4058 Background: Preoperative chemoradiotherapy improves outcomes for pts with resectable esophageal cancer compared with surgery alone. We previously reported a 41% 3-year progression-free survival (PFS) with preoperative paclitaxel/carboplatin/5FU/RT in a large phase II trial. The present multicenter community trial examined the role of a newer combination regimen. Methods: The primary endpoints were to assess the safety and response rate (RR) of O/D/C/RT in pts with resectable stage I-III cancer of the mid-/distal-esophagus or GE junction. Treatment (tx): O 40 mg/m2 IV and D 20 mg/m2 IV weekly x 5; C 1000 mg/m2 PO BID D1–7, 15–21, 29–35; and RT 45 Gy, 1.8-Gy M-F weekly x 5, starting D1. Pts were resected 4–8 weeks after tx. The phase I portion (n=10) confirmed the safety of O/D/R, and C was added in the phase II portion. Eligibility: measurable disease; ECOG PS 0–1, informed consent. Analysis was by intent to treat. Results: Nineteen pts were enrolled from 9/04 to 10/05 (trial ongoing). Baseline features: median age 60 years (38–77); male/female, 82%/18%; ECOG PS 0/1: 27%/73%; adenocarcinoma/squamous (77%/23%); I (5%), IIA (5%), IIB (33%), III (38%), primary tumor not assessable (19%). All pts completed O/D/C/RT and 14 (74%) were resected. Grade (G) 3/4 non-hematologic toxicity: anorexia (16%), nausea (16%), and fatigue (11%). Other G3/4 non-hematologic toxicities were ≤5%, with no G3/4 esophagitis. No G3/4 hematologic toxicities or tx-related deaths occurred. Complete/partial responses assessed before surgery were seen in 2 pts/11 pts, respectively, for an overall RR of 68% (95% CI 46%-84%). Four pts (21%) had stable disease and 1 pt had progression (1 pt was unevaluable). Pathological complete responses were seen in 8 of 14 evaluable pts (57%). With a median follow-up of 8 months, actuarial 1-year PFS and overall survival (OS) are 66% and 79%, respectively. Median PFS and OS have not been reached. Conclusions: O/D/C/RT is a relatively well-tolerated and active preoperative therapy for pts with resectable esophageal cancer. Additional pts and follow-up are needed to assess this regimen’s benefits. [Table: see text]
Randomized Phase II Study of Preoperative Concurrent chemoradiotherapy with or without Induction Chemotherapy with S-1 and Oxaliplatin in Patients with Resectable Esophageal Cancer
