Stable hemoglobin in hemodialysis patients: forest for the trees--a 12-week pilot observational study.

BACKGROUND: Hemoglobin (Hb) variability is a common occurrence in hemodialysis patients treated with erythropoiesis-stimulating agents. High amplitude fluctuations have been associated with greater risk of morbidity and mortality. METHODS: This prospective, single centre pilot observational study was conducted over a 3-month period in daily practice patterns, to assess per-dialysis events and inter-dialysis complications that could interfere with erythropoiesis in patients undergoing hemodialysis. RESULTS: Mean Hb levels remained stable in the 78 evaluable patients, as did darbepoetin alfa (DA) doses, including in patients suffering from diabetes or cardiac affections. In total, an average of 7.7 events / patient / month occurred, but no significant relationship with Hb excursions was shown. CONCLUSION: The observation of 7.7 events per patient per month suggests a careful monitoring of Hb and DA dosing every other week, in order to maintain Hb level within the target.

A Real-World Study of Patients with Advanced Non-squamous Non-small Cell Lung Cancer with EGFR Exon 20 Insertion: Clinical Characteristics and Outcomes.

BACKGROUND: In Europe, few data regarding the characteristics of EGFR exon 20 insertion (20ins) mutations in non-small cell lung cancer (NSCLC) are available. OBJECTIVE: Using a large real-world cohort, we assessed the incidence, characteristics, and outcomes of patients with non-squamous (nsq) NSCLC harboring EGFR exon 20ins. PATIENTS AND METHODS: The Epidemio-Strategy and Medical Economics advanced and metastatic lung cancer data platform including advanced/metastatic nsqNSCLC patients from January 2015 was analyzed (cut-off date: June 30, 2020). Characteristics, epidermal growth factor receptor (EGFR) mutation and other mutations, treatment patterns, and clinical outcomes were assessed for patients harboring EGFR exon 20ins, common EGFR mutations, other EGFR mutations, and wild-type EGFR. Survival parameters were estimated by the Kaplan-Meier method in these four groups. RESULTS: Out of 9435 nsqNSCLC patients tested for EGFR, 1549 (16.4%) had a mutation, including 61 with EGFR exon 20ins (3.9% of all mutated EGFR). These 61 patients had a mean age of 63.6 years, were mostly female (68.9%) and non-smokers (55.7%), with de novo stage IV disease (73.8%) and performance status 0-1 (76.9%). Almost all patients (95.1%) with exon 20ins received systemic therapy (median, three lines). First-line systemic treatments consisted mainly of combination chemotherapy (70.7%), single-agent EGFR tyrosine kinase inhibitors (10.3%), and single-agent immunotherapy (5.2%). After a median follow-up of 25.0 (95% confidence interval [CI] 22.3-32.4) months, the median real-world overall survival was 24.3 (19.1-32.6) months in patients with exon 20ins compared to 35.4 (95% CI 32.6-37.5) in patients with common EGFR mutation (n = 1049) (p = 0.049) and 19.6 (95% CI 18.6-20.5) in patients with wild-type EGFR (n = 7866) (p = 0.2). CONCLUSIONS: This large national study in nsqNSCLC patients confirms that EGFR exon 20ins is a rare condition (0.6%). The prognosis associated with exon 20ins appears to be in line with that of wild-type EGFR, but worse than common EGFR mutations, highlighting the need for advancements for this rare population.

Real-world Evaluation of Oral Vinorelbine in the Treatment of Metastatic Breast Cancer: An ESME-MBC Study.

BACKGROUND/AIM: Vinorelbine is indicated for use in the treatment of MBC as a single agent or in combination but there is little real world data on this molecule and even less on its oral form. We exploited the Unicancer Epidemiology Strategy Medical-Economics (ESME) metastatic breast cancer (MBC) database to investigate current patterns of use of oral vinorelbine (OV), as well as outcomes of patients receiving this drug. PATIENTS AND METHODS: Data were collected retrospectively from women and men treated for MBC between 2008 and 2014 at one of 18 French Comprehensive Cancer Centres. The efficacy of OV was evaluated in terms of progression-free (PFS) and overall survival (OS) and treatment duration. The population and patterns of OV usage were also described. RESULTS: A total of 1806 patients (11% of the ESME MBC database) were included in this analysis. OV was prescribed as monotherapy (46%) or in combination (29%), especially with capecitabine. mainly in later treatment lines. Median PFS was 3.3 months: 2.9 months for single agent, 3.6 months for combination therapy. Median OS was 40.9 months. CONCLUSION: Real-world data offer complementary results to the data from traditional clinical trials, but they concern a much larger population. In this ESME MBC cohort, OV was only prescribed to a small subset of MBC patients. OV was mainly given as single agent to patients with heavily pre-treated MBC; less commonly, it was co-administered with capecitabine or anti-HER2, in earlier lines of therapy. PFS was modest but in line with previous reports.

Efficacy of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury for Preventing Post-concussional Syndrome in Individuals With High Risk of Poor Prognosis: A Randomized Clinical Trial.

Unfavorable outcomes (UO) occur in 15-20% of patients with mild traumatic brain injury (mTBI). Early identification of patients at risk of UO is crucial for suitable management to be initiated, increasing the chances of full recovery. We previously developed a prognostic tool for early identification (8-21 days after the injury) of patients likely to develop UO. Patients whose initial risk factors indicate UO are at risk of developing post-concussion syndrome (PCS). In the present study, we examined the beneficial effects of early multidimensional management (MM) on prognosis. We used our prognostic tool to classify 221 mTBI patients into a UO (97) group or a favorable outcome (FO) group (124). We randomized the UO patients into two subgroups: a group that underwent MM (involving psychoeducation and cognitive rehabilitation) (34) and a control group with no specific treatment other than psychoeducation (46). At 6 months, these two groups were compared to assess the impact of MM. Among the followed-up patients initially classified as having FO (101), 95% had FO at 6 months and only five had PCS [as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV classification]. Among the followed-up MM patients, 94% did not have PCS 6 months after injury, whereas 52% of the control patients had PCS. The effect of MM on the recovery of patients at 6 months, once adjusted for the main confounding factors, was significant (p < 0.001). These results show that the initiation of MM after early identification of at-risk mTBI patients can considerably improve their outcomes. Clinical Trials Registration: The study was registered at ClinicalTrials.gov (NCT03811626).

Implication Of Character Traits In Adherence To Treatment In People With Gout: A Reason For Considering Nonadherence As A Syndrome.

OBJECTIVE: Various aspects of nonadherence to therapy (including medication and lifestyle nonadherence) often appear together. Here we report the association between treatment adherence in gout and the two character traits of patience and obedience, which may explain this observation. METHODS: Data were collected from a cross-sectional study conducted in a French cohort of 1441 adult patients. Patience was assessed using the choice between receiving €1500 in 1 year or €500 immediately. Obedience was evaluated with a single question assessing the use of the seatbelt in the rear seat of a car. Adherence to recommendations for medication, beverage, food and physical activity and smoking status was assessed using self-report questionnaires. RESULTS: Patience and obedience were strong determinants of adherence to medication in multivariate analysis (OR 2.056, 95% CI [1.414-2.989], P< 0.001; OR 1.844, 95% CI [1.273-2.671], P=0.001). In univariate analysis, adherence to medication was also associated with compliance with dietary directives (P<0.001), lower alcohol consumption on an ordinary day (P< 0.001), never consuming soda (P<0.001) or beer (P<0.001), practice of physical activity (P=0.002), being a nonsmoker (P<0.001) and monitoring serum levels of uric acid regularly (P=0.011). Multiple-correspondence analysis illustrated the associations of these different aspects of adherence (medication, diet and exercise, smoking status and monitoring of disease control) with patience and obedience. Finally, we observed a link between patience and obedience (P< 0.001). CONCLUSION: Character traits, which shape preferences, may cause the clustering of different aspects of nonadherence in the form of a syndrome, elucidating the still enigmatic link between nonadherence to placebo and mortality in randomised clinical trials. This concept may also explain, at least in part, the difficulty of improving adherence to long-term therapies and may lead to ethical issues.

Self-perceived health status of patients with adrenal insufficiency receiving glucocorticoid replacement therapy - French data from a worldwide patient survey.

An international survey was undertaken to investigate current practices in glucocorticoid replacement therapy and self-perceived health status of patients with adrenal insufficiency, using a 39-item questionnaire. Results were published in 2012. We analyzed data from French patients, extracted from the database. Participants were recruited via a patient advocacy group to respond anonymously to a questionnaire developed by clinical experts. Ninety-four patients participated (primary adrenal insufficiency 79% and secondary adrenal insufficiency 16%). They were treated mainly with hydrocortisone (97.5%). Dosing regimens were once daily (8%), twice daily (38%), thrice daily (30%) or other (24%). Nearly 80% of the participants considered their affection to have an impact on their physical activity, work, family or social life and 38% reported absence from work/school in the last 3 months. Fatigue in the morning or during the day was a problem for 57% and 69% of respondents respectively. Eighty percent were concerned about long-term side effects of therapy, mainly osteoporosis (79%), fatigue (57%) and obesity (43%). Despite obvious biases in the survey, we should be alerted by the high number of patients' complaints and the clear signs of quality of life impairment in this population, and think about strategies to improve their management.