A phase II study of nedaplatin and 5-fluorouracil in metastatic squamous cell carcinoma of the esophagus: The Japan Clinical Oncology Group (JCOG) Trial (JCOG 9905-DI)

摘要: This phase II study evaluated the efficacy and toxicity of combination chemotherapy with nedaplatin 5-fluorouracil (5-FU) for metastatic esophageal squamous cell carcinoma. Eligibility criteria included carcinoma organ metastasis, ECOG performance status (PS) 0–2, ≤ 75 years, measurable disease, adequate function. Chemotherapy consisted 5-FU (800 mg/m2/day) on days 1–5 a 2-h infusion (90 mg/m2) day 1, repeated every 4 weeks. Therapy was continued until disease progression or intolerable adverse events. The primary end point response rate. Secondary points overall survival, progression-free toxicities. Forty-two patients (39 men, 3 women; median age 59 years; range 44–70 years) were enrolled. Twenty-one, 21, 0 had PS 0, 2, respectively. 23, 6, 3, 18 history surgical resection, radiotherapy, adjuvant chemotherapy, no therapy, Among 38 eligible patients, 1 14 complete partial responses observed, respectively; rate 39.5 % (90 % confidence interval: 26.1–54.1 %). survival time 8.8 months. one-year 32.9 %. Grade 4 neutropenia thrombocytopenia observed in 7 2 % 41 nausea, diarrhea, stomatitis 12, 2 %, Combination therapy is highly active well tolerated recurrent cancer therefore option