Involved-field irradiation concurrently combined with nedaplatin/5-fluorouracil for inoperable esophageal cancer on basis of ¹⁸FDG-PET scans: A phase II study

Purpose: A prospective study was performed on chemoradiotherapy (CRT) for esophageal cancer using involved-field radiation therapy (IFRT) based on 18-fluorodeoxyglucose positron-emission tomography. The goal of this phase II study was to evaluate the efficacy of the IFRT procedure in newly diagnosed esophageal cancer. Patients and methods: Eligible patients were adults with newly diagnosed untreated, inoperable esophageal cancer in stages I–IV with lymph node metastases. Patients received nedaplatin 80 mg/m² per day on day 1, 5-fluorouracil 800 mg/m² on days 1–4 intravenously repeated every 28 days for 2–4 cycles, and combined IFRT. Elective nodal irradiation was not performed. Irradiation was applied only to the primary tumor and positive lymph nodes. Results: From September 2009 to July 2012, of the 63 patients enrolled, 58 were evaluable for response. The primary end point of isolated out-of-field loco-regional nodal recurrence was seen in only two patients. The expectant rate was assumed to be less than 5%. The threshold value was set as 10% to calculate the number of registrations. Progression-free and overall survival rates at 36 months were 47.7% and 51.1%, respectively. The median progression-free survival was 34.6 months, and overall survival was 38.4 months. Salvage surgery was tried for 11 patients (17.5%) due to residual or recurrent disease. Conclusion: The primary end point of the trial was demonstrated, indicating the efficacy of IFRT in the treatment of inoperable esophageal cancer mostly of squamous cell carcinoma