P1.088. Reduced-Dose Cisplatin-Based Preoperative Chemotherapy vs. Surgery Alone for Cisplatin-Unfit Esophageal Cancer: A Multicenter Retrospective Study in Japan

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Abstract Topic Esophageal Cancer: Adjuvant and Neo-Adjuvant Therapies Background Based on the results of the JCOG1109 trial, preoperative chemotherapy with docetaxel, cisplatin, and fluorouracil followed by radical resection is the standard of care for resectable esophageal squamous cell carcinoma (ESCC). However, a standard strategy has not been established for patients excluded from JCOG1109, such as those aged 76 or older or those with organ dysfunction. This study aimed to compare the efficacy and safety of preoperative reduced-dose cisplatin plus fluorouracil (RD-CF) versus surgery alone in patients with resectable ESCC who were ineligible for standard-dose cisplatin. Methods We retrospectively reviewed data from 25 institutions for resectable ESCC patients who received either RD-CF or surgery alone between January 2017 and December 2021. The inclusion criteria were as follows: (1) age ≥18 years; (2) ECOG PS 0-2; (3) Stage II-III (Japanese Classification of Esophageal Cancer, 12th Edition); (4) age ≥75 years, creatinine clearance (CCr) <60 ml/min, or cardiac dysfunction; and (5) initial cisplatin dose reduced to <65 mg/m2. The primary endpoint was overall survival (OS), and the secondary endpoints included relapse-free survival (RFS), radical resection rate, pathological response, and adverse events. Propensity score matching (PSM) was performed using covariates, including age, sex, CCr, neutrophil-to-lymphocyte ratio, cardiac dysfunction, and cT/N/M stages. Results Of the 406 registered cases, 140 in the surgery-alone group and 90 in the RD-CF group were analyzed. In the pre-PSM cohort, the median age was 79 vs. 76 years, and the median CCr was 55.2 vs. 50.7 ml/min. In the RD-CF group, the median initial doses were 60.7 mg/m2 for cisplatin and 786.8 mg/m2 for fluorouracil. Surgery was performed in 100% of the surgery-alone group and 93.3% of the RD-CF group. A pathological response was observed in 18.9% of patients in the RD-CF group. Multivariable analysis showed no significant differences in survival between the groups (RFS: hazard ratio [HR] 0.75, 95% confidence interval [CI] 0.44–1.27; OS: HR 0.70, 95% CI 0.42–1.16). After PSM, all standardized differences were <20%. Post-PSM analysis also demonstrated no significant differences in survival (RFS: HR 1.01, 95% CI 0.52–1.97; OS: HR 1.02, 95% CI 0.51–2.02). Conclusion For patients with resectable ESCC who are ineligible for standard-dose cisplatin due to advanced age, renal impairment, or cardiac dysfunction, the clinical benefit of preoperative RD-CF may be limited compared to that of surgery alone.

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