Real-World Data on Olaparib in Relapsed BRCA-mutated Ovarian Cancer: A Multicenter GINECO RETROLA Cohort Study.

BACKGROUND/AIM: Olaparib was approved in 2014 by the European Medicines Agency (EMA) as maintenance treatment for patients with breast cancer gene (BRCA)-mutated platinum-sensitive relapsed high-grade epithelial ovarian cancer (EOC) following the results of the Study 19. We present the results of a national real-world study on the effectiveness of olaparib in relapsed BRCA-mutated EOC patients. PATIENTS AND METHODS: Patients with EOC, peritoneal, and/or fallopian-tube cancer treated with olaparib in a French Center between May 2014 and March 2017 were included. The primary end-point of the study was progression-free survival. RESULTS: Of the 128 patients analyzed, 89 were treated according to the EMA label. The median progression-free survival was 17.0 months. The most common treatment-related toxicity was fatigue. Treatment-related myelodysplastic syndrome (n=5) and a second cancer (n=1) were diagnosed. CONCLUSION: In this real-life setting, olaparib confirmed its efficacy and safety profile, as previously shown in clinical trials.

First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study.

PURPOSE: Combining bevacizumab with paclitaxel significantly improves progression-free survival (PFS) versus paclitaxel alone in HER2-negative metastatic breast cancer (MBC). Eribulin is active and tolerable in pretreated MBC. To assess whether eribulin may offer a more tolerable yet effective combination partner for bevacizumab, we evaluated a bevacizumab/eribulin combination regimen as first-line therapy for MBC. METHODS: In this single-arm phase II study, patients with histologically confirmed HER2-negative MBC and no prior chemotherapy for MBC received eribulin 1.23 mg/m2 on days 1 and 8 every 3 weeks for ≥6 cycles plus bevacizumab 15 mg/kg on day 1 every 3 weeks until disease progression. The primary endpoint was non-progression rate at 1 year. Secondary endpoints included objective response rate (ORR), PFS, and safety. RESULTS: The median age of the 61 treated female patients was 59 years, 16% had triple-negative MBC, 30% had ≥3 metastatic sites, and 71% had received prior (neo)adjuvant chemotherapy. Patients received a median of six eribulin and nine bevacizumab cycles. The non-progression rate at 1 year was 32% (95% confidence interval [CI]: 20-43%), ORR was 47% (95% CI: 34-60%), and median PFS was 8.3 months (95% CI: 7.0-9.6 months). The only grade ≥3 clinical adverse events in >5% of patients were hypertension (39%), neutropenia (26%), thrombosis (10%), and paresthesia/dysesthesia (7%). CONCLUSION: First-line eribulin/bevacizumab combination therapy showed interesting activity in MBC with an acceptable safety profile, including a particularly low incidence of high-grade neuropathy.

Training with FES-assisted cycling in a subject with spinal cord injury: Psychological, physical and physiological considerations.

CONTEXT: People with spinal cord injury (SCI) experience the effects of a sedentary lifestyle very early on. Literature data suggest that programs using FES-assisted cycling would contribute to reduce the consequences of physical inactivity. The objective was to assess the feasibility of 12-month training on a FES-assisted bike of a subject with paraplegia for 21 years, T3, Asia Impairment Scale (AIS) A. An evaluation of morbidity, self-esteem, satisfaction, quality of life and duration of pedaling was performed. The impact on pain, cardiorespiratory function, body composition and bone metabolism were also assessed. FINDINGS: The acceptability score of the training constraints increased from 51 to 59/65 and satisfaction was high around 8/10. The pedaling duration increased from 1' to 26' on the recumbent bike and from 1' to 15' on open terrain. No significant changes were found with BMD and cardiorespiratory measures during exercise tests. SF 36 showed significant improvement of more than 10% and the Rosenberg Self Esteem score rapidly improved from 36 to 39/40. At the end of the training, the patient reached the objective of the Cybathlon 2016 by covering 750 m in less than 8 minutes, at an average speed of 5.80 km/hr. CONCLUSION/CLINICAL RELEVANCE: A person with high and complete level of SCI for more than 20 years can undertake this type of challenge if the prerequisites are met; this training is without danger if the safety precautions are respected; the challenge of participating in a competition had a powerful impact on JP's self-esteem and perceived quality of life.

Multiple Sclerosis and Clinical Gait Analysis before and after Fampridine: A Systematic Review.

BACKGROUND: Gait impairment is one of the most disabling symptoms in people with multiple sclerosis (PwMS). Fampridine, has demonstrated a positive effect on gait speed in PwMS after 14 days of treatment but the long-term effects have not yet been demonstrated. This study reviews the long-term effects of fampridine on gait in PwMS. SUMMARY: This systematic review was conducted according to the PRISMA statement. Studies were considered long term if treatment exceeded 28 days. From the 498 studies identified, 18 (2,200 patients) fulfilled all eligibility criteria. Only 3 studies followed-up patients for >1 year and one of these showed a non-significant improvement in the gait speed. Key Messages: Fampridine seems to be beneficial at improving gait speed in PwMS in the long term. Further long-term studies are needed on related gait and functional parameters.

Poststroke disposition and associated factors in a population-based study: the Dijon Stroke Registry.

BACKGROUND AND PURPOSE: The organization of poststroke care will be a major challenge in coming years. We aimed to assess hospital disposition after stroke and its associated factors in clinical practice. METHODS: All cases of stroke from 2006 to 2010 were identified from the population-based Stroke Registry of Dijon, France. Demographic features, risk factors, and prestroke treatments were recorded. Admission stroke severity was assessed using the National Institutes of Health Stroke Scale score. At discharge, we collected dementia, disability using the modified Rankin Scale, length of stay, and hospital disposition (home, rehabilitation, convalescent home, and nursing home). Multivariate analyses were performed using logistic regression models to identify associated factors of postdischarge disposition. RESULTS: Of the patients with 1069 stroke included, 913 survived acute care. Among them, 433 (47.4%) returned home, whereas 206 (22.6%) were discharged to rehabilitation, 134 (14.7%) were admitted to a convalescent home, and 140 (15.3%) to a nursing home. Old patients, those under anticoagulants before stroke, those with severe stroke on admission, severe disability at discharge, dementia, or prolonged length of stay were less likely to return home. Moreover, advanced age, severe initial stroke, severe disability at discharge, and dementia were associated with admission to convalescent and nursing homes rather than rehabilitation centers. CONCLUSION: This population-based study demonstrated that postdischarge destinations are associated with several factors. Our findings may be useful to establish health policy concerning the organization of poststroke care.

Emergent EEG in clinical practice.

OBJECTIVE: Emergency situations require a rapid and precise diagnostic approach. However, the exact role and value of the electroencephalogram (EEG) in emergent conditions have yet to be clearly defined. Our objective was to determine why clinicians order an emergency EEG, to assess to what extent it helps establish a correct diagnosis and to evaluate the result it has on subsequent patient management. METHODS: We studied all successive emergency EEGs ordered during a 3-month period in our institution. We analyzed the reasons why each EEG was ordered and interviewed the prescribing clinicians in order to determine the impact the result of the EEG had on the diagnosis and subsequent therapeutic management. RESULTS: We prospectively studied a total of 111 consecutive recordings. The main reasons for ordering an emergent EEG were: suspected cerebral death (21%), non-convulsive status epilepticus (19.7%), subtle status epilepticus (14%) and follow-up of convulsive status epilepticus (11.2%). In 77.5% of the cases the clinicians considered that the EEG contributed to making the diagnosis and that it helped confirm a clinically-suspected diagnosis in 36% of the cases. When subtle status epilepticus (SSE) or non-convulsive status epilepticus (NCSE) was suspected, the diagnosis was confirmed in 45% and 43.3% of the cases, respectively. In 22.2% of the requests involving follow-up of convulsive status epilepticus after initial treatment, the EEG demonstrated persistent status epilepticus. It resulted in a change in patient treatment in 37.8% of all the cases. When the EEG helped establish the diagnosis, patient treatment was subsequently modified in 46.6% of the cases. CONCLUSIONS: This prospective study confirms the value of an emergent EEG in certain specific clinical contexts: the management of convulsive status epilepticus following initial treatment or to rule out subtle status epilepticus. An emergent EEG can also be ordered if one suspects the existence of non-convulsive status epilepticus when a patient presents with mental confusion or altered wakefulness after first looking for the specific signs suggesting this diagnostic hypothesis. SIGNIFICANCE: After 50 years of development and use in daily practice, the EEG remains a dependable, inexpensive and useful diagnostic tool in a number of clearly-defined emergency situations.

Atypical language impairment in two siblings: relationship with electrical status epilepticus during slow wave sleep.

We report the case of a young girl who presented severe learning disabilities in oral and written language related to a continuous spike-waves during slow sleep (CSWS) syndrome. A sleep EEG recording obtained in her younger brother, who presented a clinical pattern suggesting developmental dysphasia, also showed a CSWS syndrome. These two clinical cases underscore the need to look for this syndrome in the siblings of an affected child when learning difficulties appear in a child who previously had normal psychomotor development.

Outcome at adulthood of the continuous spike-waves during slow sleep and Landau-Kleffner syndromes.

PURPOSE: The aim of this study was to determine the clinical, social, and/or professional and cognitive outcomes in adulthood of the continuous spike-waves during slow sleep (CSWS) and Landau-Kleffner syndromes, which are two rare epileptic syndromes occurring in children. METHODS: We enrolled seven young adults, five who had a CSWS syndrome, and two, a Landau-Kleffner syndrome in childhood. We evaluated their intellectual level as well as their oral and written language and executive functions. RESULTS: This study confirmed that the epilepsy associated with these syndromes has a good prognosis. Only one patient still had active epilepsy. However, the neuropsychological disorders particular to each syndrome persisted. Only two patients had followed a normal pathway in school. Three of the five patients with a CSWS syndrome during childhood remained globally and nonselectively mentally deficient. We found no evidence of the persistence of a dysexecutive syndrome in this study group. The intellectual functions of the two patients with Landau-Kleffner syndrome were normal; however, their everyday lives were disrupted by severe, disabling language disturbances. We discuss the role of some prognostic factors such as the location of the interictal electric focus and the age at onset of CSWS. CONCLUSIONS: These two epileptic syndromes of childhood are very similar in many respects, but their clinical outcomes in adulthood are different.