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Pembrolizumab as first-line treatment for advanced NSCLC in older adults: A phase II clinical trial evaluating geriatric and quality-of-life outcomes.
Blanco, R, Dómine, M, González, JL, Loutfi, S, Alfaro, J, Saldaña, J, Rubio, J, Campos, B, Hidalgo, J, Barba, A, et al
Lung cancer (Amsterdam, Netherlands). 2023;:107318
Abstract
OBJECTIVES Since specific data on immunotherapy in older adults with advanced non-small cell lung cancer (aNSCLC) are scarce, we designed this study to determine the overall survival (OS) at one year of first-line pembrolizumab in patients older than 70 years with aNSCLC expressing PD-L1. Secondary objectives included progression-free survival, disease-specific survival, response rate, tolerability, quality of life (QoL) changes, and geriatric assessments. MATERIALS AND METHODS A single-arm, open-label, phase II clinical trial was carried out by the Spanish Lung Cancer Group between February 2018 and November 2019 at ten active sites in Spain. We included patients 70 years old and older with histological or cytological documented stage IIIB or IV aNSCLC and PD-L1 expression ≥ 1%. Each subject received 200 mg of intravenous pembrolizumab every three weeks for a maximum of two years. RESULTS 83 patients were recruited for the study and 74 were finally analysed. Most were male (N = 64, 86.5%) and former smokers (N = 51, 68.9%). 24 patients (32.4%) completed at least one year of treatment, 62 (83.7%) discontinued treatment, and 30 (40.5%) experienced disease progression. The median follow-up of our cohort was 18.0 months [range: 0.1-47.7] and 46 patients (62.2%) died during the period of study. The estimated OS at one year was 61.7% (95% CI: 49.6-71.8%) and the median OS of our cohort was 19.2 months (95% CI: 11.3-25.5). QoL tended to improve throughout the study, although the differences were not statistically significant. The main geriatric scores remained stable, except for a worsening in nutritional status (P = 0.004) and an improvement in frailty (P = 0.028). CONCLUSION Our results support treating older adults with aNSCLC expressing PD-L1 with pembrolizumab in monotherapy. The stability of most geriatric scores and the positive trend on the patients' QoL should be highlighted, although our results did not reach statistical significance.
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Efficacy and Safety of the Adjuvant Use of Probiotic Bacillus clausii Strains in Pediatric Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study.
Vázquez-Frias, R, Consuelo-Sánchez, A, Acosta-Rodríguez-Bueno, CP, Blanco-Montero, A, Robles, DC, Cohen, V, Márquez, D, Perez, M
Paediatric drugs. 2023;25(1):115-126
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Irritable bowel syndrome (IBS) is considered both a health and a socioeconomic burden. Curative treatment for IBS is currently not available and current management strategies vary. Gut microbiota dysbiosis is increasingly considered as a vital factor in the etiopathogenetic of IBS; thus, gut microbiota are a potential therapeutic target. The aim of this study was to investigate the efficacy and safety of Bacillus clausii plus conventional treatment, compared with placebo plus conventional treatment, in children with IBS in Mexico. This study is a phase III, multicentre, randomised, placebo-controlled, double-blind, parallel clinical trial. Patients (n=259) were centrally randomised 1:1 to treatment with either B. clausii or placebo. Results show that IBS symptom relief in children was very high in both groups (B. clausii and placebo). In fact, there weren’t any significant differences between groups for proportion of patients with clinical improvements at Week 8 or any of the key secondary endpoints. Furthermore, the adverse event profile was similar between groups. Authors conclude that their study was not able to demonstrate the efficacy of B. clausii as an adjuvant to conventional treatment of patients with IBS.
Abstract
OBJECTIVES Current irritable bowel syndrome (IBS) treatments have limited efficacy and probiotics like Bacillus clausii (B. clausii) were found to be effective in the management of several gastrointestinal disorders. This phase III trial assessed the efficacy and safety of adding B. clausii (four strains: O/C, N/R, SIN, T), versus placebo, to conventional treatment of pediatric IBS in Mexico. METHODS Patients aged 6-17 years 11 months with IBS (Rome IV) for at least 2 months were randomized to receive either B. clausii (oral suspension, total dose 4 billion spores/day) or placebo once daily for 8 weeks. All patients also received conventional treatment. The primary endpoint was the difference in the proportion of patients with clinical improvements at Week 8 (Global Assessment Questions [GAQ]). Secondary endpoints included responders by Subject's Global Assessment of Relief for Children with IBS (SGARC); number/consistency of stools; abdominal distention/bloating; abdominal pain/intensity; and IBS behavior. RESULTS 73.6% (95% confidence interval [CI] 67.3-80.0; B. clausii n = 129) and 78.5% (95% CI 72.5-84.4; placebo n = 130) of patients had symptom improvement (p = 0.8182). For Week 8 SGARC, 19.2% (B. clausii) and 20.9% (placebo) reported complete symptom relief. Stool evaluations, bloating, abdominal pain/intensity, and IBS behavior were similar between groups. Both treatments were well tolerated. CONCLUSION No significant differences in efficacy between B. clausii and placebo were demonstrated in addition to conventional treatment. The sample size calculation was based on an expected placebo/conventional treatment response of 30-40%. However, the actual treatment response observed was 80% and, thus, a study with larger population would be warranted. In addition, this study was conducted during the COVID-19 pandemic, when such controlled social conditions may have resulted in better diet, greater family stability, less psychological stress, and lower risk of infections exacerbating IBS, thereby improving symptoms in both groups. EUDRACT NUMBER 2018-004519-31.
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[Interventions to prevent the development of overweight and obesity in children younger than five years].
Bonilla, C, Híjar, G, Márquez, D, Aramburú, A, Aparco, JP, Gutiérrez, EL
Revista peruana de medicina experimental y salud publica. 2017;(4):682-689
Abstract
Childhood obesity is one of the most severe public health problems worldwide. The present study describes the interventions used to prevent overweight and obesity in children younger than 5 years. The objective of the interventions was to stimulate breastfeeding, monitor the child's growth, and promote adequate complementary feeding by means of nutritional counseling using a responsive feeding approach in different settings, including health centers and residences. The interventions included physical activity and nutritional counseling, with the active participation of the parents. The quality of evidence from most studies was high because the evidence was derived from controlled clinical trials, systematic reviews, and meta-analyses. All interventions were conducted or could be replicated in Peru by adequate contextualization.
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Effectiveness and safety of tisuacryl in treating dentin hypersensitivity (DH).
Pérez, Mde L, Mayelin Guerra, R, Fernández, M, Márquez, D, Velazco, G, Rodríguez, J, Alemán, E, Garcia, L, Suárez, O, Rodríguez, Mdel C, et al
MEDICC review. 2010;(1):24-8
Abstract
INTRODUCTION Dentin hypersensitivity (DH) is a painful tooth condition affecting a large proportion of the world population. While DH is not a direct cause of tooth loss, it does cause discomfort and stress. DH treatment methods include desensitizers, such as fluoride compounds; polycyanoacrylate coating; low intensity laser therapy; and surgery as a last resort. In Cuba, a fluoride varnish, Profilac, is widely used with acceptable results. Tisuacryl, an N-butyl-2-cyanoacrylate-based tissue adhesive is licensed in Cuba as a medical device used for closing wounds and as a protective covering or dressing for oral tissues. Experimental use of Tisuacryl in DH treatment has begun recently with good results. OBJECTIVE Evaluate the effectiveness and safety of Tisuacryl in treating dentin hypersensitivity. METHODS An experimental, prospective, longitudinal, multicenter, non-controlled clinical investigation was conducted using the licensed medical device Tisuacryl. The study universe consisted of patients with DH symptoms who sought treatment at three dental clinics in Havana Province between May 2007 and February 2009. The sample consisted of 152 patients who met inclusion and diagnostic criteria for the study. DH was classified as severe, moderate, or mild. Remission of dentinal pain was the principal variable for evaluating effectiveness. Safety variables were mucosal irritation and burning sensation at the treatment site. Treatment was considered successful if DH was cured, defined as remission of pain and relief of discomfort (irritation or burning sensation) with no other adverse events by the final evaluation on day 6 after treatment initiation. RESULTS Tisuacryl treatment was successful in 96.7% of patients (81.5% with severe DH and 100% with mild to moderate DH). Mucosal irritation was observed in only 1 patient at first evaluation on day 2 but disappeared by the second evaluation. No other adverse events were reported. CONCLUSIONS Tisuacryl was shown to be an effective, safe treatment of dentin hypersensitivity, especially moderate and mild cases.