A prospective, randomized trial of simultaneous pancreatic cancer treatment with enoxaparin and chemotherapy: Final results of the CONKO-004 trial.

Abstract

4033 Background: Treatment of patients (pts) with advanced pancreatic cancer (APC) is often complicated by venous thromboembolic events (VTE). Anticoagulation therapy with low molecular weight heparin (LMWH) Enoxaparin (E) prevents VTE in APC and is under discussion to improve overall survival (OS) in cancer pts. Methods: Calculation was based on an expected reduction of the primary endpoint symptomatic VTE (sVTE) within the first 3 months (m) of treatment from 10% to 3%. Time to progression (TTP) and OS were among the secondary endpoints of the study. Chemotherapy naive pts with histologically or cytologically confirmed APC were randomized to receive (E) or not (O) to receive additional LMWH (E:1 mg/kg once daily for 3 m, followed by 40 mg/d) simultaneous to palliative systemic chemotherapy. Results: From Apr 2004 to Jan 2009 312 (O: 152/ E: 160) pts were recruited. ITT demonstrate significant decreases in sVTE after 3 m (O: 9.87%; E: 1.25%) and 12 m (O: 15.13%; E: 5.00%). Treatment was well tolerated and showed no significant differences in major bleeding. After a median follow up of 45.44 m TTP (O: 5.42 m; E: 5.03 m; p = 0.941) and OS (O: 7.98 m; E: 8.28 m; p = 0.501) are not different. Prespecified analysis excluding pts with sVTE showed no significance in OS (O: 8.15 m; E: 7.92 m; p = 0.054). Conclusions: Enoxaparin is effective and safe in the primary prevention of sVTE applied simultaneously with cytotoxic chemotherapy in pts with APC but does not prolong TTP or OS. No significant financial relationships to disclose.