Lenalidomide-dexamethasone versus observation in high-risk smoldering myeloma after 12 years of median follow-up time: A randomized, open-label study.

BACKGROUND: Smoldering multiple myeloma (SMM) is a heterogeneous disease in terms of progression to myeloma (MM), but its standard of care continues to be observation. METHODS: The QuiRedex phase 3 trial initiated in 2007 included 119 high-risk patients with SMM randomized to treatment or observation. Treatment consisted of nine 4-week induction cycles (lenalidomide [Rd], 25 mg on days 1-21 plus dexamethasone, 20 mg on days 1-4 and 12-15), followed by maintenance (R, 10 mg on days 1-21) for up to 2 years. The primary end-point was time to progression (TTP) to myeloma based on per protocol population. Secondary end-points were overall survival (OS), response rate, and safety. An update of the trial after a long-term follow-up is presented here. This trial was registered with ClinicalTrials.gov (NCT00480363). FINDINGS: After a median follow-up time of 12.5 years (range: 10.4-13.6), the median TTP to MM was 2.1 years in the observation arm and 9.5 years in the Rd arm (HR: 0.28, 95% CI: 0.18-0.44, p < 0.0001). The median OS was 8.5 years in the abstention arm and not reached in the Rd group (HR: 0.57, 95% CI: 0.34-0.95, p = 0.032). Patients who progressed received optimized treatments according to the standards of care, and the OS from progression was comparable in both arms (p = 0.96). INTERPRETATION: This analysis confirms that early treatment with Rd for high-risk SMM translates into a sustained benefit in both TTP and OS. FUNDING: Pethema (Spanish Program for the Treatment of Hematologic Diseases), Spain.

An Outsourced Health-enhancing Physical Activity Program for People with Rheumatoid Arthritis: Study of the Maintenance Phase.

OBJECTIVE: To describe changes of health-enhancing physical activity (HEPA), health perception, and functioning during the second year of a 2-year support program, determine aspects of adherence and response, and describe perceptions of the program. METHODS: Out of 220 individuals with rheumatoid arthritis (RA), 177 participated in the followup. Group support, strength training, and moderate-intensity aerobic activity were encouraged. Data collection included HEPA, perceived health, functioning, and perceptions of the program. Participants with unchanged/improved general health perception and at least 2 of aerobic capacity, grip strength, or timed standing were considered responders. RESULTS: Current and maintained HEPA decreased from 82% to 75% (p = 0.0141) and from 41% to 27% (p < 0.0001) during the second year. Minor declines in quality of life and activity limitation occurred (p = 0.0395 and 0.0038, respectively), while outcome expectations for benefits of physical activity increased (p = 0.0010 and 0.0186) and waist circumference tapered off (p = 0.0070). Strength training was performed on average 41 and 35 times among responders (n = 54) and nonresponders (n = 105), respectively (p = 0.2708); HEPA 194 and 171 days, respectively (p = 0.0828); and support group meetings 12 and 10 times, respectively (p = 0.0943). Strength training, aerobic activity, and short text message reminders were perceived as most valuable; step registration and the self-monitoring walk tests were less appreciated. CONCLUSION: About one-fourth of the originally sedentary individuals with RA sustained their new HEPA behaviors after 2 years and most improvements of health and functioning were sustained. Structured use of behavior change techniques and a second year to support maintenance with a reduced program might help patients with RA to sustain HEPA behavior.

Seasonal Influence on the Risk of Relapse at a Rise of Antineutrophil Cytoplasmic Antibodies in Vasculitis Patients with Renal Involvement.

OBJECTIVE: The objective of this study was to identify risk factors for a relapse at the time of an increase in antineutrophil cytoplasmic antibodies (ANCA) in patients with renal ANCA-associated vasculitis (AAV). METHODS: All patients between January 2000 and November 2011 with renal AAV having an ANCA rise during remission were included. Differences in time to relapse since the ANCA rise were assessed using a Cox regression model. The level of 25-hydroxy Vitamin D (25(OH)D) was assessed at the ANCA rise and at a subsequent relapse or time-matched during remission. RESULTS: Sixty patients had an ANCA rise, of whom 36 patients relapsed. Three risk factors were associated with a relapse at the time of the ANCA increase: previous disease activity not treated with cyclophosphamide or rituximab (HR 3.48, 95% CI 1.60-7.59), an ANCA rise during the fall season (HR 4.37, 95% CI 1.60-11.90), and an extended ANCA rise (HR 3.57, 95% CI 1.50-8.48). Levels of 25(OH)D significantly decreased during followup in relapsing patients, but not in patients who remained in remission (difference -6.3 ± 14.4, p = 0.017 vs 2.7 ± 16.3, p = 0.430). CONCLUSION: ANCA rises occurring during the fall season are more frequently followed by a relapse than ANCA rises occurring during other seasons. Although it is tempting to speculate that decreasing Vitamin D levels following the ANCA rise can be held responsible for the subsequent relapse, this remains to be determined.

One year after mild injury: comparison of health status and quality of life between patients with whiplash versus other injuries.

OBJECTIVE: To compare health status, effect on family, occupational consequences, and quality of life (QOL) 1 year after an accident between patients with whiplash versus other mild injuries, and to explore the relationship between initial injury (whiplash vs other) and QOL. METHODS: This was a prospective cohort study. The study used data from the ESPARR cohort (a representative cohort of road accident victims) and included 173 individuals with "pure" whiplash and 207 with other mild injuries. QOL at 1-year followup was assessed on the World Health Organization Quality of Life questionnaire. Correlations between explanatory variables and QOL were explored by Poisson regression to provide adjusted relative risks, with ANOVA for the various QOL scores explored. RESULTS: One year post-accident, more patients who had whiplash than other casualties complained of nonrecovery of health status (56% vs 43%) and of the occupational effect of pain (31% vs 23%). QOL and posttraumatic stress disorder (PTSD) were similar in the 2 groups. Impaired QOL did not correlate with whiplash when models were adjusted on sociodemographic variables and history of psychological distress. Whatever the initial lesion, PTSD was a determining factor for poorer QOL. CONCLUSION: Sociodemographic factors, preaccident psychological history prior to the accident, and PTSD were the main factors influencing QOL, rather than whether the injury was whiplash. PTSD may also be related to pain.

Cinco años de tratamiento de niños y adolescentes con trastorno obsesivo compulsivo en el Hospital de la Misericordia en la ciudad de Bogotá / Five years of treating children and adolescents suffering obsessive compulsive disorder in the Misericordia Hospital in Bogota

Antecedentes. se encuentran algunos vacíos en las diferentes revisiones científicas respecto al análisis de diversas variables en el trastorno obsesivo compulsivo en niños y adolescentes. Objetivo. describir respuestas a preguntas planteadas por los autores en relación a factores sociodemográficos, interferencias, comorbilidades, curso, seguimiento y tratamiento. Material y métodos. Estudio Descriptivo observacional y retrospectivo; realizado en el servicio de la psiquiatría infantil de consulta externa de la Fundación Hospital la Misericordia, a menores de 18 años que presentaron diagnóstico de trastorno obsesivo compulsivo entre enero del 2006 a diciembre del 2010, con revisión de 88 historias clínicas. Resultados. Los factores sociodemográficos presentaron predominio en género masculino, promedio de edad once años, Comorbilidades se presentaron tanto médicas en un 52%, como psiquiátricas 92%. Interferencias: Se presentó mayor interferencia asociada en colegio y vida social en un 28%, además de mayor dificultad en tener amigos en un 65%. Seguimiento, curso y tratamiento: seguimiento en lapso mayor de un año se presentó en el 34% de los sujetos; con reporte de mejoría en la última consulta realizada del 53%; cuyo principal síntoma en mejorar fue la ansiedad en la totalidad de pacientes en un 69%; con tratamiento farmacológico en el 86% de los 88 sujetos evaluados. Conclusión. Es llamativo en el curso de la enfermedad la presencia como uno de los ejes cardinales de comorbilidades tanto como causa de solicitud de atención médica, como en su curso y pronóstico, seguido por la presencia de interferencia en el paciente que en la mayoría de ocasiones no es evidenciado por los padres razón que probablemente explicaría la demora en el diagnóstico de esta patología.

Background. The present study describes gaps in scientific reviews regarding obsessive compulsive disorder (OCD) in children and adolescents concerning. questions raised about sociodemographic factors, interference, comorbidity, ongoing monitoring and treatment. Methods. This retrospective, observationaldescriptive study was carried out in the Misericordia Hospital's child psychiatry service's outpatient clinic; it involved reviewing 88 medical records for children aged less than 18 who had been diagnosed as suffering from OCD between January 2006 and December 2010. Results. The sociodemographic factors revealed male predominance, average age being eleven years old. There was 52% medical and 92% psychiatric comorbidity. Greater emotional interference occurred regarding school and social life (28%) and greater difficulty in having/keeping friends (65%). The study revealed that 34% of the subjects had been followedup for longer than one year, improvement in 53% of the cases having been reported by the time of the last consultation. Anxiety was the main symptom reported to have become improved in all patients (69%), 86% of the 88 subjects' records evaluated having shown that they had received pharmacological management. Conclusion. The presence of comorbidity was striking in the course of the disease; it was the cause of medical care having been sought (during its course and prognosis) and patients' emotional interference which was usually not noted by their parents. This would probably explain the delay in diagnosing this disorder.

An Effective Followup Protocol of Renal Cell Carcinoma after Radical Nephrectomy Based on Pathological Stage / 대한비뇨기과학회지

There is little information about which laboratory and imaging study and when should be taken to assess patients after nephrectomy of renal cell carcinoma. Commonly ordered tests during the postoperative followup include serum liver function studies, chest X-ray, and abdominal pelvic computerized tomography, Less commonly used test include bone scans and chest computerized tomography. To define better which patients require more intensive followup, we retrospectively reviewed 52 patients who underwent radical nephrectomy with a final pathological diagnosis of renal cell carcinoma. Of the patients 8 were excluded for node positive or extension to an adjacent organ. Among the remaining 44 patients, localized disease 15 cases with stage TlN0M0 recurred null, 16 cases with stage T2N0M0 recurred in 12.5%, 9 cases with T3aN0M0 and 4 cases with T3bN0M0 recurred in 55.6% and 100% respectively. The average interval to recur was 22 months for patients with stage T2 tumor and 16.8 months with stage T3a, and 5.7 months for those with stage T3b disease. Based on our data, followup studies should be done appropriately and cost effectively according to the pathological stage of disease.