Perioperative FLOT in resectable gastric cancer: Italian real-world data from the RealFLOT study.

Authors

null

Elisa Giommoni

Medical Oncology, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy

Elisa Giommoni , Ferdinando De Vita , Irene Pecora , Francesco Iachetta , Antonia Strippoli , Maria Antonietta Satolli , Andrea Spallanzani , Marco Puzzoni , Silvia Stragliotto , Michele Sisani , Vincenzo Formica , Filippo Giovanardi , Carmelo Pozzo , Michele Prisciandaro , Samantha Di Donato , Angelica Petrillo , Silvia Catanese , Giuseppe Tirino , Daniele Lavacchi , Lorenzo Antonuzzo

Organizations

Medical Oncology, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy, Division of Medical Oncology, Department of Precision Medicine, University of Study of Campania "L. Vanvitelli", Naples, Italy, Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy, Medical Oncology Unit, Clinical Cancer Center, AUSL-IRCCS, Reggio Emilia, Italy, Medical Oncology, Fondazione Policlinico Universitario “A. Gemelli”, IRCCS, Rome, Italy, Department of Medical Oncology, University of Turin, Turin, Italy, University Hospital of Modena, Modena, Italy, Medical Oncology Department, University Hospital, University of Cagliari, Cagliari, Italy, Oncology Unit - Dipartimento di Oncologia Clinica e Sperimentale Istituto Oncologico Veneto IOV-IRCCS, Padua, Italy, Medical Oncology, Usl Toscana Sudest, Arezzo, Italy, Internal Medicine Department "Tor Vergata" University Hospital, Rome, Italy, Medical Oncology, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, Medical Oncology, Department Nuovo Ospedale-Santo Stefano Instituto Toscano Tumori, Prato, Italy, Division of Medical Oncology, Department of Precision Medicine, University of Study of Campania “L. Vanvitelli”, Naples, Italy

Research Funding

No funding received
None

Background: Perioperative treatments have significantly improved survival in patients with resectable gastric cancer, increasing 5-year overall survival from 23% with surgery alone to 45% with FLOT (fluorouracil, oxaliplatin, docetaxel). Pathological regression is a prognostic marker of better survival. Methods: In this observational, retro- and prospective study we collected data from patients with resectable gastric or gastro-oesophageal junction (GEJ) adenocarcinoma treated, as clinical practice, with perioperative FLOT. All patients had clinical T2 or higher and/or nodal involvement, according to FLOT4-AIO trial. Results: A total of 206 patients received perioperative chemotherapy with FLOT at 15 Italian centres, between September 2016 and September 2019. Overall, 186 (90.3%) patients completed the preoperative phase, 190 (92%) 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 less intensive regimens (e.g. FOLFOX or De Gramont), depending on performance status after surgery or toxicity in the preoperative phase. Pathological complete response (pCR) was obtained in 7.3% of cases. In the preoperative phase, grade (G) 3-4 hematological and gastrointestinal adverse events (AEs) were reported in 42 (20.4%) and 13 (6.3%) patients, respectively. Conclusions: These real data confirmed the feasibility of perioperative FLOT in a less-selected population, representative of the clinical practice. The pCR rate was lower than in the FLOT4-AIO trial. The survival outcomes, potential predictive or prognostic factors and comprehensive safety data will be included in the final analysis.

Charateristics Patients (n = 206)
Sex
 Male 141 (68%)
 Female 65 (32%)
Location
 Gastric 114 (55%)
 GEJ 92 (45%)
cT
 T3-4 180 (87%)
 T1-2 26 (13%)
cN
 N+ 174 (85%)
 N0 32 (15%)
Compliance
 Completed preoperative phase 186 (90%)
 Started postoperative phase 142 (69%)
 Received 4 courses of postoperative FLOT without dose reduction 29 (14%)
Pathological response
 ypN0 60 (29%)
 ypCR 15 (7.3%)
AEs in preoperative phase
 Hematological G3-4 42 (20.4%)
 Gastrointestinal G3-4 13 (6.3%)

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Abstract Details

Meeting

2020 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Esophageal and Gastric Cancer and Other GI Cancers

Track

Esophageal and Gastric Cancer,Other GI Cancer

Sub Track

Patient-Reported Outcomes and Real-World Evidence

Citation

J Clin Oncol 38, 2020 (suppl 4; abstr 300)

Abstract #

300

Poster Bd #

A19

Abstract Disclosures