Efficacy and Safety of Anti-PD-1 Immunotherapy in Patients With Advanced NSCLC With BRAF, HER2, or MET Mutations or RET Translocation: GFPC 01-2018.

INTRODUCTION: Immune-checkpoint inhibitor (ICI) efficacy in patients with NSCLC harboring molecular alterations remains poorly elucidated. This study was undertaken to determine ICI efficacy against BRAF-, HER2-, MET-, and RET-NSCLC in a real-world setting. METHODS: In this retrospective, multicenter study in ICI-treated BRAF-, HER2-, MET- or RET-NSCLCs, we analyzed clinical characteristics and outcomes: ICI-treatment duration, progression-free survival (PFS), objective response rate, duration of response, and overall survival (OS). RESULTS: There were 107 patients with NSCLC (mean age, 65.5 y) included from 21 centers: 37% were never-smokers, 54% were men, and 93% had adenocarcinoma. Among them, 44 had BRAF mutation (V600: 26), 23 had HER2 mutation, 30 had MET mutation, and nine had RET translocation. Programmed cell death ligand 1 (PD-L1) status was known for 70 patients and was greater than or equal to 1% in 34 patients. Before ICI, patients had received a median of one treatment line. Median duration of response, PFS, and OS were 15.4 (95% confidence interval [CI]: 12.6-not reached [NR]) months, 4.7 (95% CI: 2.3-7.4) months, and 16.2 (95% CI: 12.0-24.0) months, respectively, for the entire cohort. The response rates for BRAF-V600, BRAF-non-V600, HER2, MET, and RET-altered NSCLC were 26%, 35%, 27%, 36%, and 38%, respectively. For patients who were PD-L1 negative and those who were PD-L1 positive, PFS was 3.0 (95% CI: 1.2-NR) and 4.3 (95% CI: 2.1-8.5) months, respectively, and OS was 11.7 (95% CI: 4.1-NR) and 35.8 (95% CI: 9.0-35.2) months, respectively. Toxicities were reported in 28 patients (26%), including 11 patients (10%) with a grade greater than or equal to three. CONCLUSIONS: In this real-world setting, ICI efficacy against patients with BRAF-, HER2-, MET-, or RET-NSCLC seemed close to that observed in unselected patients with NSCLC. Large prospective studies on these subsets of patients are needed.

Impact of Programmed Death Ligand 1 Expression in Advanced Non-Small-Cell Lung Cancer Patients, Treated by Chemotherapy (GFPC 06-2015 Study).

BACKGROUND: Few data have been published on the clinical and histopathological characteristics of advanced non-small-cell lung cancer (NSCLC) patients with high PD-L1 expression versus intermediate or none and the prognostic value of PD-L1 expression for patients treated with chemotherapy is unknown. This study was undertaken to prospectively assess the prognostic value of tumor-cell (TC) and immune-cell (IC) PD-L1 expressions for advanced NSCLC patients. METHODS: It was a prospective, multicenter study on advanced NSCLC patients, with performance status 0/1, scheduled, consecutively, to receive first-line platin-based chemotherapy. PD-L1 expression was determined immunochemically (Dako Autostainer and monoclonal antibody 22C3) and its impact on progression-free survival (PFS) and overall survival (OS) assessed. RESULTS: Among 198 patients screened in 19 centers, 140 were included median age: 66.5 ± 10 years; 76.4% men; 79.3% Caucasians; 10.7% nonsmokers; 63.6% adenocarcinomas; <1%, 1-50% and ≥50% TC PD-L1-expression rates were 47.1%, 25.7% and 27.2% of patients, respectively; respective null, intermediate and high rates on ICs were 35.7%, 38.6% and 25.7%. Second- and third-line chemotherapies were administered to 58.6% and 26.4% of the patients, respectively. None received immunotherapy. First-, second- and third-line median (95% CI) PFS lasted 4.6 (3.6-5.2), 3.7 (2.3-4.7) and 2.2 (1.5-4.3) months, respectively; median OS was 16.9 (11.4-19.9) months. No significant PFS and OS differences were observed according to TC or IC PD-L1 expression. CONCLUSION: According to the results of this prospective, multicenter study, neither TC nor IC PD-L1 expression appears to be prognostic for chemotherapy-managed advanced NSCLC patients.

Performance de l'oxymétrie nocturne dans le diagnostic du syndrome d'apnées du sommeil. Etude monocentrique menée au centre Hospitalier de Longjumeau/France

Contexte & objectif. Le syndrome d'apnées du sommeil est une pathologie fréquemment sous diagnostiquée et souvent méconnue; particulièrement à cause d'une accessibilité insuffisante au gold-standard du diagnostic, la polysomnographie ou la polygraphie ventilatoire. Et pourtant, l'affection est responsable des complications surtout cardiovasculaires majeures. L'objectif de la présente étude était d'évaluer le niveau de performance de l'oxymétrie nocturne dans le diagnostic du syndrome d'apnées du sommeil. Méthodes. Enquête transversale menée entre le 1er janvier 2016 et le 30 septembre 2017. Tous les patients hospitalisés pour suspicion du syndrome d'apnées du sommeil ont bénéficié d'une oxymétrie nocturne et d'une polygraphie ventilatoire. Les logiciels Excel 2010 et SSPSS 21.0 ont permis d'analyser les données. Nous avons déterminé la sensibilité, la spécificité, la valeur prédictive positive et la valeur prédictive négative. La courbe ROC a été calculée. p < 0,05. Résultats. Au total 201 patients d'âge moyen de 64,6±11,8 ans, avec une prédominance masculine (55%) et en majorité obèses (IMC moyen de 32kg/m²) ont été inclus. La sensibilité et la spécificité de l'oxymétrie nocturne sont respectivement de 87 et de 85% avec une courbe ROC montrant une surface importante sous la courbe de 0,75. Conclusion. Avec sa sensibilité et spécificité élevées, l'oxymétrie nocturne peut constituer une alternative valable au diagnostic du syndrome d'apnées du sommeil. Son innocuité et sa bonne acceptabilité en font un outil facilement exportable et recommandable en cas de carence de moyens appropriés