126P - Late line FOLFOX therapy after prior cisplatin-based regimen in advanced esophageal squamous cell carcinoma: A multi-institutional retrospective study

Background

FOLFOX (5-fluorouracil, l-leucovorin and oxaliplatin [L-OHP]) is one of the treatment options for patients (pts) with advanced esophageal squamous cell carcinoma (aESCC). Because it is suggested that L-OHP showed activity in pts resistant to Cisplatin (CDDP), we evaluated the efficacy and safety of FOLFOX in pts who received prior CDDP-containing regimen.

Methods

We retrospectively evaluated aESCC pts who received FOLFOX as second- or later-line after becoming refractory or intolerance to CDDP based therapy between April 2019 and October 2020 at 18 institutes. CDDP refractory defined as progression during treatment with a CDDP-containing regimen or progression within 6 months after the last dose of CDDP. CDDP intolerant defined as physician determines that CDDP administration is not possible due to toxicity or other reasons. Major inclusion criteria were ECOG PS of 0-2 and adequate organ function.

Results

Thirty-nine pts were evaluated. The patient characteristics were as follows: median age (range), 68 (47-85) years; male/female, 28/10; ECOG PS 0/1/2, 9/27/3; stage IVB/recurrence, 16/23; the number of metastatic sites (range), 2 (1-6); median number of prior CT (range), 2 (1-4); and prior CDDP refractory/intolerance 35/4. With median follow-up period of 17.7 months, median PFS and OS were 2.4 (95% CI 2.1-3.8) and 7.2 (95% CI 5.3-9.8) months, respectively. Twenty five pts had target lesion. Objective response rate (ORR) and disease control rate (DCR) were 4% and 36%, respectively. Median PFS, ORR, and DCR for pts with or without prior nivolumab received were 2.1/2.4, months, 0/4% and 45/33%, respectively. Eighteen pts (47%) received subsequent chemotherapy (CT), which consisted of nivolumab (67%) and taxane (28%). Grade 3 or 4 AEs were neutropenia (18%), anorexia (13%), anemia (11%), nausea (11%), peripheral sensory neuropathy (8%), infection (5%), thrombocytopenia (5%), vomit (5%), allergy (3%), hematemesis (3%), peripheral motor neuropathy (3%) and weight loss (3%).

Conclusions

FOLFOX for aESCC pts who received prior CDDP-containing CT showed modest efficacy, regardless of prior use of nivolumab.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

Y. Matsubara: Financial Interests, Personal, Invited Speaker: Takeda, Taiho. M. Furuta: Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb, ONO Pharmaceutical Co. S. Mitani: Financial Interests, Personal, Advisory Board: Chugai Pharmaceutical Co.; Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical Co. S. Boku: Financial Interests, Personal, Speaker’s Bureau: Daiichi Sankyo, Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Yakult Honsha Co., Ltd.; Financial Interests, Institutional, Research Grant: Daiichi Sankyo. K. Tsuchihashi: Financial Interests, Personal, Invited Speaker: Ono Pharma. Y. Kito: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical, Daiichi Sankyo. A. Sugaya: Financial Interests, Personal, Speaker’s Bureau: Bayer, Taiho Pharmaceutical Co., Ltd., Bristol Myers Squibb. T. Masuishi: Financial Interests, Personal, Invited Speaker: Takeda, Chugai, Merck Bio Pharma, Taiho, Bayer, Eli Lilly, Yakult Honsha, Sanofi, Daiichi Sankyo, Ono, Bristol Myers Squibb; Financial Interests, Institutional, Funding: Daiichi Sankyo, Ono, Novartis, Amgen, Syneos Healthe Clinical, Boehringer-Ingelheim, Pfizer, Cimic Shift Zero, Eli Lilly. T. Matsumoto: Financial Interests, Institutional, Principal Investigator: Sanofi KK. K. Hirata: Financial Interests, Personal, Research Grant: Taiho Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb Company, EA Pharma Co., Ltd., Pfizer Inc.; Financial Interests, Personal, Invited Speaker: Eli Lilly Japan K.K., Taiho Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb Company, Yakult Honsha Co., Ltd. All other authors have declared no conflicts of interest.