Randomized phase II trial comparing gemcitabine/cisplatin-based chemoradiotherapy (CRT) to 5-FU-based CRT in patients with locally advanced pancreatic cancer

Abstract

4038 Background: CRT is a relevant treatment option for patients with unresectable pancreatic cancer. Up to now, 5-FU has been the drug of choice for concurrent CRT. Based on evidence that also gemcitabine may improve the antitumor activity of radiation, a randomized phase II trial was undertaken. Methods: Patients with locally advanced, non-metastatic and histologically proven pancreatic cancer were included into a three-arm trial. In arm treatment arm A, radiation (CTV I up to 50.0 Gy, conventional fractionation) was applied concurrently with protracted venous infusion of 5-FU (350 mg/m2/irradiation day). In treatment arm B, patients received radiotherapy together with gemcitabine (300 mg/m2/d 30 minute infusion) and cisplatin (30 mg/m2/d 60 minute infusion) applied on days 1, 8, 22, and 29. In treatment arm C, patients received an identical regimen of CRT as described for arm B which was followed by 4 cycles of chemotherapy with gemcitabine (1000mg/m2, 30 min iv) plus cisplatin (50mg/m2) applied at 2-week intervals. Patients were stratified for Karnofsky performance status (KPS ≥80% vs. <80%). The primary end-point of the trial was the 9-months survival rate. Results: Ninety-six patients with a median age of 63.5 years (range 40–75 years) were included into the trial from 01/02 until 06/05 (arm A: 32 patients, arm B: 33 patients, arm C: 31 patients). Two patients did not complete CRT. At the time of evaluation, 66 patients (70.2%) had died. 9-months survival rate was 60%, 58%, and 46% in treatment arms A, B, and C, respectively. Median overall survival in arm A was 9.6 mo (95% CI, 8.7–10.5 mo), in arm B 9.6 mo (95%CI, 7.4–11.8 mo), and in arm C 6.1 mo (95% CI, 1.6–10 mo). Secondary end-points such as treatment-related toxicity, response rate, secondary resectability, and time to progression are under evaluation. Conclusions: CRT with gemcitabine plus cisplatin is not superior to 5-FU-based CRT with regard to the primary end-point of 9-months survival rate. Updated results will be presented at the meeting. No significant financial relationships to disclose.