At time of diagnosis, less than 10% of patients with pancreatic adenocarcinomas (PDAC) are considered to be immediately operable (i.e. resectable). Considering their poor overall survival (OS), only tumours without vascular invasion (NCCN 2017) should be considered for resection, i.e. those for which resection with disease-free margins (R0) is theoretically possible in absence of presurgery treatment. With regard to high R1 rates and undetectable locoregional and/or metastatic spreading prior to surgery explain (at least in part) the observed 1-year relapse and mortality rates of 50 and 25%, respectively. Today, upfront surgery followed by adjuvant chemotherapy is the reference treatment in Europe. The main limitation of the adjuvant approach is the low rate of completion of the full therapeutic sequence. Indeed, only 47 to 60% patients received any adjuvant therapy after resection compared to more than 75% for neoadjuvant therapy. No previous prospective study has compared this approach to a neoadjuvant FOLFIRINOX or FOLFOX chemotherapy for resectable PDAC. PANACHE01-PRODIGE48 is a prospective multicentre controlled randomized non comparative Phase II trial, evaluating the safety and efficacy of two regimens of neo-adjuvant chemotherapy (4 cycles of mFOLFIRINOX or FOLFOX) relative to the current reference treatment (surgery and then adjuvant chemotherapy) in patients with resectable PDAC. The main co-primary endpoints are OS rate at 12 months and the rate of patients undergoing the full therapeutic sequence. The “ideal” cancer treatment for resectable PDAC would have the following characteristics: administration to the highest possible proportion of patients, ability to identify fast-progressing patients (i.e. poor candidates for surgery), a low rate of R1 resections (through optimisation of local disease control), and an acceptable toxicity profile. The neoadjuvant approach may meet all these criteria. With respect to published data on the efficacy of FOLFOX and mFOLFIRINOX, these two regimens are potential candidates for neoadjuvant use in the aim to optimising oncological outcomes in resectable PDAC. ClinicalTrials.gov , NCT02959879 . Trial registration date: November 9, 2016.
28 February 2013 in Multiple Sclerosis International
While the physical disability aspect of multiple sclerosis (MS) is of great importance, quality of life (QoL) measurements are being considered increasingly important with regard to evaluating disease progression, treatment, and the management of care provided to MS patients. Despite the acknowledged need to consider QoL issues, QoL assessment remains underutilized in clinical practice. These issues should be explored and understood to promote the use of measuring QoL in MS clinical practice. We explore the difficulties for clinicians: choosing and determining the most appropriate QoL measure and how to best integrate QoL measurements into clinical practice. This paper discusses several avenues to provide to clinicians arguments of the clinical relevance and accuracy of QoL instruments and ultimately to enhance the use of QoL measures in clinical practice for MS patients.
Background: The Scale to Assess Unawareness in Mental Disorder (SUMD) is widely used in clinical trials and epidemiological studies but more rarely in clinical practice because of its length (74 items). In clinical practice, it is necessary to provide shorter instruments. The aim of this study was to investigate the validity and reliability of the abbreviated version of the SUMD. Methods: Design: We used data from four cross-sectional studies conducted in several psychiatric hospitals in France. Inclusion criteria: a diagnosis of schizophrenia based on DSM-IV criteria. Data collection: socio-demographic and clinical data (including duration of illness, Positive and Negative Syndrome Scale, and the Calgary Depression Scale); quality of life; SUMD. Statistical analysis: confirmatory factor analyses, item-dimension correlations, Cronbach’s alpha coefficients, Rasch statistics, relationships between the SUMD and other parameters. We tested two different scoring models and considered the response ‘not applicable’ as ‘0’ or as missing data. Results: Five hundred and thirty-one patients participated in this study. The 3-factor structure of the SUMD (awareness of the disease, consequences and need for treatment; awareness of positive symptoms; and awareness of negative symptoms) was confirmed using LISREL confirmatory factor analysis for the two models. Internal item consistency and reliability were satisfactory for all dimensions. External validity testing revealed that dimension scores correlated significantly with all PANSS scores, especially with the G12 item (lack of judgement and awareness). Significant associations with age, disease duration, education level, and living arrangements showed good discriminant validity. Conclusion: The abbreviated version of the SUMD appears to be a valid and reliable instrument for measuring insight in patients with schizophrenia and may be used by clinicians to accurately assess insight in clinical settings.