Evolution of the Therapeutic Care in Ovarian Cancer From 2011

NCT03275298SuspendedOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

UNICANCER

Enrollment

13331

Start Date

2017-04-01

Completion Date

2019-12-31

Study Type

OBSERVATIONAL

Official Title

Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Database : Evolution of the Therapeutic Care in Ovarian Cancer Across the French Comprehensive Cancer Centers From 2011

Conditions

Ovarian Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion criteria :

* 18 years old female
* Female who received surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, diagnostic procedure, other specific therapeutic procedure) for ovarian cancer in a French Comprehensive Cancer Center.

Exclusion criteria : None

Outcome Measures

Primary Outcomes

Describe the evolution of therapeutic care in ovarian cancer across the French comprehensive cancer centers

Patient characteristics, tumor characteristics and treatment patterns

Time frame: baseline

Secondary Outcomes

Describe the impact of therapeutic strategies on survival criteria

Overall survival

Time frame: From date of diagnosis or first treatment until the date of date of death from any cause. Follow up until 2022.

Locations

Institut de Cancérologie de l'Ouest - Paul Papin, Angers, France

Institut Bergonié, Bordeaux, France

Centre François Baclesse, Caen, France

Centre Jean Perrin, Clermont-Ferrand, France

Centre Georges-François Leclerc, Dijon, France

Centre Oscar Lambret, Lille, France

Centre Léon Bérard, Lyon, France

Institut Paoli-Calmettes, Marseille, France

Institut régional du Cancer Montpellier / Val d'Aurelle, Montpellier, France

Institut de Cancérologie de Lorraine, Nancy, France

Institut de cancérologie de l'Ouest - René Gauducheau, Nantes, France

Centre Antoine Lacassagne, Nice, France

Institut Curie, Paris, France

Institut Jean Godinot, Reims, France

Centre Eugène Marquis, Rennes, France

Centre Henri Becquerel, Rouen, France

Institut Curie - Hôpital René Huguenin, Saint-Cloud, France

Centre Paul Strauss, Strasbourg, France

Institut Claudius Regaud, Toulouse, France

Institut Gustave Roussy, Villejuif, France

Linked Papers

2021-07-19

Clinicopathological characterization of a real-world multicenter cohort of endometrioid ovarian carcinoma: Analysis of the French national ESME-Unicancer database

Prognostic significance of endometrioid epithelial ovarian cancer (EOC) is controversial. We compared clinical, pathological, and biological features of patients with endometrioid and serous EOC, and assessed the independent effect of histology on outcomes. We conducted a multicenter retrospective analysis of patients with EOC selected from the French Epidemiological Strategy and Medical Economics OC database between 2011 and 2016. Our main objective was to compare overall survival (OS) in endometrioid and serous tumors of all grades. Our second objectives were progression-free survival (PFS) and prognostic features. Out of 10,263 patients included, 3180 cases with a confirmed diagnosis of serous (N = 2854) or endometrioid (N = 326) EOC were selected. Patients with endometrioid histology were younger, more often diagnosed at an early stage, with lower-grade tumors, more frequently dMMR/MSI-high, and presented more personal/familial histories of Lynch syndrome-associated cancers. BRCA1/2 mutations were more frequently identified in the serous population. Endometrioid patients were less likely to receive chemotherapy, with less bevacizumab. After median follow-up of 51.7 months (95CI[50.1-53.6]), five-year OS rate was 81% (95CI[74-85]) in the endometrioid subgroup vs. 55% (95CI[53-57] in the serous subset (p < 0.001, log-rank test). In multivariate analyses including [age, ECOG-PS, FIGO, grade, and histology], the endometrioid subtype was independently associated with better OS (HR = 0.38, 95CI[0.20-0.70], p= 0.002) and PFS (HR = 0.53, 95CI[0.37-0.75], p < 0.001). Clinicopathological features at diagnosis are not the same for endometrioid and serous EOC. Endometrioid histology is an independent prognosis factor in EOC. These observations suggest the endometrioid population requires dedicated clinical trials and management.

PARP inhibitors as maintenance therapy in ovarian cancer after platinum-sensitive recurrence: real-world experience from the Unicancer network

Abstract Background Based on results of randomized clinical trials, polyADP-ribose polymerase inhibitors (PARPi) have become the standard of care in patients with platinum-sensitive recurrent ovarian cancer (OvC) in patients responding to platinum chemotherapy. However, little is known about their impact on survival in a real-world setting. Patients and methods This retrospective French multicenter observational study included women with platinum-sensitive recurrent OvC (not limited to the first platinum-sensitive relapse) receiving PARPi as maintenance after response to platinum-based chemotherapy. They were compared to patients with similar characteristics undergoing observation after chemotherapy completion. Data were collected in the Ovarian Cancer Epidemiological Strategy and Medical Economics (ESME-OC) database between 2011 and 2021. We explored progression-free survival (PFS) and overall survival (OS) benefits with PARPi maintenance. Results One hundred and twenty-three patients matching the selection criteria were included in the PARPi group and 397 patients in the control group. Median PFS was 19.9 months (95CI [15.0-21.9]) in the PARPi group vs 13.4 months (95CI [11.8-15.0]) in the control group, with a HR = 0.71 (95CI [0.55-0.93]), P = .01). Median OS was 82.0 months (95CI [48.6-Not Estimable]) in the PARPi group vs 44.7 months (95CI [38.8-53.7]) in the control group (HR = 0.47, 95CI [0.30-0.74], P &amp;lt; .001). Multivariate analyses including performance status, histological subtype, achievement of cytoreductive surgery at relapse, and platinum-free interval, confirmed the independent prognostic impact of PARPi treatment. Conclusion This first national study focusing on the efficacy of PARPi in a real-world population shows similar benefits than in randomized clinical trials, supporting their use in clinical routine practice. Database registration clinicaltrials.gov Identifier NCT03275298.