Journal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 27, No 18S (June 20 Supplement), 2009: LBA4506
© 2009 American Society of Clinical Oncology

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Abstract

A prospective, randomized trial of chemotherapy with or without the low molecular weight heparin (LMWH) enoxaparin in patients (pts) with advanced pancreatic cancer (APC): Results of the CONKO 004 trial

Universitätsmedizin Berlin - Charité, Berlin, Germany; Hospital, Hagen, Germany; Hospital St. Elisabeth and St. Barbara, Halle, Germany; Outpatient Department, Kronach, Germany; Sana Hospital, Berlin-Lichtenberg, Germany; Outpatient Department, Jena, Germany

LBA4506

Background: The course of pts with APC is often complicated by venous thromboembolic events (VTE). Anticoagulation therapy with LMWH may prevent VTE and is under discussion to improve overall survival (OS) in cancer. Based on our previous pilot study (Hilbig et al, Onkologie 2005;28(suppl 3)) indicating the safety and feasibility to the addition of the LMWH enoxaparin to chemotherapy in pts with APC we started the open, prospective, randomized, multicenter study to investigate the role of enoxaparin in these pts. Methods: Primary endpoint was the reduction of symptomatic VTE (sVTE) from an expected 10% to 3% within the first 12 weeks of treatment. The occurrence of sVTE (secured by an independent, blinded event review board) in 24 pts was calculated to be necessary in order to define the role of enoxaparin in decreasing the risk of VTE. Toxicity, time to progression (TTP), and OS were among the secondary endpoints of the study approved by the ethics committees of the participating centers. VTE-naive and chemotherapy-naive pts with histologically or cytologically confirmed APC were randomized to receive or not to receive additional LMWH (enoxaparin 1mg/kg once daily) starting in parallel to palliative systemic chemotherapy. Results: In January 2009 after recruitment of 312 pts the study was closed. There were 22 sVTE in 152 pts of the observation group (O) and 8 in 160 pts of the enoxaparin group (E). ITT and PP analyses demonstrated significant risk reductions from 14.5% to 5.0% (65% RRR) and 14.5% to 3.8% (74% RRR) for E, respectively. Major bleeding events were 9.9% for O and 6.3% for E (ITT; n.s.). In each group there was one tumor-related fatal hemorrhage. Preliminary data show no difference in TTP (O:19 vs. E:22 w) and OS (O:29 vs. E:31 w). Conclusions: Enoxaparin is effective and safe in the primary prevention of sVTE applied in parallel with cytotoxic chemotherapy in pts with APC. Final results on TTP and OS are pending.

No significant financial relationships to disclose.

Abstract presentation from the 2009 ASCO Annual Meeting