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Observational Study
. 2021 Oct 8;21(1):1086.
doi: 10.1186/s12885-021-08768-7.

Results of the observational prospective RealFLOT study

Elisa Giommoni  1 , Daniele Lavacchi  1 , Giuseppe Tirino  2 , Lorenzo Fornaro  3 , Francesco Iachetta  4 , Carmelo Pozzo  5 , Maria Antonietta Satolli  6 , Andrea Spallanzani  7 , Marco Puzzoni  8 , Silvia Stragliotto  9 , Michele Sisani  10 , Vincenzo Formica  11 , Filippo Giovanardi  12 , Antonia Strippoli  5 , Michele Prisciandaro  13 , Samantha Di Donato  14 , Luca Pompella  2 , Irene Pecora  3 , Alessandra Romagnani  4 , Sara Fancelli  1 , Marco Brugia  1 , Serena Pillozzi  1 , Ferdinando De Vita  2 , Lorenzo Antonuzzo  15   16   17
Affiliations
Observational Study

Results of the observational prospective RealFLOT study

Elisa Giommoni et al. BMC Cancer. .

Abstract

Background: Perioperative FLOT (5-fluorouracil, oxaliplatin and docetaxel) has recently become the gold standard treatment for fit patients with operable gastric (GC) or gastroesophageal (GEJ) adenocarcinoma, getting a 5-year overall survival (OS) of 45%, over 23% with surgery alone.

Methods: RealFLOT is an Italian, multicentric, observational trial, collecting data from patients with resectable GC or GEJ adenocarcinoma treated with perioperative FLOT. Aim of the study was to describe feasibility and safety of FLOT, pathological complete response rate (pCR), surgical outcomes and overall response rate (ORR) in an unselected real-world population. Additional analyses evaluated the correlation between pCR and survival and the prognostic role of microsatellite instability (MSI) status.

Results: Of 206 patients enrolled that received perioperative FLOT at 15 Italian centers, 124 (60.2%) received at least 4 full-dose cycles, 190 (92.2%) underwent surgery, and 142 (68.9%) started the postoperative phase. Among patients who started the postoperative phase, 105 (51.0%) received FLOT, while 37 (18%) received de-intensified regimens, depending on clinical condition or previous toxicities. pCR was achieved in 7.3% of cases. Safety profile was consistent with literature. Neutropenia was the most common G 3-4 adverse event (AE): 19.9% in the preoperative phase and 16.9% in the postoperative phase. No toxic death was observed and 30-day postoperative mortality rate was 1.0%. ORR was 45.6% and disease control rate (DCR) was 94.2%. Disease-free survival (DFS) and OS were significantly longer in case of pCR (p = 0.009 and p = 0.023, respectively). A trend towards better DFS was observed among MSI-H patients.

Conclusions: These real-world data confirm the feasibility of FLOT in an unselected population, representative of the clinical practice. pCR rate was lower than expected, nevertheless we confirm pCR as a predictive parameter of survival. In addition, MSI-H status seems to be a positive prognostic marker also in patients treated with taxane-containing triplets.

Keywords: FLOT; Gastric cancer; Gastro-oesophageal junction adenocarcinoma; MSI; Perioperative chemotherapy; pCR.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Treatment exposure. Percentages refer to the total study population (n = 206). Abbreviations: FLOT: fluorouracil, leucovorin, oxaliplatin, and docetaxel; pts.: patients
Fig. 2
Fig. 2
Disease free survival (DFS) and overall survival (OS). Abbreviations: DFS: disease-free survival; OS: overall survival; pCR: pathological complete response; NaN: not reached
Fig. 3
Fig. 3
Disease free survival (DFS) according to MSI status. 0 = MSI-H; 2 = MSS
See this image and copyright information in PMC

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