关键词: 食管癌, 紫杉醇, 氟尿嘧啶, Ⅱ期临床研究, 同期放化疗

Abstract: Background and purpose: Concurrent radiochemotherapy is the standard modality for locally advanced esophageal squamous cell carcinoma (ESCC) patients. This clinical trial aimed to assess the effectiveness and toxicity of continuous infusion of 5-fluorouracil (5-FU) and weekly paclitaxel combined with radiotherapy in ESCC patients. Methods: Patients with locally advanced (T_2-4N_0-1M_0-1a) esophageal squamous cell carcinoma were enrolled in a prospective, single-institutional, single-arm study of definitive chemoradiotherapy. Patients received 61.2 Gy with IMRT in 34 fractions. Patients had a Karnofsky performance status of 70 or greater, and normal liver, renal, and bone marrow functions. Patients were recommended to receive concurrent 5-FU (300 mg/m² civ 96 h) for 5 days a week for 5 weeks, plus paclitaxel (50 mg/m²) given during 3 hours every week for 5 weeks. Patients were recommended to receive 2 courses of consolidation chemotherapy after concurrent radio (chemo) therapy (5-FU 1 800 mg/m² civ 72 h, plus paclitaxel 175 mg/m2 every 28 days). The primary endpoints of the study were 5 year overall survival and acute toxicity. Results: Fifty patients were enrolled in this study, including 38 male patients and 12 female patients; median age: 58 years (ranged 26 to 75 years). 72% patients completed all the chemotherapy and 98% patients received the full dose of radiotherapy. 1-, 2-, 3-, and 5- year survival were 75%, 56%, 42% and 28% respectively. Among haematological toxicities, grade 3 leukopenia (16%) was recorded, and no patients experienced any ≥ grade 2 thrombocytopenia or anaemia. Among non-haematological toxicities, the rates of grade 2 peripheral neurotoxicity, arthralgias and myalgias, nausea, vomiting, and fatigue were 8%, 4%, 4%, 2% and 6% respectively. The rates of ≥ grade 2 acute radiationinduced esophageal toxicity, radiation pneumonitis and skin toxicity were 32%, 44% and 14% respectively. No treatment-related deaths occurred and no patients experienced any ≥ grade 4 toxicities. Conclusion: Continuous infusion of 5-FU plus paclitaxel given concurrently with radiotherapy may be an effective and tolerable treatment option for ESCC patients.

Key words: Esophageal cancer, Paclitaxel, 5-fluorouracil, Phase Ⅱ study, Chemoradiotherapy