Seiji Mabuchi1, Misa Yamamoto2, Hiroko Murata3, Takuya Yokoe4, Junzo Hamanishi5, Yoshito Terai6, Hikaru Imatake7, Yasushi Mabuchi8, Taisuke Mori9, Fuminori Kitada10, Yasuhiro Hashiguchi11, Akimasa Takahashi12, Satoe Fujiwara13, Hirokazu Naoi14, Sho Matsubara15. 1. Department of Obstetrics and Gynecology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan. smabuchi@naramed-u.ac.jp. 2. Department of Obstetrics and Gynecology, Osaka University, Suita, Osaka, Japan. 3. Department of Gynecologic Oncology, Osaka International Cancer Institute, Osaka, Osaka, Japan. 4. Department of Obstetrics and Gynecology, Kansai Medical University, Hirakata, Osaka, Japan. 5. Department of Obstetrics and Gynecology, Kyoto University, Kyoto, Kyoto, Japan. 6. Department of Obstetrics and Gynecology, Kobe University Graduate School of Medicine, Kobe, Hyogo, Japan. 7. Department of Obstetrics and Gynecology, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan. 8. Department of Obstetrics and Gynecology, Wakayama Medical University, Wakayama, Wakayama, Japan. 9. Department of Obstetrics and Gynecology, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan. 10. Department of Obstetrics and Gynecology, Suita Tokusyukai Hospital, Suita, Osaka, Japan. 11. Department of Obstetrics and Gynecology, Nara Prefecture General Medical Center, Nara, Nara, Japan. 12. Department of Obstetrics and Gynecology, Shiga University of Medical Science, Otsu, Shiga, Japan. 13. Department of Obstetrics and Gynecology, Osaka Medical College, Takatsuki, Osaka, Japan. 14. Department of Obstetrics and Gynecology, Kaizuka City Hospital, Kaizuka, Osaka, Japan. 15. Department of Obstetrics and Gynecology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.
Abstract
BACKGROUND: The development of perforations or fistulas in the Gastrointestinal (GI) tract or genitourinary (GU) system is a serious adverse effect of bevacizumab. The aim of this study was to investigate the incidences of these GI/GU events as well as their association with previous radiotherapy (RT) in Japanese women with cervical cancer. METHODS: We conducted a written questionnaire survey among 14 gynecological institutions belonging to the Oncology Research Committee of the Obstetrical and Gynecological Society of Kinki District, Japan. The severity of GI/GU events was classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0. All data were extracted from survey responses and maintained in an Excel spreadsheet and summarized using descriptive statistics. RESULTS: The information of 224 Japanese women with cervical cancer (152 recurrent and 72 advanced) who were treated with bevacizumab-containing chemotherapy was collected from 14 institutions. Of these, 65% had been previously treated with RT. GI/GU events of any grade developed in 25 (11.2%) patients, leading directly to death in 3 (1.3%) patients. When compared, the incidence of GI/GU events was higher in recurrent disease patients than in advanced disease patients (13.8% vs 5.6%, p = 0.0728). When examined according to the history of RT, the incidence of GI/GU events was greater in patients with a history of RT than in those without (14.5% vs 5.1%, p = 0.044). CONCLUSION: More than 10% of patients experience GI/GU events during or after receiving bevacizumab-containing chemotherapies. Prior RT is a risk factor for bevacizumab-associated GI/GU events.
BACKGROUND: The development of perforations or fistulas in the Gastrointestinal (GI) tract or genitourinary (GU) system is a serious adverse effect of bevacizumab. The aim of this study was to investigate the incidences of these GI/GU events as well as their association with previous radiotherapy (RT) in Japanese women with cervical cancer. METHODS: We conducted a written questionnaire survey among 14 gynecological institutions belonging to the Oncology Research Committee of the Obstetrical and Gynecological Society of Kinki District, Japan. The severity of GI/GU events was classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0. All data were extracted from survey responses and maintained in an Excel spreadsheet and summarized using descriptive statistics. RESULTS: The information of 224 Japanese women with cervical cancer (152 recurrent and 72 advanced) who were treated with bevacizumab-containing chemotherapy was collected from 14 institutions. Of these, 65% had been previously treated with RT. GI/GU events of any grade developed in 25 (11.2%) patients, leading directly to death in 3 (1.3%) patients. When compared, the incidence of GI/GU events was higher in recurrent disease patients than in advanced disease patients (13.8% vs 5.6%, p = 0.0728). When examined according to the history of RT, the incidence of GI/GU events was greater in patients with a history of RT than in those without (14.5% vs 5.1%, p = 0.044). CONCLUSION: More than 10% of patients experience GI/GU events during or after receiving bevacizumab-containing chemotherapies. Prior RT is a risk factor for bevacizumab-associated GI/GU events.