Prophylactic Radiotherapy Of MInimally Symptomatic Spinal Disease (PROMISSeD): study protocol for a randomized controlled trial.

BACKGROUND: Early palliative/pre-emptive intervention improves clinical outcomes and quality of life for patients with metastatic cancer. A previous signal-seeking randomized controlled trial (RCT) demonstrated that early upfront radiotherapy to asymptomatic or minimally symptomatic high-risk osseous metastases led to reduction in skeletal-related events (SREs), a benefit driven primarily by subgroup of high-risk spine metastasis. The current RCT aims to determine whether early palliative/pre-emptive radiotherapy in patients with high-risk, asymptomatic or minimally symptomatic spine metastases will lead to fewer SREs within 1 year. METHODS: This is a single-center, parallel-arm, in-progress RCT in adults (≥ 18 years) with ECOG performance status 0-2 and asymptomatic or minimally symptomatic (not requiring opioids) high-risk spine metastases from histologically confirmed solid tumor malignancies with > 5 sites of metastatic disease on cross-sectional imaging. High-risk spine metastases are defined by the following: (a) bulkiest disease sites ≥ 2 cm; (b) junctional disease (occiput to C2, C7-T1, T12-L2, L5-S1); (c) posterior element involvement; or (d) vertebral body compression deformity > 50%. Patients are randomized 1:1 to receive either standard-of-care systemic therapy (arm 1) or upfront, early radiotherapy to ≤ 5 high-risk spine lesions plus standard-of-care systemic therapy (arm 2), in the form of 20-30 Gy of radiation in 2-10 fractions. The primary endpoint is SRE, a composite outcome including spinal fracture, spinal cord compression, need for palliative radiotherapy, interventional procedures, or spinal surgery. Secondary endpoints include (1) surrogates of health care cost, including the number and duration of SRE-related hospitalizations; (2) overall survival; (3) pain-free survival; and (4) quality of life. Study instruments will be captured pre-treatment, at baseline, during treatment, and at 1, 3, 6, 12, and 24 months post-treatment. The trial aims to accrue 74 patients over 2 years to achieve > 80% power in detecting difference using two-sample proportion test with alpha < 0.05. DISCUSSION: The results of this RCT will demonstrate the value, if any, of early radiotherapy for high-risk spine metastases. The trial has received IRB approval, funding, and prospective registration (NCT05534321) and has been open to accrual since August 19, 2022. If positive, the trial will expand the scope and utility of spine radiotherapy. TRIAL REGISTRATION: ClinicalTrials.Gov NCT05534321 . Registered September 9, 2022. TRIAL STATUS: Version 2.0 of the protocol (2021-KOT-002), revised last on September 2, 2022, was approved by the WCG institutional review board (Study Number 1337188, IRB tracking number 20223735). The trial was first posted on ClinicalTrials.Gov on September 9, 2022 (NCT05534321). Patient enrollment commenced on August 19, 2022, and is expected to be completed in 2 years, likely by August 2024.

Health-related quality of life and radiological and functional lung changes of patients with COVID-19 Pneumonia 3 and 10 months after discharge.

BACKGROUND: Few studies have evaluated the long-term impact on health-related quality of life (HRQoL) in patients who have been hospitalized for COVID-19 pneumonia. Specific follow-up should be carried out to detect and treat possible pulmonary abnormalities, and the worsening of HRQoL should be estimated to target necessary resources for care of these patients after acute phase. The objective was to know the impact on HRQoL of patients who have been admitted for COVID-19 pneumonia, and to evaluate the clinical-radiological and functional changes of patients who have overcome COVID-19 pneumonia at 3 and 10 months of follow-up. METHODS: Prospective observational study of patients who required hospitalization for COVID-19 pneumonia between April and December 2020. All patients filled out the EuroQol five-dimension (EQ-5D) questionnaire with the EuroQol Visual Analogue Scale (E-VAS) for self-assessment of health status. Respiratory function tests and chest X-ray were carried out at 3 and 10 months of follow-up. RESULTS: 61 patients were included in the study. The need for ventilatory support was associated with anxiety/depression on the EQ-5D scale, as well as patients admitted to the intensive care unit (ICU). The mean EQ-5D and E-VAS index scores decreased with hospitalization time, the number of days spent in intermediate respiratory care unit (IRCU) and the level of dyspnoea at the beginning of the hospitalization period. Pulmonary sequelae were observed in 25 patients (41%) at 3 months and 17 (27.9%) at 10 months. Patients improve their forced vital capacity (FVC) by 196 ml (p = 0.001) at 10 months as well as 9% in diffusing capacity of lung for carbon monoxide (DLCO) (p = 0.001) at 10 months. DLCO was found to be correlated to lymphopenia and time spent in IRCU. Low FVC values were detected 10 months after discharge for subjects exhibiting high levels of dyspnoea at 3 months after discharge. CONCLUSIONS: Hospitalization for COVID-19 pneumonia affects the HRQoL of patients, with greater anxiety/depression in those who were more serious affected and are younger. A significant percentage of patients present fibrotic abnormalities and lung function impairment at the first and second follow-up after discharge.

Spirituality and financial toxicity among Hispanic breast cancer survivors in New Jersey.

OBJECTIVE: Cancer survivors often incur significant out-of-pocket costs; this can result in financial toxicity, defined as the adverse financial impact of cancer due to direct or indirect costs related to the disease. There has been little research on whether spirituality is associated with the experience of financial toxicity. In this study, we tested the hypothesis that spirituality would be inversely associated with financial toxicity. METHODS: We evaluated these associations in a cross-sectional study of Hispanic breast cancer survivors (n = 102) identified through the New Jersey State Cancer Registry. Participants completed the FACIT-Sp-12, which has two spirituality subscales (meaning/peace; faith). Financial toxicity was assessed using the 11-item COST measure; lower scores suggest worse toxicity. In multivariable linear regression analyses, we examined the associations between spirituality scores and financial toxicity, adjusting for age, race, education, household income, and insurance status. RESULTS: The spirituality total score (ß = 0.49, 95% confidence interval (CI): 0.17, 0.8), meaning/peace subscale score (ß = 0.71, 95% CI: 0.12, 1.31), and faith (ß = 0.71, 95% CI: 0.2, 1.21) subscale score were all inversely associated with financial toxicity. CONCLUSIONS: Spirituality may be an important factor in ameliorating the detrimental effects of financial toxicity among Hispanic breast cancer survivors and should be considered in interventions for financial toxicity in this population.

Effects of cigarette smoke on methacholine- and AMP-induced air trapping in asthmatics.

UNLABELLED: Abstract Objective: No information is available on the effect of cigarette smoke on bronchoconstrictor-induced air trapping in asthma. The aim of this study was to evaluate the additional influence of smoking on methacholine- and adenosine 5'-monophosphate (AMP)-induced air trapping in subjects with asthma. METHODS: Airway responsiveness to methacholine and AMP, bronchial (J'awNO) and alveolar (CANO) nitric oxide (NO) and exhaled breath condensate pH were measured in 68 adults (23 current smokers with asthma, 23 non-smokers with asthma and 22 current or former smokers with chronic obstructive pulmonary disease; COPD). The degree of air trapping induced by each bronchoconstrictor agent was expressed by the percent fall in forced vital capacity (FVC) at a 20% fall in forced expiratory volume in 1 s relative to FVC after saline inhalation (ΔFVC%). RESULTS: The ΔFVC% for AMP was higher in both smokers with asthma and patients with COPD than in non-smokers with asthma (p<0.001). By contrast, ΔFVC% for methacholine was similar in the three groups of subjects (p=0.69). In smokers with asthma, but not in the other two groups, there was a correlation between the residual volume/total lung capacity at baseline and the ΔFVC% induced by each bronchoconstrictor agent. Mean values for J'awNO were higher in non-smokers with asthma than in the other two groups (p<0.05). CONCLUSIONS: The results of this study suggest that factors underlying bronchoconstriction induced by indirect agonists are different in smokers and non-smokers with asthma. These observations might be clinically relevant, because triggers that frequently induce bronchial obstruction in the real world act by an indirect mechanism.

Evaluación psicológica del paciente con cáncer en el pulmón frente al tratamiento quirúrgico / Psychological evaluation of patients with lung cancer before surgical treatment

Entre julio de 1987 y mayo de 1989 se entrevistaron desde el punto de vista psicológico 200 pacientes quirúrgicos. La observación de 32 pacientes con cáncer primario o secundario en el pulmón motivó el presente trabajo. Se investigó la actitud psicológica del paciente frente a la operación y su evolución médica postoperatoria. La evaluación se realizó mediante entrevistas y los resultados se trasladaron a 3 formularios diferentes. El 91% de los pacientes deseaba ser escuchado y aceptó la atención psicológica. La evolución médica postoperatoria resultó ser un correlato significativo de la disposición psicológica observada en el preoperatorio; los 9 pacientes con una disposición psicológica normal no sufrieron complicaciones; de los 23 con una actitud prequirúrgica patológica, 12 tuvieron complicaciones médicas postoperatorias tales como, empiema, atelectasia, inexpansión pulmonar, hemorragia digestiva, trombosis venosa profunda, insuficiencia cardíaca, hemotórax postoperatorio, infección de pared y neumonitis.