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).
Redondo, A., Colombo, N., McCormack, M., Dreosti, L., Nogueira-Rodrigues, A., Scambia, G., et al. (2020). Primary results from CECILIA, a global single-arm phase II study evaluating bevacizumab, carboplatin and paclitaxel for advanced cervical cancer. GYNECOLOGIC ONCOLOGY, 159(1), 142-149.
|Citazione:||Redondo, A., Colombo, N., McCormack, M., Dreosti, L., Nogueira-Rodrigues, A., Scambia, G., et al. (2020). Primary results from CECILIA, a global single-arm phase II study evaluating bevacizumab, carboplatin and paclitaxel for advanced cervical cancer. GYNECOLOGIC ONCOLOGY, 159(1), 142-149.|
|Tipo:||Articolo in rivista - Articolo scientifico|
|Carattere della pubblicazione:||Scientifica|
|Presenza di un coautore afferente ad Istituzioni straniere:||Si|
|Titolo:||Primary results from CECILIA, a global single-arm phase II study evaluating bevacizumab, carboplatin and paclitaxel for advanced cervical cancer|
|Autori:||Redondo, A; Colombo, N; McCormack, M; Dreosti, L; Nogueira-Rodrigues, A; Scambia, G; Lorusso, D; Joly, F; Schenker, M; Ruff, P; Estevez-Diz, M; Irahara, N; Donica, M; Gonzalez-Martin, A|
COLOMBO, NICOLETTA (Primo)
|Data di pubblicazione:||2020|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1016/j.ygyno.2020.07.026|
|Appare nelle tipologie:||01 - Articolo su rivista|