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

Masafumi Toyoshima,^1,2 Muneaki Shimada,¹ Satomi Sasaki,¹ Masumi Ishibashi,¹ Shogo Shigeta,^1,3 Keita Tsuji,¹ Tomoyuki Nagai,¹ Hideki Tokunaga,¹ Hitoshi Niikura^1,3 and Nobuo Yaegashi¹

¹Department of Obstetrics and Gynecology, Tohoku University School of Medicine, Sendai, Miyagi, Japan
²Department of Obstetrics and Gynecology and the Center for Genetic Medicine, Japanese Red Cross Ishinomaki Hospital, Ishinomaki, Miyagi, Japan
³Department of Obstetrics and Gynecology, National Hospital Organization Sendai Medical Center, Sendai, Miyagi, Japan

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.

Keywords —— advanced or recurrent; bevacizumab; cervical cancer; platinum-based chemotherapy; single maintenance

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Tohoku J. Exp. Med 2021, 254, 145-153.

Correspondence: Muneaki Shimada, Ph.D., M.D., Department of Obstetrics and Gynecology, Tohoku University School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan.

e-mail: muneaki.shimada.b7@tohoku.ac.jp