Primary results from CECILIA, a global single-arm phase II study evaluating bevacizumab, carboplatin and paclitaxel for advanced cervical cancer

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dc.creatorAndres Redondo
dc.creatorPaul Ruff
dc.creatorMaria Estevez-Diz
dc.creatorNatsumi Irahara
dc.creatorMargarita Donica
dc.creatorAntonio Gonzalez-martín
dc.creatorNicoletta Colombo
dc.creatorMary Mccormack
dc.creatorLydia Dreosti
dc.creatorAngélica Nogueira Rodrigues
dc.creatorGiovanni Scambia
dc.creatorDomenica Lorusso
dc.creatorFlorence Joly
dc.creatorMichael Schenker
dc.date.accessioned2023-08-14T20:30:42Z
dc.date.accessioned2025-09-08T23:26:47Z
dc.date.available2023-08-14T20:30:42Z
dc.date.issued2020-08-04
dc.format.mimetypepdf
dc.identifier.doihttps://doi.org/10.1016/j.ygyno.2020.07.026
dc.identifier.issn0090-8258
dc.identifier.urihttps://hdl.handle.net/1843/57811
dc.languageeng
dc.publisherUniversidade Federal de Minas Gerais
dc.relation.ispartofGynecologic Oncology
dc.rightsAcesso Restrito
dc.subjectBevacizumab
dc.subjectCarboplatina
dc.subjectPaclitaxel
dc.subjectNeoplasias do colo do útero
dc.subjectFístula
dc.subjectPerfuração Uterina
dc.subject.otherBevacizumab
dc.subject.otherCarboplatin
dc.subject.otherPaclitaxel
dc.subject.otherFístula
dc.subject.otherCervical cancer
dc.subject.otherUterine Perforation
dc.subject.otherOverall survival
dc.titlePrimary results from CECILIA, a global single-arm phase II study evaluating bevacizumab, carboplatin and paclitaxel for advanced cervical cancer
dc.typeArtigo de periódico
local.citation.epage149
local.citation.issue2020
local.citation.spage142
local.citation.volume159
local.description.resumoObjective: Adding bevacizumab to cisplatin–paclitaxel for advanced cervical cancer significantly improves overall and progression-free survival. We evaluated bevacizumab with a widely used carboplatin–paclitaxel backbone.Methods: Patients with metastatic/recurrent/persistent cervical cancer not amenable to curative surgery and/ or radiotherapy received 3-weekly bevacizumab 15 mg/kg, paclitaxel 175 mg/m2, and carboplatin AUC 5 until progression or unacceptable toxicity. Maintenance bevacizumab was allowed. Patients with ongoing bladder/ rectal involvement, prior cobalt radiotherapy, a history of fistula/gastrointestinal perforation, or recent bowel re section/chemoradiation were excluded. The primary objective was to determine incidences of gastrointestinal perforation/fistula, gastrointestinal-vaginal fistula, and genitourinary fistula.Results: Among 150 treated patients, disease at study entry was persistent in 21%, recurrent in 56%, and newly diagnosed metastatic in 23%. After 27.8 months' median follow-up, median bevacizumab duration was 6.7 months; 57% received maintenance bevacizumab. Seventeen patients (11.3%; 95% CI: 6.7–17.5%) experienced ≥1 perforation/fistula event: gastrointestinal perforation/fistula in 4.7% (1.9–9.4%), gastrointestinal-vaginal fistula in 4.0% (1.5–8.5%), and genitourinary fistula in 4.7% (1.9–9.4%). Of these, 16 were previously irradiated, several with ongoing radiation effects. The most common grade 3/4 adverse events were neutropenia (25%), anemia CI: 52–69%), median progression-free survival was 10.9 (10.1–13.7) months, and median overall survival was 25.0 (20.9–30.4) months. Conclusions: Bevacizumab can be combined with carboplatin–paclitaxel in the CECILIA study population. The fistula/gastrointestinal perforation incidence is in line with GOG-0240; efficacy results are encouraging.
local.publisher.countryBrasil
local.publisher.departmentMED - DEPARTAMENTO DE CLÍNICA MÉDICA
local.publisher.initialsUFMG
local.url.externahttps://www.gynecologiconcology-online.net/article/S0090-8258(20)33661-1/fulltext

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