conducted in accordance with the Declaration of Helsinki and the Japanese Ethical Guidelines for Medical and Health Research Involving Human Subjects. The Institutional Review Board of Tohoku University provided approval for the study (CRB2200003). The Institutional Review Board of Tohoku University Hospital provided approval for the molecular analysis (2015-2-126–1, 2023-1-971). Informed consent statement Informed consent was obtained from all subjects involved in the study.
(© 2024. The Author(s).)
Databáze: MEDLINE
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