Carfilzomib and dexamethasone maintenance following salvage ASCT in multiple myeloma: A randomised phase 2 trial by the Nordic Myeloma Study Group.

OBJECTIVE: We investigated the efficacy and safety of carfilzomib-containing induction before salvage high-dose melphalan with autologous stem-cell transplantation (salvage ASCT) and maintenance with carfilzomib and dexamethasone after salvage ASCT in multiple myeloma. METHODS: This randomised, open-label, phase 2 trial included patients with first relapse of multiple myeloma after upfront ASCT who were re-induced with four cycles of carfilzomib, cyclophosphamide and dexamethasone. Two months after salvage, ASCT patients were randomised to either observation or maintenance therapy with iv carfilzomib 27 â†’ 56 mg/sqm and p.o. dexamethasone 20 mg every second week. The study enrolled 200 patients of which 168 were randomised to either maintenance with carfilzomib and dexamethasone (n = 82) or observation (n = 86). RESULTS: Median time to progression (TTP) after randomisation was 25.1 months (22.5-NR) in the carfilzomib-dexamethasone maintenance group and 16.7 months (14.4-21.8) in the control group (HR 0.46, 95% CI 0.30-0.71; P = .0004). The most common adverse events during maintenance were thrombocytopenia, anaemia, hypertension, dyspnoea and bacterial infections. CONCLUSION: In summary, maintenance therapy with carfilzomib and dexamethasone after salvage ASCT prolonged TTP with 8 months. The maintenance treatment was in general well-tolerated with manageable toxicity.

Health-related quality of life of patients with haematologic cancer during COVID-19 and their opinions on telehealth consultations - a Danish single site cross-sectional survey.

INTRODUCTION: During the COVID-19 pandemic, high-risk patient groups might have practiced social distancing and sheltering, and hospitals may have changed or postponed treatments and examinations. We aimed to explore health-related quality of life (QoL) in patients with haematological diseases during the early phase of the pandemic and their acceptability of using telehealth. PATIENTS AND METHODS: We performed a cross-sectional survey among patients at the Department of Haematology, Odense University Hospital, Denmark. Eligible participants were patients receiving either active treatment or survivors in a follow-up program. The survey was open from 22 May to 13 June 2020. The survey contained questions on concerns and the impact of COVID-19 and acceptability on telehealth in addition to the assessment of health-related QoL. The later was assessed by the European Organisation for Research and Treatment of Cancer core QoL (EORTC QLQ-C30) questionnaire with the subdomains Global QoL, emotional functioning (EF) and social functioning (SF) being of primary interest. Further, anxiety during COVID-19 was assessed by use of an adapted version of the generalised anxiety disorder (GAD-7) questionnaire. RESULTS: 4420 patients were eligible to participate. The response rate was 53% (n = 2239) of which 37% where in a treatment program and 63% where in a follow-up program. The majority (80%) of patients were concerned about contracting COVID-19. The global QoL score (69.0, ±SD 22.6) was markedly lower than EF (84.5, ±SD 18.9) and SF (85.0, ±SD 23.4). Regression analysis showed that being concerned (a little, moderately, very, extremely) about contracting COVID-19 correlated with lower scores of global QoL (-3.86 to -22.76), EF (-3.81 to -26.41) and SF (-1.14 to -22.49). The GAD-7 score showed that approximately 20% of patients had symptoms of COVID-19 associated generalised anxiety. Finally, 67% of the patients were positive towards replacing face-to-face consultancies with phone calls, but video consultations were less preferred (47%). CONCLUSION: Danish patients with haematological cancer presented with low global QoL during the early phase of COVID-19, and 20% of the patients showed symptoms of generalised anxiety. Patients were overall positive towards the implementation of telehealth consultancies.

The translated Danish version of the Western Ontario Meniscal Evaluation Tool (WOMET) is reliable and responsive.

PURPOSE: The purpose of this study was to translate and cross-culturally adapt the Western Ontario Meniscal Evaluation Tool (WOMET) for use in Denmark and evaluate its test-retest reliability and comparative responsiveness. METHODS: Sixty patients (mean age 50 years (range 19-71 years), females 57%) with meniscal injury scheduled for arthroscopic meniscal surgery at a small Danish hospital in the period from September 2017 to February 2018 were included in this study. The WOMET was translated into Danish using forward and backward translation. The WOMET was completed at baseline (pre-surgery), at 3 and 6 months postoperatively. Additionally, reliability was assessed at 3 months and 3 months plus 1 week, for patients with a stable symptom state (global response question) between test and retest. Comparative responsiveness was assessed between the WOMET and the Knee Injury and Osteoarthritis Outcome Score (KOOS4-aggregate score of 4 of the 5 KOOS subscales). RESULTS: The Danish version of WOMET showed excellent test-retest reliability, intraclass correlation coefficient of 0.88 (95% CI 0.84-0.92) for the total score. The standard error of measurement was 125 points and the minimal detectable change was 347 points (i.e. 8% and 22% of the total score, respectively). The WOMET was responsive with an effect size (ES) of 1.12 at 6 months after surgery, which was comparable to the KOOS4 (ES 1.10). CONCLUSION: The Danish version of the WOMET is a reliable and responsive measure of health-related quality of life in patients with meniscal pathology. LEVEL OF EVIDENCE: Level II.

Quality of Life in Vulnerable Older Patients with Metastatic Colorectal Cancer Receiving Palliative Chemotherapy-The Randomized NORDIC9-Study.

Quality of life data from randomized trials are lacking in older patients with metastatic colorectal cancer (mCRC). In the randomized NORDIC9-study, reduced-dose S1+oxaliplatin (SOx) showed superior efficacy compared to full-dose S1 monotherapy. We hypothesized that treatment with SOx does not result in inferior quality of life. Patients with mCRC aged ≥70 years and that were not a candidate for standard combination chemotherapy were included and randomly assigned to receive either S1 or SOx. The EORTC QLQ-C30 questionnaire was completed at baseline, after 9, and 18 weeks. The primary endpoint was global Quality of Life (QoL) at 9 weeks. For statistical analysis, a non-inferiority design was chosen applying linear mixed effects models for repeated measurements. The results were interpreted according to statistical significance and anchor-based, clinically relevant between-group minimally important differences (MID). A total of 160 patients aged (median (Interquartile range (IQR))) 78 years (76-81) were included. The QLQ-C30 questionnaire was completed by 150, 100, and 60 patients at baseline, at 9, and 18 weeks, respectively. The difference at 9 weeks in global QoL was 6.85 (95%CI-1.94; 15.65) and 7.37 (0.70; 14.05) in the physical functioning domain in favor of SOx exceeding the threshold for MID. At 18 weeks, the between-group MID in physical functioning was preserved. Dose-reduced combination chemotherapy may be recommended in vulnerable older patients with mCRC, rather than full-dose monotherapy.

Neuromuscular Exercises Improve Shoulder Function More Than Standard Care Exercises in Patients With a Traumatic Anterior Shoulder Dislocation: A Randomized Controlled Trial.

BACKGROUND: There is an important gap in knowledge about the effectiveness of nonoperative treatment (exercise) for patients with traumatic primary and recurrent anterior shoulder dislocations (ASDs). PURPOSE/HYPOTHESIS: The purpose of this study was to assess the efficacy and safety of physical therapist-supervised, shoulder instability neuromuscular exercise (SINEX) versus self-managed, home-based, standard care shoulder exercise (HOMEX) in patients with traumatic ASDs. The hypothesis was that SINEX would have a larger effect and fewer adverse events compared with HOMEX. STUDY DESIGN: Randomized controlled trial; Level of evidence, 2. METHODS: A total of 56 participants with radiographically verified, trauma-initiated primary or recurrent ASDs and self-reported decreased shoulder function were randomized to 12 weeks of either SINEX or HOMEX. The SINEX program consisted of 7 exercises, individually progressing from basic (2 × 20 repetitions each day) to elite (2 × 10 repetitions, 3 times weekly). The HOMEX program included 5 shoulder exercises performed 3 times weekly (2 × 10 repetitions). The primary outcome was the Western Ontario Shoulder Instability Index (WOSI) score, ranging from 0 (best possible) to 2100. The between-group minimal clinically important difference at 12 weeks was 250 points. Secondary outcomes included WOSI subdomain scores, patient-reported ratings of kinesiophobia and pain, objective shoulder function, patient satisfaction, and number of adverse events. RESULTS: The between-group mean difference in the WOSI total score at 12 weeks significantly favored SINEX over HOMEX (-228.1 [95% CI, -430.5 to -25.6]). SINEX was furthermore superior to HOMEX in most of the secondary outcomes (3/4 subdomains of the WOSI and pain level during the past 7 days as well as clinical signs of anterior shoulder instability). Also, although not statistically significant, less than half the proportion of the SINEX patients compared with the HOMEX patients (3/27 [11%] vs 6/24 [25%], respectively; P = .204) underwent or were referred for shoulder stabilizing surgery. Satisfaction with both exercise programs was high, and no serious adverse events were reported. CONCLUSION: Neuromuscular shoulder exercise (SINEX) was superior to standard care exercise (HOMEX) in patients with traumatic ASDs. Further long-term follow-ups on treatment effects are needed. REGISTRATION: NCT02371928 (ClinicalTrials.gov identifier).