Abstract
4065 Background: Metastases occurs in > 85% resected PC and ~25% will not receive systemic therapy due to postoperative morbidity. NT offers higher likelihood of systemic therapy delivery to all Pts. We conducted a single institution (MSKCC), phase II trial of NT in Pts with resectable PC to assess 18-month survival rate. Methods: Eligibility: radiographically resectable PC, ECOG 0-1. Resectability adjudicated by multidisciplinary team. Borderline resectable Pts ineligible. Prior to NT, all had a CT pancreas angiogram, laparoscopy, research core biopsy (RCB) for xenograft implantation (if feasible). NT: 4 cycles of gemcitabine 1,000mg/m2/100mins and oxaliplatin 80mg/m2/120mins, q2 weeks before surgery. Following R0/R1 resection, 5 cycles of adjuvant gemcitabine were given. Biostatistics: 18-month survival from MSKCC database for resected PC (CT angiogram, laparoscopic staging): 53%. NT promising if 18-month survival was ≥ 73%, type I, II errors = 10%. Planned enrolment of N= 37. Secondary endpoints: response to NT, sites of failure, toxicity, overall survival. Correlative: pathologic RR (pRR) to NT, proteomic analyses, feasibility of obtaining RCB. Results: From 1/08-1/11, N= 45 screened: 34 staged with potentially resectable PC and received NT. Median age: 70 yrs. ECOG 0/1: 29%/71%. M/F: 62%/38%. Head (n= 26), body (n= 4), tail (n= 4). N= 24 R0/R1 resection: 18 R0, 6 R1. Unresectable n= 7: distal progression (n= 2), T4 artery/vein (n= 4), portal hypertension (n= 1). N= 2 grade 5 events, cardiac/CVA pre-surgery. pRR: 0-50%, n= 21; >50%, n= 3. NT gd 3-4 toxicities: hyperglycemia (n= 16), biliary stent (n= 5), hematologic (n= 14), infusion reactions (n= 2). Current disposition: 1 NT, 15 free of recurrence, 4 alive with disease, 14 dead of disease. RCB obtained n= 7 and successful xenograft in n= 4. 18-month survival pending (mature by 05/11). Conclusions: Delivery of NT for resectable PC is feasible, well-tolerated and requires multidisciplinary collaboration. RCB obtainable in body/tail PC. Analysis of primary endpoint will be presented. It remains to be seen whether NT for resectable PC is a superior approach to immediate resection.
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