Efficacy of prophylactic low-molecular weight heparin for ambulatory patients with advanced pancreatic cancer: Outcomes from the CONKO-004 trial

Journal of Clinical Oncology

Volumn 33, Issue 18, 2015, Pages 2028-2034

  Pelzer, Uwe ^a   Opitz, Bernhard ^c   Deutschinoff, Gerd ^d   Stauch, Martina ^e   Reitzig, Peter C ^b   Hahnfeld, Sabine ^f   Müller, Lothar ^e   Grunewald, Martina ^g   Stieler, Jens M ^a   Sinn, Marianne ^a   Denecke, Timm ^a   Bischoff, Sven ^a   Oettle, Helmut ^h   Dörken, Bernd ^a   Riess, Hanno ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b SANA KLINIKUM OFFENBACH   (Germany)

^c Krankenhaus St Elisabeth und St Barbara   (Germany)

^d Department of Internal Medicine   (Germany)

^e Clinical Center   (Germany)

^f Biomagnetic Center   (Germany)

^g Research Aschersleben   (Germany)

^h Clinical Center   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

CREATININE; ENOXAPARIN; ANTINEOPLASTIC AGENT; LOW MOLECULAR WEIGHT HEPARIN;

ADVANCED CANCER; ARTICLE; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER INCIDENCE; CANCER MORTALITY; CANCER STAGING; CANCER SURVIVAL; CLINICAL EFFECTIVENESS; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; DRUG EFFICACY; FEMALE; HUMAN; KARNOFSKY PERFORMANCE STATUS; KIDNEY FUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTPATIENT; OVERALL SURVIVAL; PANCREAS CANCER; PRIMARY PREVENTION; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROPHYLAXIS; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; VENOUS THROMBOEMBOLISM; ADULT; AGED; CLINICAL TRIAL; COMPLICATION; MIDDLE AGED; PANCREATIC NEOPLASMS; STATISTICAL MODEL; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; ENOXAPARIN; FEMALE; HEPARIN, LOW-MOLECULAR-WEIGHT; HUMANS; MALE; MIDDLE AGED; MODELS, STATISTICAL; PANCREATIC NEOPLASMS; PROSPECTIVE STUDIES; TREATMENT OUTCOME; VENOUS THROMBOEMBOLISM;

EID: 84937622422     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2014.55.1481     Document Type: Article

References (46)

1. Heit JA, Silverstein MD, Mohr DN, et al: Risk factors for deep vein thrombosis and pulmonary embolism: A population-based case-control study. Arch Intern Med 160:809-815, 2000
2. Agnelli G, Gussoni G, Bianchini C, et al: 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. Lancet Oncol 10:943-949, 2009
3. Lyman GH: Venous thromboembolism in the patient with cancer: Focus on burden of disease and benefits of thromboprophylaxis. Cancer 117:1334-1349, 2011
4. Lee AY, Levine MN, Baker RI, et al: Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med 349:146-153, 2003
5. Khorana AA, Kuderer NM, Culakova E, et al: Development and validation of a predictive model for chemotherapy-associated thrombosis. Blood 111:4902-4907, 2008
6. Haas SK, Freund M, Heigener D, et al: Low-molecular-weight heparin versus placebo for the prevention of venous thromboembolism in metastatic breast cancer or stage III/IV lung cancer. Clin Appl Thromb Hemost 18:159-165, 2012
7. Chew HK, Davies AM, Wun T, et al: The incidence of venous thromboembolism among patients with primary lung cancer. J Thromb Haemost 6:601-608, 2008
8. Prandoni P, Falanga A, Piccioli A: Cancer and venous thromboembolism. Lancet Oncol 6:401-410, 2005
9. Noble S, Pasi J: Epidemiology and pathophysiology of cancer-associated thrombosis. Br J Cancer 102:S2-S9, 2010 (suppl 1)
10. Jemal A, Bray F, Center MM, et al: Global cancer statistics. CA Cancer J Clin 61:69-90, 2011
11. Burris HA 3rd, Moore MJ, Andersen J, et al: Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial. J Clin Oncol 15:2403-2413, 1997
12. Moore MJ, Hamm J, Dancey J, et al: Comparison of gemcitabine versus the matrix metalloproteinase inhibitor BAY 12-9566 in patients with advanced or metastatic adenocarcinoma of the pancreas: A phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 21:3296-3302, 2003
13. Arshad A, Al-Leswas D, Al-Taan O, et al: Pooled survival and response data from phase III randomized controlled trials for gemcitabine-based regimes in the treatment of advanced pancreatic cancer. Am J Clin Oncol 36:411-414, 2013
14. Stathis A, Moore MJ: Advanced pancreatic carcinoma: Current treatment and future challenges. Nat Rev Clin Oncol 7:163-172, 2010
15. Pelzer U: First-line chemotherapy in advanced pancreatic cancer. Recent Results Cancer Res 177:57-60, 2008
16. Heinemann V, Philip PA, Pelzer U: Accomplishments in 2008 in the treatment of metastatic pancreatic cancer. Gastrointest Cancer Res 3:S43-S47, 2009 (suppl 2)
17. Cunningham D, Chau I, Stocken DD, et al: Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol 27:5513-5518, 2009
18. Heinemann V, Boeck S, Hinke A, et al: Meta-analysis of randomized trials: Evaluation of benefit from gemcitabine-based combination chemotherapy applied in advanced pancreatic cancer. BMC Cancer 8:82, 2008
19. Conroy T, Desseigne F, Ychou M, et al: FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 364:1817-1825, 2011
20. Menapace LA, Peterson DR, Berry A, et al: Symptomatic and incidental thromboembolism are both associated with mortality in pancreatic cancer. Thromb Haemost 106:371-378, 2011
21. Sørensen HT, Mellemkjaer L, Olsen JH, et al: Prognosis of cancers associated with venous thromboembolism. N Engl J Med 343:1846-1850, 2000
22. Khorana AA: Cancer and thrombosis: Implications of published guidelines for clinical practice. Ann Oncol 20:1619-1630, 2009
23. Bullano MF, Willey V, Hauch O, et al: Longitudinal evaluation of health plan cost per venous thromboembolism or bleed event in patients with a prior venous thromboembolism event during hospitalization. J Manag Care Pharm 11:663-673, 2005
24. Elting LS, Escalante CP, Cooksley C, et al: Outcomes and cost of deep venous thrombosis among patients with cancer. Arch Intern Med 164:1653-1661, 2004
25. th Edition). Chest 133:113S-122S, 2008 (suppl)
26. Lee AY, Rickles FR, Julian JA, et al: Randomized comparison of low molecular weight heparin and coumarin derivatives on the survival of patients with cancer and venous thromboembolism. J Clin Oncol 23:2123-2129, 2005
27. Agnelli G, George DJ, Kakkar AK, et al: Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med 366:601-609, 2012
28. Pelzer U, Hilbig A, Stieler JM, et al: Intensified chemotherapy and simultaneous treatment with heparin in outpatients with pancreatic cancer: The CONKO 004 pilot trial. BMC Cancer 14:204, 2014
29. Riess H, Pelzer U, Hilbig A, et al: Rationale and design of PROSPECT-CONKO 004: A prospective, randomized trial of simultaneous pancreatic cancer treatment with enoxaparin and chemotherapy. BMC Cancer. 8:361, 2008
30. Pocock J: Group sequential methods in the design and analysis of clinical trials. Biometrika 64:191-199, 1977
31. Kuk D, Varadhan R: Model selection in competing risks regression. Stat Med 32:3077-3088, 2013
32. Gray RJ: A class of K-sample tests for comparing the cumulative incidence of a competing risk. http://www.jstor.org/stable/2241622
33. Altmann D: Practical Statistics for Medical Research. London, United Kingdom, Chapman and Hall, 1991
34. Khorana AA: Venous thromboembolism and prognosis in cancer. Thromb Res 125:490-493, 2010
35. Prandoni P, Lensing AW, Piccioli A, et al: Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood 100:3484-3488, 2002
36. Kleber F-X, Witt C, Vogel G, et al: Randomized comparison of enoxaparin with unfractionated heparin for the prevention of venous thromboembolism in medical patients with heart failure or severe respiratory disease. Am Heart J 145:614-621, 2003
37. Turpie AG: Thrombosis prophylaxis in the acutely ill medical patient: Insights from the prophylaxis in MEDical patients with ENOXaparin (MEDENOX) trial. Am J Cardiol 86:48M-52M, 2000
38. Cohen AT, Zaw HM, Alikhan R: Benefits of deep-vein thrombosis prophylaxis in the nonsurgical patient: The MEDENOX trial. Semin Hematol 38:31-38, 2001 (suppl 5)
39. Akl EA, Gunukula S, Barba M, et al: Parenteral anticoagulation in patients with cancer who have no therapeutic or prophylactic indication for anticoagulation. Cochrane Database Syst Rev 4:CD006652, 2011
40. Van Doormaal FF, Di Nisio M, Otten HM, et al: Randomized trial of the effect of the low molecular weight heparin nadroparin on survival in patients with cancer. J Clin Oncol 29:2071-2076, 2011
41. Haas S, Schellong SM, Tebbe U, et al: Heparin based prophylaxis to prevent venous thromboembolic events and death in patients with cancer: A subgroup analysis of CERTIFY. BMC Cancer 11:316, 2011
42. Maraveyas A, Waters J, Roy R, et al: Gemcitabine versus gemcitabine plus dalteparin thromboprophylaxis in pancreatic cancer. Eur J Cancer 48:1283-1292, 2012
43. Klerk CP, Smorenburg SM, Otten HM, et al: The effect of low molecular weight heparin on survival in patients with advanced malignancy. J Clin Oncol 23:2130-2135, 2005
44. Lazo-Langner A, Goss GD, Spaans JN, et al: The effect of low-molecular-weight heparin on cancer survival: A systematic review and meta-analysis of randomized trials. J Thromb Haemost 5:729-737, 2007
45. Von Delius S, Ayvaz M, Wagenpfeil S, et al: Effect of low-molecular-weight heparin on survival in patients with advanced pancreatic adenocarcinoma. Thromb Haemost 98:434-439, 2007
46. Altinbas M, Coskun HS, Er O, et al: A randomized clinical trial of combination chemotherapy with and without low-molecular-weight heparin in small cell lung cancer. J Thromb Haemost 2:1266-1271, 2004