Nadroparin, a blood-thinning drug, halves the risk of developing blood clots in ambulatory cancer patients receiving chemotherapy, and as such could become an important preventive treatment in these patients, according to an Article published Online First and in the October edition of the Lancet Oncology.
It is well known that patients with cancer who receive chemotherapy are at a high risk of developing blood clots. Preventing such complications can have a substantial effect on patient care. Indeed, thromboembolic events are difficult to manage in cancer patients, can interrupt chemotherapy and increase health expenditure. However, there is a lack of evidence from randomised trials to establish whether the preventive use of blood-thinning drugs could reduce thromboembolic events in ambulatory patients with cancer.
To provide more evidence, Giancarlo Agnelli from the University of Perugia in Italy and colleagues conducted the PROTECHT (PROphylaxis of ThromboEmbolism during CHemoTherapy) trial to assess the efficacy of nadroparin, a low-molecular-weight heparin, for the preventive treatment of thromboembolic events in cancer patients receiving chemotherapy on an outpatient basis.
In total, 1150 patients aged 18 years or older receiving chemotherapy for advanced lung, gastrointestinal, pancreatic, breast, ovarian, or head and neck cancer were recruited from 62 centres across Italy between October 2003 and May 2007. Patients were randomly assigned to once-daily subcutaneous injections of nadroparin or placebo in a 2:1 ratio. Treatment was started on the first day of the current course of chemotherapy and given for the duration of chemotherapy up to a maximum of 4 months.
Overall, nadroparin almost halved the risk of developing a thromboembolic event—only 15 (2.0%) of the 769 patients treated with nadroparin had a thromboembolic event compared with 15 (3.9%) of the 381 patients in the placebo group.
Findings also showed that only five (0.7%) patients in the nadroparin-treated group and no patients in the placebo group had a major bleeding event. Yet, the incidence of minor bleeding was very similar in the two groups.
Interestingly, patients with lung cancer experienced the highest overall rate of thromboembolic events, 3.5% (7 of 199) in the nadroparin group and 8.8% (7 of 80) in the placebo group.
The authors conclude: "Further studies should focus on patients at high risk of thromboembolism, such as patients with lung cancer…On its own, the PROTECHT study supports the concept that thromboembolic events can be prevented in ambulatory patients with cancer receiving chemotherapy and this has potential implications for future therapeutic scenarios."