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Efficacy of FLOT regimen in the Polish population – real-world data from a prospective biomarker study
Background
Gastric cancer is associated with poor prognosis. Currently in Europe the preferred management of locally advanced gastric cancer (GC) and gastroesophageal junction (GEJ) cancer is perioperative chemotherapy using FLOT regimen. According to previously published data, such treatment is associated with improved disease-free survival (DFS) as well as overall survival (OS) compared to ECF/ECX regimen.
Methods
It was an academic, nonrandomized, prospective study, conducted in Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw, Poland. Between January 2018 and November 2019 we analysed a total of 61 patients aged 30-77 (median 63 years, 52.5% male and 47.5% female) with histologically confirmed GC or GEJ cancer. The patients were qualified by multidisciplinary team for perioperative treatment (FLOT regimen). All cases of reported adverse events were recorded and analysed. All patients received G-CSF prophylactically. After gastrectomy, assessment of pathological regression was performed according to the Becker classification.
Results
A total of 93.4% (57) patients completed four cycles of preoperative chemotherapy and 78.7% (48) received postoperative chemotherapy. All of them experienced grade 1/2 toxicities. The common AE G1/G2 in preoperative versus postoperative chemotherapy were: fatigue (75% vs. 60%), anaemia (64% vs 62%) nausea (60% vs 60%), peripheral neuropathy (60% vs 60%) and oral mucositis (59% vs 50%), respectively. Only 24.6% (15) had any G3/4 adverse events during preoperative chemotherapy and only 20.8% (10) during postoperative chemotherapy. The estimated disease-free survival (DFS) at 3 years was 53% (95% CI 40.5%-66.1%) and estimated overall survival (OS) at 3-years was 60.2% (95% CI 45.1%-72.3%).
Conclusions
FLOT regimen significantly improved GC and GEJ cancer patients’ prognosis with acceptable side-effect profiles.
Legal entity responsible for the study
The author.
Funding
Maria Sklodowska-Curie National Institute of Oncology in Warsaw - grant number SN/GW24/2017.
Disclosures
All authors have declared no conflicts of interest.
