RESUMEN
Physical exercise both during and after curative cancer treatment has been shown to reduce side effects. Evidence in the metastatic cancer setting is scarce, and interventions that improve health-related quality of life (HRQOL) are much needed for patients with metastatic breast cancer (MBC). The multinational randomized controlled PREFERABLE-EFFECT trial assessed the effects of exercise on fatigue and HRQOL in patients with MBC. In total, 357 patients with MBC and a life expectancy of ≥6 months but without unstable bone metastases were recruited at eight study centers across five European countries and Australia. Participants were randomly assigned (1:1) to usual care (control group, n = 179) or a 9-month supervised exercise program (exercise group, n = 178). Intervention effects on physical fatigue (European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-FA12 scale) and HRQOL (EORTC QLQ-C30 summary score) were determined by comparing the change from baseline to 3, 6 (primary timepoint) and 9 months between groups using mixed models for repeated measures, adjusted for baseline values of the outcome, line of treatment (first or second versus third or higher) and study center. Exercise resulted in significant positive effects on both primary outcomes. Physical fatigue was significantly lower (-5.3 (95% confidence interval (CI), -10.0 to -0.6), Bonferroni-Holm-adjusted P = 0.027; Cohen's effect size, 0.22) and HRQOL significantly higher (4.8 (95% CI, 2.2-7.4), Bonferroni-Holm-adjusted P = 0.0003; effect size, 0.33) in the exercise group than in the control group at 6 months. Two serious adverse events occurred (that is, fractures), but both were not related to bone metastases. These results demonstrate that supervised exercise has positive effects on physical fatigue and HRQOL in patients with MBC and should be recommended as part of supportive care.ClinicalTrials.gov Identifier: NCT04120298 .
RESUMEN
BACKGROUND: Many patients with metastatic breast cancer experience cancer- and treatment-related side effects that impair activities of daily living and negatively affect the quality of life. There is a need for interventions that improve quality of life by alleviating fatigue and other side effects during palliative cancer treatment. Beneficial effects of exercise have been observed in the curative setting, but, to date, comparable evidence in patients with metastatic breast cancer is lacking. The aim of this study is to assess the effects of a structured and individualized 9-month exercise intervention in patients with metastatic breast cancer on quality of life, fatigue, and other cancer- and treatment-related side effects. METHODS: The EFFECT study is a multinational, randomized controlled trial including 350 patients with metastatic breast cancer. Participants are randomly allocated (1:1) to an exercise or control group. The exercise group participates in a 9-month multimodal exercise program, starting with a 6-month period where participants exercise twice a week under the supervision of an exercise professional. After completing this 6-month period, one supervised session is replaced by one unsupervised session for 3 months. In addition, participants are instructed to be physically active for ≥30 min/day on all remaining days of the week, while being supported by an activity tracker and exercise app. Participants allocated to the control group receive standard medical care, general written physical activity advice, and an activity tracker, but no structured exercise program. The primary outcomes are quality of life (EORTC QLQ-C30, summary score) and fatigue (EORTC QLQ-FA12), assessed at baseline, 3, 6 (primary endpoint), and 9 months post-baseline. Secondary outcomes include physical fitness, physical performance, physical activity, anxiety, depression, pain, sleep problems, anthropometric data, body composition, and blood markers. Exploratory outcomes include quality of working life, muscle thickness, urinary incontinence, disease progression, and survival. Additionally, the cost-effectiveness of the exercise program is assessed. Adherence and safety are monitored throughout the intervention period. DISCUSSION: This large randomized controlled trial will provide evidence regarding the (cost-) effectiveness of exercise during treatment of metastatic breast cancer. If proven (cost-)effective, exercise should be offered to patients with metastatic breast cancer as part of standard care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04120298 . Registered on October 9, 2019.
Asunto(s)
Neoplasias de la Mama , Calidad de Vida , Actividades Cotidianas , Neoplasias de la Mama/terapia , Ejercicio Físico , Terapia por Ejercicio/efectos adversos , Fatiga/etiología , Fatiga/terapia , Femenino , HumanosRESUMEN
The DESIREE project has developed a platform offering several complementary therapeutic decision support systems (DSSs) to improve care quality for breast cancer patients. A first assessment of the system was carried out in close-to-real tumor boards (TBs). Fourteen TB sessions were organized corresponding to a total of 125 exploitable decisions previously made without the system and re-played with the system after a washout period in three pilot sites. Results show an overestimation of declared compliance with guidelines when not using the system as compared to measured compliance with the recommendations issued from the guideline-based DSS of DESIREE. After using the system, measured compliance rate of decisions with guidelines was significantly improved from 74.4% to 89.6%. Most of the changes in decisions when using the guideline-based DSS were associated with non-compliant decisions that became compliant. Qualitative analysis and interviews showed that despite maturity issues, clinicians found DESIREE DSSs innovative and promising.
Asunto(s)
Neoplasias de la Mama/terapia , Sistemas de Apoyo a Decisiones Clínicas , Calidad de la Atención de Salud , Femenino , Adhesión a Directriz , HumanosRESUMEN
Prostatic cancer can be a silent tumor, with no symptoms remaining undetectable throughout life . But when it keeps growing, enough to produce symptoms such as bladder neck obstruction, invasion of adjacent organs or distant metastasis, curative treatment is usually impossible. Since PSA emerges, data shows a dramatic increasing in the diagnosis of prostatic cancer, specially low risk tumor. Since then, We are wondering which tumors are suitable to be treated and which ones remain asymptomatic without treatment. Analysing the natural history of prostate cancer, helps us to choose the best atitude treating the tumor, this subjet has been in constant discusión in the last decade. Our article consistes of a reviewing the main publications treating natural history of prostate cancer in prehyphen;and post-PSA era. The indicated studied suggest that most prostate tumors diagnosed today are low grade cancer, as a result with a low mortality. This conclusión shows us the importance of modifying the algorithm of treatment of these tumors.
Asunto(s)
Neoplasias de la Próstata/patología , Biomarcadores de Tumor , Progresión de la Enfermedad , Humanos , Masculino , Antígeno Prostático Específico/análisis , Neoplasias de la Próstata/epidemiología , Neoplasias de la Próstata/mortalidadRESUMEN
El cáncer de próstata puede ser un tumor indolente, que no presenta síntomas y permanecer indetectable a lo largo de la vida. Pero cuando ha crecido lo suficiente como para producir sintomatología como obstrucción infravesical, invasión de órganos vecinos o metástasis a distancia, la curación es habitualmente imposible. La aparición del PSA ha supuesto un incremento dramático en el diagnóstico de los tumores de próstata de bajo riesgo. Todos nos preguntamos cuáles son los tumores que debemos de tratar y cuáles son los tumores que permanecerán asintomáticos. Conocer la historia natural del cáncer de próstata, nos ayudará a indicar correctamente su tratamiento, que en la actualidad está en permanente discusión. Realizamos en este trabajo una revisión de los principales estudios publicados en la literatura sobre la historia natural del cáncer de próstata en la era pre y post-PSA. Los datos que tenemos sugieren que la mayoría de los tumores de próstata que diagnosticamos en la actualidad son de bajo grado y por lo tanto con una baja mortalidad. Es necesario replantearse el algoritmo del tratamiento de estos tumores
Prostatic cancer can be a silent tumor, with no symptoms remaining undetectable throughout life. But when it keeps growing, enough to produce symptoms such as bladder neck obstruction, invasion of adjacent organs or distant metastasis, curative treatment is usually impossible. Since PSA emerges, data shows a dramatic increasing in the diagnosis of prostatic cancer, specially low risk tumor. Since then, We are wondering which tumors are suitable to be treated and which ones remain asymptomatic without treatment. Analysing the natural history of prostate cancer, helps us to choose the best atitude treating the tumor, this subjet has been in constant discusión in the last decade. Our article consistes of a reviewing the main publications treating natural history of prostate cancer in pre-and post- PSA era. The indicated studied suggest that most prostate tumors diagnosed today are low grade cancer, as a result with a low mortality. This conclusión shows us the importance of modifying the algorithm of treatment of these tumors