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http://hdl.handle.net/1843/57811| Type: | Artigo de Periódico |
| Title: | Primary results from CECILIA, a global single-arm phase II study evaluating bevacizumab, carboplatin and paclitaxel for advanced cervical cancer |
| Authors: | Andres Redondo Paul Ruff Maria Estevez-Diz Natsumi Irahara Margarita Donica Antonio Gonzalez-martín Nicoletta Colombo Mary Mccormack Lydia Dreosti Angélica Nogueira Rodrigues Giovanni Scambia Domenica Lorusso Florence Joly Michael Schenker |
| Abstract: | Objective: 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. |
| Subject: | Bevacizumab Carboplatina Paclitaxel Neoplasias do colo do útero Fístula Perfuração Uterina |
| language: | eng |
| metadata.dc.publisher.country: | Brasil |
| Publisher: | Universidade Federal de Minas Gerais |
| Publisher Initials: | UFMG |
| metadata.dc.publisher.department: | MED - DEPARTAMENTO DE CLÍNICA MÉDICA |
| Rights: | Acesso Restrito |
| metadata.dc.identifier.doi: | https://doi.org/10.1016/j.ygyno.2020.07.026 |
| URI: | http://hdl.handle.net/1843/57811 |
| Issue Date: | 4-Aug-2020 |
| metadata.dc.url.externa: | https://www.gynecologiconcology-online.net/article/S0090-8258(20)33661-1/fulltext |
| metadata.dc.relation.ispartof: | Gynecologic Oncology |
| Appears in Collections: | Artigo de Periódico |
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