Timed‑flat infusion of 5‑fluorouracil with docetaxel and oxaliplatin as first‑line treatment of gastroesophageal adenocarcinoma: A single institution experience with the FD/FOx regimen.

To date, there is no consensus regarding first‑line chemotherapy for patients with HER2‑negative, locally advanced/metastatic gastric cancer (a/m GC). In the present study we reported a retrospective case‑series of patients treated with a weekly regimen containing timed‑flat infusion of 5‑fluorouracil (TFI/5‑FU), docetaxel and oxaliplatin. From June 2007 to July 2017, 32 consecutive a/m GC patients were treated with first‑line standard (st) or modulated (mod) 'FD/FOx' regimen: Weekly 12 h (from 10.00 p.m. to 10.00 a.m.) TFI/5‑FU for two consecutive nights at 900 mg/m2/day, associated to weekly alternating docetaxel, 50 mg/m2 and oxaliplatin, 80 mg/m2. The median age of the patients was 60 years and their Eastern Cooperative Oncology Group‑performance status (ECOG‑PS) was as follows: i) ECOG‑PS 0/1, (n=28, 87.5%); and ii) ECOG‑PS 2 (n=4, 12.5%). Patient activity, efficacy and safety data were collected and subgroup analyses were conducted among patients treated with st and mod FD/FOx. In the intention‑to‑treat (ITT) analysis, the objective response rate (ORR) was 75% (95% CI, 53‑90) and the disease control rate (DCR) was 87.5% (95% CI, 67.6‑97.3). After a median follow‑up of 16 months, median progression‑free survival (PFS) and median overall survival (OS) were 14.0 and 19.0 months, respectively. The received dose‑intensities were ~80% of the standard doses for each agent. The most relevant treatment‑related grade 3 adverse events were: Neutropenia (40.6%), asthenia (18.7%) and diarrhea (18.7%). The only treatment‑related grade 4 adverse event was neutropenia (9.3%). No febrile neutropenia was observed and none of the patients died as a result of adverse events. FD/FOx regimen appeared to be a feasible option as a first‑line treatment of a/m GC patients, especially in case of high‑tumor burden, with the need of rapid tumor shrinkage and disease‑related symptoms palliation.