asco@alo33:161747
|
Background: 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 CS for locally advanced unresectable esophageal cancer LAUEC . Methods: Esophageal cancer patients pts ith clinical T4 disease andor unresectable supraclavicular lymph node metastasis ere eligible. The treatment starts ith 3 cycles of DCF-IC, folloed by CS if resectable, or by concurrent radiation plus chemotherapy ith 5-fluorouracil and cisplatin CF-RT if not resectable. In case of CF-RT, the resectability is re-evaluated at 30 Gy-40Gy, folloed by CS if resectable, or by additional CF-RT ith total irradiation dose of 60Gy. If resectable after completion of CF-RT, CS is performed. The primary endpoint is 1-year overall survival OS . We assumed a null hypothesis ith 50 percent and expected 65 percent of 1-year OS. Results: Characteristics of 48 pts enrolled ere as follos: median age, 66 years; PS01, 2820; primary tumor sites, UtMtLt, 13332; T3T4aT4b, 5142; N0N1N2N3, 4122210; M0M1, 399. Eleven pts 22.9 percent developed febrile neutropenia related to DCF-IC. CS as performed in 20 pts 41.7 percent , including DCF-CS n = 18 , DCF-CF-RT40Gy-CS n = 1 , and DCF-CF-RT60Gy-CS n = 1 . R0 resection as confirmed in 19 pts 39.6 percent . Grade 3 postoperative complications includes 1 recurrent laryngeal nerve palsy, 1 lung infection, 1 ound infection, 1 pulmonary fistula, and 1 dysphagia; but no remarkable postoperative complications ere observed in pts ho underent CS. The overall cure rate including R0 resection or the clinical complete response after CF-RT as 47.9 percent. The estimated 1-year OS as 67.7 percent and loer limit of 80 percent confidence interval as 59.5 percent. The OS for pts ho underent R0 resection as significantly longer than those ho did not undergo R0 resection median survival time: not reached vs. 326 days, p lt 0.01 . There as 1 treatment-related death in patient ho received DCF-CF-RT60Gy. Conclusions: DCF-IC folloed by CS shoed promising signs of tolerability and efficacy in pts ith LAUEC. Clinical trial information: 000011089.,J Clin Oncol 34, 2016 suppl; abstr 4021 ,11089,00:00.0,Gastrointestinal Noncolorectal Cancer
|
Annnotations
blinded