Abstract 415P
Background
Docetaxel (DTX), cisplatin (CDDP) and 5-FU (DCF) therapy has been established as a standard neoadjuvant treatment for resectable locally advanced esophageal squamous cell carcinoma (LA-ESCC) based on the results of the JCOG1109 study. However, DCF requires hydration to prevent CDDP-induced nephrotoxicity. In Western countries, 5-FU/leucovorin, oxaliplatin (L-OHP) and DTX (FLOT) therapy is a standard neoadjuvant treatment for resectable gastric and esophagogastric junction adenocarcinomas and does not require hydration. However, there are limited data on the safety and efficacy of neoadjuvant FLOT(NeoFLOT) in LA-ESCC patients.
Methods
Patients with resectable LA-ESCC diagnosed as cT1N1-3M0, cT2-3N0-3M0, or cT1-3N0-3M1 (UICC-TNM 8th edition) who received NeoFLOT in our hospital between February 2021 and December 2023 were retrospectively analyzed. Four cycles of NeoFLOT (DTX [50 mg/m2], L-OHP [85 mg/m2], l-leucovorin [200 mg/m2], and 5-FU [2600 mg/m2], every 2 weeks) were administered. We evaluated adverse events (CTCAE ver. 5.0) and the histopathological response.
Results
We identified 46 eligible patients (median age, 76 years; male, 80%; clinical stage I/II/III/IVA/IVB, 11/7/61/2/20%). Eight patients (17%) developed progressive disease, while 36 (78%) underwent surgery. R0 resection was achieved in all cases, and a pathological complete response was seen in 8 patients (22%). The most common adverse events were hematologic toxicities, with grade 3 or 4 leukopenia in 50% and grade 3 or 4 neutropenia in 65%. The most common non-hematological toxicities were any-grade malaise in 48%, followed by anorexia in 28% and peripheral sensory neuropathy in 28%. Median progression-free survival was 15.0 months and median overall survival was 25.2 months (median follow-up period: 10.9 months).
Conclusions
NeoFLOT was well-tolerated and showed efficacy comparable to that of neoadjuvant DCF therapy.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
S. Yamamoto: Financial Interests, Personal, Invited Speaker: Ono Pharmaceuticals, Merck Sharp &Dohme, Taiho; Financial Interests, Personal, Expert Testimony: Bristol Myers Squibb. Y. Honma: Financial Interests, Personal, Advisory Board: Janssen, Rakuten Medical Japan; Financial Interests, Personal, Invited Speaker: Novartis, Chugai Pharma, MSD, Ono Pharmaceutical, Bristol Myers Squibb, Merck Biopharma, Eisai, Eli Lilly, Nutri, Teijin Pharma, Baye, Taiho Pharmaceutical; Financial Interests, Personal, Research Grant: Taiho Pharmaceutical, Chugai Pharma, MSD, GSK, Janssen, Adlai Nortye Biopharma, Maruho, Merck Biopharma, Genmab, Astellas Pharma, Rakuten Medical Japan, AstraZeneca. K. Kato: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical, Bristol Myers Squibb, Merck and Co; Financial Interests, Personal, Advisory Board: Ono Pharmaceutical, Bristol Myers Squibb, Merck & Co., Bayer, AstraZeneca, BeiGene, Taiho, Merck Biopharma, Amgen, Novartis; Financial Interests, Personal, Expert Testimony: Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker: Ono Pharmaceuticals, Merck & Co., Bayer, AstraZeneca, BeiGene, Chugai, Taiho, Oncolys Biopharma, Janssen Pharmaceutical. All other authors have declared no conflicts of interest.