Real-World Data About Treatment Pattern and Outcomes of Patients With Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma in France: Results From the Fregat Database
Author(s)
Piessen G1, Adenis A2, Renaud F1, Devaux S1, Bergeat D3, El Hajbi F4, Regenet N5, Régimbeau JM6, Gricar J7, Singh P7, Casabianca P8, Baklouti M9, Thomas C9, Emery C10, Torreton E10, Fagnani F10
1CHU Lille, Lille, France, 2Institut du Cancer de Montpellier & IRCM, Montpellier, France, 3CHU Rennes, Rennes, France, 4Centre Oscar Lambret, Lille, France, 5CHU Nantes, Nantes, France, 6CHU Amiens, Amiens, France, 7Bristol-Myers Squibb, Princeton, NJ, USA, 8Bristol-Myers Squibb, Paris 8e Arrondissement, 75, France, 9Bristol-Myers Squibb, Rueil-Malmaison, 75, France, 10CEMKA, Bourg-La-Reine, France
Presentation Documents
OBJECTIVES: Esophageal cancer is the seventh most common cancer and sixth leading cause of cancer death, worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020. Squamous-cell carcinoma accounts for approximately 60% of cases in Europe. The study aim was to describe real-world treatment and outcomes of French patients presenting with UnResectable Advanced, or Metastatic Esophageal Squamous-Cell Carcinoma (URAM-ESCC) from 2014 to 2019 before approval of immune-checkpoint inhibitors (ICI).
METHODS: We conducted a retrospective cohort study to characterize the clinical characteristics and treatment of patients from 35 French centres within the FREGAT database identified to have URAM-ESCC at treatment initiation or during follow-up. Overall-Survival (OS) and Progression-Free Survival (PFS) were assessed using Kaplan-Meier method.
RESULTS: FREGAT included 225 patients diagnosed with URAM-ESCC as de novo in 137 (61%) and as recurrent in 86 (39%). Median age was 62 years, 77% were male. 174 (77%) patients received first-line chemotherapy, most frequently with 5FU+Oxaliplatin (n = 124; 71%) or 5FU+Cisplatin in (n = 12; 7%). Among patients receiving first-line chemotherapy, 44 (25%) received second-line chemotherapy, most frequently Paclitaxel (n=10; 23%) or FOLFIRI (n=8; 18%)). Median OS and PFS were 9.0 months (95% CI: 7.2-11.5) and 6.4 months (95% CI: 5.5-7.4), respectively, with no significant differences by time of diagnosis (at treatment initiation versus follow-up) or first-line chemotherapy regimen. A total of 120 (69%) patients met selection criteria of randomized Phase-III CheckMate 648 evaluating nivolumab + chemotherapy or nivolumab + ipilimumab in this indication and might have benefitted from these new therapeutic options. Median OS and PFS for this subpopulation were 9.0 months (95% CI 7.1 – 12.2) and 6.3 months (95% CI 5.3– 7.7), respectively, consistent with outcomes in the CheckMate 648 control arm.
CONCLUSIONS: This study offers insights in current practice and outcomes in unselected French patients with URAM-ESCC before approval of ICI.
Conference/Value in Health Info
Value in Health, Volume 25, Issue 12S (December 2022)
Code
RWD123
Topic
Clinical Outcomes, Epidemiology & Public Health
Topic Subcategory
Clinical Outcomes Assessment, Safety & Pharmacoepidemiology
Disease
STA: Drugs