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

A. Redondo, N. Colombo, M. McCormack, L. Dreosti, A. Nogueira-Rodrigues, G. Scambia, D. Lorusso, F. Joly, M. Schenker, P. Ruff, M. Estevez-Diz, N. Irahara, M. Donica, A. Gonzalez-Martín

Research output: Contribution to journalArticlepeer-review

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 resection/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 (19%), and hypertension (14%). Five patients (3%) had fatal adverse events. Objective response rate was 61% (95% 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. Trial registration number. NCT02467907 (ClinicalTrials.gov). © 2020 Elsevier Inc.
Original languageEnglish
Pages (from-to)142-149
Number of pages8
JournalGynecol. Oncol.
Volume159
Issue number1
DOIs
Publication statusPublished - 2020

Keywords

  • Bevacizumab
  • Carboplatin
  • Cervical cancer
  • Fistula
  • Overall survival
  • Perforation
  • bevacizumab
  • carboplatin
  • paclitaxel
  • adult
  • advanced cancer
  • aged
  • alopecia
  • anemia
  • aortoduodenal fistula
  • Article
  • cancer radiotherapy
  • chemoradiotherapy
  • digestive system fistula
  • digestive system perforation
  • disease exacerbation
  • drug efficacy
  • drug withdrawal
  • febrile neutropenia
  • female
  • follow up
  • human
  • hypertension
  • major clinical study
  • nausea
  • neuropathy
  • neutropenia
  • overall survival
  • peripheral neuropathy
  • phase 2 clinical trial
  • pneumothorax
  • priority journal
  • progression free survival
  • proteinuria
  • radiation response
  • thrombocytopenia
  • uterine cervix cancer
  • vagina disease

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