METHODS: This retrospective study of patients with NSCLC from 18 major hospitals (public, private or university teaching hospitals) enrolled in Malaysia's National Cardiovascular and Thoracic Surgical Database (NCTSD) assessed the efficacy of lower doses of afatinib on treatment outcomes in a real-world clinical practice. Data on clinical characteristics, afatinib dosing, and treatment outcomes for patients included in NCTSD from 1st January 2015 to 31st December 2020 were analyzed.
RESULTS: Of the 133 patients studied, 94.7% had adenocarcinoma. Majority of the patients (60.9%) had EGFR exon 19 deletion and 23.3% had EGFR exon 21 L858R point mutation. The mean age of patients was 64.1 years and majority (83.5%) had Eastern Cooperative Oncology Group performance status of 2-4 at diagnosis. The most common afatinib starting doses were 40 mg (37.6%), 30 mg (29.3%), and 20 mg (26.3%) once daily (OD), respectively. A quarter of patients had dose reduction (23.3%) due to side effects or cost constraints. Majority of the patients had partial response to afatinib (63.2%) whilst 2.3% had complete response. Interestingly, the objective response rate was significantly higher (72.3%) with afatinib OD doses of less than 40 mg compared to 40 mg (54.0%) (P=0.032). Patients on lower doses of afatinib were two times more likely to achieve an objective response [odds ratio =2.64; 95% confidence interval (CI): 1.20-5.83; P=0.016]. These patients had a numerically but not statistically longer median time to treatment failure (TTF). Median TTF (95% CI) for the overall cohort was 12.4 (10.02-14.78) months. Median overall survival (95% CI) was 21.30 (15.86-26.75) months.
CONCLUSIONS: Lower afatinib doses (<40 mg OD) could be equally effective as standard dose in patients with EGFR-mutant advanced NSCLC and may be more suited to Asian patients, minimizing side effects that may occur at higher dosages of afatinib leading to dose interruptions and affecting treatment outcomes.
MATERIALS AND METHODS: This prospective cross-sectional study comprised 78 growing children in the age range of 11-14 years with polysomnography (PSG)-proven OSA and 86 non-OSA corresponding controls. BMI, tonsil size (Friedman grading scale), and Mallampati score were determined for both groups, and related differences were assessed with a t-test, while their independent association with OSA severity was tested with a regression analysis. Statistical significance was set at p <0.05.
RESULTS: Male gender, BMI, tonsil size, and Mallampati score were significantly higher in the OSA group (p < 0.05). A significant correlation was recorded between the Mallampati score and OSA severity (p < 0.01), but not with BMI or tonsil size (p > 0.05). For every 1-point increase in the Mallampati scale, the apnea-hypopnea index (AHI) increased by more than five events per hour in the bivariate analysis and by more than three events per hour in the multivariate analysis.
CONCLUSION: Male gender, increased BMI, high tonsil, and Mallampati scores were clinical indicators of the presence of OSA. However, only Mallampati scale had a significant association with OSA severity. Clinical diagnostic indicators should be established and encouraged especially in community-based studies.
CLINICAL SIGNIFICANCE: Clinical diagnostic indicators are very useful in examining and screening children who are at risk of developing OSA as PSG is expensive and unsuitable for universal use in the pediatric population.