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Purpose Data on long-term treatment with low-molecular-weight heparins (LMWH) in cancer patients treated for venous thromboembolism are scarce. Study objectives were to document the long-term clinical use of LMWH and patient perception in this setting. Methods Adult cancer patients receiving antineoplastic treatment or palliative care and LMWH for cancer associated venous thromboembolism (CAT) were eligible to participate in this prospective observational study. Main outcome was adherence to clinical practice guidelines based on recommended LMWH treatment doses for at least 3 months in the absence of severe renal insufficiency. Patients' perception of the treatment was assessed in an ancillary study using the Perception Anticoagulant Treatment Questionnaire (PACT-Q). Results Among 409 included cancer patients aged 65 ± 12.1 years, overall adherence to practice guidelines as defined in the protocol was 55.3% (226 patients). However, 98.0% of patients received a prescription for 3 months or more and mean LMWH treatment duration for VTE was 6.27 ± 0.15 months which meets guidelines recommendations. Main patients' expectations scored on a 1–5 scale were blood clots prevention (mean 3.94 ± 0.75), symptom relief (mean 3.98 ± 1.04) and ease of use (mean 4.22 ± 0.9). LMWH treatment appeared convenient (global score 79.7 ± 17.1 on a 0 to 100 scale) and 69.1% of patients were satisfied or very satisfied. Conclusion Despite incomplete strict adherence to guidelines, treatment duration with LMWH was adequate showing substantial progress in the management of CAT patients. Patients expectations were high while treatment was perceived convenient with a high degree of satisfaction.

// Dominique Farge 1 , Francis Cajfinger 2 , Nicolas Falvo 3 , Toufek Berremili 4 , Francis Couturaud 5 , Okba Bensaoula 6 , Lionel Vedrine 7 , Hocine Bensalha 1 , Isabelle Bonnet 8 , Denis Pere-Verge 9 , Marie Coudurier 10 , Veronique Li 11 , Hanadi Rafii 1 , Ilham Benzidia 1 , Jean M. Connors 12, * and Matthieu Resche-Rigon 13, * 1 Assistance Publique-Hopitaux de Paris, Saint-Louis Hospital, Internal Medicine, Autoimmune and Vascular Disease Unit, UF 04, Diderot University, Paris, France 2 Medical Oncology, Hopital Pitie-Salpetriere, Paris, France 3 Departement de Pathologie Vasculaire, CHU Dijon, Dijon Cedex, France 4 Department of Cardiology, Annecy Hospital, Annecy, France 5 Brest University Hospital, CHU de Brest, Brest, France 6 Department of Oncology, CLCC Curie Institute, Centre Rene Huguenin, Saint Cloud, France 7 Hopital d'Instruction des Armees du Val-de-Grâce, Paris, France 8 Department of Oncology, Hospital of Valenciennes, Valenciennes, France 9 CH Saint Joseph Saint Luc, Lyon, France 10 Chambery CH, Chambery, France 11 CH Thonon-Les-Bains, Thonon-les-Bains, France 12 Hematology Division, Harvard Medical School, Boston, MA, USA 13 Service de Biostatistique et Information Medicale, AP-HP Hopital Saint-Louis, Paris, France * These authors contributed equally to this work Correspondence to: Dominique Farge, email: dominique.farge-bancel@aphp.fr Keywords: cancer thrombosis; venous thromboembolism; anticoagulation therapy; quality of life; LMWH Received: March 30, 2018 Accepted: May 02, 2018 Published: June 05, 2018 ABSTRACT Background: Clinical guidelines recommend at least 3-months low molecular weight heparin (LMWH) treatment for established venous thromboembolism (VTE) in cancer patients. However, no study has analyzed the impact of 3–6 months of LMWH therapy on quality-of-life (QoL) in cancer patients. Results: Among 400 cancer patients included at M0, 88.8% received long-term LMWH. Using a random-effects linear regression model with time as covariate, QoL scores in the MOS SF-36 (Global HRQoL, 1.3-fold per month [95% confidence interval (CI) 0.81–1.79], p < 0.0001) and EORTC QLQ-C30 (global health status/qol, 2.25-fold per month [95% CI 1.63–2.88]; p < 0.0001) questionnaires significantly improved over the 6-month study period in patients treated with LMWH, while VEINES-QOL scores did not change. In the MOS SF-36 and EORTC QLQ-C30, the following factors were associated with change in QoL: symptomatic VTE, cancer dissemination and histological type. Factors pertaining to reduced mobility were also identified as significant predictors of QoL outcomes, including being bedridden in the MOS SF-36 and ECOG score ≥ 2 in the EORTC QLQ-C30. Presence of acute infection and not undergoing anti-angiogenic therapy were additional factors associated with QoL improvement in the EORTC QLQ-C30. Methods: QUAVITEC, a prospective, longitudinal, multicenter study, recruited all consecutive eligible adult cancer patients with objectively confirmed VTE between February 2011 and 2012. Patients were asked to answer three QoL questionnaires at anticoagulant treatment initiation (M0) and at 3 (M3) and 6 (M6)-month follow-ups. Conclusion: QUAVITEC is the first study to show that QoL was improved in cancer patients receiving long-term LMWH treatment for established VTE.

Direct oral anticoagulants (DOACs) have proven efficacy and safety and are approved for use in the prevention and treatment of thromboembolic events in patients with venous thromboembolism (VTE) and those with atrial fibrillation (AF). There is no clear guidance on the use of DOACs in the significant proportion of these patients who have or will develop concomitant cancer. The occurrence of nausea and vomiting in these patients, despite implementation of guideline-recommended antiemetic strategies, is a particular concern because it may affect oral drug intake and consequently outcomes with anticoagulation therapy. Here, we review recent data on the incidence and management of cancer-associated nausea and vomiting and the current evidence and guidance relating to the use of DOACs in patients with cancer. On the basis of this evidence, an international working group of experts in the fields of cancer-associated thrombosis/hemostasis, hematology, and oncology discussed key issues related to the use of DOACs in patients with VTE or AF and cancer who are at risk of nausea and vomiting and developed some consensus recommendations. We present these consensus recommendations, which outline strategies for the use and management of anticoagulants, including DOACs, in patients with VTE or AF and cancer for whom oral drug intake may pose challenges. Guidance is provided on managing patients with gastrointestinal obstruction or nausea and vomiting that is caused by cancer treatments or other cancer-related factors. The recommendations outlined in this review provide a useful reference for health care professionals and will help to improve the management of anticoagulation in patients with VTE or AF and cancer. Implications for Practice Direct oral anticoagulants (DOACs) offer several advantages over traditional anticoagulants, including ease of administration and the lack of need for routine monitoring. However, the management of patients with an indication for anticoagulation and concomitant cancer, who are at high risk of thromboembolic events, presents several challenges for administering oral therapies, particularly with regard to the risk of nausea and vomiting. In the absence of robust data from randomized trials and specific guidelines, consensus recommendations were developed for healthcare professionals regarding the use of DOACs in patients with cancer, with a focus on the management of patients who are at risk of nausea and vomiting.

Le congres de l’ASCO est un congres de cancerologie pure ou la part reservee a la thrombose veineuse, que ce soit la thrombose veineuse profonde des membres inferieurs (TVP) ou l’embolie pulmonaire (EP), est habituellement faible. Les publications sur les thromboses sur catheter veineux central, qui representent quand meme 3 % des patients uniquement pour les evenements symptomatiques, sont encore plus rares. Cette edition 2015 qui, comme les annees precedentes, s’est deroulee [...]

Venous thromboembolism (VTE) is the second leading cause of death in patients with cancer. These patients are at an increased risk of developing VTE and are more likely to have a recurrence of VTE and bleeding while taking anticoagulants. Management of VTE in patients with cancer is a major therapeutic challenge and remains suboptimal worldwide. In 2013, the International Initiative on Thrombosis and Cancer (ITAC-CME), established to reduce the global burden of VTE in patients with cancer, published international guidelines for the treatment and prophylaxis of VTE and central venous catheter-associated thrombosis. The rapid global adoption of direct oral anticoagulants for management of VTE in patients with cancer is an emerging treatment trend that needs to be addressed based on the current level of evidence. In this Review, we provide an update of the ITAC-CME consensus recommendations based on a systematic review of the literature ranked according to the Grading of Recommendations Assessment, Development, and Evaluation scale. These guidelines aim to address in-hospital and outpatient cancer-associated VTE in specific subgroups of patients with cancer.

International audience; Venous thromboembolism (VTE) is a major therapeutic issue in cancer patients. Advances in this field and heterogeneities in clinical practices prompted us to establish guidelines in the management of VTE in cancer patients according to the SOR (Standards, Options and Recommendations) methodology. A literature review of the studies published on this topic between 1999 and 2007 was performed. The guidelines were developed from the analysis of 38 out of 418 publications selected. They were peer-reviewed by 65 independent experts. The treatment of VTE in patients with cancer, including those with intracranial malignancies, should be based on low-molecular-weight heparins administered at therapeutic doses for at least 3 months. In the event of recurrent VTE, pulmonary embolism with hemodynamic failure or contra-indication to anticoagulant treatment, the indications and usages of vena cava filters and thrombolytic drugs should be the same as in non-cancer patients.

The "Standards, Options: Recommendations" (SOR) project has been undertaken by the French National Federation of Cancer Centers (FNCLCC) and is now part of the French National Cancer Institute. The project involves the development and updating of evidence-based Clinical Practice Guidelines (CPG) in oncology. In order to answer questions related to venous thromboembolic events (VTE) treatment and to central venous catheter thrombosis (CVCT) management in cancer patients, the SOR elaborated national guidelines, here presented in a short report. It results of a collaborative work with members from three learned societies ( > : SNFMI, > : SFMV and > : SFAR).

The Standards, Options: Recommendations (SOR) project has been undertaken by the French National Federation of Cancer Centers (FNCLCC) is now part of the French National Cancer Institute. The project involves the development and updating of evidence-based Clinical Practice Guidelines (CPG) in oncology. In order to answer questions related to venous thromboembolic events(VTE) treatment and to central venous catheter thrombosis (CVCT) management in cancer patients, the SOR elaborated national guidelines, here presented in a short report. It results of a collaborative work with members from three learned societies("societe nationale francaise de medicine interne": SNFMI, "societe francaise de medicine vasculaire": SFMV and "societe francaise dEanesthesie-reanimation:SFAR).

Cancer is an independent and major risk factor for venous thromboembolism (VTE), defined by symptomatic or asymptomatic DVT, including catheter-related thrombosis (CRT), and/or pulmonary embolism (PE). Over the past 20 years, VTE has become the second cause of death in cancer patients, where it accounts for increased morbidity, mortality, and healthcare costs. Incidental VTE is increasingly diagnosed on systematic computed tomography in cancer patients, raising new questions in daily oncology practice. Risk factors for VTE in cancer include patient-, cancer-, and treatment-related parameters, which vary for a single patient throughout the course of cancer disease and necessitate repeated individual risk assessments. The use of biomarkers and risk assessment models allow identification of cancer patients at high risk for VTE. Anticoagulant therapy for the prophylaxis and the treatment of established VTE is efficient and relatively safe when contraindications are respected, but the variety of risk factors and the number of comorbidities remain major challenges for adequate VTE treatment in cancer patients. Several national guidelines for primary prevention and treatment of VTE in cancer patients were issued in the past 10 years. To homogeneize existing Clinical Practice Guidelines (CPGs), an international consensus working group released specific guidelines for the treatment and prophylaxis of VTE in cancer patients in 2013, so as to make each CPG easier to use at the national level. In cancer patients treated for VTE, the use of low-molecular-weight heparins (LMWHs) is preferred over other anticoagulants in most cases, and LMWHs were shown to be superior to vitamin K antagonists (VKAs). For the prophylaxis of VTE, LMWHs have been validated in surgical patients. For medical cancer patients, ongoing or recent clinical trials will inform our practice. However, several questions remain unanswered due to the number of comorbities in a single patient and expert opinion regarding special situations is required. Better adherence worldwide to CPGs necessitates adequate educational and active implementation strategies, which could substantially decrease the burden of VTE and increase survival in cancer patients.

Introduction: Treatment and prevention of VTE is crucial, yet anticoagulation is under-prescribed in cancer patients. The recommended treatment for established VTE in cancer patients is low molecular weight heparin (LMWH) once daily for at least 3 months, and termination or continuation of treatment after 3-6 months is still based on individual evaluation of the benefit-risk ratio, tolerability, drug availability, patient preference, and cancer. Despite important concerns about long-term patient tolerance for LMWH treatment (after 10 days) and its side effects, no study has analyzed the overall impact of LMWH on quality-of-life (QoL) in cancer patients. Methods: In this prospective, longitudinal, multicenter study, consecutive eligible adult cancer patients (>18 years), diagnosed with either deep vein thrombosis or a pulmonary embolism (PE), were recruited at participating centers between February 2011 and 2012. Patients were asked to answer three questionnaires administered at time of VTE diagnosis (M0), and 3 (M3) and 6 (M6) months after start of anticoagulant treatment: 1) the Medical Outcome Study 36-item Short-Form Health Survey (MOS SF-36) for generic Health-Related Quality of Life (HRQoL), 2) the European Organization for Research and Treatment of Cancer (EORTC) QoL Questionnaire, and 3) the Venous Insufficiency Epidemiological and Economic Study (VEINES)-QOL questionnaire. Results (median[iqr], Wilcoxon Signed Rank Test): At M0, 400 cancer patients (51.5% female) were included, 60.4% with metastatic disease and 67.0% on chemotherapy. The choice of anticoagulant was made by the attending physician. 88.75% of patients received LMWH, 5.5% a vitamin K antagonist, 1.5% unfractionated heparin, and 3.75% a direct oral anticoagulant. Throughout the study, 18.9% of patients on LMWH reported at least one side effect with injection (number of reports: pain, 26 (7.3%); ecchymosis, 57(16.1%); pruritis, 2(0.6%); nodules, 28 (7.9%)). Mortality rate was 24.73%, with 79 deaths attributable to cancer progression and 3 to VTE. At M3, patients on LMWH showed a significant increase of 3.9 [5.7-14 ] points in the MOS SF-36 global HRQoL score (p=0.0007) and 8.3 [-8.3;17] points in the EORTC global Health status/QoL survey (p=0.0001). The veinsQoL score decreased by 2 [-5.2-4] points (p=0.022). Logistic regression analysis identified predictive factors common to both MOS SF-36 and EORTC: ECOG scores (MOS SF-36, p=0.050; EORTC, p=0.006) and whether patients were ambulatory as opposed to bedridden (MOS SF-36, p=0.001; EORTC, p=0.019). Cancer surgery (p=0.005), presence of central venous catheter (CVC) (p=0.018) or PE (p=0.029), and absence of chemotherapy (p=0.017), or acute infection (p=0.048) were also positive predictors of cancer-related QoL in the EORTC survey. No predictive factors were identified for veinsQoL. At M6, patients on LMWH showed sustained point increases of 5.5 [-5.6; 22] in the MOS SF-36 global HRQoL score (p There was no change in the MOS SF-36 global HRQoL score between 3 and 6 months, but there was significant improvement in the sub-dimensions of general health (1.9 pts, p=0.057) and vitality (3.7 pts; p=0.016). The improved global health status/QoL score in the EORTC was also maintained between 3 and 6 months, with a significant 4.7 point reduction in the fatigue symptom subscale (p=0.016). No change was observed in the VeinsQoL. Painful side effects of LMWH treatment did not predict diminished QoL in the logistic regression analysis. Cancer progression was a negative predictor of MOS SF-36 global HRQoL in these patients (p=0.051). Conclusion: In cancer patients with established VTE who survive to 3 and 6 month follow-ups under recommended anticoagulant treatment, QoL increases despite long term treatment with LMWH. This analysis is the first to show that LMWH treatment from 3 to 6 months does not diminish QoL in cancer patients diagnosed with VTE. Disclosures No relevant conflicts of interest to declare.

Cet article propose le rapport abrege d’une recommandation pour la pratique clinique (RPC), elaboree selon la methodologie « Standards, Options: Recommandations (SOR) », sur le traitement de la maladie thromboembolique veineuse (MTEV) et sur la prise en charge des thromboses veineuses sur catheter central (TVKTC) chez les patients atteints de cancer. la recommandation a ete realisee en collaboration avec des membres de la Societe nationale francaise de medecine interne (SNFMI), de la Societe francaise de medecine vasculaire (SFMV) et de la Societe francaise d’anesthesie-reanimation (SFAR). Le programme SOR, initie par la Federation nationale des centres de lutte contre le cancer (FNCLCC), a pour objectif la redaction de RPC en cancerologie et est pilote, depuis mai 2008, par l’institut national du cancer (INCa).

Purpose Venous thromboembolism (VTE) is an increasingly frequent complication of cancer and its treatments, and is associated with worsened mortality and morbidity in patients with cancer. Design The Italian Association of Medical Oncology, the National Comprehensive Cancer Network, the American Society of Clinical Oncology, the French National Federation of the League of Centers Against Cancer, and the European Society of Medical Oncology have recently published guidelines regarding VTE in patients with cancer. This review, authored by a working group of members from these panels, focuses on the methodology and areas of consensus and disagreement in the various clinical guidelines as well as directions for future research. Results There is broad consensus regarding the importance of thromboprophylaxis in hospitalized patients with cancer, including prolonged prophylaxis in high-risk surgical patients. Prophylaxis is not currently recommended for ambulatory patients with cancer (with exceptions) or for central venous catheters. All of the panels agree that low molecular weight heparins are preferred for the long-term treatment of VTE in cancer. Areas that warrant further research include the benefit of prophylaxis in the ambulatory setting, the risk/benefit ratio of prophylaxis for hospitalized patients with cancer, an understanding of incidental VTE, and the impact of anticoagulation on survival. Conclusion We call for a sustained research effort to investigate the clinical issues identified here to reduce the burden of VTE and its consequences in patients with cancer.

88 Background: In the TROPIQUE study CAT pts had high expectations for anticoagulant treatment & long-term LMWH was perceived as convenient with high degree of treatment satisfaction. In this study, using the Perception of Anti-Coagulant Treatment Questionnaires (PACT-Q), we assessed the inpact of patient profile on treatment expectations, convenience and satisfaction. Methods: PACT-Q (1&2) were proposed on a voluntarily basis to cancer pts recently diagnosed with symptomatic venous thromboembolism; the global mean scores±SD was correlated to pts characteristics. Results: 269 PACT-Q1 & 139 PACT-Q2 were analysed &135 pts done both of them. In all pts, the highest mean scores were for expectations of symptom relief (4.22±0.9), confidence in preventing clots (3.98±1.04) & importance of simplicity of use (3.94±0.75). For clot prevention men were more confident (4.06±0.81) vs women (3.85±0.88). Expectations of symptom relief was higher in women (4.07±0.98) vs men (3.89±1.09). Importance of ease of use was higher in treated pts (4.27±0.89) vs no therapy (4.00±0.99) & pts with age ≥ 49 (4.46±0.59) vs < 49 years (3.98±1.07). At the end of the study, PACT-Q2 answers showed, an Anticoagulant Treatment Satisfaction scores of 62.9±16.7. 67.2% of pts felt strongly reassured & 48.5% were satisfied with symptom decrease. 69.1% of pts were satisfied / very satisfied with their anticoagulant treatment. Treatment-related side effects were as expected (41.7%), better/much better than expected (45.5%). 80.6% of pts reported higher ease with tinzaparin and 76.2% with other LMWH. According to pts characteristics, satisfaction was higher in men (64.4±17.7) vs women (61.0±15.0), in non-metastatic (64.6±16.9) vs metastatic (61.1±16.2). ECOG (3-4) pts reported lower treatment convenience with higher satisfaction vs ECOG (0-1); 80.0% of ECOG (3-4) pts were satisfied/very satisfied with anticoagulant treatment. 70.0% of ECOG (1-0) patients stated symptom decrease & 80.0 % a feeling of reassurance. Conclusions: pt’s profile influenced positively the perception of long-term LMWH treatment but not the convenience & treatment satisfaction.

e13008 Background: A 25% incidence rate of VTE is reported in GBM patients. The risk of intracranial bleeding under anticoagulation is the main concern. Methods: The ANOCEF has conducted a survey o...

Introduction Few data are available on the long-term LMWH prescription and treatment follow-up in clinical practice in patients with cancer-associated VTE. Study objectives were to document the prescription and use of treatment doses of LMWH in cancer patients and to assess adherence to established recommendations. Methods Adult cancer patients receiving antineoplastic treatment or palliative care, age ≥18 years, with recent symptomatic VTE in whom treatment with LMWH had been initiated within 7 days prior to inclusion, were eligible to participate in this prospective observational French multicenter study. Patients with a contra-indication to LMWH were not eligible for participation. Main study outcome was the description of LMWH use and prescription in usual medical care. Adherence to recommendations was measured as the proportion of patients receiving a prescription of a LMWH at treatment doses according to the approved dosing schedule and treated for at least 3 months in the absence of severe renal insufficiency (CrCl Results A total of 409 patients aged 65±12.1 years of whom 49.9% female were consecutively included from November 2012 to August 2013. A history of previous VTE was found in 54 (13.2%), surgery or trauma in 100 (24.4%), central venous catheter (CVC) in 303 (74.1%) and immobilization >1 month in 47 (11.5%) patients, respectively. Four (1.03%) patients had severe renal insufficiency. VTE diagnosis at inclusion included lower-limb deep-vein thrombosis (DVT) in 193 (47.2%), pulmonary embolism in 145 (35.5%), CVC-associated thrombosis in 66 (16.1%), upper-limb DVT in 45 (11.0%) and visceral thrombosis in 16 (3.9%) patients, respectively. Most cancers were solid tumors gastro-intestinal (24.4%), lung (17.4%) or breast (15.9%); 81% of patients received chemotherapy and 61.4% were metastatic cancers. LMWH prescriptions included dalteparin in 42 (10.3%), enoxaparin in 61 (14.9%), nadroparin in 5 (1.2%) and tinzaparin in 301 (73.6%) patients. Only 4 (1%) patients received LMWH despite severe renal insufficiency. Table 1 –Prescription adherence to recommendations at inclusion [n (%)]Adherence criteriaTinzaparin (N=301)Other LMWH (N=108)All (N=409)Treatment duration > 3 months293 (97.3)108 (100)401 (98.0)Adequate dosing regimen*231 (76.7)14 (13.0)245 (59.9)Adequate dosing schedule296 (98.3)45 (41.7)341 (83.4)Overall adherence219 (72.8)7 (6.5)226 (55.3) *includes adequate treatment dose and dose adjustment according to recommendations A total of 274 (67.0%) patients received the recommended treatment dose, while 87 (21.3%) patients received doses exceeding this by more than 10% and 39 (9.5%) patients received doses more than 10% below the recommended doses. Based on the pre-defined adherence criteria, 226 (55.3%) [95% CI 50.4-60.1] patients had a LMWH prescription consistent with recommendations. Tinzaparin prescriptions were associated with higher adherence scores compared to other LMWH. During follow-up, actual mean treatment duration was 5.28 ± 2.07 months and 85.7% of patients were treated for 3 months or more Table 2 - Adherence to recommendations at inclusion according to cancer characteristics (N=409) [n (%)] Cancer characteristics Proportion of study population Proportion of adherence to recommendations Gastro-intestinal Lung Breast Hemato lymphopoietic Other Metastatic Chemotherapy (n=405)* 100 (24.4) 71 (17.4) 65 (15.9) 54 (13.2) 119 (29.1) 251 (61.4) 328 (81.0) 53 (53.0) 37 (52.1) 46 (70.8) 28 (51.9) 62 (52.1) 133 (53.0) 186 (56.7) *405 patients documented with chemotherapy At inclusion, the rate of prescriptions consistent with recommendations was low (55.3%) while the highest rate of adherence (70.8%) was observed in patients with breast cancer known to be at rather lower risk of VTE recurrence. Conclusion Adherence to treatment duration was adequate whereas dosing regimen was insufficiently compliant with recommendations. Overall adherence with tinzaparin seemed higher compared to other LMWH Management of patients with cancer-associated VTE requires further education and information of health care professionals. Farge D, J Thromb Haemost. 2013 Jan; 11(1):56-70. Disclosures Farge: Pfizer: Research Funding; LEO Pharma: Research Funding. Debourdeau:Pfizer: Research Funding; LEO Pharma: Research Funding. Cajfinger:Pfizer: Research Funding; LEO Pharma: Research Funding.

Introduction Long-term treatment with LMWH is the recommended standard for patients with cancer-associated VTE [1, 2]. Data on the long-term prescription of LMWH and treatment follow-up in clinical practice, and particularly the patient’s view on the treatment, are scarce. The main objective of TROPIQUE was to document the prescription and use of LMWH in these patients. A sub-study aimed to assess patients’ perception of long-term anticoagulant treatment with LMWH based on the validated Perception AntiCoagulant Treatment Questionnaire (PACT-Q) [2]. Methods Adult cancer patients with recent symptomatic VTE from the TROPIQUE study were asked to fill-in a PACT-Q at inclusion and at 6 months or study end. PACT-Q1 administered at study start included “Treatment Expectations” (7 items) measured by separate scores expressed on a 5-point Likert scale. PACT-Q2 performed at 6 months or at the end of the study included “Convenience” and “Anticoagulant Treatment Satisfaction” (13 and 7 items, respectively) measured by global scores on a 0-to-100 scale. Results A total of 409 patients (49.9% female), aged 65±12.1 years, were consecutively included from November 2012 to August 2013. Most of cancers were solid tumors; 81% of patients received chemotherapy and 60.9% of cancers were metastatic. Mean treatment duration was 5.28 ± 2.07 months and 98.0% of patients were treated for 3 months or more. PACT-Q1 and PACT-Q2 were collected on a voluntarily basis from 269 (67.8%) and 139 (34.0%) patients, respectively. At study start patients’ treatment expectations were high, particularly regarding the confidence in the treatment to prevent blood clots (mean 3.94 ± 0.75), the expectations of symptom relief (mean 3.98 ± 1.04) and the importance of ease of use (mean 4.22 ± 0.9) while 54.3% of patients had low or no expectations of treatment-related side effects (bruise, bleeding) (mean 2.45±1.1). The treatment was considered convenient (global score 79.7 ± 17.1), with the majority of patients reporting small or no difficulties with taking the treatment (subcutaneous injections) and with regards to impact on daily life. The impact of treatment-related side effects on activities was reported as low. A proportion of 69.1% of patients were overall satisfied or very satisfied with their anticoagulant treatment whereas the experience with treatment-related side effects was worse or much worse than expected for only 12.9% of patients. The “Anticoagulant Treatment Satisfaction” global score was 62.9 ± 16.7. Abstract 4272. Table 1: Cancer patient’s perception of long-term anticoagulant treatment with LMWH [n (%)] Selected perception items* Not at all or to a small extent Moderately Very much or extremely Mean score on Likert scale ± SD PACT-Q1 Treatment expectations (n=269) Confident in preventing clots Symptom relief Side effects (n=267) Importance of ease to use - 10 (3.7) 22 (8.2) 145 (54.3) 17 (6.3) - 45 (16.7) 38 (14.1) 76 (28.5) 14 (5.2) - 214 (79.6) 209 (77.7) 46 (17.2) 238 (88.5) - 3.94 ± 0.75 3.98 ± 1.04 2.45 ± 1.1 4.22 ± 0.9 PACT-Q2 Convenience (n=138) Difficulty in taking treatment (n=137) Difficulties regarding daily life Bother in follow-up required Difficulties on regular intake Side effects impact on activities - 92 (67.2) 101 (73.2) 101 (73.2) 114 (82.6) 116 (84.1) - 37 (27) 26 (18.8) 16 (11.6) 17 (12.3) 14 (10.1) - 8 (5.8) 11 (8.0) 7 (5.1) 7 (5.1) 8 (5.8) 79.7 ± 17.1 Treatment satisfaction (n=137) Experience with side effects (n=132) Worse or much worse 17 (12.9) As expected 55 (41.7) Better or much better 60 (45.5) 62.9 ± 16.7 Overall satisfaction (n=136) Unsatisfied or very unsatisfied 10 (7.4) Neutral 32 (23.5) Satisfied or very satisfied 94 (69.1) *Only some items selected from the PACT questionnaire are shown Conclusion Patients with cancer-associated VTE had high expectations regarding anticoagulant treatment and long-term treatment with LMWH is perceived as convenient with a high degree of patient satisfaction. These results suggest that cancer patient’s capability to accept long-term injectable anticoagulant treatment is probably underestimated. These encouraging observations of patient perception of the anticoagulant therapy are essential in view of improving health professional’s adherence to established treatment recommendations on cancer-associated VTE [3]. 1- Farge D, J Thromb Haemost. 2013 Jan;11(1):56-70. 2- Prins MH, Health Qual Life Outcomes, 2009. 7: p. 9. 3- Debourdeau P, Support Care Cancer. 2008 Dec;16(12):1333-41 Disclosures Farge: Pfizer: Research Funding; LEO Pharma: Research Funding. Debourdeau:Pfizer: Research Funding; LEO Pharma: Research Funding. Cajfinger:Pfizer: Research Funding; LEO Pharma: Research Funding.

Introduction Long-term treatment with LMWH is the standard therapy for patients with cancer-associated VTE. Recommended treatment regimen include the prescription of LMWH at treatment doses according to approved administration schedule for at least 3 months in the absence of severe renal insufficiency (CrCl Methods Adult patients with cancer-associated VTE receiving antineoplastic treatment or palliative care were eligible to participate. Efficacy outcomes measures were VTE recurrence including deep-vein thrombosis (DVT) and pulmonary embolism (PE), visceral thrombosis and central venous catheter (CVC)-associated thrombosis. Safety outcomes included all and major bleeding according to ISTH definition [3], thrombocytopenia and deaths. Incidences of 7% of VTE recurrence and 6% of major bleeding were expected. With a sample of 384 patients, the rate of VTE recurrence and major bleeding would be detected with a precision of ±2.6% and ±2.4%, respectively, with a 95% confidence interval. A total of 400 patients were therefore planned to be included in the study. Results A total of 409 patients with symptomatic cancer-associated VTE (Table 1) aged 65±12.1 years of whom 49.9% female were consecutively included from November 2012 to August 2013. A history of previous VTE was found in 54 (13.2%), surgery or trauma in 100 (24.4%), CVC in 303 (74.1%) and an immobilization over 1 month in 47 (11.5%) patients, respectively. At study inclusion, 30 (7.3%) patients had platelet count ≤ 100 x109/L, and 129 (31.5%) had reported anemia while 16 (3.9%) patients had a history of bleeding in the last month. At baseline, more than 80% of patients presented with at least a PE or a lower-limb DVT of s. Table 1 VTE diagnosis at baseline (patients at least with one of the following) VTE diagnosis (at least one of the following) n (%) PE 145 (35.5) DVT lower limb 193 (47.2) Proximal 107 (56.0) Distal 72 (37.7) DVT upper limb 45 (11.0) Visceral thrombosis 16 (3.9) CVC-associated thrombosis 66 (16.1) Mean treatment duration was 5.28 ± 2.07 months. As the majority of patients were treated with tinzaparin (73.6%), clinical outcomes are therefore presented for tinzaparin, other LMWH and all LMWH (Table 2). A total of 21 events of VTE recurrence occurred in 19 patients during the overall study period, with a Kaplan-Meir estimate of the probability of VTE recurrence at 6 months of 6.1%. Table 2 Outcomes in patients with cancer-associated VTE treated with long-term LMWH [n (%)]. Patients treated Tinzaparin n=301 Other LMWH n=108 All LMWH n=409 Patients documented n=292 n=100 n=392 Patients with at least 14 (4.8) 5 (5) 19 (4.8) one VTE recurrence - - - Events (2 patients had 3 4 7 more than one event) 5 1 6 DVT 0 1 1 PE 6 1 7 Visceral thrombosis CVC-associated thrombosis Bleeding n=292 n=100 n=392 All 44 (15.1) 11 (11.0) 55 (14.0) Major 16 (5.5) 7 (7.0) 23 (5.9) Thrombocytopenia n=290 n=100 n=390 (n platelets/mm3) 53 (18.3) 15 (15.0) 68 (17.4) All n=65 n=17 n=82 < 50,000 22 5 27 Drop > 50% 15 2 17 Deaths n=301 n=107 n=408 All 102 (33.9) 44 (41.1) 146 (35.8) Cause of death* n=100 n=44 n=144 LMWH treatment** 1# 0 1## Cancer 87 39 126 Sepsis 4 1 5 Bleeding 4 1 5 Antineoplastic treatment 1 0 1 PE 0 1 1 Other 7 3 10 *Multiple causes of death may have been reported in the same patient; **fatal bleeding reported as LMWH-related; #n=99; ## n=143 Kaplan-Meier estimate of the probability of bleeding at 6 months was 15.9% while corresponding estimates were 18.1% for thrombocytopenia and 34.5% for deaths. Of the five (3.5%) patients who reported fatal bleedings one was reported as related to the LMWH treatment. No heparin-induced thrombocytopenia was reported in the study. Conclusion Clinical outcomes were consistent with previous observations in this patient population except a lower incidence of VTE recurrence compared with previous studies. Study results tend to confirm the favorable efficacy and safety profile of LMWH for the long-term treatment of patients with cancer-associated VTE, when used according to recommended treatment duration and respecting contra-indications. Schulman. J Throm Haemost. 2005 Apr;3(4):692-4.Farge J Thromb Haemost. 2013 Jan;11(1):56-70.Debourdeau P, J Thromb Haemost. 2013 Jan;11(1):71-80 Disclosures Farge: Pfizer: Research Funding; LEO Pharma: Research Funding. Debourdeau:Pfizer: Research Funding; LEO Pharma: Research Funding. Cajfinger:Pfizer: Research Funding; LEO Pharma: Research Funding.

Most cases of advanced carcinoma of the prostate are hormonosensitive. The use of combined androgen blockade (CAB) seems to improve survival and quality of life, but only when combined with chemical castration by luteinizing-hormone-releasing hormone analog and without the use of steroidal antiandrogens. After CAB, further hormonal treatments remain efficacious, such as antiandrogen withdrawal followed by estrogens, aromatase inhibitors, and hormone-refractory prostate cancer multiple cytotoxic agents. For painful bone lesions, external beam radiotherapy, biphosphonates, and strontium 89 or samarium 153 provide pain relief. The use of new methods for the evaluation of response and quality of life will allow the rapid identification of effective treatments and permit powered phase III trials.

1580 Background: Long-term treatment with low-molecular-weight heparin (LMWH) is recommended for treatment of venous thromboembolism (VTE) in cancer patients. Few data are available on compliance in this population. Our study measured whether the management of VTE in patients with cancer was consistent with French recommendations. Methods: Compliance with recommendations (CR+) was analysed according to malignancy and VTE from a 500-patient cross-sectional observational study run between May and October 2010. CR+ was defined as the compliance to initial 10-day treatment followed by long-term LMWH for at least 3 months, avoiding LMWH in patients with renal insufficiency (SRI). All inpatients with a diagnosis of cancer and VTE of less than 6 months were included in the study. Results: Of 500 patients included in 47 centers, 242 (49%) were male, 81 (18%) had local (T+), 83 (18%) had loco-regional (N+) and 287 (64%) had metastatic malignancies. Malignancies were gastro-intestinal (25%), gynaecologic (23%), pulmonary (21%), haematological (14%), urologic (10%) or other (8%). Twelve patients had SRI. Overall, treatment was CR+ in 289/500 patients (58% [95% CI 53%-62%]). Out of 12 patients with SRI only 3 (25%) were treated long-term with vitamin K antagonists (VKA), as usually recommended. Tumour site influenced CR+ (p=0.02). Treatment for haematological malignancy was poorly compliant with recommendations (32%) while patients with lung malignancy had the best compliance (68%). TNM stage and VTE location had no influence on treatment compliance. Conclusions: In French practice, treatment of cancer-related VTE is CR+ in 58% of cases. TNM stage and VTE location do not influence compliance which remains insufficient, especially in patients with haematological malignancy. [Table: see text]

Venous thromboembolism (VTE) is a major therapeutic issue in cancer. Advances in this field and heterogeneities in clinical practices prompted us to establish guidelines related to VTE treatment and to central venous catheter thrombosis (CVCT) management. in cancer patients according to the SOR Standards, Options: Recommendations (SOR) methodology for the development of evidence-based Clinical Practice Guidelines (CPG) as endorsed by the French National Cancer Institute. Methods: After reviewing the published studies on the topics between 1999 and 2007, a first version of the guidelines was based on the levels of evidence derived from analysis of the 38 out of 418 selected studies for VTE treatment and the 40 out of 175 selected studies for the CVCT management. The recommendations were classified as Standards or Options and then peer-reviewed by 65 independent experts. Detailed methodology is available at www.sor-cancer.fr Standards in cancer patients: The treatment of VTE should be based on Low Molecular Weight Heparins (LMWH) at curative doses for at least 3 months. During the initial treatment (up to 10 days), there are no specific requirements and all drugs approved (including LMWH, Unfractionnated Heparin (UFH), fondaparinux and danaparoid) may be used. Beyond the first 10 days, VTE treatment should be based on LMWH at curative doses for at least 3 and optimally for 6 months, as validated with the following drugs and dosage regimens: dalteparin 200 IU/kg once daily for one month, then 150 IU/kg once daily; enoxaparin 150 IU/kg once daily; and tinzaparin 175 IU/kg once daily. In case of: severe renal impairment, UFH should be used rapidly followed by Vitamins K Antaogonist (VKA) for at least 3 months; severe Pulmonary Embolism (hemodynamic failure), the indications and usages of thrombolytic drugs are the same as in non-cancer patients; absolute contra-indication to anticoagulation or VTE recurrence despite optimal anticoagulation, vena cava filters (VCF) should be considered; intracranial malignancies, VTE treatment is the same as in cancer patients with non-intracranial tumors. CVCT treatment relies on long term use of LMWH. In case of severe renal failure, UFH with early AVK must be used. Treatment is to be continued as long as the catheter is maintained. This can only be achieved if the catheter is functional, well positioned, not infected and if adapted anticoagulation has resumed the CVCT. If catheter withdrawal is necessary, there is no standard concerning the anticoagulation management. CVCT prophylaxis relies on positioning the catheter distal extremity at the “superior vena cava - right atrium” junction. Systematic CVCT anticoagulant prophylaxis is not recommended. Options: Treatment of VTE: If LMWH administration for 3 months is impossible, short-term use of LWMH followed by VKA for at least 3 months may be proposed. It is recommended to administer LMWH for 3 to 6 months; LMWH should be used according to the same curative dosage regimen as during the first 3 months. Beyond the first 6 months, the anticoagulant treatment should be continued as long as the cancer is active or treated. In the event of a first VTE episode secondary to a transient risk factor and if the cancer is not active nor treated, anticoagulation may be discontinued after 6 months. The choice between LMWH and VKA depends on their benefit-risk ratio (influenced by drug interactions, chemotherapy, invasive procedures, and general health status) and acceptability. If a VCF is considered, a retrievable VCF may be discussed. CVCT treatment: If another catheter has to be inserted, prior evaluation of the venous circulation by scanner or ultrasound examination is recommended. If prolonged use of LMWH is impossible, VKA can be proposed. In case of severe superior vena cava syndrome, fibrinolytics can be used in the absence of contra-indications. Treatment by LMWH can be stopped 6 weeks after catheter withdrawal in non active cancer or after 3 to 6 months of LMWH followed by VKA in the other cases. CVCT prophylaxis: Right side catheter insertion and vein localisation by ultrasonography are preferred. Conclusion: The French recommendations further support the 2006 Italian and the 2007 North American guidelines on VTE treatment in cancer patients and were extended to the use of VCF and treatment of patients with intracranial malignancies. In addition, we provide recommendations on CVCT treatment in cancer patients.