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Start Over Author "Sisani, Michele" Topic gastric cancer
2 results on '"Sisani, Michele"'

1. Results of the observational prospective RealFLOT study

Author

Giommoni, Elisa, Lavacchi, Daniele, Tirino, Giuseppe, Fornaro, Lorenzo, Iachetta, Francesco, Pozzo, Carmelo, Satolli, Maria Antonietta, Spallanzani, Andrea, Puzzoni, Marco, Stragliotto, Silvia, Sisani, Michele, Formica, Vincenzo, Giovanardi, Filippo, Strippoli, Antonia, Prisciandaro, Michele, Di Donato, Samantha, Pompella, Luca, Pecora, Irene, Romagnani, Alessandra, Fancelli, Sara, Brugia, Marco, Pillozzi, Serena, De Vita, Ferdinando, and Antonuzzo, Lorenzo

Published
2021
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2. Results of the observational prospective RealFLOT study

Author

Vincenzo Formica, Carmelo Pozzo, Irene Pecora, Serena Pillozzi, Elisa Giommoni, Lorenzo Antonuzzo, Daniele Lavacchi, Samantha Di Donato, Filippo Giovanardi, Maria Antonietta Satolli, Andrea Spallanzani, Michele Prisciandaro, Ferdinando De Vita, Marco Puzzoni, Giuseppe Tirino, Marco Brugia, Alessandra Romagnani, Michele Sisani, Luca Pompella, Antonia Strippoli, Lorenzo Fornaro, Silvia Stragliotto, Sara Fancelli, Francesco Iachetta, Giommoni, Elisa, Lavacchi, Daniele, Tirino, Giuseppe, Fornaro, Lorenzo, Iachetta, Francesco, Pozzo, Carmelo, Satolli, Maria Antonietta, Spallanzani, Andrea, Puzzoni, Marco, Stragliotto, Silvia, Sisani, Michele, Formica, Vincenzo, Giovanardi, Filippo, Strippoli, Antonia, Prisciandaro, Michele, Di Donato, Samantha, Pompella, Luca, Pecora, Irene, Romagnani, Alessandra, Fancelli, Sara, Brugia, Marco, Pillozzi, Serena, De Vita, Ferdinando, and Antonuzzo, Lorenzo

Subjects
Male, Cancer Research, FLOT, Docetaxel, Gastric cancer, Gastro-oesophageal junction adenocarcinoma, MSI, pCR, Perioperative chemotherapy, Adenocarcinoma, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Disease-Free Survival, Feasibility Studies, Female, Fluorouracil, Humans, Italy, Microsatellite Instability, Middle Aged, Neutropenia, Oxaliplatin, Prognosis, Prospective Studies, Stomach Neoplasms, Esophagogastric Junction, Gastroenterology, Surgical oncology, RC254-282, education.field_of_study, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Oncology, Human, medicine.drug, medicine.medical_specialty, Prognosi, Population, Stomach Neoplasm, Internal medicine, Genetics, medicine, education, Adverse effect, Antineoplastic Combined Chemotherapy Protocol, business.industry, Research, Perioperative, medicine.disease, Feasibility Studie, Prospective Studie, business
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.

Published
2021

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