Treatment of venous thromboembolism in patients with cancer: subgroup analysis of the Matisse clinical trials.
In the initial treatment of venous thromboembolism (VTE) fondaparinux, a pentasaccharide, is a good alternative to heparin. Whether this is also true for cancer patients is unknown. We performed two post-hoc analyses of two randomized studies to compare efficacy, safety and overall survival of fondaparinux to standard initial (low-molecular-weight) heparin (LMWH) treatment in cancer patients with venous thromboembolism. Two hundred thirty-seven cancer patients with deep venous thrombosis (DVT) were initially treated with fondaparinux or enoxaparin. Two hundred forty cancer patients with pulmonary embolism (PE) received fondaparinux or unfractionated heparin. The initial treatment was followed by vitamin K antagonists. In DVT patients, the three-month recurrence rate was 5.4% in the enoxaparin recipients compared to 12.7% in those treated with fondaparinux [absolute difference 7.3%, 95% CI 0.1, 14.5]. A recurrence was observed in 8.9% of the PE patients treated with fondaparinux compared to 17.2% in the unfractionated heparin recipients [absolute difference -8.3, 95% CI -16.7, 0.1]. In both studies no difference in bleeding and overall survival was observed. Regarding overall survival and bleeding fondaparinux is comparable to enoxaparin and unfractionated heparin in cancer patients. No significant differences in recurrent VTE were observed when comparing fondaparinux with unfractionated or LMWH. Because of study limitations these results should be considered hypothesis-generating.
van Doormaal
Frederiek F
FF
Academic Medical Center, Amsterdam, The Netherlands. F.F.vanDoormaal@amc.uva.nl
Raskob
Gary E
GE
Davidson
Bruce L
BL
Decousus
Hervé
H
Gallus
Alexander
A
Lensing
Anthie W A
AW
Piovella
Franco
F
Prins
Martin H
MH
Büller
Harry R
HR
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D017984:Enoxaparin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D000077425:Fondaparinux; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000150:complications* / Q000401:mortality / Q000628:therapy; D011134:Polysaccharides / Q000009:adverse effects / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D011655:Pulmonary Embolism / Q000097:blood / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D018570:Risk Assessment; D055502:Secondary Prevention; D013997:Time Factors; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000097:blood / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D020246:Venous Thrombosis / Q000097:blood / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D014812:Vitamin K / Q000037:antagonists & inhibitors; D055815:Young Adult
D000925:Anticoagulants; D017984:Enoxaparin; D011134:Polysaccharides; D014812:Vitamin K; D006493:Heparin; D000077425:Fondaparinux