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Background: The standard treatment for locally advanced unresectable squamous cell carcinoma (SCC) of the oesophagus is chemoradiation with cisplatin and 5-fluorouracil (CF-RT). This multicentre phase II trial assessed the safety and efficacy of chemoselection with docetaxel plus cisplatin and 5-fluorouracil (DCF) induction chemotherapy (ICT) and subsequent conversion surgery (CS) for initially unresectable locally advanced SCC of the oesophagus. Methods: Patients with clinical T4 and/or unresectable supraclavicular lymph node metastasis were eligible. Treatment started with three cycles of DCF-ICT, followed by CS if resectable, or by CF-RT if unresectable. The resectability was re-evaluated at 30–40 Gy of CF-RT, followed by CS if resectable, or by completion of 60 Gy of CF-RT. If resectable after CF-RT, CS was performed. The primary end point was 1-year overall survival (OS). Results: From April 2013 to July 2014, 48 patients were enrolled. CS was performed in 41.7% (n=20), including DCF-CS (n=18), DCF-CF-RT40Gy-CS (n=1), and DCF-CF-RT60Gy-CS (n=1). R0 resection was confirmed in 19 patients (39.6%). Grade ⩾3 postoperative complications included one event each of recurrent laryngeal nerve palsy, lung infection, wound infection, pulmonary fistula, and dysphagia; but no serious postoperative complications were observed in patients undergoing CS. Clinical complete response after CF-RT was confirmed in 4 patients (8.3%). The estimated 1-year OS was 67.9% and lower limit of 80% confidence interval was 59.7%. There was one treatment-related death in patient receiving DCF-CF-RT60Gy. Conclusions: Chemoselection with DCF-ICT followed by CS as a multidisciplinary treatment strategy showed promising signs of tolerability and efficacy in patients with locally advanced unresectable SCC of the oesophagus.

Background A multicenter phase II trial revealed that docetaxel plus 5-fluorouracil and cisplatin (DCF) induction chemotherapy (IC) and subsequent conversion surgery (CS) was tolerable and effective in patients with locally advanced unresectable esophageal cancer (LAUEC) (Br J Cancer 2016;115:1328–1334). Here, we report updated 3-year analyses to further characterize the impact of DCF-IC followed by CS. Methods Esophageal cancer patients with clinical T4 disease and/or unresectable supraclavicular lymph node metastasis were eligible. The treatment starts with 3 cycles of DCF-IC, followed by CS if resectable, or by concurrent radiation plus chemotherapy with 5-fluorouracil and cisplatin (CF-RT) if not resectable. This updated analysis represents 3-year overall survival (OS), 3-year progression free survival (PFS), location of relapse, and subsequent therapy. Results As of October 11, 2017, 25 patients were dead. The median follow-up period in patients surviving without death was 39.3 months (95%CI: 38.7 - 41.7months). The estimated 1-year OS was 66.7% and lower limit of 95% confidence interval was 54.6%. The estimated 3-year OS was 46.6% (95% CI; 34.2 - 63.5%). The OS for patients who underwent R0 resection (n = 19) was significantly longer than those who did not undergo R0 resection (3-year OS: 71.4% vs. 30.1%). The estimated 1-year PFS was 50.6% (95%CI: 38.1 - 67.3%) and the estimated 3-year PFS was 39.6% (95%CI: 27.7 - 56.6%). The PFS for patients who underwent R0 resection (n = 19) was significantly longer than those who did not undergo R0 resection (3-year PFS: 61.3% vs. 25%). The recurrence or progression in primary site was observed in 31% of non R0 group. There was no significant difference in the rates of distant metastasis between the two groups (non R0 group vs. R0 group; 21% vs. 16%). The subsequent therapy after protocol therapy included chemotherapy (n = 18), radiotherapy (n = 11), and surgery (n = 5). Conclusion This longer follow up of DCF-IC followed by CS strategy for patients with LAUEC revealed promising OS and PFS. Based on this phase 2 trial, JCOG1510, a prospective randomized controlled trial to compare chemoselection with DCF-IC followed by CS versus CF-RT as a standard treatment is in preparation for LAUEC. Disclosure All authors have declared no conflicts of interest.

4021Background: This multicenter phase II trial assessed the safety and efficacy of docetaxel plus 5-fluorouracil and cisplatin (DCF) induction chemotherapy (IC) and subsequent conversion surgery (...