Abstract
4573 Background: The induction of EGFR targeting with cetuximab in radiation based therapy of solid tumors has yielded promising results. Thus, we initiated a prospective phase II trial designed to analyze the feasibility and effectivity of trimodal therapy with gemcitabine-based chemoradiation and cetuximab in locally advanced inoperable pancreatic cancer. Methods: In this phase 2 study, pts with locally advanced pancreatic cancer without prior cytotoxic therapy were treated with radiotherapy (RT), gemcitabine weekly (300mg/m2), and cetuximab weekly (loading dose 400mg/m2 day 1, and concomitant with radiation day 8,15,22,29,36 250mg/m2). RT was delivered by using an integrated IMRT boost concept (54 Gy GTV, 45 Gy CTV) over 5 weeks. RT was followed by gemcitabine (1,000mg/m2) weekly x 3 in 4 weeks. Response evaluation using CT followed at week 12. All pts were intended for surgical treatment between week 12–15. Pts were followed for adverse events and response. Results: 55 pts were enrolled. Preliminary results are presented on 36 pts with the following characteristics: pancreatic adenocarcinoma c2 T4 N1 36/36, median age = 61.5 (range 48–79); M/F = 24/12; ECOG PS 0/1/2 = 6/26/4; median days on treatment: 90 (range 70–100). Treatment-related toxicities were observed in 22 pts. Grade 3 toxicities included diarrhea (n=5), fatigue (n=4), nausea (n=6), neutropenia (n=10), thrombocytopenia (n=4), and vomiting (n=4). 34/36 pts developed some acneiforme rush during therapy. No omittance of cetuximab was necessary in any of the pts. 1 patient died during treatment due to tumor bleeding. Median follow-up at present is 13 month, 1-year survival was 57%, median survival has not been reached. Partial remissions 12/36, stable disease 20/36, progressive disease 4/36 (RECIST). 21/36 pts were amenable for secondary potentially curative resection. 9 pts could be resected, while 8 pts were found to have abdominal metastatic spread. Conclusions: Early data from trimodal therapy in pancreatic adenocarcinoma with chemoradiation (IMRT), gemcitabine, and cetuximab indicate feasibility without increased toxicity profile. The local response appears to be very promising in pancreatic cancer. [Table: see text]
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