An article published Online First and in the October edition of The Lancet Oncology reports that the blood-thinning drug nadroparin halves the risk of developing blood clots in ambulatory cancer patients receiving chemotherapy. Consequently, it could become an important preventive treatment in these patients.
Patients with cancer who receive chemotherapy are at a high risk of developing blood clots. Patient care can be improved by preventing such complications. In fact, thromboembolic events are difficult to manage in cancer patients and can disrupt chemotherapy and increase health expenditure. But, there is little data from randomized trials to determine whether the preventive use of blood-thinning drugs could be beneficial in reducing thromboembolic events in ambulatory patients with cancer.
To provide supplementary verification, Giancarlo Agnelli from the University of Perugia in Italy and colleagues conducted the PROTECHT (PROphylaxis of ThromboEmbolism during CHemoTherapy) trial. They assessed the effectiveness 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, 1,150 patients were recruited from 62 centres across Italy between October 2003 and May 2007. They were all aged 18 years or older and receiving chemotherapy for advanced lung, gastrointestinal, pancreatic, breast, ovarian, or head and neck cancer. Patients were assigned at random to once-daily subcutaneous injections of nadroparin or placebo in a 2:1 ratio. Treatment was initiated on the first day of the current course of chemotherapy and given for the extent of chemotherapy up to a maximum of four months.
In general, nadroparin nearly reduced by half the risk of developing a thromboembolic event. Only 15 (2.0 percent) of the 769 patients treated with nadroparin had a thromboembolic event, compared with 15 (3.9 percent) of the 381 patients in the placebo group.
Results indicated that only five (0.7 percent) patients in the nadroparin-treated group had a major bleeding event. There were none in the placebo group. However, the frequency of minor bleeding was comparable in the two groups.
An interesting fact was that lung cancer patients experienced the highest overall rate of thromboembolic events. The rate was 3.5 percent (7 of 199) in the nadroparin group and 8.8 percent (7 of 80) in the placebo group.
The authors write in conclusion: “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.”
“Nadroparin for the prevention of thromboembolic events in ambulatory patients with metastatic or locally advanced solid cancer receiving chemotherapy: a randomised, placebo-controlled, double-blind study”
Giancarlo Agnelli, Gualberto Gussoni, Carlo Bianchini, Melina Verso, Mario Mandalà, Luigi Cavanna, Sandro Barni, Roberto Labianca, Franco Buzzi, Giovanni Scambia, Rodolfo Passalacqua, Sergio Ricci, Giampietro Gasparini, Vito Lorusso, Erminio Bonizzoni, Maurizio Tonato, on behalf of the PROTECHT Investigators
DOI: 10.1016/S1470-2045(09)70232-3
Written by Stephanie Brunner (B.A.)