Abstract 1440P
Background
Gastric cancer is associated with poor prognosis. Currently in Europe the preferred management of locally advanced gastric cancer is perioperative chemotherapy using FLOT regimen. According to previously published data, such treatment is associated with improved relapse-free survival (RFS) as well as overall survival (OS) compared to ECF/ECX. We aimed at a prospective study in order to collect biomaterial for identification of serum biomarkers of early response to neoadjuvant chemotherapy. Here we report the safety and clinical efficacy of this prospective cohort.
Methods
It was an academic, nonrandomized, prospective study, conducted in Maria Sklodowska-Curie National Institute of Oncology in Warsaw, Poland. Between January 2018 and January 2020, a total of 70 patients aged 31-74 (median 64 years, 51.35% male and 48.65% female) with histologically confirmed resectable gastric cancer were enrolled in the study. The patients were qualified by multidisciplinary team to preoperative treatment (FLOT regimen). All 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 criteria.
Results
A total of 94.28% (n=66) patients completed four cycles of chemotherapy, 17.14% (n=12) required dose reduction. All patients experienced grade 1/2 toxicities. The common AE G1/G2 included: fatigue (75%), nausea (65%), vomiting (25%), diarrhoea (23%) and oral mucositis (43%). Only 17.0% (12/70) had any G3/4 adverse events: one case of life-threatening neutropenic sepsis, diarrhoea (n=5), nausea/vomiting (n=6). Pathological regression G1a according to the Becker criteria was achieved in seven cases (10.0%, n=7/70) and G1b in six cases (8.57%, n=6/70).
Conclusions
FLOT regimen was an effective and well-tolerated treatment in the Polish population.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Maria Sklodowska-Curie National Institute of Oncology in Warsaw - grant number SN/GW24/2017.
Disclosure
All authors have declared no conflicts of interest.