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N Engl J Med. 2012 Feb 16;366(7):601-9. doi: 10.1056/NEJMoa1108898.

Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer.

Collaborators (414)

Turpie AG, Agnelli G, George DJ, Fisher W, Kakkar AK, Lassen MR, Mismetti P, Mouret P, Levine M, Leizorovicz A, Borris L, Buyse M, Fisher MR, White RH, Larrey D, Roca E, Tatangelo M, Palazzo F, Temperley G, Medina C, Coughlin PB, Karapetis CS, McRae SJ, Keefe DM, Atkinson VV, Leyden MJ, Brighton TA, Wong M, Jackson D, Samonigg H, Scheithauer W, Ulsperger E, Zhavrid E, Beliakouski V, Gedrevich Z, Karchmit Y, Azerad MA, Deleu I, D'Hondt R, Nielander AJ, Laurent S, van Eygen KM, Wynendaele WL, Polus M, Majois F, Efira A, Duck L, Alencar VH, Alvares MN, Campos ES, Cesário FK, Fernandes HZ, de Freitas R Jr, Gampel O, Jendiroba DB, Liberatti M, Rocha Lima A, Andrade LM, Martinelli de Oliveira FA, Peclat de Paula AA, Tadokoro H, Filho CA, Vinholes JJ, Wiermann EG, Zereu M, Franke F, Vacaro GZ, Lazaretti N, Guenova K, Kalev D, Bouchard N, Carrier M, Hirsch A, Gagnon G, Rao S, Sperlich C, Webster TM, Whitlock P, Wilson J, Yee A, Dolan S, Yañez E, Liu J, Liu W, Xu J, Zhang H, Zhou C, Zhuang Z, Chen L, Jia L, Wu G, Yao Y, Zhang T, Zhu Y, Bai C, Lin L, Pan H, Wang N, Xu Q, Liang J, Hu X, Li W, Yepes A, Rojas GA, Lopera DE, Lema M, Salazar RD, Gonzalez M, Gonzalez J, Cucevic B, Knezevic A, Kusic Z, Stimac D, Trivanovic D, Vojnovic Z, Herceg D, Prausova J, Smakal M, Klepetko P, Mellemgaard A, Paija O, Goncalves A, Chavaillon JM, Debourdeau P, Deplanque G, Desauw C, Farge-Bancel D, Husseini F, Lafitte JJ, Martinet Y, Miglianico L, Muir JF, Oddou S, Prevost A, Ychou M, Adenis A, Mahé I, Baumgart D, Becker M, Behringer D, Derigs GH, Engel-Riedel W, Fenner M, Fietz T, Folprecht G, Guetz S, Harenberg J, Heinrich B, Held H, Jacobasch L, Karthaus M, Kretzschmar A, Kröning H, Hentrich UM, Müller L, Ostermann H, Otremba B, Pihusch M, Reichert D, Riess H, Späth-Schwalbe E, Stahl M, Südhoff T, von Pawel J, Wolf HH, Gaska T, Stein U, Nagel S, Fountzilas G, Georgoulias V, Stergiou I, Ng TY, Bassam A, Fónay K, Kocsis J, Magyar T, Ruzsa Á, Szentpéteri I, Zsiray M, Király Z, Csöszi T, Albert I, Advani SH, Aggarwal S, Biswas J, Karandikar SM, Subramanian KK, Lakshmaiah KC, Ross CR, Sahoo TP, Maru A, Pedapenki RM, Mukhopadhyay A, Pavithran K, Saxena R, Tuljapurkar VB, Goswami C, Ramesh A, Balasubramanian S, Srinivasan K, Pathak AB, Sachin HS, Sairam C, Bakta IM, Sumantri R, Gani S, Grogan L, McDermott R, Ben-Shahar M, Gabizon AA, Dror Y, Stemmer S, Amadori D, Barni S, Bertolini A, Carnaghi C, Cruciani G, Faedi M, Ferraù F, Gamboni A, Gamucci T, Gasparro D, Lorusso V, Dazzi C, Pasquini E, Passalacqua R, Ravaioli A, Sacco C, Buzzi F, Crinò L, Chung HC, Kim JH, Kang JH, Kim HK, Kim YH, Lim HY, Oh DY, Song HS, Kim JS, Krievins D, Krilova A, Zvirbule Z, Inciura A, Jankevicius F, Teoh CY, Roslani AC, Chakraborty S, Thangadorai AR, Gaytán Angel M, Gomez Villanueva A, Lopez Lopez F, Lopez Hernandez J, Mejia Novelo A, Pardo Tejeda R, Tellez Bernal E, Beeker A, de Jongh FE, Kuenen BC, Pieters WR, Sleeboom HP, Sandset PM, Alvarez Barreda R, Auqui Flores R, Benites Benites M, Carracedo Gonzales CF, Casanova Marquez LA, Chumbes Sipan ML, Falcon Lizaraso SG, Guevara Guevara JS, Montenegro Beltran P, Pimentel Alvarez PR, Vargas Quezada EA, Badzio A, Jedrzejczak WW, Kaiser A, Koralewski P, Mruk A, Nowara E, Porzuczek-Zuziak D, Poznański J, Ramlau R, Sawrycki P, Slomian G, Tomeczko J, Palasik MG, Rogowski W, Szczęsna A, Mellidez JC, Moreira A, Rosales M, Sottomayor C, Coutinho C, Ciuleanu T, Croitoru AE, Ganea Motan DE, Iacob IC, Nagy VM, Niculescu A, Volovat C, Akhmadullina L, Cheporov S, Dykhno Y, Dvorkin M, Gladkov OA, Gurina L, Kolomietz S, Uvarova S, Krikunova L, Krivorotko P, Lipatov O, Mosin I, Orlov S, Pimenov I, Elkova V, Sinyakov A, Solovyov V, Takhtamysh M, Udovitsa D, Vladimirov V, Vladimirova L, Litvinov I, Jovanovic D, Milinic N, Rancic M, Andjelkovic N, Dienerova M, Takac I, Triller N, Jordaan JP, Landers GA, Alés JE, Almenar D, Galán A, Gascón P, Alonso MA, Guillot M, Pachón V, López G, Munoz AJ, Ortega E, Puente J, Sanchez A, Fernebro E, Berglund A, Gustavsson B, Nestler G, Korte W, Mueller A, Heizmann M, Andrusenko O, Bondarenko I, Galaychuk I, Komisarenko V, Lisovska N, Paramonov V, Senyutovych R, Shparyk Y, Vynnychenko I, Awwad ST, Baumohl J, Epurescu D, Hasan J, Maraveyas A, McAdam K, McKinna F, O'Callaghan AM, Rankin E, Lord R, Sothi S, Stuart NS, Baumohl J, Siddique N, Vrindavanam NS, Dhami MS, Garcia MM, Moss RA, Slaughter MT, Young D, Kloecker GH, Galvez A, Reed RD, Guthrie TH Jr, Ortel TL, Altomare IP, Francis C, Sethi HS, Chinnasami B, Ali MA, LeBerthon BJ, Gajra A, Starodub A, Gressot L, Scouros M, Khaira DK, Khorana AA, Sabbath KD, Priego VM, Phooshkooru VR, Cosgriff T, Zaydan MA, Fink M, Perry DJ, Kellum AH, Brooks DJ, Rado T, Brandt D, De Shields MS, Ramachandran S, Upadhyaya G, Steis RG, Lawler W, Fiorica J, Amin D, Armenio V.

Author information

  • 1Division of Internal and Cardiovascular Medicine and Stroke Unit, Department of Internal Medicine, University of Perugia, Perugia, Italy. agnellig@unipg.it

Abstract

BACKGROUND:

Patients receiving chemotherapy for cancer are at increased risk for venous thromboembolism. Limited data support the clinical benefit of antithrombotic prophylaxis.

METHODS:

In this double-blind, multicenter trial, we evaluated the efficacy and safety of the ultra-low-molecular-weight heparin semuloparin for prevention of venous thromboembolism in patients receiving chemotherapy for cancer. Patients with metastatic or locally advanced solid tumors who were beginning to receive a course of chemotherapy were randomly assigned to receive subcutaneous semuloparin, 20 mg once daily, or placebo until there was a change of chemotherapy regimen. The primary efficacy outcome was the composite of any symptomatic deep-vein thrombosis, any nonfatal pulmonary embolism, and death related to venous thromboembolism. Clinically relevant bleeding (major and nonmajor) was the main safety outcome.

RESULTS:

The median treatment duration was 3.5 months. Venous thromboembolism occurred in 20 of 1608 patients (1.2%) receiving semuloparin, as compared with 55 of 1604 (3.4%) receiving placebo (hazard ratio, 0.36; 95% confidence interval [CI], 0.21 to 0.60; P<0.001), with consistent efficacy among subgroups defined according to the origin and stage of cancer and the baseline risk of venous thromboembolism. The incidence of clinically relevant bleeding was 2.8% and 2.0% in the semuloparin and placebo groups, respectively (hazard ratio, 1.40; 95% CI, 0.89 to 2.21). Major bleeding occurred in 19 of 1589 patients (1.2%) receiving semuloparin and 18 of 1583 (1.1%) receiving placebo (hazard ratio, 1.05; 95% CI, 0.55 to 1.99). Incidences of all other adverse events were similar in the two study groups.

CONCLUSIONS:

Semuloparin reduces the incidence of thromboembolic events in patients receiving chemotherapy for cancer, with no apparent increase in major bleeding. (Funded by Sanofi; ClinicalTrials.gov number, NCT00694382.).

Comment in

PMID:
22335737
[PubMed - indexed for MEDLINE]
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