TY - JOUR
T1 - Efficacy and safety of carmustine wafers, followed by radiation, temozolomide, and bevacizumab therapy, for newly diagnosed glioblastoma with maximal resection
AU - Kanamori, Masayuki
AU - Shibahara, Ichiyo
AU - Shimoda, Yoshiteru
AU - Akiyama, Yukinori
AU - Beppu, Takaaki
AU - Ohba, Shigeo
AU - Enomoto, Toshiyuki
AU - Ono, Takahiro
AU - Mitobe, Yuta
AU - Hanihara, Mitsuto
AU - Mineharu, Yohei
AU - Ishida, Joji
AU - Asano, Kenichiro
AU - Yoshida, Yasuyuki
AU - Natsumeda, Manabu
AU - Nomura, Sadahiro
AU - Abe, Tatsuya
AU - Yonezawa, Hajime
AU - Katakura, Ryuichi
AU - Shibui, Soichiro
AU - Kuroiwa, Toshihiko
AU - Suzuki, Hiroyoshi
AU - Takei, Hidehiro
AU - Matsushita, Haruo
AU - Saito, Ryuta
AU - Arakawa, Yoshiki
AU - Sonoda, Yukihiko
AU - Hirose, Yuichi
AU - Kumabe, Toshihiro
AU - Yamaguchi, Takuhiro
AU - Endo, Hidenori
AU - Tominaga, Teiji
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2025/1
Y1 - 2025/1
N2 - 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.
AB - 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.
KW - Bevacizumab
KW - Carmustine wafers
KW - Glioblastoma
KW - Maximal resection
KW - Temozolomide
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U2 - 10.1007/s10147-024-02650-9
DO - 10.1007/s10147-024-02650-9
M3 - Article
C2 - 39527165
AN - SCOPUS:85208808867
SN - 1341-9625
VL - 30
SP - 51
EP - 61
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
IS - 1
ER -