Purpose: Adjuvant pembrolizumab improved disease-free survival (DFS) and overall survival (OS) versus placebo in participants with renal cell carcinoma (RCC) at increased risk of recurrence after nephrectomy in the global phase 3 KEYNOTE-564 study. This post hoc subgroup analysis evaluated the efficacy and safety of adjuvant pembrolizumab in East Asian (Japan, South Korea, and Taiwan) participants enrolled in KEYNOTE-564. Materials and Methods: Eligible participants were randomly assigned 1:1 to receive adjuvant pembrolizumab 200 mg or placebo intravenously every 3 weeks for ≤ 17 cycles. The primary endpoint was DFS by investigator assessment. OS was a key secondary endpoint. Safety was a secondary endpoint. Results: The East Asian subgroup included 126 participants (pembrolizumab, n=58; placebo, n=68). Median follow-up was 62.1 months (range, 49.6 to 73.0 months). Hazard ratio for DFS with pembrolizumab versus placebo was 0.70 (95% confidence interval 0.41 to 1.20). Median DFS was not reached with pembrolizumab versus 58.8 months with placebo; estimated 48-month rate was 61.3% versus 51.2%. Hazard ratio for OS was 0.47 (95% confidence interval, 0.15 to 1.49). Median OS was not reached with pembrolizumab and placebo; estimated 48-month rate was 94.8% versus 91.2%. Treatment-related adverse events occurred in 70.7% of participants (29.3% grade 3 or 4) receiving pembrolizumab and 36.8% of participants (0.0% grade 3 or 4) receiving placebo. No pembrolizumab-related deaths occurred. Conclusion In the KEYNOTE-564 East Asian subgroup, adjuvant pembrolizumab provided DFS and OS benefits versus placebo and had a safety profile consistent with the global results. These results further support pembrolizumab as adjuvant treatment for East Asian patients with RCC at increased risk of recurrence after nephrectomy.

Bipolar disorder (BD) is a major psychiatric disorder that is easily misdiagnosed. Patient adherence to a treatment regimen is of utmost importance for successful outcomes in BD. Several trials of antipsychotics suggested that depot antipsychotics, including long-acting first- and second-generation agents, are effective in preventing non-adherence, partial adherence, and in reducing relapse in BD. Various long-acting injectable (LAI) antipsychotics are available, including fluphenazine decanoate, haloperidol decanoate, olanzapine pamoate, risperidone microspheres, paliperidone palmitate, and aripiprazole monohydrate. Due to the increasing number of BD patients receiving LAI antipsychotics, treatment guidelines have been developed. However, the clinical applicability of LAI antipsychotics remains a global cause for concern, particularly in Asian countries. Expert physicians from Taiwan participated in a consensus meeting, which was held to review key areas based on both current literature and clinical practice. The purpose of this meeting was to generate a practical and implementable set of recommendations for LAI antipsychotic use to treat BD; target patient groups, dosage, administration, and adverse effects were considered. Experts recommended using LAI antipsychotics in patients with schizophrenia, rapid cycling BD, BD I, and bipolar-type schizoaffective disorder. LAI antipsychotic use was recommended in BD patients with the following characteristics: multiple episodes and low adherence; seldom yet serious episodes; low adherence potential per a physician's clinical judgment; preference for injectable agents over oral agents; and multiple oral agent users still experiencing residual symptoms.
Antipsychotic Agents* ; Asian Continental Ancestry Group ; Bipolar Disorder* ; Consensus* ; Fluphenazine ; Haloperidol ; Humans ; Judgment ; Microspheres ; Patient Compliance ; Psychotic Disorders ; Recurrence ; Risperidone ; Schizophrenia ; Taiwan ; Aripiprazole ; Paliperidone Palmitate

INTRODUCTIONHealth-related quality of life (HRQoL) is an important patient-centred outcome in chronic obstructive pulmonary disease (COPD). The aim of the current study is to compare the discriminative capacity of the modified Medical Research Council (mMRC) dyspnoea scale and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) spirometric classification of COPD on HRQoL, as well as determine other factors that are simple and determinative of HRQoL.

METHODSIn this cross-sectional observational study, a total of 328 patients with COPD were enrolled from the pulmonology outpatient clinic. HRQoL was measured using the St George's Respiratory Questionnaire (SGRQ) and the World Health Organization Quality of Life-BREF (WHOQOL-BREF). HRQoL scores were compared between the four GOLD stages and the five grades of the mMRC scale. Significant differences were determined using analysis of variance with Scheffe post-hoc test. Multiple linear regression was applied to explore the major determinants of HRQoL and exclude confounding factors.

RESULTSSignificant differences were found in many more domains of the two questionnaires between mMRC grades than between GOLD stages. In the multiple linear regression model, the mMRC scale was the only factor that remained determinative of all the domains of SGRQ and WHOQOL-BREF. Patients with chronic productive cough, sleep disorders and frequent exacerbations had poorer HRQoL, as reflected by higher scores in SGRQ or lower scores in WHOQOL-BREF.

CONCLUSIONThe mMRC dyspnoea scale is a concise and practical tool to assess the HRQoL of patients with COPD in daily clinical practice.

Adult ; Aged ; Aged, 80 and over ; Cough ; Cross-Sectional Studies ; Dyspnea ; diagnosis ; psychology ; Female ; Humans ; Male ; Middle Aged ; Pulmonary Disease, Chronic Obstructive ; diagnosis ; psychology ; Quality of Life ; Regression Analysis ; Spirometry ; Surveys and Questionnaires