239 Background: We previously developed a regimen of full dose gemcitabine (gem), oxaliplatin (ox) and RT to maximize systemic and loco-regional disease control in pancreas cancer (JCO 25:4587, 2007). A multi-institution phase II trial was conducted to test efficacy of this regimen as neoadjuvant therapy in R/BR disease. Methods: Eligibility criteria included path confirmation, no metastasis, R/BR lesion, PS ≤2, and adequate organ function. Treatment consisted of 2, 28 day cycles of gem (1g/m2 over 30 min D1, 8, 15) and ox (85mg/m2 D1, 15) with RT during cycle 1 (30Gy in 2Gy fractions). Pts were then re-evaluated for surgery. Resected pts received 2 additional cycles of chemotherapy. Results: 68 evaluable pts were treated at 4 centers in 2007-2010. Median age was 64 (42-83), 32 men, PS 0:1:2 in 40:26:2. Median tumor size 3.2 cm (1.4–7.8), lesion in head 49, body 9, tail 10, R in 24 and BR in 44. 66 pts (97%) completed cycle 1/RT and 61 (90%) cycle 2. Therapy related adverse events ≥ grade 3 in cycles1/2 included ANC (32%), plts (24%), GI (16%), biliary/cholangitis (15%). Best response in primary was partial (10%) or stable (81%). 20 pts not operated on protocol: 8 progression (4 local, 4 distant), 8 judged not resectable, 3 toxicity, 1 early death. Of 48 laparotomies,10 not resected due to vascular involvement (6) or M1 disease (4). Resection completed in 15 of 18 R pts (13 R0, 2 R1) and 23 of 30 BR pts (19 R0, 2 R1, 2 R2). 26 pts received post-op therapy. With median fu 11.3 mos (0.7-35), 42 pts are alive, 20 pts are NED. Median survival (OS) for all pts is 21.2 mos (95%CI 13.3-not defined [ND]), resected 31.1 mos (95%CI 13.7-ND), unresected 16.0 mos (95%CI 5.8-ND). Time to treatment failure (death, progression, toxicity, no resection) and OS in R pts are 9.1 mos (95%CI 2.4-23.8) and 31.1 mos (95%CI 9.8-ND) and in BR pts 5.5 mos (95%CI 2.4-11.8) and 18.0 mos (95%CI 13.3-ND). Correlation of pathologic response and outcome is ongoing. Conclusions: Neoadjuvant therapy with full dose gem, ox and RT was possible in a large proportion of pts with localized pancreas cancer and resulted in a high percentage of R0 resections. Results are particularly encouraging given a majority of pts with BR disease. [Table: see text]
Editorial About: “A Prospective, Open-Label, Multicenter Phase II Trial of Neoadjuvant Therapy Using Full-Dose Gemcitabine and S-1 Concurrent with Radiation for Resectable Pancreatic Ductal Adenocarcinoma”
