TY - JOUR
T1 - A single arm prospective pilot study examining the efficacy and safety of bevacizumab single maintenance therapy following platinum-based chemotherapy in patients with advanced or recurrent cervical cancer
AU - Toyoshima, Masafumi
AU - Shimada, Muneaki
AU - Sasaki, Satomi
AU - Ishibashi, Masumi
AU - Shigeta, Shogo
AU - Tsuji, Keita
AU - Nagai, Tomoyuki
AU - Tokunaga, Hideki
AU - Niikura, Hitoshi
AU - Yaegashi, Nobuo
N1 - Funding Information:
We thank all patients and investigators who participated in this clinical trial. This work was supported in part by The National Cancer Center Research and Development Fund (2020-J-3). We would like to thank Editage (https:// www.editage.com) for English language editing.
Publisher Copyright:
© 2021 Tohoku University Medical Press.
PY - 2021
Y1 - 2021
N2 - Although the addition of bevacizumab to platinum-based combination chemotherapy has been recommended as a standard regimen for patients with advanced or recurrent cervical cancer, there is no clear evidence regarding the effectiveness of bevacizumab monotherapy as salvage chemotherapy. This study prospectively examined the efficacy and safety of switching from platinum-based chemotherapy combined with bevacizumab to single maintenance therapy in patients with advanced or recurrent cervical cancer. Patients were first treated with standard combination chemotherapy. However, if chemotherapy was discontinued because of an adverse event, bevacizumab monotherapy was continued for patients who agreed to participate in this study and provided written informed consent. The study protocol was approved by the Independent Review Board of Tohoku University School of Medicine (reception number 2017-1-540). A total of 15 patients (median age of 55 years, range 33-69 years) participated in this study. The median number of cycles of bevacizumab single maintenance administration was 8, and the main reasons for discontinuation were disease progression and adverse events. Bevacizumab single maintenance therapy had a disease control rate of 53.3% (CR 40%, PR 6.7%, SD 6.7%). The most frequent grade 3/4 clinical adverse events were proteinuria (5/15) and hypertension (4/15). No treatment-related deaths occurred. Bevacizumab single maintenance therapy was effective as salvage chemotherapy in patients with advanced or recurrent cervical cancer, and the safety profile was generally consistent with those reported in previous studies of bevacizumab monotherapy.
AB - Although the addition of bevacizumab to platinum-based combination chemotherapy has been recommended as a standard regimen for patients with advanced or recurrent cervical cancer, there is no clear evidence regarding the effectiveness of bevacizumab monotherapy as salvage chemotherapy. This study prospectively examined the efficacy and safety of switching from platinum-based chemotherapy combined with bevacizumab to single maintenance therapy in patients with advanced or recurrent cervical cancer. Patients were first treated with standard combination chemotherapy. However, if chemotherapy was discontinued because of an adverse event, bevacizumab monotherapy was continued for patients who agreed to participate in this study and provided written informed consent. The study protocol was approved by the Independent Review Board of Tohoku University School of Medicine (reception number 2017-1-540). A total of 15 patients (median age of 55 years, range 33-69 years) participated in this study. The median number of cycles of bevacizumab single maintenance administration was 8, and the main reasons for discontinuation were disease progression and adverse events. Bevacizumab single maintenance therapy had a disease control rate of 53.3% (CR 40%, PR 6.7%, SD 6.7%). The most frequent grade 3/4 clinical adverse events were proteinuria (5/15) and hypertension (4/15). No treatment-related deaths occurred. Bevacizumab single maintenance therapy was effective as salvage chemotherapy in patients with advanced or recurrent cervical cancer, and the safety profile was generally consistent with those reported in previous studies of bevacizumab monotherapy.
KW - Advanced or recurrent
KW - Bevacizumab
KW - Cervical cancer
KW - Platinum-based chemotherapy
KW - Single maintenance
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U2 - 10.1620/tjem.254.145
DO - 10.1620/tjem.254.145
M3 - Article
C2 - 34219103
AN - SCOPUS:85110310357
SN - 0040-8727
VL - 254
SP - 145
EP - 153
JO - Tohoku Journal of Experimental Medicine
JF - Tohoku Journal of Experimental Medicine
IS - 3
ER -