| アブストラクト | OBJECTIVE: To assess the incidence of bevacizumab-associated gastrointestinal (GI) perforation during first-line treatment of patients with ovarian, fallopian tube, or peritoneal cancer receiving neoadjuvant chemotherapy (NAC) in Japanese real-world clinical practice. METHODS: A retrospective study was conducted using a healthcare claims database owned by Medical Data Vision Co., Ltd. (study period, 2008-2020). Patients who initiated first-line treatment of ovarian, fallopian tube, or peritoneal cancer were identified and divided into NAC and primary debulking surgery (PDS) groups. The incidence of bevacizumab-associated GI perforation was compared within the NAC group and between the groups. RESULTS: Paclitaxel + carboplatin (TC) was most commonly used as first-line treatment (39.5% and 59.6% in the NAC and PDS groups, respectively). TC + bevacizumab was used in 9.3% and 11.6% of patients in the NAC and PDS groups, respectively. In the NAC group receiving TC, the proportion of patients with risk factors for GI perforation was lower among patients with versus without concomitant bevacizumab. The incidence of GI perforation in the NAC group was 0.38% (1/266 patients) in patients receiving TC + bevacizumab and 0.18% (2/1,131 patients) in patients receiving TC without bevacizumab (risk ratio=2.13; 95% confidence interval [CI]=0.19 to 23.36; risk difference=0.20; 95% CI=-0.58 to 0.97). None of the 319 patients in the PDS group receiving TC + bevacizumab had GI perforation. CONCLUSION: No notable increase was observed in GI perforation associated with NAC containing bevacizumab. We conclude that bevacizumab is prescribed with sufficient care in Japan to avoid GI perforation. |
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| 投稿者 | Ueda, Akihiko; Watari, Hidemichi; Mandai, Masaki; Fukuhara, Shunichi; Sugitani, Yasuo; Ogino, Kiyoko; Kamijima, Shuichi; Enomoto, Takayuki |
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| 組織名 | Department of Gynecology and Obstetrics, Graduate School of Medicine and Faculty;of Medicine, Kyoto University, Kyoto, Japan. aueda@kuhp.kyoto-u.ac.jp.;Department of Obstetrics and Gynecology, Hokkaido University School of Medicine,;Sapporo, Japan.;of Medicine, Kyoto University, Kyoto, Japan.;Section of Clinical Epidemiology, Department of Community Medicine, Kyoto;University, Kyoto, Japan.;Department of Health Policy and Management, Johns Hopkins Bloomberg School of;Public Health (JHSPH), Baltimore, Maryland, USA.;Biometrics Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.;Medical Science Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.;Department of Obstetrics and Gynecology, Niigata University Graduate School of;Medical and Dental Sciences, Niigata, Japan. |
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