A phase II study of radiation and docetaxel and cisplatin in the treatment of locally advanced pancreatic carcinoma. FNCLCC-ACCORD 09 /0201 trial.

4625 Background: Locally advanced pancreatic carcinoma remains a challenging tumor with no clear standard of care in terms of radio-chemotherapy. The purpose of this phase II trial was to determine the efficacy and the toxicity of radiotherapy and docetaxel and cisplatin in histologically proven adenocarcinoma of the pancreas. METHODS Patients (pts) received external beam radiotherapy (54 Gy in 1.8 Gy fractions, six weeks) and weekly chemotherapy regimen of association docetaxel and cisplatine (20 mg/m2/weeks each) for six weeks. RESULTS 51 pts (20 women and 31 men, with median age of 62 years) with disease considered to be unresectable but confined to pancreas area and celiac nodes were included between 06/10/2003 and 15/02/2008. Location of the tumor: head (33 pts), body (13 pts), and tail (5 pts). The median dose of radiotherapy received by the patients was 54 Gy. The median dose of docetaxel and cisplatin administered was 19.8 mg/m2/w (relative dose intensity 97%). Radiotherapy has to be interrupted in 7 pts. 30 pts experienced at least one episode of grade 3 or 4 toxicity (asthenia 12 pts, anorexia 11 pts, vomiting 10 pts, nausea 9 pts, abdominal pain 5 pts). No toxic death was observed. 6 pts underwent secondary pancreatic resection (4 compete resection and 1 pt with histological complete remission). The objective response rate (CR 5 pts, PR 3 pts), was 16% with a median duration of 7.6 months. At 6 months, 30 pts had progressed. Median progression free survival was 5.8 months. With a 21 months median follow up, median overall survival was 9.6 months and 18 months survival rate of 31%. CONCLUSIONS The association docetaxel+cisplatin+radiotherapy has limited effect in patients with locally advanced pancreatic carcinoma but major objective responses have been observed allowing secondary resections. Grant by sanofi-aventis, Amgen, and Ligue Nationale Contre Le Cancer. No significant financial relationships to disclose.