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
3330 - Tumour-infiltrating lymphocytes and BRCA-like status in stage III breast cancer patients treated with intensified carboplatin-based chemotherapy
Presenter: Leonora De Boo
Session: Poster Display session 2
Resources:
Abstract
3971 - Unravelling the biological characteristics of MammaPrint extreme risk subgroups
Presenter: Rajith Bhaskaran
Session: Poster Display session 2
Resources:
Abstract
5871 - Residual Cancer burden as a prognostic factor in a large series of Neoadjuvant chemotherapy. Subgroup analysis per molecular surrogated subtypes
Presenter: Catalina Falo
Session: Poster Display session 2
Resources:
Abstract
5014 - Clinical validation of CanAssist Breast in a Spanish cohort
Presenter: Manjiri Bakre
Session: Poster Display session 2
Resources:
Abstract
2787 - Meta-analysis on association of pathological complete response with long-term survival outcomes in triple-negative breast cancer
Presenter: Peter A. Fasching
Session: Poster Display session 2
Resources:
Abstract
4301 - Immune infiltrate composition across intrinsic subtypes in hormone receptor (HR)+/HER2- early breast cancer (BC) enrolled in the prospective LETLOB trial
Presenter: Gaia Griguolo
Session: Poster Display session 2
Resources:
Abstract
3205 - Frequency of germline mutations in women's cancer susceptibility genes in a large cohort of Chinese breast cancer patients
Presenter: Ning Liao
Session: Poster Display session 2
Resources:
Abstract
4091 - Triple blinded Prospective Study assessing the Impact of Genomics & Artificial Intelligence Watson For Oncology (WFO) on MDT’s Decision of Adjuvant Systemic Therapy for Hormone Receptor Positive Early Breast Carcinoma-
Presenter: Somashekhar Sampige Prasannakumar
Session: Poster Display session 2
Resources:
Abstract
4359 - Prognostic significance of Progesterone Receptor levels in luminal-like Her2- early Breast Cancer patients. A retrospective single Cancer Center analysis.
Presenter: Anna Diana
Session: Poster Display session 2
Resources:
Abstract
1369 - PAM50 HER2-enriched subtype and pathological complete response in HER2-positive early breast cancer: a meta-analysis
Presenter: Francesco Schettini
Session: Poster Display session 2
Resources:
Abstract