MO1-17-2Long-term results of a PII study of chemoradiotherapy with docetaxel, nedaplatin, and fluorouracil for esophageal cancer

Purpose We previously reported early efficacy results from a phase I/II study of definitive chemoradiotherapy using docetaxel, nedaplatin and 5-fluorouracil (DNF-R), and confirmed strong antitumor activity with an acceptable early toxicity profile for patients with esophageal cancer. Here, we present the long-term results of the study including late toxicity and survival. Methods Thirty-one patients were enrolled. Patients received 5-fluorouracil (400 mg/m2 civ, d1-5 and d8-12), nedaplatin (50 mg/m2 on d1 and 8), and docetaxel (20-30 mg/m2 on d1 and 8), repeated twice every 5 weeks with concurrent radiotherapy (59.4Gy/33fr). Study objectives in the phase II part included the CR rate, progression-free survival (PFS), overall survival (OS), and safety. Results Between December 2008 and February 2014, a total of 28 patients were registered. Grade 3/4 acute toxicities included neutropenia (43%), febrile neutropenia (7%), thrombocytopenia (18%), and esophagitis (21%). Grade 3/4 late toxicity included esophagostenosis (11%) and pleural effusion (7%), though these resolved with dilation and thoracic drainage, respectively. All patients achieved a response, with 23 (82.1%) CR cases (stege II/III 89%, T4/M1LYM 67%). With a median follow-up time of 69.8 months, the 3-/5-year PFS and OS were 68.4/68.4% and 71.5/66.8%, respectively. 5-year OS for stage II/III (nonT4) and T4/M1LYM were 68.4% and 28.6%, respectively. Conclusions The long-term results show that efficacy was maintained with high rate of PFS and OS compared with those of historical control, with durable responses and acceptable safety profile. DNF-R might be a promising regimen for definitive CRT for esophageal cancer.