TY - JOUR
T1 - Results of the observational prospective RealFLOT study
AU - Giommoni, Elisa
AU - Lavacchi, Daniele
AU - Tirino, Giuseppe
AU - Fornaro, Lorenzo
AU - Iachetta, Francesco
AU - Pozzo, Carmelo
AU - Satolli, Maria Antonietta
AU - Spallanzani, Andrea
AU - Puzzoni, Marco
AU - Stragliotto, Silvia
AU - Sisani, Michele
AU - Formica, Vincenzo
AU - Giovanardi, Filippo
AU - Strippoli, Antonia
AU - Prisciandaro, Michele
AU - Di Donato, Samantha
AU - Pompella, Luca
AU - Pecora, Irene
AU - Romagnani, Alessandra
AU - Fancelli, Sara
AU - Brugia, Marco
AU - Pillozzi, Serena
AU - De Vita, Ferdinando
AU - Antonuzzo, Lorenzo
N1 - Publisher Copyright:
© 2021, The Author(s).
PY - 2021/10/8
Y1 - 2021/10/8
N2 - 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.
AB - 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.
KW - FLOT
KW - Gastric cancer
KW - Gastro-oesophageal junction adenocarcinoma
KW - MSI
KW - pCR
KW - Perioperative chemotherapy
UR - http://www.scopus.com/inward/record.url?scp=85116812174&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85116812174&partnerID=8YFLogxK
U2 - 10.1186/s12885-021-08768-7
DO - 10.1186/s12885-021-08768-7
M3 - Article
C2 - 34625033
AN - SCOPUS:85116812174
SN - 1471-2407
VL - 21
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 1086
ER -