A randomized trial in patients with gemcitabine refractory pancreatic cancer. Final results of the CONKO 003 study

Abstract

4508 Background: For nearly ten years gemcitabine (G) was standard first line therapy for patients (pts) with advanced pancreatic cancer (APC). There is no consensus about second line therapy after disease progression while receiving G, but 5-FU-based regimens are considered. Randomized second line studies in APC are very rare. Our phase II study (ASCO 2002) showed activity of the OFF (oxaliplatin/folinic acid (FA)/5-Fluorouracil (FU) [24h] ) regimen in 23 pts. To examine the impact and the side effects of oxaliplatin we initiated a multicenter phase III study to compare OFF and FF in pts with G refractory APC. Methods: Pts with CT/ MRT confirmed PD on G in first line therapy, Karnofsky Performance Status (KPS) >60%, controlled pain, adequate hematological, renal and liver functions were eligible. Pts were stratified according to duration of first line therapy, KPS and tumor stage. We planned to randomized 165 pts to outpatient treatment with FF (5-FU 2g/m² (24h)/ FA 200 mg/m² (30min) on d1, d8, d15 and d22) or OFF (FF+oxaliplatin 85mg/m², d8, d22). In both arms the next cycle started on day 43. Pts were followed with regular staging at least every 3 months or at any signs of disease progression. Results: We recruited 168 pts between 02/2004 and 06/2007. Drop out rate is 4.8%. There is a full data assessment of 160 pts. Conclusions: We are able to present final results (side effects, progression free survival, overall survival) with an one year surveillance after study closure at the meeting. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Lilly Oncology, Pfizer Oncology, sanofi-aventis, GlaxoSmithKline, Amgen, Hoffman-La Roche