PROTECHT: Prophylactic nadroparin reduced thromboembolic events

50th ASH Annual Meeting

Nadroparin was an effective prophylactic approach towards the reduction in the number of thromboembolic events in patients receiving chemotherapy, according to the results of the placebo-controlled, double blind, multicenter PROTECHT study.

“Our study actually showed that it is possible to prevent thromboembolic events in patients receiving chemotherapy for cancer,” said Giancarlo Agnelli, MD, internal and cardiovascular medicine, University of Perugia, Italy.

Researchers enrolled 1,166 patients and randomly assigned them in a 2:1 ratio to either subcutaneous nadroparin 3,800 anti-Xa IU once daily or placebo. Treatment began at chemotherapy initiation and lasted throughout chemotherapy treatment or up to four months.

At 12 months, fewer patients assigned to nadroparin experienced a thromboembolic event compared with patients assigned to placebo (2.0% vs. 3.9%). A majority of the thromboembolic events in both groups were venous thromboembolism.

In addition, the researchers determined that patients with lung or pancreatic cancer were more likely to experience thromboembolic events compared with patients with breast, gastrointestinal, ovarian or head and neck cancers. – by Leah Lawrence

For more information:

Agnelli G. #6. Presented at: 50th Annual Meeting of the American Society of Hematology; December 5-9, 2008; San Francisco.

This study addresses the important question of pharmacologic VTE prophylaxis in ambulatory patients with cancer, especially those in whom the VTE risk is compounded by chemotherapy administration. One future issue to be resolved is the identification of the subset of patients in whom the risk/benefit ratio more clearly favors prophylaxis over no intervention. Although showing some modest overall benefit of prophylaxis in cancer patients receiving chemotherapy, this study may be more important for the fact that it begins to identify specific subsets of patients who could particularly stand to benefit. A recently published clinical risk prediction model for VTE in cancer might be used to select patients at highest risk (Khorana A, et al. Blood. 2008;111;4902) – a hypothesis that is eminently testable in a clinical trial.

– Nigel Key, MD

HemOnc Today Editorial Board member

I remain unconvinced that the rather small absolute decrease in thromboembolism when related to the significant increase in significant hemorrhages (noted in the oral presentation of this study) will prove cost effective.

– Harry S. Jacob, MD

HemOnc Today Chief Medical Editor