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Primary results from CECILIA, a global single-arm phase 2 study evaluating bevacizumab (BEV), carboplatin (C) and paclitaxel (P) for advanced cervical cancer (aCC)

Date

29 Sep 2019

Session

Poster Display session 2

Presenters

Andres Redondo

Citation

Annals of Oncology (2019) 30 (suppl_5): v403-v434. 10.1093/annonc/mdz250

Authors

A. Redondo1, N. Colombo2, L.M. Dreosti3, M. McCormack4, A. Nogueira Rodrigues5, G. Scambia6, A. Roszak7, M. Donica8, B. Ulker9, A. González Martín10

Author affiliations

  • 1 Dept. Oncologia Medica, Hospital Universitario La Paz, 28046 - Madrid/ES
  • 2 Department Of Gynecologic Oncology, European Institute of Oncology and University of Milan-Bicocca, Milan/IT
  • 3 Department Of Medical Oncology, University of Pretoria, 1 - Pretoria/ZA
  • 4 Department Of Oncology, University College London Hospitals, NW1 2BU - London/GB
  • 5 Medical Oncology Department, Federal University of Minas Gerais Brazil and Brazilian Group of Gynecologic Oncology, Belo Horizonte/BR
  • 6 Policlinico Universitario ‘agostino Gemelli’, Università Cattolica del Sacro Cuore, 00168 - Roma/IT
  • 7 Apteka Szpitalna, Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej- Curie, Poznań/PL
  • 8 Product Development Medical Affairs Biometrics, F Hoffmann-La Roche Ltd, Basel/CH
  • 9 Product Development Medical Affairs, F Hoffmann-La Roche Ltd, 4070 - Basel/CH
  • 10 Medical Oncology Department, Clínica Universidad de Navarra, 28036 - Madrid/ES
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Background

Adding BEV to P + cisplatin/topotecan for aCC significantly improved overall survival (OS) and progression-free survival (PFS) in the phase 3 GOG240 trial. CECILIA (NCT02467907) evaluated BEV with a more widely used CP backbone.

Methods

The primary objective was to determine the safety of BEV + CP for aCC, defined by the frequency and severity of gastrointestinal (GI) perforation/fistula, GI-vaginal fistula and genitourinary (GU) fistula. Eligible patients (pts) had metastatic/recurrent/persistent CC not amenable to curative surgery and/or radiotherapy (RT). Pts with ongoing bladder/rectal involvement, prior cobalt RT, history of fistula/GI perforation, or bowel resection ≤6 wk or chemoRT ≤3 mo before first dose were excluded. Pts received BEV 15 mg/kg, P 175 mg/m2 and C AUC 5 q3w until disease progression (PD), unacceptable toxicity or consent withdrawal. If BEV, C or P was stopped for adverse events (AEs), the remaining drug(s) could be continued alone.

Results

From Jul 2015 to Dec 2016, 150 pts began treatment. Disease status at study entry was persistent in 20%, recurrent in 53% and metastatic at diagnosis in 27%; 71% had received prior RT (chemoRT in 58%) and 59% prior platinum. At data cutoff (31 Dec 2018), median follow-up was 27.8 mo. The most common reasons for stopping treatment were PD (39%) and AEs (34%). Median BEV duration was 6.7 (range <1–39) mo; 57% received BEV alone after stopping CP. 17 pts (11.3%, 95% CI 6.7–17.5%) had ≥1 perforation/fistula event: GI perforation/fistula in 4.7% (1.9–9.4%), GI-vaginal fistula in 4.0% (1.5–8.5%) and GU fistula in 4.7% (1.9–9.4%). All but 1 pt with fistula/GI perforation had received prior RT; several had ongoing radiation effects. The most common grade 3/4 AEs were neutropenia (21%), anaemia (19%) and hypertension (14%). 5 pts (3%) had fatal AEs. Objective response rate was 61% (95% CI 52–69%), including complete responses in 14%. Median PFS was 10.9 (95% CI 10.1–13.7) mo and median OS 25.0 (20.9–30.4) mo.

Conclusions

These results show that BEV can be combined with CP in the CECILIA study population. The fistula/GI perforation incidence is in line with GOG240 and efficacy results are encouraging.

Clinical trial identification

NCT02467907.

Editorial acknowledgement

Jennifer Kelly (Medi-Kelsey Ltd), funded by F. Hoffmann-La Roche.

Legal entity responsible for the study

F. Hoffmann-La Roche.

Funding

F. Hoffmann-La Roche.

Disclosure

A. Redondo: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche Farma; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Tesaro; Honoraria (self), Advisory / Consultancy: Clovis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: PharmaMar; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Research grant / Funding (institution): Eisai. N. Colombo: Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: PharmaMar; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Travel / Accommodation / Expenses: Tesaro; Advisory / Consultancy: Clovis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: MSD; Advisory / Consultancy: BIOCAD; Advisory / Consultancy: Takeda; Advisory / Consultancy: Lilly; Non-remunerated activity/ies, ESMO Clinical Guidelines: ESMO; Non-remunerated activity/ies, Scientific Committee Chair: ACTO Onlus. L.M. Dreosti: Honoraria (self), Advisory / Consultancy: Eli Lilly; Honoraria (self), Advisory / Consultancy: MSD; Travel / Accommodation / Expenses: Janssen; Travel / Accommodation / Expenses: Merck. M. McCormack: Honoraria (self): AstraZeneca; Honoraria (self): Roche. A. Nogueira Rodrigues: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD. M. Donica: Shareholder / Stockholder / Stock options: Novartis; Full / Part-time employment: Roche. B. Ulker: Full / Part-time employment: F. Hoffmann-La Roche AG. A. González Martín: Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Non-remunerated activity/ies, PI of PRIMA: Tesaro; Advisory / Consultancy: Clovis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: ImmunoGen; Advisory / Consultancy, Speaker Bureau / Expert testimony: PharmaMar; Advisory / Consultancy: MSD; Advisory / Consultancy: Genmad. All other authors have declared no conflicts of interest. Scientific clarification

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