AIMS: Many patients diagnosed with esophageal cancer have dysphagia from their primary tumor and de novo metastatic disease. The purpose of this study was to test the safety and efficacy of nivolumab given concurrently with hypofractionated chemoradiotherapy to patients with oligometastatic and obstructing esophageal tumors. METHODS: Patients were enrolled in a planned single-arm, phase 2 clinical trial. Eligible participants had previously untreated oligometastatic (≤5 metastases on fludeoxyglucose-18 positron emission tomography scan outside the primary tumor radiotherapy field) esophageal or gastroesophageal carcinoma, dysphagia, and Eastern Cooperative Oncology Group performance status 0-1. Treatment was with 2 weeks of concurrent hypofractionated radiotherapy (30 Gy/10#) to the primary tumor, weekly carboplatin AUC2, weekly paclitaxel 50 mg/m2, and q2weekly nivolumab 240 mg, followed by nivolumab 480 mg continuing q4weekly until disease progression or 24 months total. A single metastasis was treated with stereotactic radiotherapy (SBRT) (24 Gy/3#) in week 7. RESULTS: Five patients were recruited before trial closure to new participants for logistical reasons. Existing participants continued treatment per protocol as a pilot study at one center. All five patients completed chemoradioimmunotherapy and SBRT. All patients derived an improvement in their dysphagia. Two patients completed 24 months of nivolumab without disease progression. Grade 3 adverse events (AEs) occurred in 3 patients, however, there were no grade 4 AEs, AEs due to SBRT, or AEs of special interest as defined by the protocol. CONCLUSION: Pilot results from five patients at one center found that treatment was well tolerated and effective for dysphagia relief. The efficacy of hypofractionated chemoradiotherapy with concurrent checkpoint inhibition should be tested in a multicentre study.
Background: Delirium is difficult to measure in the Intensive Care Unit (ICU). It is possible that by considering the rate of screening, incidence, and rate of treatment with antipsychotic medications (APMs) for suspected delirium, a clearer picture can emerge. Methods: A retrospective, observational study was conducted at two ICUs in Australia, between April and June of 2020. All adult ICU patients were screened; those who spoke English and did not have previous neurocognitive pathology or intracranial pathology were included in the analysis. Data were collected from the hospitals' electronic medical records. The primary outcome was incidence of delirium based on the use of the Confusion Assessment Method for ICU (CAM-ICU). Secondary outcomes included measures of screening for delirium, treatment of suspected delirium with APMs, and identifying clinical factors associated with both delirium and the use of APMs. Results: From 736 patients that were screened, 665 were included in the analysis. The incidence of delirium was 11.3% (75/665); on average, the Richmond Agitation and Sedation Scale (RASS) was performed every 2.9 h and CAM-ICU every 40 h. RASS was not performed in 8.4% (56/665) of patients and CAM-ICU was not performed in 40.6% (270/665) of patients. A total of 17% (113/665) of patients were prescribed an APM, with quetiapine being the most used. ICU length of stay (LOS), APACHE-III score, and the use of alpha-2 agonists were associated with the presence of delirium, while ICU LOS, the use of alpha-2 agonists, and the presence of delirium were associated with patients receiving APMs. Conclusions: The incidence of delirium was lower than previously reported, at 11.3%. The rate of screening for delirium was low, while the use of APMs for delirium was higher than the incidence of delirium. It is possible that the true incidence is higher than what was measured. Critical prospective assessment is required to optimize APM indications in the ICU.
Background: Good sleep quantity and quality are essential for patient recovery while in the intensive care unit (ICU). Patients commonly report poor sleep while in the ICU, and therefore, identifying the modifiable factors that patients perceive as impacting their sleep is important to improve sleep and recovery. This study also assessed night-time light and sound levels in an ICU in an effort to find modifiable factors. Methods: A total of 137 patients (51F) aged 58.1 ± 16.8 years completed a survey including questions about their sleep before and during their ICU stay, factors contributing to poor sleep in the ICU, and perceived factors that may have improved their sleep in the ICU. Night-time light and sound levels were measured in patient rooms and nurses' stations. Results: Patients reported poorer sleep quantity and quality while in the ICU compared to home. Among the most common reasons for poor sleep, easily modifiable factors included noise (50.4%) and lights (45.3%), potentially modifiable factors included pain (46.7%), and non-modifiable factors included IV lines (42.3%). Patients felt their sleep would have been improved with interventions such as dimming lights (58.4%) and closing doors/blinds at night (42.3%), as well as potentially implementable interventions such as a sleeping pill (51.8%). Overnight sound levels in bedrooms were above the recommended levels (40 dB) and light levels averaged over 100 lux. Conclusions: Sleep quality and quantity were both worse in ICU than at home. Modifiable factors such as sound and light are common factors that patients perceive impact their sleep in the ICU. Readily implementable sleep management strategies aimed at minimizing the impacts of sound and light levels in the ICU are ways to improve patients' sleep in the ICU.
