Abstract 3795
Background
Bevacizumab (bev) is approved in Europe (EU) for first line therapy of OC patients (pts). This study aimed to evaluate the use of Bev in real life, with a focus on toxicity.
Methods
Representative centers in France of French regions and of mode of practice were asked to participate. From 04/13 to 02/15, among the consecutive OC pts treated in each center, were selected those who were newly diagnosed and planned to receive Bev. An independent CRA captured the clinical data at baseline, 6, 12, 18 and 36 months.
Results
A total of 104 centers participated: Private practice (44%), non-academic hospital (31%), academic (11%), anticancer center (14%). 1290 pts were screened, 500 registered and 468 were evaluable. Pts characteristics at baseline were: median age 65 yrs, antihypertensive therapy (26%), anticoagulant (10%), cardiac history (5%), serous histology (83%), interval surgery (47%), complete surgical debulking (74%) and carboplatin-paclitaxel chemotherapy (98%). Only 3.4% were not FIGO stage IIIB-IV. Pts received Bev at 15 mg/kg (80%) during a median of 18 cycles (10-21) and 7.8% stopped treatment for toxicity. Main toxicity was HTA requiring new therapy (38%), PRES (1.3%), venous thrombosis (5%), proteinuria (9.8%) and nephrotic syndrome (2.6%). Other toxicities mostly reported include low grade epistaxis, gingivorrhagia, arthralgia, headache and dysphonia. Gastrointestinal perforation, fistula, arterial events and grade 3-4 bleeding were very low: 0.2%, 0.8%, 0,1% and 0.2% respectively. No pts developed congestive heart failure nor died from toxicity. Median PFS was 17.4 months (IC95% [16.4-19.1]) and % of pts alive at 3 years was 62.4% (IC95 % [58.1-67.1]).
Conclusions
In routine practice among French centers, first-line Bev administration is consistent with the EU label in most of the cases. Efficacy and safety in the real life were in line with that reported in trials excepted for a higher incidence of observed HTA and complications, suggesting the importance of increased education on HTA monitoring.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
ARCAGY-GINECO.
Funding
Roche.
Disclosure
A. Floquet: Advisory / Consultancy: Tesaro; Advisory / Consultancy: Clovis; Advisory / Consultancy: AstraZeneca; Travel / Accommodation / Expenses: Tesaro; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Roche. O. Tredan: Honoraria (self): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): Novartis; Honoraria (self): Lilly; Honoraria (self): BMS; Honoraria (self): MSD. J. Alexandre: Honoraria (self): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Ipsen; Honoraria (self): Novartis; Honoraria (self): PharmaMar; Advisory / Consultancy: Roche; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Novartis; Research grant / Funding (institution): Janssen; Travel / Accommodation / Expenses: Janssen; Travel / Accommodation / Expenses: Novartis. C. Garnier Tixidre: Honoraria (self): Lilly; Honoraria (self): AstraZeneca; Advisory / Consultancy: Pfizer; Advisory / Consultancy: AstraZeneca; Travel / Accommodation / Expenses: Pfizer. P. Follana: Advisory / Consultancy: Novartis; Advisory / Consultancy: AstraZeneca; Speaker Bureau / Expert testimony: Novartis; Speaker Bureau / Expert testimony: AstraZeneca; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Amgen; Travel / Accommodation / Expenses: Tesaro. C. Levaché: Travel / Accommodation / Expenses: Sanofi. E. Pujade-Lauraine: Honoraria (self): AstraZeneca; Honoraria (self): Tesaro; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Roche; Advisory / Consultancy: Clovis; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Genmab; Advisory / Consultancy: Incyte; Advisory / Consultancy: MSD; Advisory / Consultancy: Pfizer; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Tesaro; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Roche; Research grant / Funding (institution): Tesaro. F. Selle: Honoraria (self): Roche; Honoraria (self): MSD France; Honoraria (self): PharmaMar; Honoraria (self): Tesaro; Honoraria (self): Clovis; Honoraria (self): AstraZeneca; Advisory / Consultancy: Roche; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: MSD France; Travel / Accommodation / Expenses: Tesaro; Travel / Accommodation / Expenses: AstraZeneca. All other authors have declared no conflicts of interest.
Resources from the same session
3536 - Palbociclib plus an aromatase inhibitor as first-line therapy for metastatic breast cancer in US clinical practices: Real-world progression-free survival analysis
Presenter: Mylin Torres
Session: Poster Display session 2
Resources:
Abstract
4022 - Ribociclib (RIB) plus letrozole (LET) in male patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor-2–negative (HER2–) advanced breast cancer (ABC) from the CompLEEment-1 trial
Presenter: Mario Campone
Session: Poster Display session 2
Resources:
Abstract
3599 - Comparative effectiveness of palbociclib plus letrozole vs letrozole for metastatic breast cancer in US real-world clinical practices
Presenter: Rachel Layman
Session: Poster Display session 2
Resources:
Abstract
901 - Pharmacokinetics (PK), safety, and efficacy of [fam-] trastuzumab deruxtecan with OATP1B/CYP3A inhibitors in subjects with HER2-expressing advanced solid tumors
Presenter: Yung-Jue Bang
Session: Poster Display session 2
Resources:
Abstract
2777 - A Phase 2 study of abemaciclib in patients (pts) with brain metastases (BM) secondary to non-small cell lung cancer (NSCLC) or melanoma (MEL).
Presenter: Solmaz Sahebjam
Session: Poster Display session 2
Resources:
Abstract
3980 - Ribociclib (RIB) + letrozole (LET) in patients (pts) with visceral metastases (VM) or bone-only metastases (BOM) in hormone receptor-positive (HR+), human epidermal growth factor receptor-2–negative (HER2–) advanced breast cancer (ABC): Subgroup analysis from the CompLEEment-1 trial
Presenter: Michelino De Laurentiis
Session: Poster Display session 2
Resources:
Abstract
4024 - Ribociclib (RIB) + letrozole (LET) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor-2–negative (HER2–) advanced breast cancer (ABC) and central nervous system (CNS) metastases: Subgroup analysis from the phase 3b CompLEEment-1 trial
Presenter: Paul Cottu
Session: Poster Display session 2
Resources:
Abstract
2151 - Clinical outcome and toxicity data in patients with advanced breast cancer treated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors combined with endocrine therapy in a real-world clinical setting.
Presenter: Elena Fountzilas
Session: Poster Display session 2
Resources:
Abstract
3994 - Safety and efficacy of Ribociclib (RIBO) + letrozole (LET) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC): Interim results from the Italian cohort of the CompLEEment-1 (C-1) study.
Presenter: Michele De Laurentiis
Session: Poster Display session 2
Resources:
Abstract
1370 - Interim Results From CompLEEment-1 (A Phase 3b Study of Ribociclib and Letrozole as First-Line Therapy for Advanced Breast Cancer in an Expanded Population): Spanish cohort results
Presenter: Javier Salvador
Session: Poster Display session 2
Resources:
Abstract