AMAFRICA, a patient-navigator program for accompanying lymphoma patients during chemotherapy in Ivory Coast: a prospective randomized study.

BACKGROUND: Previous studies have indicated that accompanying socially underserved cancer patients through Patient Navigator (PN) or PN-derived procedures improves therapy management and reassurance. At the Cancer Institute of Toulouse-Oncopole (France), we have implemented AMA (Ambulatory Medical Assistance), a PN-based procedure adapted for malignant lymphoma (ML) patients under therapy. We found that AMA improves adherence to chemotherapy and safety. In low-middle income countries (LMIC), refusal and abandonment were documented as major adverse factors for cancer therapy. We reasoned that AMA could improve clinical management of ML patients in LMIC. METHODS: This study was set up in the Abidjan University Medical Center (Ivory Coast) in collaboration with Toulouse. One hundred African patients were randomly assigned to either an AMA or control group. Main criteria of judgment were refusal and abandonment of CHOP or ABVD chemotherapy. RESULTS: We found that AMA was feasible and had significant impact on refusal and abandonment. However, only one third of patients completed their therapy in both groups. No differences were noted in terms of complete response rate (CR) (16% based on intent-to-treat) and median overall survival (OS) (6 months). The main reason for refusal and abandonment was limitation of financial resources. CONCLUSION: Altogether, this study showed that PN may reduce refusal and abandonment of treatment. However, due to insufficient health care coverage, its ultimate impact on OS remains limited.

Fear of cancer recurrence in Non- and Hodgkin lymphoma survivors during their first three years of survivorship among French patients.

The aim of this study was to measure the prevalence of FCR among a sample of French lymphoma survivors and to determine factors associated with clinical levels of FCR. The study was conducted with two cross-sectional measures: sociodemographic and anxiety, depression as well as health-related quality of life (HRQoL) scores were measured at the baseline of the post-cancer period and FCR was evaluated during the first 3 years of survivorship. The prevalence of clinical levels of FCR (≥13) was evaluated by the Fear of Cancer Recurrence Inventory - Short Form (FCRI-SF) among non- and Hodgkin lymphoma survivors undergoing prior first-line chemotherapy. Among 108 lymphoma survivors with an average follow-up of 1.6 years (range 0.3-3.0 years), clinical levels of FCR (≥13) were observed for 44.4% (n = 48). Multivariate analysis indicated that baseline anxiety and low quality of life were related to clinically significant FCR levels.

The care center influences the management of lymphoma patients in a universal health care system: an observational cohort study.

BACKGROUND: Healthcare providers-related disparities in adherence to the treatment plan among lymphoma patients are found even in a universal healthcare system, but the mechanism remains unclear. We investigated the association between the type of care center and the relative dose intensity and determined whether it persists after adjustment for patients' recruitment differences. METHODS: Prospective observational cohort study of 294 patients treated with standard protocols for diffuse large B-cell lymphoma (DLBCL) in teaching or community public hospitals or in private centers in the French Midi-Pyrénées region from 2006-2013. To test our assumptions, we used multinomial and mixed-effect logistic models progressively adjusted for patients' biomedical characteristics, socio-spatial characteristics and treatment-related toxicity events. RESULTS: Patients treated using standard protocols in the teaching hospital had more advanced stage and poorer initial prognosis without limitation regarding the distance from the residence to the care center. Patients' recruitment profile across the different types of care center failed to explain the difference in relative dose intensity. Low relative dose intensity was less often observed in teaching hospital than elsewhere. CONCLUSION: We showed that even in a universal healthcare system, disparities in the management of DLBCL patients' do exist according to the types of care center. A main issue may be to find and diffuse the reasons of this benefit in cancer management in the teaching hospital to the other centers.

Peripheral arterial occlusive disease during ponatinib therapy after failure of imatinib: a case report.

WHAT IS KNOWN AND OBJECTIVE: Peripheral vascular adverse events have been reported with ponatinib treatment in chronic myeloid leukaemia (CML) after failure of dasatinib or nilotinib. We here report peripheral arterial occlusive disease (PAOD) in a patient who had previously received only imatinib as tyrosine kinase inhibitor. CASE DESCRIPTION: The patient was a 70-year-old man with no history of cardiovascular disease. He developed arterial hypertension 5 months after the initiation of ponatinib and PAOD 41 months later. WHAT IS NEW AND CONCLUSION: Peripheral arterial occlusive disease can occur several years after the initiation of ponatinib in patients who had previously received only imatinib. Long-term surveillance is required for preventing the complications of ponatinib-associated PAOD.

Cardiovascular risk profile of patients with peripheral arterial occlusive disease during nilotinib therapy.

BACKGROUND: Over the past few years, data have suggested that severe peripheral arterial occlusive disease (PAOD) is associated with nilotinib exposure. However, the characteristics of this adverse drug reaction are poorly described since its frequency is low. As far as we know, no study using a spontaneous adverse drug reactions reporting system was performed to describe the characteristics of cases of PAOD related to nilotinib. OBJECTIVE: We performed a study to describe the cardiovascular risk profile of cases of PAOD in patients treated with nilotinib spontaneously reported to the French Pharmacovigilance Database (FPVD). PATIENTS/METHODS: We selected all cases of "vascular disorders," as the System Organ Class in MedDRA®, in which nilotinib was "suspected" and recorded in the French Pharmacovigilance Database between 2007 and 21 October 2014. We then identified cases of PAOD with a Low Level Term and through a detailed summary of the clinical description. RESULTS: We identified 25 cases of POAD. Most of the patients were older than 60 years (84 %) or had another cardiovascular risk factor such as hypercholesterolemia, arterial hypertension, overweight/obesity, smoking, or diabetes mellitus (72 %). Females (13 cases) and males (12 cases) were equally represented, but the presence of cardiovascular risk factors was more frequent in females than in males. The mean time from initiation of nilotinib to PAOD onset was 24 months and was significantly longer in patients aged less than 60 years compared with those aged over 60 years (33.8 ± 24.6 months vs. 22.6 ± 17.5 months, p = 0.002). Pre-existing cardiovascular risk factors, especially diabetes mellitus, also seem to accelerate its occurrence. CONCLUSIONS: The FPVD is a useful tool in describing the cardiovascular risk profile of patients with PAOD during nilotinib exposure. Physicians have to be particularly vigilant in patients older than 60 years of age; in patients younger than 60 years of age, long-term surveillance has to be maintained.

Pharmacology of levosimendan: inotropic, vasodilatory and cardioprotective effects.

WHAT IS KNOWN AND OBJECTIVE: Positive inotropic agents are frequently used in acute decompensated heart failure (ADHF) due to left ventricular systolic dysfunction. These agents are known to improve cardiac performance and peripheral perfusion in the short-term treatment. However, several preclinical and clinical studies emphasized detrimental effects of these drugs on myocardial oxygen demand and on sympathetic tone entailing arrhythmogenesis. Levosimendan is an inotropic agent with an original mechanism of action. This review focuses on major data available for levosimendan. METHODS: A literature search was conducted in the PubMed database by including studies published in English using combinations of the following key words, levosimendan, inotropic drugs and acute heart failure. Furthermore, bibliographies of selected references were also evaluated for relevant articles. The collection for this review was limited to the most recently available human and animal data. RESULTS AND DISCUSSION: Levosimendan's vasodilatory and cardioprotective effects are mediated by calcium sensitization of contractile proteins and opening of adenosine triphosphate (ATP)-dependent K+ channels in vascular smooth muscle cells and on mitochondrial ATP-sensitive potassium [mito.K(ATP)] channels. This inotropic agent has mild PDE inhibitory action. Unlike other inotropic agents, levosimendan improves cardiac performance without activating the sympathetic nervous system. Moreover, there are evidences that levosimendan has additional anti-inflammatory and anti-apoptotic properties that prevent cardiac toxicity and contributes to positive hemodynamic response of the drug. Four randomized trials evaluated the effects of levosimendan on mortality in patients with acute decompensated chronic heart failure; nevertheless, a clear benefit has not been demonstrated so far. Although levosimendan is indicated for the treatment of ADHF (class of recommendation IIa, level of evidence B), it is has not been approved in all countries. WHAT IS NEW AND CONCLUSION: This review summarizes the characteristics and the current knowledge of the literature on levosimendan and its active metabolite OR-1896.