Thrombosis in Cancer - Expanding Focus for Anticoagulants
Despite the high risk of VTE in cancer and the availability of safe and efficacious injectable anticoagulants, thromboprophylaxis rates in surgical and medical oncology patients remains suboptimal. This Brief has been written in response to the growing unmet needs for anticoagulant use in cancer patients highlighted at the recent ISTH meeting and the publication of two important studies. The report provides an overview of the role for anticoagulants in cancer patients, examining the potential of existing and R&D drugs, and key factors limiting their use.
Table of Contents
- EXECUTIVE SUMMARY - page 4
- Introduction - page 4
- Scope and coverage of the Brief - page 4
- Key findings about the topic - page 5
- Cancer is an important risk factor for the development of venous thromboembolism and these acute thrombotic events affect a significant patient population - page 6
- There has been increased clinical trial activity for existing and new anticoagulants in cancer over the past six years. However, due to the difficulty of conducting clinical trials in cancer patients, the focus of clinical trial strategies is shifting from standalone cancer studies to the use of general medical and surgical trials including larger samples of cancer patients - page 6
- Routine use of thromboprophylaxis in cancer patients, both surgical and medical remains low despite the demonstration that LMWH is safe, effective and convenient for physicians and patients - page 7
- Although progress has been made with the LMWH class, the key unmet need for long-term thromboprophylaxis in cancer patients is for an oral compound requiring little or no monitoring - page 8
- EPIDEMIOLOGY - page 9
- Pathogenesis: thrombosis and cancer - page 9
- Mechanism of action - page 9
- POTENTIAL ROLE FOR ANTICOAGULANTS IN CANCER - page 13
- Surgical prophylaxis - page 13
- Extended surgical prophylaxis - page 14
- Medical prophylaxis - page 14
- Treatment of VTE - page 15
- Prevention of CVC thrombosis - page 18
- Anti-tumor properties - page 18
- Rationale for new anticoagulants - page 19
- PROPHYLAXIS AND TREATMENT OF VTE IN CANCER PATIENTS - page 21
- Perception of risk - page 21
- VTE prophylaxis - page 21
- Duration of prophylaxis - page 23
- Supporting evidence from Datamonitor’s VTE prophylaxis survey - page 24
- Treatment of VTE - page 26
- Hospital versus outpatient treatment - page 26
- Duration of treatment - page 26
- Thrombosis associated with venous access devices - page 27
- CLINICAL TRIALS - page 29
- CANTHANOX study: secondary prevention - page 36
- Trial Design - page 36
- Trial results - page 36
- ENOXACAN II: extended prophylaxis post abdominal surgery - page 37
- Trial design - page 37
- Results - page 38
- FAMOUS trial: cancer survival - page 40
- Trial design - page 40
- Results - page 42
- CLOT in Cancer Trial: prevention of recurrent VTE - page 43
- Trial design - page 43
- Results - page 44
- ONCENOX: secondary prevention - page 46
- Trial design - page 46
- Results - page 47
- MALT trial: cancer survival - page 48
- MATISSE PE trial: VTE treatment - page 48
- Trial design - page 49
- Results - page 49
- PEGASUS trial: general surgery prophylaxis - page 50
- Trial design - page 51
- Results - page 51
- MEDENOX: prophylaxis in medical patients - page 52
- PREVENT trial: recurrent idiopathic VTE - page 53
- WARP study: CVC thromboprophylaxis - page 55
- LITE/HOME-LITE trials: secondary prevention - page 55
- Other ongoing trials and registries - page 57
- CANTHANOX study: secondary prevention - page 36
- ANTICOAGULANT DEVELOPMENT STRATEGIES IN CANCER - page 59
- Aventis: cancer not the key priority for Lovenox - page 61
- Pfizer (Pharmacia): to divest Fragmin? - page 62
- Sanofi-Synthelabo: rapid roll-out of indications for Arixtra - page 63
- Fraxiparine - page 63
- Arixtra - page 63
- Leo Pharmaceuticals/Pharmion: niche cancer/hematology focus - page 64
- AstraZeneca: development for Exanta in cancer recommended - page 65
- CONCLUSIONS AND RECOMMENDATIONS FOR FURTHER RESEARCH - page 67
- Summary of conclusions and recommendations - page 68
- APPENDIX - page 70
- Bibliography - page 70
- Disclaimer - page 73
- Bibliography - page 70
- List of Tables
- Table 1: VTE risk factors associated with cancer therapies - page 10
- Table 2: Estimated prevalence of VTE during the course of cancer and prevalence of key types of cancer, in the seven major markets in 2003 - page 10
- Table 3: Estimated prevalence of key cancer types in the seven major markets, 2003–10 - page 12
- Table 4: Results from meta-analyses of randomized controlled trials comparing LMWH and UFH in the initial treatment of VTE - page 16
- Table 5: Initial treatment for VTE: outpatient LMWH versus inpatient UFH - page 17
- Table 6: Comparison of LMWHs - page 19
- Table 7: Approaches to thromboprophylaxis (%) - page 23
- Table 8: Rates of VTE prophylaxis in surgical and medical patients - page 25
- Table 9: Initial treatment of VTE (%) - page 26
- Table 10: Treatment of patients with central venous access device (%) - page 27
- Table 11: Thromboprophylaxis regimen used in patients with central venous access (%) - page 28
- Table 12: Cancer specific trials examining the use of anticoagulants in any of the cancer indications - page 31
- Table 13: Key clinical trials considering the use of anticoagulants in the general surgical and medical population, where significant cancer patient samples are included - page 33
- Table 14: Key registries examining thrombosis in cancer patients - page 35
- Table 15: Incidence of venous thromboembolic events during the ENOXACAN II study - page 38
- Table 16: Incidence of bleeding during the ENOXACAN II study - page 39
- Table 17: Baseline patient characteristics - page 41
- Table 18: Key results of the FAMOUS trial - page 42
- Table 19: Primary efficacy outcome events in the CLOT in cancer trial - page 45
- Table 20: Secondary efficacy outcomes for the CLOT in cancer trial - page 46
- Table 21: ONCENOX results - page 47
- Table 22: Recurrent VTE and bleeding events in patients with/without active cancer in the MATISSE-PE trial - page 50
- Table 23: Cancer patients in the MEDENOX trial - page 53
- Table 24: Major study endpoints according to treatment groups - page 54
- Table 25: Key results from the LITE study - page 56
- List of Figures
Figure 1: CANTHANOX study - page 36
- List of Figures
- Figure 2: ENOXACAN II (Prolonged vs. in-hospital thromboprophylaxis with Enoxaparin after surgery for abdominal malignancy) - page 37
- Figure 3: FAMOUS Trial (Fragmin Advanced Malignancy Outcome Study) - page 41
- Figure 4: Clot in Cancer Trial (Randomized comparison of LMWH vs. oral warfarin for long term) - page 44
- Figure 5: ONCENOX trial design - page 47
- Figure 6: MATISSE PE trial design - page 49
- Figure 7: PEGASUS trial design - page 51
- Figure 8: Key clinical trials in the development of LMWHs for use in cancer patients - page 60
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