Abstract

Abstract Background The 1st line regimens including Immunocheckpoint Inhibitor (ICI) have lately been approved for unresectable advanced or recurrent esophageal squamous cell carcinoma (ESCC). However, evidence of these regimens in clinical practice remains limited. Methods A total of 67 unresectable advanced or recurrent ESCC patients who received FP (5-FU + CDDP) + Pembrolizumab/Nivolumab (FP + ICI group; n = 43) or Ipilimumab+Nivolumab (ICI + ICI group; n = 24) as the 1st line treatment from December 2017 to March 2023 at our hospital were evaluated. Results Patient characteristics(FP + ICI: ICI + ICI) were as follows; age = 69:74 year-old, male/female = 36/7:22/2, recurrent/unresectable = 17(40%)/26(60%):13(54%)/11(46%), number of administered courses = 4 [1–35]: 2 [1–17], follow up period = 9: 6 months. Best response rate was CR/PR/SD/PD = 6/22/9/6:4/9/6/5 cases, while response/disease control rates were 65:54% and 86:79%, respectively. Regarding survival analysis, median OS = 23 months:did not reach, and 1-year OS = 83.7:87.5%, median PFS = 8:5 months, 1-year PFS = 48.8:49.3%, and DOR (duration of response) = 4[2–38]:5[5–9] months. The most common treatment-related adverse events (CTCAE Grade 3 or higher) were neutropenia in 18 cases, followed by anorexia in 7 cases (FP + ICI group), and adrenal hypofunction in 2 cases and pruritus in 2 cases (ICI + ICI group). Conclusion Both 1st line regimens for unresectable advanced or recurrent esophageal squamous cell carcinoma seemed to be feasible and promising in clinical use.

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