Long-Term Results of a Phase 2 Study of Definitive Chemoradiation Therapy Using S-1 for Esophageal Squamous Cell Carcinoma Patients Who Were Elderly or With Serious Comorbidities

• DOI: 10.3389/fonc.2022.839765
• Publication Date: 2022-04-05T13:13:08Z
• Authors: Yun Chen; Zhengfei Zhu; Weixin Zhao; Qi Liu; Junhua Zhang; Jiaying Deng; Dashan Ai; Saiquan Lu; Liuqing Jiang; Ihsuan Tseng; Huixun Jia; Kuaile Zhao
• Keywords: Pneumonitis; Leukopenia; Esophagitis; Clinical endpoint; Chemoradiotherapy; Regimen

The optimal evidence-based management for the subsets of locally advanced esophageal squamous cell carcinoma (ESCC) patients who rejected or were intolerant to intravenous chemotherapy due old age serious comorbidities is currently lacking. This study aimed assess safety and local control rate (LCR) S-1 (tegafur-gimeracil-oteracil potassium) combined with radiotherapy in these ESCC patients.Locally >75 years enrolled a prospective, single-arm, phase 2 trial. treated definitive concurrent chemoradiotherapy S-1, which was administered orally twice daily 28 days. dose 61.2 Gy delivered 34 fractions. primary end-point 3-year LCR.One hundred five recruited between March 2013 October 2015. At median follow-up 73.1 months (IQR 65.5-81.4 months), LCR 61.1%, 1, 3, 5-year overall survival 77.9, 42.3, 24.8% respectively. For analysis, ≥grade 3 acute adverse events included thrombocytopenia (6.7%), leukopenia (2.9%), anemia (1.0%), anorexia fatigue (10.5%), hiccup pneumonitis (4.8%), esophagitis (3.8%). Two (1.9%) died late hemorrhage, one patient (1.0%) radiation-induced pneumonitis.S-1 promising regimen low toxicity favorable comorbidities.ClinicalTrials.gov, NCT01831531.