Results of the landmark CATCH (Comparison of Acute Treatments in Cancer Haemostasis) study were published on the 18th August in The Journal of American Medical Association (JAMA), comparing innohep® (tinzaparin), a low-molecular weight heparin (LMWH), with warfarin in patients with cancer associated thrombosis (CAT). In the study, sponsored by LEO Pharma, the six-month incidence of recurrent VTE was 7.2% in the innohep® arm versus 10.5% in the warfarin arm. This means that patients in the innohep® arm are 35% less likely to experience a VTE during the first six months of treatment compared to patients in the warfarin arm. Even though this primary endpoint was not met at the 5% level (p=0.07) this difference may be clinically relevant in the management of patients with CAT.

As a secondary outcome measure innohep® reduced symptomatic deep vein thrombosis (DVT) by 52% (p=0.04). This significant reduction in symptomatic DVT should be considered hypothesis-generating and exploratory as the secondary analyses were not adjusted for multiple comparisons. With innohep® once daily at a full therapeutic dose of 175 IU/kg there was no increase in major bleeding or mortality, but it was associated with a lower rate of clinically relevant non-major bleeding (p=0.004).

Thromboembolism or blood clots are one of the leading causes of death in patients with cancer. Approximately 1 in 10 patients with cancer dies from a blood clot related event rather than the cancer itself, yet the risk of CAT is not commonly discussed with patients.1, 2

Professor Mike Laffan, Professor of Haemostasis and Thrombosis, Honorary Consultant in Haematology, Faculty of Medicine Imperial College, London said, "CATCH is the largest randomised, controlled trial on the treatment of thrombosis in cancer patients and the results support current clinical guidelines recommending the use of LMWH rather than warfarin to prevent recurrent blood clots in these patients. It provides us with further data for evidence-based therapeutic choices and better understanding of the natural history of patients with cancer and thrombosis."

Eve Knight, Chief Executive and Co-founder of Anticoagulation Europe (UK), a charity whose aim is the prevention of thrombosis and the provision of information, education and support said, "Although it is not widely known, cancer patients are at an increased risk of blood clots and getting the right treatment to avoid recurrence is vital. The CATCH study is the largest of its kind and gives us important answers which could benefit the 50,000 cancer patients living with Cancer Associated Thrombosis in the UK."

Geraldine Murphy, Managing Director of LEO Pharma UK & Ireland said, "LEO Pharma is very pleased that its commitment to the CATCH study has yielded important answers which will ultimately benefit patients living with CAT. CATCH is a landmark study - the world's largest randomised controlled study in treatment of CAT and will add significantly to the understanding of this area."

Despite clinical practice guidelines recommending the use of LMWH, including innohep®, warfarin remains a frequently used anticoagulant treatment worldwide for cancer patients with recurrent VTE.3 The CATCH study results are a significant addition to the existing evidence base and Clinical Practice Guidelines, particularly as the trial was conducted in the modern era of rapidly evolving cancer treatment.4 - 6

Study design

The CATCH study (Comparison of Acute Treatments in Cancer Haemostasis/A Randomized Trial of Long-Term Tinzaparin, a Low-Molecular Weight Heparin, versus Warfarin for Treatment of Acute Venous Thromboembolism in Cancer Patients) is a Phase III, multinational, randomised, active-controlled, open-label trial with blinded adjudication. The lead investigator is Dr Agnes Y Y Lee, Associate Clinical Professor, Division of Haematology and Thromboembolism at Vancouver General Hospital. In total, 900 cancer patients from five continents (Europe, Africa, Asia, North America and South America) were enrolled in the study; 449 patients were treated with innohep® (tinzaparin) and 451 were treated with warfarin over a period of 180 days.

The study is listed on ClinicalTrials.gov (http://www.clinicaltrials.gov identifier NCT01130025.)

Click here for a link to the full journal article: http://jama.jamanetwork.com/article.aspx?articleid=2428955.

About innohep®

innohep® is a low-molecular-weight heparin (LMWH) for subcutaneous injection for the treatment of venous thrombosis and thromboembolic disease including deep vein thrombosis (DVT) and pulmonary embolism (PE). innohep® is manufactured by LEO Pharma.

About the CATCH study

CATCH (Comparison of Acute Treatments in Cancer Haemostasis) is the largest randomized study conducted to date on extended treatment with LMWH to prevent recurrence of VTE in patients with active cancer7. CATCH is a Phase III, multinational, concealed, randomised, active-controlled, open-label trial with blinded adjudication assessing the efficacy and safety of long-term (6 months) innohep® (tinzaparin sodium) therapy (175 IU/kg) versus anticoagulation with warfarin for the treatment of VTE in 900 cancer patients. For further information please refer to the design paper published in BMC Cancer 2013, 13:284 by Lee et al., the primary publication in JAMA 2015;314(7):677-686 or http://www.clinicaltrials.gov website (identifier: NCT01130025).

About Cancer Associated Thrombosis (CAT)

For the general population, the standard treatment for acute VTE consists of initial therapy with a low-molecular-weight heparin (LMWH) followed by longer-term treatment (3 - 6 months) with an oral vitamin K antagonist (VKA). Although this approach can be effective for many patients, cancer patients have a substantial risk of recurrent VTE. Several studies have reported incidences of recurrent VTE as high as 20% in patients with cancer.8, 9 However, studies on how to treat and identify those at risk of recurrent VTE are limited.10, 11 Moreover, the frequent monitoring and dose adjustments required for VKA treatment have a negative impact on Quality of Life.12

Guidelines in Europe and North America recommend long-term treatment of symptomatic VTE in all cancer patients.3,13-16 The major treatment objective is to reduce recurrent thrombosis, including fatal and non-fatal PE.

For more information, visit http://www.CAThrombosis.com