Search

Background Adding radiotherapy (RT) to systemic therapy improves progression-free survival (PFS) and overall survival (OS) in oligometastatic non-small cell lung cancer (NSCLC). Whether these findings translate to epidermal growth factor receptor (EGFR)–mutated NSCLC remains unknown. The SINDAS trial (NCT02893332) evaluated first-line tyrosine kinase inhibitor (TKI) therapy for EGFR -mutated synchronous oligometastatic NSCLC and randomized to upfront RT vs no RT; we now report the prespecified interim analysis at 68% accrual. Methods Inclusion criteria were biopsy-proven EGFR -mutated adenocarcinoma (per amplification refractory mutation system or next generation sequencing), with synchronous (newly diagnosed, treatment naïve) oligometastatic (≤5 metastases; ≤2 lesions in any one organ) NSCLC without brain metastases. All patients received a first-generation TKI (gefitinib, erlotinib, or icotinib), and randomization was between no RT vs RT (25-40 Gy in 5 fractions depending on tumor size and location) to all metastases and the primary tumor/involved regional lymphatics. The primary endpoint (intention to treat) was PFS. Secondary endpoints included OS and toxicities. All statistical tests were 2-sided. Results A total of 133 patients (n = 65 TKI only, n = 68 TKI with RT) were enrolled (2016-2019). The median follow-up was 23.6 months. The respective median PFS was 12.5 months vs 20.2 months (P  < .001), and the median OS was 17.4 months vs 25.5 months (P  < .001) for TKI only vs TKI with RT. Treatment yielded no grade 5 events and a 6% rate of symptomatic grade 3-4 pneumonitis in the TKI with RT arm. Based on the efficacy results of this prespecified interim analysis, the ethics committee recommended premature cessation of this trial. Conclusions As compared with a first-line TKI alone, addition of upfront local therapy using RT statistically significantly improved PFS and OS for EGFR -mutated NSCLC. [ABSTRACT FROM AUTHOR]

Background: Adding radiotherapy (RT) to systemic therapy improves progression-free survival (PFS) and overall survival (OS) in oligometastatic non-small cell lung cancer (NSCLC). Whether these findings translate to epidermal growth factor receptor (EGFR)-mutated NSCLC remains unknown. The SINDAS trial (NCT02893332) evaluated first-line tyrosine kinase inhibitor (TKI) therapy for EGFR-mutated synchronous oligometastatic NSCLC and randomized to upfront RT vs no RT; we now report the prespecified interim analysis at 68% accrual., Methods: Inclusion criteria were biopsy-proven EGFR-mutated adenocarcinoma (per amplification refractory mutation system or next generation sequencing), with synchronous (newly diagnosed, treatment naïve) oligometastatic (≤5 metastases; ≤2 lesions in any one organ) NSCLC without brain metastases. All patients received a first-generation TKI (gefitinib, erlotinib, or icotinib), and randomization was between no RT vs RT (25-40 Gy in 5 fractions depending on tumor size and location) to all metastases and the primary tumor/involved regional lymphatics. The primary endpoint (intention to treat) was PFS. Secondary endpoints included OS and toxicities. All statistical tests were 2-sided., Results: A total of 133 patients (n = 65 TKI only, n = 68 TKI with RT) were enrolled (2016-2019). The median follow-up was 23.6 months. The respective median PFS was 12.5 months vs 20.2 months (P < .001), and the median OS was 17.4 months vs 25.5 months (P < .001) for TKI only vs TKI with RT. Treatment yielded no grade 5 events and a 6% rate of symptomatic grade 3-4 pneumonitis in the TKI with RT arm. Based on the efficacy results of this prespecified interim analysis, the ethics committee recommended premature cessation of this trial., Conclusions: As compared with a first-line TKI alone, addition of upfront local therapy using RT statistically significantly improved PFS and OS for EGFR-mutated NSCLC., (© The Author(s) 2022. Published by Oxford University Press.)

Objective: This study examined the levels of exhaled nitric oxide (eNO) and peripheral blood eosinophils (EOS) as well as the correlation between the two markers in children with bronchial asthma (AS),AS complicated by allergic rhinitis (AS/AR) and chronic cough variant asthma (CVA), in order to explore the value of eNOS detection in children with AS., Methods: The eNO level was measured using light-emitting electrochemical photometry in 12 children with AS, 29 children with AS/AR and 10 children with CVA. Peripheral blood EOS was counted by blood cell counter (Coulter JT). Forced expiratory volume in one second (FEV1) was assessed by lung function measurement. Thirty children without atopic disease and acute respiratory infection as well as without a family history of atopic diseasea served as the control group., Results: The levels of eNO and blood EOS in the AS, the AS/AR and the CVA groups were significantly higher than those in the control group (p<0.01). The AS/AR group showed increased levels of eNO (50.3 + or - 6.7 ppb) and EOS (5.9 + or -4.2 x 109 ) compared with the AS (30.5 + or - 8.8 ppb and 4.2 + or - 3.2 x 109 respectively) and the CVA groups (26.0 + or - 3.2 ppb and 3.7 + or - 6.9 x 109 respectively) (p<0.05). There were no significant differences in eNO and EOS levels between the AS and the CVA groups. The eNO level was positively correlated with the EOS level (r=0.51, p<0.05), but not with FEV1 (r=0.144, p>0.05) in the AS group., Conclusions: NO is highly expressed in children with symptoms of atopy and can reflect the levels of eosinophilic airway inflammation in children with AS.