Chemotherapy-associated thromboembolic risk in cancer outpatients and effect of nadroparin thromboprophylaxis: results of a retrospective analysis of the PROTECHT study.
BACKGROUND
Cancer patients receiving chemotherapy are at increased risk of thrombosis. Nadroparin has been demonstrated to reduce the incidence of venous and arterial thrombotic events (TEs) by about 50% in cancer outpatients receiving chemotherapy. The aims of this retrospective analysis were to evaluate the thromboembolic risk and the benefit of thromboprophylaxis according to type of chemotherapy.


METHODS
Cancer outpatients were randomly assigned to receive subcutaneous injections of nadroparin or placebo. The incidence of symptomatic TEs was assessed according to the type of chemotherapy. Results were reported as risk ratios with associated 95% CI and two-tailed probability values.


RESULTS
769 and 381 patients have been evaluated in the nadroparin and placebo group, respectively. In the absence of thromboprophylaxis, the highest rate of TEs was found in patients receiving gemcitabine- (8.1%) or cisplatin-based chemotherapy (7.0%). The combination of gemcitabine and cisplatin or carboplatin increased the risk to 10.2%. Thromboprophylaxis reduced TE risk by 68% in patients receiving gemcitabine; with a further decrease to 78% in those receiving a combination of gemcitabine and platinum.


CONCLUSIONS
This retrospective analysis confirms that patients undergoing chemotherapy including gemcitabine, platinum analogues or their combination are at higher risk of TEs. Our results also suggest that outpatients receiving chemotherapy regimens including these agents might achieve an increased benefit from thromboprophylaxis with nadroparin.


BACKGROUND
NCT 00951574.
Oncology Department, San Filippo Neri Hospital, via Martinotti 20, Rome, 00135, Italy.
Sandro
S
Barni
Roberto
R
Labianca
Giancarlo
G
Agnelli
Erminio
E
Bonizzoni
Melina
M
Verso
Mario
M
Mandalà
Matteo
M
Brighenti
Fausto
F
Petrelli
Carlo
C
Bianchini
Tania
T
Perrone
Giampietro
G
Gasparini
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D016190:Carboplatin / Q000009:adverse effects / Q000627:therapeutic use; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017762:Nadroparin / Q000009:adverse effects* / Q000627:therapeutic use*; D009369:Neoplasms / Q000188:drug therapy*; D010045:Outpatients; D012307:Risk Factors; D013923:Thromboembolism / Q000139:chemically induced* / Q000517:prevention & control*
D017762:Nadroparin; D016190:Carboplatin; D002945:Cisplatin