ABSTRACT
BACKGROUND: First-line standard-of-care for unresectable, pleural mesothelioma (PM) changed with the phase 3 CheckMate 743 study results, showing that nivolumab plus ipilimumab (Nivo + Ipi) significantly extended overall survival (OS) versus platinum + pemetrexed chemotherapy for PM (median OS 18.1 versus 14.1 months; hazard ratio: 0.74; p = 0.002). Efficacy and safety data in real-world (rw) settings are needed to confirm these results. METHODS: This French multicenter, retrospective cohort study was undertaken to assess the outcomes of treatment-naïve PM patients given Nivo + Ipi via an early-access program (EAP). The primary objective was investigator-assessed real world -progression-free survival (PFS). The secondary objectives were the combination's -overall survival (OS) and safety. RESULTS: From 1 April 2021 to 15 Feb 2022, the analysis included 201 of the 305 EAP-enrolled patients treated in 63 centers (79.6 % men; median age: 75 years; 91.8 % Eastern Cooperative Oncology Group performance status (ECOG-PS) 0/1; 74.5 % epithelioid histology). With median (95 % CI) follow-up for all patients of 18.4 (17.7-19.2) months, -PFS and OS were 6.3 (5.3-7.5) and 18.9 (17.6-not reached (NR)) months, with 1-year OS at 66.4 % (60.1-73.3 %). Median OS and 1-year survival rates were 21.0 (18.7-NR) and 70.8 % (63.9 %-780.6 %), and 14.1 (10.9-21.0) months and 54.9 % (42.8 %-70.4 %) for epithelioid and non-epithelioid PM subgroups, respectively. PFS was equal between the two subgroups. Grade 3-4 adverse events occurred in 23.3 % of patients and three deaths were treatment-related. CONCLUSIONS: For this unselected PM population, efficacy and safety outcomes compared favorably with CheckMate 743 trial results.
ABSTRACT
Studies have reported persistent symptoms in patients hospitalized for COVID-19 up to 6 months post-discharge; however, sequalae beyond 6 months are unknown. This study aimed to investigate the clinical status of COVID-19 patients one year after hospital discharge and describe the factors related to poor outcomes. We conducted a single-center, prospective, cohort study of patients in Le Havre hospital (France) between 1 March 2020 and 11 May 2020. Baseline characteristics were collected from medical charts (including KATZ index and Clinical Frailty scale (CFS)), and a remote assessment was conducted 12 months after discharge. The main outcomes were the scores of the physical and mental components (PCS and MCS) of the Short-Form 36 (SF-36) and performance on the one-minute sit-to-stand test (STST1'). Scores <50% of the predicted values were considered as poor, and univariate and multivariate analyses were undertaken to investigate factors related to poor outcomes. Remote assessment was performed for 128 of the 157 (82%) eligible patients. Twenty-two patients were admitted to the intensive care unit (ICU), 45 to the intermediate care unit (IU), and 61 to the general ward (GW). Patients who spent time in ICU were more independent and younger. A large proportion of the sample had poor physical (30%) and mental health (27%) and a poor functional exercise capacity (33%) at the remote assessment. Higher levels of frailty at admission and hospital discharge were, respectively, associated with a higher risk of poor functional exercise capacity (StdOR 3.64 (95%CI 1.39-10.72); p = 0.01) and a higher risk of poor mental health (StdOR 2.81 (95%CI 1.17-7.45); p = 0.03). Long-term outcomes following hospitalization for COVID-19 infection may be negative for at least one year after discharge. Remote follow-up assessment could be highly beneficial for COVID-19 patients.
ABSTRACT
OBJECTIVE: To assess the additional effect of a home-based neuromuscular electrical stimulation (NMES) program as an add-on to pulmonary rehabilitation (PR), on functional capacity in subjects with chronic obstructive pulmonary disease (COPD). DESIGN: Single-blind, multicenter randomized trial. SETTING: Three PR centers. PARTICIPANTS: Subjects with severe to very severe COPD (N=73; median forced expiratory volume in 1 second, 1L (25th-75th percentile, 0.8-1.4L) referred for PR. Twenty-two subjects discontinued the study, but only 1 dropout was related to the intervention (leg discomfort). INTERVENTION: Subjects were randomly assigned to either PR plus quadricipital home-based NMES (35Hz, 30min, 5 time per week) or PR without NMES for 8 weeks. MAIN OUTCOME MEASURE: The 6-minute walk test (6MWT) was used to assess functional capacity. RESULTS: Eighty-two percent of the scheduled NMES sessions were performed. In the whole sample, there were significant increases in the distance walked during the 6MWT (P<.01), peak oxygen consumption (P=.02), maximal workload (P<.01), modified Medical Research Council dyspnea scale (P<.01), and Saint George's Respiratory Questionnaire total score (P=.01). There was no significant difference in the magnitude of change for any outcome between groups. CONCLUSIONS: Home-based NMES as an add-on to PR did not result in further improvements in subjects with severe to very severe COPD; moreover, it may have been a burden for some patients.
