Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: extended follow-up of outcomes and quality of life analysis.

BACKGROUND: To provide pooled longer term data from three groups of a phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC), and to determine duration of response (DOR) and impact on quality of life (QoL). METHODS: Patients received cemiplimab 3 mg/kg every 2 weeks (group 1, metastatic CSCC [mCSCC], n=59; group 2, locally advanced CSCC, n=78) or cemiplimab 350 mg every 3 weeks (group 3, mCSCC, n=56). Primary endpoint was objective response rate (ORR) per independent central review (ICR). QoL was repeatedly measured at day 1 of each treatment cycle (groups 1 and 2: 8 weeks; group 3: 9 weeks). RESULTS: Median duration of follow-up was 15.7 months. Overall, ORR per ICR was 46.1% (95% CI: 38.9% to 53.4%). Complete response (CR) rates were 20.3%, 12.8%, and 16.1% for groups 1, 2, and 3, respectively. Median time to CR was 11.2 months. Among patients with partial response or CR, the estimated proportion of patients with ongoing response at 12 months from the first objective response was 87.8% (95% CI: 78.5% to 93.3%), with median DOR not reached. Kaplan-Meier estimated probability of overall survival (OS) was 73.3% (95% CI: 66.1% to 79.2%) at 24 months, with median OS not reached. Global Health Status (GHS)/QoL improvements were observed as early as cycle 2 and were significantly improved and durable until last assessment. Kaplan-Meier estimate of median time to first clinically meaningful improvement for pain was 2.1 (95% CI: 2.0 to 3.7) months and was significantly improved in responders versus non-responders (p<0.0001). CONCLUSIONS: This is the largest (n=193) clinical dataset for a programmed cell death-1 inhibitor against advanced CSCC, confirming the sustained substantial clinical activity of cemiplimab in these patients, including new findings of improved CR rates over time, increasing DOR, and durable pain control and GHS/QoL improvement. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT02760498), https://clinicaltrialsgov/ct2/show/NCT02760498.

Correction to: Effects of transcutaneous electrical nerve stimulation in the Management of PostInjection Sciatic Pain in a non-randomized controlled clinical trial in Nnewi, Nigeria.

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Effects of transcutaneous electrical nerve stimulation in the Management of Post-Injection Sciatic Pain in a non-randomized controlled clinical trial in Nnewi, Nigeria.

BACKGROUND: Many studies on transcutaneous electrical nerve stimulation (TENS) had been undertaken to explore its pain relieving efficiency on several medicals/surgical conditions but none, specifically, had been carried out to determine the effect it has on post-injection sciatic pain (PISP) which comes about from wrong administration of intramuscular pain. This study aims to assess the effects of TENS in the management of PISP. METHODS: A total of 72 PISP subjects comprising 40 test subjects and 32 control subjects participated in a non-randomized controlled clinical trial in the current study. Participants were recruited from Department of Physiotherapy, Nnamdi Azikiwe University Teaching Hospital, Nnewi and Landmark Physiotherapy Services, Nnewi. The participants were however blinded to the intervention method they will receive before being allotted conveniently to test/experimental group (TG) or control group (CG). A written informed consent was obtained from participants before enrollments in the study. TENS and sham TENS (STENS) was applied to 40 test and 32 subjects respectively, 3 times a week, and 1 hour per session for the 10 weeks the study lasted. The Visual Analogue Scale was used to collect baseline data as well as those of 2nd, 4th, 6th, 8th and 10th weeks after TENS and STENS interventions. The data analysis was performed with the Descriptive statistic of Mean ± SD, mean comparison test, repeated analysis of variance and paired wise t-test. Statistical level of significance was set at P < 0.05. RESULT: Results of repeated measure ANOVA showed that the pain level among participants in the treatment group at the end (after 10 weeks) of the intervention was significantly lower than that of their counterparts in the control group (F = 16.26; p = 0.01); with the intervention accounting for the 19% of the variance. The effect size (partial eta squared) = 0.19. CONCLUSION: The outcome of this research has proved the effectiveness of TENS in the management of PISP and is being recommended in the management of PISP. TRIAL REGISTRATION: Pan Africa Clinical Trial Registry ( PACTR201805003408271 ). The study was registered retrospectively on the 29th May, 2018.

Community reintegration and related factors in a Nigerian stroke sample.

BACKGROUND: The goal of stroke rehabilitation has shifted from mere survival of a victim to how well a survivor can be effectively reintegrated back into the community. OBJECTIVES: The present study determined the level of satisfaction with community reintegration (CR) and related factors among Nigerian community-dwelling stroke survivors (CDSS). METHODS: This was a cross-sectional survey of 71 volunteering CDSS (35 males, 36 females) from selected South-Eastern Nigerian communities. Reintegration to Normal Living Index was used to assess participants' CR. Data was analysed using Spearman rank-order correlation, Kruskal-Wallis and Mann-Whitney U tests at p≤0.05. RESULTS: Participants generally had deficits in CR which was either mild/moderate (52.1%) or severe (47.9%). Scores in the CR domains of distance mobility, performance of daily activities, recreational activities and family roles were particularly low (median scores ≤ 4). CR was significantly correlated with and influenced by age (r=-0.35; p=0.00) and presence/absence of diabetes mellitus (u=3.56.50; p=0.01), pre- (k=6.13; p=0.05) and post-stroke employment (k=18.26; p=0.00) status, type of assistive mobility device being used (AMD) (k=25.39; p=0.00) and support from the community (k=7.15; p=0.03) respectively. CONCLUSION: CR was generally poor for this CDSS sample. Survivors who are older, having diabetes as co-morbidity, using AMD (particularly wheel-chair) and without employment pre- and/or post-stroke may require keener attention. Rehabilitation focus may be targeted at enhancing mobility functions, vocational and social skills.