1. The subcommittee convened at 8 AM
2. The chairman opened the meeting and authorized the morningís program by explaining that the session would be divided into 2 parts. Work in progress: clinical trails and coagulation markers in cancer. The objectives of the session were the following: to learn more about ongoing clinical trials and interface laboratory research in the field with a view to compiling an International registry of studies of antithrombotic therapy in cancer and preparation for the eventual development of International guidelines on the management of thromboembolic disease in the cancer patient.
3. Part I: Work in Progress

a. Trails of thromboprophylaxis in cancer patients undergoing operation.

1. Professor David Berguist presented the Eroxacan II Study of the low molecular weight heparin (LMWH). Enoxaparin for prolonged thromboprophylaxis in patients undergoing major abdominal/pelvic surgery for malignancy ó The study is complete and demonstrates an advantage in prolonging thromboprophylaxis in this high risk population.
2. Dr. Morten Rasmussen presented a study evaluating the LMWH dalteparin for prolonged thromboprophylaxis in patients with malignancy undergoing major abdominal/Pelvic operations. The study is ongoing and will complete this year.

b. Trials of thromboprophylaxis in non-surgical cancer patients.

1. Mr. A. Kakkar presented outlines of the TOPIC I and II studies which are designed to evaluate the efficacy and safety of the LMWH Certoparin in the prevention of venous thromboembolism in patients with advanced breast (Topic I) or non-small cell lung (Topic II) cancers on behalf of the principal investigators, Professor M Freund and Professor U. Gatzmeier. Both studies are currently actively recruiting and will undergo planned interim analysis in the autumn.
2. Dr. S. Deitcher presented the INVEST study that will evaluate the LMWH Tinzaparin for the prevention of venous thromboembolism in patients with advanced cancer and its effect on prolonging survival. The protocol will open for recruitment in September 2001.
3. Professor M. Levine presented a study proposal for the evaluation of the LMWH dalteparin in the prevention of venous thromboembolic disease in patients with advanced glioblastoma. The study may commence early in 2002.

c. Trials of thromboprophylaxis in patients with indwelling central venous catheters.

1. Dr. A. Reichart presented a large study evaluating the LMWH dalteparin in the prevention of central catheter associated thrombosis. The study is closed and data will be available in the autumn.
2. Ms. Annie Young presented the WARP study which is evaluating low fixed dose with dose adjusted wafarin for the prevention of central catheter related thrombosis. The study continues to recruit.
3. Dr. A. Lee presented the results of a survey on the management of catheter related thrombosis. This demonstrated considerable variations in practice and uncertainty about management of this clinical problem. A study in this area, although difficult, would be valuable.
4. Professor G. Agnelli presented the ETHICS study which is evaluating the LMWH enoxaparin in the prevention of central catheter related thrombosis. The study continues to recruit.

d. Trials of DVT Treatment in cancer patients.

1. Professor M. Levine presented the CLOT in cancer study, which is evaluating the LMWH dalteparin against the oral anticoagulant wafarin/coumadin in the secondary prevention of venous thromboembolism after initial treatment with dalteparin. The study will complete recruitment in September 2001.
2. Dr. S. Deitcher presented the ONCENOX study which is evaluating the LMWH enoxparin in secondary prevention of VTE. This pilot dosing/feasibility study has just opened recruitment.
3. Dr. R. Hull presented the outline of the LITE/HOME LITE studies evaluating the LMWH Tinzeparin in the treatment of DVT. Cancer subgroup analysis is not currently available.
4. Dr. A. Lee presented a proposal for a study on the duration of anticoagulation after initial treatment of DVT in cancer patients.


e. Trials of Low Molecular Weight Heparin to prolong survival in cancer patients.

1. Mr. A. Kakkar presented the FAMOUS trial, designed to determine whether the LMWH dalteparin given for 1 year can prolong survival in patients with advanced cancer. The study is now closed to recruitment and will report early next year.
2. Professor H. Büller presented the MALT study designed to evaluate whether the LMWH Nardoparin given for 6 weeks can prolong survival in patients with advanced caner. The study should complete recruitment by the end of this year.


f. Surveys and registries

1. Mr. A. Kakkar presented the FRONTLINE survey, which is the first comprehensive global survey designed to assess current perceptions and patterns of practice towards the risk, prevention and management of venous thromboembolism in cancer. It is hoped to collect information from 5,000-10,000 clinicians. The survey can be accessed on line at <www.frontlinesurvey.com>.
2. Dr. S. Schulman made a proposal for joint registries on cancer outcome in patients receiving long term anticoagulation on behalf of the control of anticoagulation subcommittee. This was accepted.

Part II: Coagulation markers in cancer.

1. Dr. A. Falanga presented an overview of the state of the art with regard to markers.
2. Dr. D. Walsh presented a study on markers of Haemostasis in Brain Tumor patients.
3. Dr. J. Fareed and Dr. B. Kuenen presented data on Haemostatic abnormalities and clinical thrombosis in patients receiving anti-angiogenic therapies for treatment of cancer.

The meeting closed at 12:15.