Adjuvant durvalumab for esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy: a placebo-controlled, randomized, double-blind, phase II study.

BACKGROUND: We evaluated the efficacy of adjuvant durvalumab after neoadjuvant concurrent chemoradiotherapy (CCRT) in patients with esophageal squamous cell carcinoma (ESCC). PATIENTS AND METHODS: This randomized, double-blind, phase II study included patients with ESCC who underwent curative surgery after neoadjuvant CCRT. Patients were randomized to receive either durvalumab (20 mg/kg/i.v. every 4 weeks for 12 months) or placebo in a 1:1 ratio and were stratified by age and pathologic tumor stage. The primary endpoint was disease-free survival (DFS). RESULTS: Between March 2016 and June 2018, 86 patients were randomized to the durvalumab (n = 45) or placebo (n = 41) arm. The median follow-up duration was 38.7 months. There was no difference in DFS [hazard ratio (HR) 1.18, 95% confidence interval (CI) 0.62-2.27, P = 0.61] or overall survival (HR 1.08, 95% CI 0.52-2.24, P = 0.85) between the two arms. Subgroup analysis was performed for patients for whom the post-CCRT programmed death-ligand 1 (PD-L1) expression profile could be assessed (n = 54). In the PD-L1-positive group, based on tumor proportion score ≥1%, durvalumab was associated with longer overall survival compared with the placebo (36-month survival rate: 94% versus 64%; HR 0.42, 95% CI 0.10-1.76), while in the PD-L1-negative group, it was associated with shorter overall survival (42% versus 55%; HR 1.53, 95% CI 0.48-4.83), showing the tendency of interaction between post-CCRT PD-L1 status and adjuvant durvalumab therapy for overall survival (interaction P = 0.18). CONCLUSIONS: We failed to demonstrate that adjuvant durvalumab improved survival after neoadjuvant CCRT in patients with ESCC. However, post-CCRT PD-L1 expression could predict the survival of patients who receive adjuvant durvalumab after neoadjuvant CCRT, which needs to be validated.

[A study on nurse-patient interacting behavior patterns].

The purpose of the present study is to confirm the interacting behavior between nurses and patients and other things concerned herewith. Subjects of investigation were: 42 nurses selected out of the average nurses who serve in hospital as nurses assigned to medical and surgical wards: and 42 male and female adult patients selected out of the average patients who were under the care of the nurse individuals and can make themselves understood verbally. A nurse and her patient were paired off for questioning. Materials for statistics were gathered by means of observing interactions--verbal and nonverbal--of the chosen subjects for four hours every day from 7:30 a.m. through 7:30 p.m. between on July 15, 1988 and on Aug. 16, 1988. Classified by patterns, the materials observed and gathered were preliminarily analyzed by this researcher, and then reexamined in a full-fledged way by one professor, three nurses and three non-nurses. The researcher depended chiefly on Frequency, ANOVA, Pearson's Correlation Coefficient attached to SPSS Computer System for the process of gathered materials. The results of this investigations are follows 1) A total of 98 times' interactions between nurses and patients were provided during observation of 16 8 hours. 2) It took them the averaged 264.8 seconds (around 4.4 minutes) per a couple of subjects to interact between nurses and patients during observation of four hours. 3) The aim of interactions between nurses and patients appear that 29 times of injection amounted to 29.6% the most, 27 times of PO around to 27.6% the next most, 25 times of vital check to 25.5% the next most, 17 times of independent nursing works and round to 17.3% the least most. 4) As a result of qualitative analyzing the interactions between nurses and patients by the distinctive method of words were positively recognized in 19 cases with 45.2% and negatively in 23 cases with 54.8%. 5) A total of 2,193 times, interaction behaviours between nurses and patients were provided. The frequency of these interaction behaviours took place 1,3 64 times with 62.2% to nurse, and 829 times with 3 7.8% to patients. 6) The classification of verbal and nonverbal interaction behaviour between nurses and patients indicated that it is amounted to 64.9% for verbal behaviour numbered 1,423 and 35.1% for nonverbal one numbered 770. 7) The frequency of verbal behaviour between nurses and patients numbered 1,423 in total. They took place 924 times to nurses and 499 times to patients, it can be also amounted to 64.9% and 35.1% respectively in percentage-wise.(ABSTRACT TRUNCATED AT 400 WORDS)