Randomized phase III trial of standard therapy plus low molecular weight heparin in patients with lung cancer: FRAGMATIC trial

Journal of Clinical Oncology

Volumn 34, Issue 5, 2016, Pages 488-494

  Macbeth, Fergus ^a   Noble, Simon ^a   Evans, Jessica ^a   Ahmed, Sheikh ^a   Cohen, David ^b   Hood, Kerenza ^a   Knoyle, Dana ^e   Linnane, Seamus ^k   Longo, Mirella ^b   Moore, Barbara ^c   Woll, Penella J ^f   Appel, Wiebke ^g   Dickson, Jeanette ^h   Ferry, David ⁱ   Brammer, Caroline ^j   Griffiths, Gareth ^a,d  

^a CARDIFF UNIVERSITY   (United Kingdom)

^b UNIVERSITY OF GLAMORGAN   (United Kingdom)

^c National Institute for Social Care and Health Research Clinical Research Centre   (United Kingdom)

^d UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

^e PRINCE CHARLES HOSPITAL   (United Kingdom)

^f WESTON PARK HOSPITAL   (United Kingdom)

^g ROYAL PRESTON HOSPITAL   (United Kingdom)

^h MOUNT VERNON CANCER CENTRE   (United Kingdom)

ⁱ ROYAL WOLVERHAMPTON HOSPITALS NHS TRUST   (United Kingdom)

^j STAFFORDSHIRE GENERAL HOSPITAL   (United Kingdom)

^k BEAUMONT HOSPITAL   (Ireland)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DALTEPARIN; PROTEIN TYROSINE KINASE INHIBITOR; ANTICOAGULANT AGENT; ANTINEOPLASTIC AGENT; LOW MOLECULAR WEIGHT HEPARIN;

ADULT; AGED; ARTICLE; BLEEDING; CANCER PALLIATIVE THERAPY; CANCER STAGING; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; COST UTILITY ANALYSIS; DEEP VEIN THROMBOSIS; DIARRHEA; FEMALE; HUMAN; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; METASTASIS FREE SURVIVAL; MULTICENTER STUDY; NON SMALL CELL LUNG CANCER; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; SMALL CELL LUNG CANCER; THROMBOSIS PREVENTION; VENOUS THROMBOEMBOLISM; CLINICAL TRIAL; COMBINATION DRUG THERAPY; COMPARATIVE STUDY; COMPLICATION; FOLLOW UP; HEALTH CARE QUALITY; LUNG NEOPLASMS; MIDDLE AGED; MORTALITY; PROGNOSIS; SURVIVAL RATE;

AGED; ANTICOAGULANTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HEPARIN, LOW-MOLECULAR-WEIGHT; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; PROGNOSIS; STANDARD OF CARE; SURVIVAL RATE; VENOUS THROMBOEMBOLISM;

EID: 84958811293     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2015.64.0268     Document Type: Article

References (33)

1. Ferlay J, Shin HR, Bray F, et al: Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 127:2893-2917, 2010
2. Blom JW, Doggen CJ, Osanto S, et al: Malignancies, prothrombotic mutations, and the risk of venous thrombosis. JAMA 293:715-722, 2005
3. Noble S, Pasi J: Epidemiology and pathophysiology of cancer-associated thrombosis. Br J Cancer 102:S2-S9, 2010 (suppl 1)
4. Levitan N, Dowlati A, Remick SC, et al: Rates of initial and recurrent thromboembolic disease among patients with malignancy versus those without malignancy. Risk analysis using Medicare claims data. Medicine (Baltimore) 78:285-291, 1999
5. Sørensen HT, Mellemkjaer L, Olsen JH, et al: Prognosis of cancers associated with venous thromboembolism. N Engl J Med 343:1846-1850, 2000
6. Stevenson JL, Choi SH, Varki A: Differential metastasis inhibition by clinically relevant levels of heparins-correlation with selectin inhibition, not antithrombotic activity. Clin Cancer Research 11: 7003-7011, 2005
7. Rickles FR, Patierno S, Fernandez PM: Tissue factor, thrombin, and cancer. Chest 124:58S-68S, 2003 (suppl 3)
8. Lebeau B, Chastang C, Brechot JM, et al: Subcutaneous heparin treatment increases survival in small cell lung cancer. "Petites Cellules" Group. Cancer 74:38-45, 1994
9. 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
10. Akl EA, Kahale LA, Ballout RA, et al: Parenteral anticoagulation in ambulatory patients with cancer. Cochrane Database Syst Rev 12: CD006652, 2014
11. Griffiths GO, Burns S, Noble SI, et al: FRAGMATIC: A randomised phase III clinical trial investigating the effect of fragmin added to standard therapy in patients with lung cancer. BMC Cancer 9:355, 2009
12. Tanaka K, Akechi T, Okuyama T, et al: Development and validation of the Cancer Dyspnoea Scale: A multidimensional, brief, self-rating scale. Br J Cancer 82:800-805, 2000
13. Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand 67: 361-370, 1983
14. Rabin R, de Charro F: EQ-5D: A measure of health status from the EuroQol Group. Ann Med 33: 337-343, 2001
15. National Cancer Institute: Common Terminology Criteria for Adverse Events v3.0 (CTCAE) http://ctep.cancer.gov/protocolDevelopment/electronic-applications/docs/ctcaev3.pdf
16. Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis: Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 3:692-694, 2005
17. Cohen AT, Spiro TE, Büller HR, et al: Extendedduration rivaroxaban thromboprophylaxis in acutely ill medical patients: MAGELLAN study protocol. J Thromb Thrombolysis 31:407-416, 2011
18. Parmar MKB, Machin D: Survival analysis: A practical approach. John Wiley and Sons Ltd., Chichester, UK, 1995
19. Albert-Weil J, Nehorias J: [Two cases of neoplasms not justified for classical therapy, treated with intravenous injections of heparin and intramuscular injections of leech extracts]. Rev Pathol Gen Physiol Clin 54:1014-1020, 1954
20. Borsig L: Heparin as an inhibitor of cancer progression. Prog Mol Biol Transl Sci 93:335-349, 2010
21. Noble S: Low-molecular-weight heparin and survival in lung cancer. Thromb Res 129:S114-S118, 2012 (suppl 1)
22. Kakkar AK, Levine MN, Kadziola Z, et al: Low molecular weight heparin, therapy with dalteparin, and survival in advanced cancer: The fragmin advanced malignancy outcome study (FAMOUS). J Clin Oncol 22:1944-1948, 2004
23. 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
24. 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
25. Sideras K, Schaefer PL, Okuno SH, et al: Lowmolecular-weight heparin in patients with advanced cancer: A phase 3 clinical trial. Mayo Clin Proc 81: 758-767, 2006
26. National Health Service Information Centre: National Lung Cancer Audit Report, 2011. http://www.hscic.gov.uk/catalogue/PUB02676/clin-audisupp-prog-lung-canc-nlca-2011-rep.pdf
27. Cancer Research UK: Lung cancer survival statistics. http://www.cancerresearchuk.org/healthprofessional/cancer-statistics/statistics-by-cancertype/lung-cancer/survival#heading-Zero
28. Maraveyas A, Waters J, Roy R, et al: Gemcitabine versus gemcitabine plus dalteparin thromboprophylaxis in pancreatic cancer. Eur J Cancer 48: 1283-1292, 2012
29. Noble S: The challenges of managing cancer related venous thromboembolism in the palliative care setting. Postgrad Med J 83:671-674, 2007
30. Seaman S, Nelson A, Noble S: Cancerassociated thrombosis, low-molecular-weight heparin, and the patient experience: A qualitative study. Patient Prefer Adherence 8:453-461, 2014
31. Khorana AA, Kuderer NM, Culakova E, et al: Development and validation of a predictive model for chemotherapy-associated thrombosis. Blood 111: 4902-4907, 2008
32. Noble S, Robbins A, Alikhan R, et al: Prediction of venous thromboembolism in lung cancer patients receiving chemotherapy. International Society of Thrombosis and Haemostasis 13:143, 2015 (suppl 2)
33. Meyer G, Besse B, Friard S, et al: [Effect of tinzaparin on survival in non-small-cell lung cancer after surgery. TILT: Tinzaparin in lung tumours]. Rev Mal Respir 28:654-659, 2011