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The clinical\/treatment status of patients with pelvic fistulas was assessed in an additional retrospective case series study.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>142 patients were included in the PMS study (median age 51\u00a0years; 66.9% squamous cell carcinoma; 66.2% recurrent cervical cancer; 64.1% previous radiotherapy). Patients received a median of seven bevacizumab doses. Six patients, all of whom had a history of pelvic irradiation, developed seven fistulas (4.2%; 95% confidence interval, 1.56\u20138.96), and five patients had also undergone pelvic surgery. The case series study of the patients who developed fistulas indicated that three patients had high cumulative bladder and rectal doses of radiation, and two of them had undergone salvage re-irradiation for pelvic recurrence. The other three patients underwent both radical hysterectomy and adjuvant radiotherapy, but did not receive an excessive radiation dose to the bladder or rectum.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>This study found that the upper limit of the 95% confidence interval for pelvic fistula incidence did not exceed the incidence reported in the GOG 240 study. To ensure an adequate benefit-risk assessment of bevacizumab in cervical cancer patients, a comprehensive evaluation of prior treatment is essential and the possibility of unexpected fistulas, even after careful evaluation, should be considered.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10147-022-02196-8","type":"journal-article","created":{"date-parts":[[2022,6,27]],"date-time":"2022-06-27T20:02:51Z","timestamp":1656360171000},"page":"1517-1528","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Incidence of fistula occurrence in patients with cervical cancer treated with bevacizumab: data from real-world clinical practice"],"prefix":"10.1007","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2385-9040","authenticated-orcid":false,"given":"Toru","family":"Sugiyama","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8863-5921","authenticated-orcid":false,"given":"Noriyuki","family":"Katsumata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3907-0228","authenticated-orcid":false,"given":"Takafumi","family":"Toita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8661-8765","authenticated-orcid":false,"given":"Masako","family":"Ura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8597-1241","authenticated-orcid":false,"given":"Ayaka","family":"Shimizu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1642-4495","authenticated-orcid":false,"given":"Shuichi","family":"Kamijima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9596-8326","authenticated-orcid":false,"given":"Daisuke","family":"Aoki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,6,27]]},"reference":[{"issue":"6","key":"2196_CR1","doi-asserted-by":"publisher","first-page":"394","DOI":"10.3322\/caac.21492","volume":"68","author":"F Bray","year":"2018","unstructured":"Bray F, Ferlay J, Soerjomataram I et al (2018) Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. 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The requirement for IRB\/IEC approval was waived under GPSP. Although the need for informed consent to participate in the post-marketing surveillance study was also waived under GPSP, informed consent was obtained for all patients receiving bevacizumab according to the product label. The case series study was conducted in compliance with the Declaration of Helsinki and the Ethical Guidelines for Medical Research in Humans, and approved by the IRB\/IEC of the Non-Profit Organization MINS, St. Mary\u2019s Hospital and institutions where patients\u2019 medical records were collected. Written informed consent or opt-out method was applied for all patients according to the Japanese Ethical Guidelines for Medical and Health Research Involving Human Subjects.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Research ethics"}}]}}