The ongoing French metastatic breast cancer (MBC) cohort: the example-based methodology of the Epidemiological Strategy and Medical Economics (ESME).

PURPOSE: The currently ongoing Epidemiological Strategy and Medical Economics (ESME) research programme aims at centralising real-life data on oncology care for epidemiological research purposes. We draw on results from the metastatic breast cancer (MBC) cohort to illustrate the methodology used for data collection in the ESME research programme. PARTICIPANTS: All consecutive ≥18 years patients with MBC treatment initiated between 2008 and 2014 in one of the 18 French Comprehensive Cancer Centres were selected. Diagnostic, therapeutic and follow-up data (demographics, primary tumour, metastatic disease, treatment patterns and vital status) were collected through the course of the disease. Data collection is updated annually. FINDING TO DATE: With a recruitment target of 30 000 patients with MBC by 2019, we currently screened a total of 45 329 patients, and >16 700 patients with a metastatic disease treatment initiated after 2008 have been selected. 20.7% of patients had an hormone receptor (HR)-negative MBC, 73.7% had a HER2-negative MBC and 13.9% were classified as triple-negative BC (ie, HER2 and HR status both negative). Median follow-up duration from MBC diagnosis was 48.55 months for the whole cohort. FUTURE PLANS: These real-world data will help standardise the management of MBC and improve patient care. A dozen of ancillary research projects have been conducted and some of them are already accepted for publication or ready to be issued. The ESME research programme is expanding to ovarian cancer and advanced/metastatic lung cancer. Our ultimate goal is to achieve a continuous link to the data of the cohort to the French national Health Data System for centralising data on healthcare reimbursement (drugs, medical procedures), inpatient/outpatient stays and visits in primary/secondary care settings. TRIAL REGISTRATION NUMBER: NCT03275311; Pre-results.

Totally implanted venous access-associated adverse events in oncology: Results from a prospective 1-year surveillance programme.

INTRODUCTION: During the last decade, most studies on totally implanted venous access-associated adverse events (TIVA-AE) were conducted retrospectively and/or were based on a limited sample size. The aim of our survey was two-fold: to estimate the incidence of TIVA-AE and to identify risk factors in patients with cancer. METHODS: Data from our routine surveillance of TIVA-AE were collected prospectively between October 2009 and January 2011 in two oncology referral centers in Northern France. The open cohort under surveillance during the same time period was reconstituted retrospectively using data from the hospital information systems. Incidences of first TIVA-AE per 1000 TIVA-days were calculated. Risk factors were identified using multivariate logistic regressions. RESULTS: We included 2286 cancer patients, corresponding to 582,347 TIVA-days. Among the 133 first TIVA-AE observed (incidence 0.23 per 1000 TIVA-days [0.19-0.27]), there were 50 infectious AE (incidence 0.09 [0.06-0.11]) and 83 non-infectious AE (incidence 0.14 [0.11-0.17]). Compared to non-metastatic solid cancers, metastatic cancers (aOR=2.3 [0.9-6.0]), and hematologic malignancies (aOR=3.2 [1.1-8.8]) tended to be associated with a higher risk of infectious TIVA-AE (P=0.087). Solid cancer type was associated with non-infectious TIVA-AE (P=0.030), especially digestive cancers. DISCUSSION: We report accurate estimations of TIVA-AE incidences in one of the largest populations among previously published studies. As in previous studies, metastatic cancers and hematologic malignancies tended to be associated with a higher risk of infectious TIVA-AE. Further studies are warranted to confirm the effect of digestive cancers.