China Oncology ›› 2016, Vol. 26 ›› Issue (11): 926-931.doi: 10.19401/j.cnki.1007-3639.2016.11.008

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Results of a phase Ⅱ study of concurrent 5-fluorouracil/paclitaxel plus radiotherapy in patients with carcinoma of the esophagus

CHEN Yun1, AI Tashan1, XIA Yi2, LIU Qi1, ZHANG Junhua1, ZHAO Kuaile1   

  1. 1. Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China; 2. Department of Radiation Oncology, Shanghai Minhang District Cancer Hospital, Shanghai 200240, China
  • Online:2016-11-30 Published:2017-01-22
  • Contact: ZHAO Kuaile E-mail: kuaile_z@sina.com

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 (T2-4N0-1M0-1a) 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