Interim results of preoperative gemcitabine (gem) plus cisplatin followed by rapid fractionation chemoradiation for resectable pancreatic adenocarcinoma

4037 Background: Over 80% of pts who undergo potentially curative pancreaticoduodenectomy (PD) for pancreatic adenocarcinoma develop local or distant recurrence. Chemotherapy and external-beam radiation therapy (EBRT) prior to surgery maximizes the number of pts who receive multimodality therapy and undergo a complete (R0) resection. Methods: Pts with biopsy proven, stage I/II adenocarcinoma of the pancreatic head or uncinate process received systemic therapy with 4 infusions of gem (750 mg/m2) + cisplatin (30 mg/m2) every 2 wks followed by 30 Gy of EBRT (3 Gy/Fx, M-F over 2 wks) and 4 weekly doses of gem (400 mg/m2). Pts underwent complete restaging 4–6 wks after the last dose of gem. Those without disease progression and with acceptable PS underwent surgery. Results: This study has currently enrolled 87 pts over 4 years. Median age is 65 yrs (38–80), most pts (96%) had ECOG-PS (0–1) at study entry. Median CA19–9 is 170. Six pts were excluded from analysis and 4 are currently on treatment. Of the 77 pts who finished chemoradiation, 72 completed restaging (3 await restaging, 2 drop outs). Of these 72 pts, 10 had disease progression, 1 had a decline in PS, and 61 (79 %) went to surgery. 49 of 61 pts (64 %) underwent a successful PD and metastatic or locally advanced disease was found in 12 (15 %). 44 (90 %) of 49 pts underwent R0 resection. Pathologic PR rate (>50 % tumor kill) was 61 %. The predominant toxicity prompting hospitalization during preoperative therapy was biliary stent occlusion (44 %). Gastrointestinal toxicity ≤ grade 3 was common but controllable. Grade 3 and 4 neutropenia was seen in 19 (25 %) and 3 pts (4 %) respectively. Grade 3–4 thrombocytopenia was rare. Median survival for resected pts was ∼ 21 months. Conclusions: This study, builds on our previous gem-based preop chemoradiation program ( ASCO 2002, Abs # 516) producing good local treatment effect and a high R0 resection rate. However, interim analysis suggests that the addition of systemic chemotherapy delivered prior to preoperative chemoradiation does not appear to improve survival. Optimal treatment sequencing of chemoradiation, systemic therapy and surgery needs further refinement. Supported in part by Eli Lilly and Co. [Table: see text]