Abstract 3284
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
Resources from the same session
3278 - Immune-Related Gene Expression Profiling after Neoadjuvant Chemotherapy (NACT) of Ovarian High-Grade Serous Carcinoma
Presenter: Luis Manso
Session: Poster Display session 2
Resources:
Abstract
4906 - Tumor-infiltrating lymphocytes (TILs) in patients with epithelial ovarian cancer undergoing neoadjuvant chemotherapy: A restrospective study
Presenter: Sara Giovannoni
Session: Poster Display session 2
Resources:
Abstract
3919 - Prognostic significance of elements of the adaptive immunity in the microenvironment of epithelial ovarian cancer.
Presenter: Periklis Foukas
Session: Poster Display session 2
Resources:
Abstract
5139 - Neutrophil-to-lymphocyte ratio predicts platinum sensitivity in epithelial ovarian cancer patients: a MITO24 retrospective study
Presenter: Alberto Farolfi
Session: Poster Display session 2
Resources:
Abstract
4212 - The prognostic impact of monocyte to lymphocyte ratio (MLR) in advanced epithelial ovarian cancer (EOC)
Presenter: Marc Cucurull Salamero
Session: Poster Display session 2
Resources:
Abstract
5123 - TP53 Hotspot mutations as immunoreactive neoantigens define a signature with differential survival outcomes in advanced ovarian cancer
Presenter: Marica Garziera
Session: Poster Display session 2
Resources:
Abstract
3795 - Use of bevacizumab (Bev) in real life for first-line (fl) treatment of ovarian cancer (OC)/ The GINECO ENCOURAGE cohort of 500 French patients
Presenter: Dominique Berton-Rigaud
Session: Poster Display session 2
Resources:
Abstract
2359 - Phase II study: Letrozole maintenance therapy after first line chemotherapy in patients with advanced serous and endometrioid ovarian cancer
Presenter: Alexandra Tyulyandina
Session: Poster Display session 2
Resources:
Abstract
3619 - Baseline IPI (Immune Prognostic Index) predicts survival in patients with advanced cervical cancer treated with immune checkpoint inhibitors (ICI).
Presenter: Felix Blanc-Durand
Session: Poster Display session 2
Resources:
Abstract
3474 - Preselecting tumor-infiltrating lymphocyte subsets to implement adoptive inmmunotherapy in ovarian cancer
Presenter: Diego Salas-Benito
Session: Poster Display session 2
Resources:
Abstract