Peripheral T-cell lymphomas (PTCL) are a heterogeneous group of rare lymphoid malignancies that mostly have poor prognoses with currently available treatments. Upfront consolidation with autologous stem cell transplantation (ASCT) is frequently carried out, but its efficacy has never been investigated in randomized trials. We designed a multicenter, international, retrospective study with the main objective of comparing progression-free survival and overall survival of patients with PTCL who underwent ASCT in complete remission (CR) after first-line chemotherapy with a control group who did not undergo ASCT. From the initial population of 286 registered patients, 174 patients with PTCL other than anaplastic large cell lymphoma, ALK-positive, deemed fit for ASCT at the time of diagnosis, and who were in CR or uncertain CR after induction therapy (CR1) were included in our analysis. one hundred and three patients underwent ASCT, whereas 71 did not, in most cases (n=53) because the physician decided against it. With a median follow-up of 65.5 months, progression-free survival was significantly better in the transplanted patients than in the non-transplanted group: 63% versus 48% at 5 years (P=0.042). Overall survival was significantly longer for ASCT patients in the subgroup with advanced stage at diagnosis (5-year overall survival: 70% vs. 50%, P=0.028). In the multivariate analysis, first-line ASCT was associated with significantly prolonged progression-free survival (HR=0.57, 95% CI: 0.35-0.93) and overall survival (HR=0.57, 95% CI: 0.33-0.99). In conclusion, our study supports the use of ASCT as a consolidation strategy for patients with PTCL in CR1. These results should be confirmed in a prospective randomized study.
Objectives To (1) create a single metric of disability using Rasch modelling to be used for comparing disability severity levels across groups and countries, (2) test whether the interval-level measures were invariant across countries, sociodemographic and health variables and (3) examine the gains in precision using interval-level measures relative to ordinal scores when discriminating between groups known to differ in disability. Design Cross-sectional, population-based study. Setting/participants Data were drawn from the Survey of Health, Ageing and Retirement in Europe (SHARE), including comparable data across 16 countries and involving 58 489 community-dwelling adults aged 50+. Main outcome measures A single metric of disability composed of self-care and instrumental activities of daily living (IADLs) and functional limitations. We examined the construct validity through the fit to the Rasch model and the know-groups method. Reliability was examined using person separation reliability. Results The single metric fulfilled the requirements of a strong hierarchical scale; was able to separate persons with different levels of disability; demonstrated invariance of the item hierarchy across countries; and was unbiased by age, gender and different health conditions. However, we found a blurred hierarchy of ADL and IADL tasks. Rasch-based measures yielded gains in relative precision (11–116%) in discriminating between groups with different medical conditions. Conclusions Equal-interval measures, with person-invariance and item-invariance properties, provide epidemiologists and researchers with the opportunity to gain better insight into the hierarchical structure of functional disability, and yield more reliable and accurate estimates of disability across groups and countries. Interval-level measures of disability allow parametric statistical analysis to confidently examine the relationship between disability and continuous measures so frequent in health sciences (eg, cholesterol, blood pressure, C reactive protein).
Although case-control analyses have suggested an additive value with the association of clarithromycin to continuous lenalidomide and dexamethasone (Rd), there are not phase III trials confirming these results. In this phase III trial, 286 patients with MM ineligible for ASCT received Rd with or without clarithromycin until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). With a median follow-up of 19 months (range, 0–54), no significant differences in the median PFS were observed between the two arms (C-Rd 23 months, Rd 29 months; HR 0.783, p = 0.14), despite a higher rate of complete response (CR) or better in the C-Rd group (22.6% vs 14.4%, p = 0.048). The most common G3–4 adverse events were neutropenia [12% vs 19%] and infections [30% vs 25%], similar between the two arms; however, the percentage of toxic deaths was higher in the C-Rd group (36/50 [72%] vs 22/40 [55%], p = 0.09). The addition of clarithromycin to Rd in untreated transplant ineligible MM patients does not improve PFS despite increasing the ≥CR rate due to the higher number of toxic deaths in the C-Rd arm. Side effects related to overexposure to steroids due to its delayed clearance induced by clarithromycin in this elderly population could explain these results. The trial was registered in clinicaltrials.gov with the name GEM-CLARIDEX: Ld vs BiRd and with the following identifier NCT02575144. The full trial protocol can be accessed from ClinicalTrials.gov. This study received financial support from BMS/Celgene.
1 June 2018 in Journal of Pain and Symptom Management
The aim of this study was to translate and adapt the physical activity and leisure motivation scale (PALMS) into Spanish, and to analyse its validity and reliability. The sample comprised 867 adolescents, with a mean age of 14.04 ± 1.19 years, 53.9% of whom were male. During the translation process, some of the items in the instrument were modified slightly, improving its comprehensibility. On the other hand, the exploratory factor analysis did not present an adequate factor structure, so a more in-depth analysis was carried out, using item response theory and confirmatory factor analysis; the conclusion was that it would be appropriate to eliminate several items from the scale. From this, a final shortened version, consisting of 25 items, was produced, with adequate fit indices—CFI = 0.933, TLI = 0.918, SRMR = 0.042, RMSEA = 0.052 (90% CI 0.048; 0.056)—and good reliability for each of the dimensions, ranging from 0.625 to 0.835. It can be concluded that the abbreviated version of the PALMS instrument, adapted for Spanish adolescents (PALMS-e), is a valid and reliable instrument for assessing their motives for doing physical activity.