OA03-RF01.03. Non-Cisplatin-Based Preoperative Chemotherapy 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 Although cisplatin-based neoadjuvant chemotherapy is the standard for resectable esophageal squamous cell carcinoma in Japan, some patients are unfit due to age, renal, or cardiac dysfunction. No established treatment option exists for cisplatin-unfit patients. We compared the efficacy between non-cisplatin-based preoperative chemotherapy (noCDDP) followed by surgery and surgery alone (Sx). Methods This multicenter retrospective study included patients from 25 institutions in the Young Investigators’ Group of Japan Esophageal Oncology Group. Patients treated with noCDDP or Sx between 2017 and 2021 were included if they had resectable thoracic esophageal squamous cell carcinoma, ECOG PS 0–2, and were considered unfit for cisplatin due to advanced age (≥75 years), renal dysfunction (creatinine clearance 20–59 mL/min), or cardiac dysfunction (ejection fraction <50%, heart failure history, or uncontrolled arrhythmia). Overall survival (OS) and progression-free survival (PFS) were analyzed using Kaplan–Meier estimates, log-rank tests, and Cox proportional hazards models. To adjust for baseline imbalances, inverse probability of treatment weighting (IPTW) was applied using clinical covariates including age, sex, ECOG PS, body mass index, creatinine clearance, hemoglobin, neutrophil–lymphocyte ratio, cardiac dysfunction, tumor location, and cT, cN, cM factors. Results A total of 298 patients were included (noCDDP, n=80; Sx, n=218). Preoperative therapy in the noCDDP group consisted of nedaplatin + fluorouracil therapy (46%), fluorouracil, levofolinate plus oxaliplatin (FOLFOX) therapy (42%), and fluorouracil, levoflinate, oxaliplatin plus docetaxel (FLOT) therapy (11%). After IPTW, baseline characteristics were well balanced between groups. The 1-year/3-year PFS rates were 73%/62% in the noCDDP group and 70%/56% in the Sx group (hazard ratio [HR] 0.99, 95% confidence interval [CI] 0.60–1.64, p=0.98). The 1-year/3-year OS rates were 84%/67% and 85%/62%, respectively (HR 0.84, 95% CI 0.53–1.33, p=0.45). No significant survival difference was observed. Conclusion In cisplatin-unfit patients with resectable esophageal squamous cell carcinoma, non-cisplatin-based preoperative chemotherapy did not improve survival compared with surgery alone after adjustment for confounding factors. These findings do not support a clear survival benefit of routine use of noCDDP regimens in this population Prospective studies are warranted to identify subgroups that could benefit from preoperative treatment and to establish optimal therapeutic strategies for cisplatin-unsuitable patients.

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