This study demonstrates the high efficacy and feasibility of primary pharmacologic prevention of symptomatic VTEs in outpatients with APC. Treatment efficacy was not affected by simultaneous treatment with enoxaparin in this trial setting.

Our data more closely resemble those of the APACHE II database, demonstrating a higher degree of overall goodness-of-fit of APACHE II than APACHE III and SAPS II. Although discrimination was slightly better for the two new systems, calibration was good with a close fit for APACHE II only. Hospital mortality was higher than predicted for both new models but was underestimated to a greater degree by APACHE III. Both score systems demonstrated a considerable variation across the spectrum of diagnostic categories, which also differed between the two models.

Background: Mortality predictions calculated using scoring scales are often not accurate in populations other than those in which the scales were developed because of differences in case-mix. The present study investigates the effect of first-level customization, using a logistic regression technique, on discrimination and calibration of the Acute Physiology and Chronic Health Evaluation (APACHE) II and III scales.

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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.

LBA4506 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. No significant financial relationships to disclose.

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