Real world data of efficacy and safety of erlotinib as first-line TKI treatment in EGFR mutation-positive advanced non-small cell lung cancer: Results from the EGFR-2013-CPHG study.

BACKGROUND: Phase III clinical trials have demonstrated the merits of epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKI) in the treatment of non-small cell lung cancer (NSCLC) patients with EGFR-activating mutations. Using a cohort of unselected patients treated with erlotinib, we sought to further describe patient and tumour characteristics, and to evaluate their progression-free survival (PFS) and overall survival (OS). METHODS: Overall, 44 pulmonologists included patients with the required characteristics as follows: Stage IIIB-IV NSCLC, EGFR-activating mutation, age≥18 years, and having to start erlotinib therapy or receiving erlotinib therapy as the first-line TKI, regardless of treatment-line. The analyses were performed using R software, with survival rates calculated according to the Kaplan-Meier method. RESULTS: A total of 177 patients, aged 72 years on average, were enrolled over a 2-year period. The cohort included 123 women (69.5%), 158 Caucasians (89.3%), 112 non-smokers (63.2%), and 167 adenocarcinomas (94.3%), at either stage IIIB (21) or IV (156), with a good performance status (PS 0-1, 127). Overall, 40 exhibited brain metastases at baseline (22.6%), while 75 had undergone earlier treatment (42.4%). Median PFS was 11.7 months and OS 25.8 months, with respectively a 1-year rate of 48.6% and 74%. The risk of death correlated with ECOG status (PS=2, HR=4.48, P<0.001) but not with brain metastasis (HR=1.67, P=0.278). CONCLUSIONS: This study has confirmed erlotinib's efficacy and safety for unselected patients, with PFS and OS comparable to those obtained in phase III trials.

[Patients in the IDEAL cohort: A snapshot of severe asthma in France]. / Les patients de la cohorte IDEAL : une photographie de l'asthme sévère en France.

INTRODUCTION: This paper reports the French data from a post-hoc analysis of the international IDEAL study, which aimed to describe a recent cohort of patients with severe asthma, the impact of the disease on quality of life, as well as the population of patients eligible for treatment with omalizumab, mepolizumab and reslizumab. METHODS: Eligible patients were≥12 years of age, with severe asthma (GINA steps 4 and 5). RESULTS: A total of 129 patients were included in this post-hoc analysis. Their mean age was 53 years, the majority were overweight, they were mainly women (64%) and had at least one medical comorbidity (85%). More than half had suffered from asthma for more than 25 years and were non-smokers. Lung function was moderately impaired. Blood eosinophil count was≥150 cells/µL in 66% of patients,≥300 cells/µL in 34% of patients, and≥500 cells/µL in 12% of patients. One out of three patients was currently treated with omalizumab and 24% had maintenance oral corticosteroids. Asthma was poorly controlled with a negative impact on quality of life (ACQ≥1.5) in 67% of patients. In this population 40% of patients were eligible for omalizumab, 27% for mepolizumab and 2% for reslizumab. CONCLUSIONS: These findings show that a considerable proportion of patients with severe asthma remain uncontrolled and are not eligible for any of the available biological treatments. This underlines the need for therapeutic innovations in this disease.

Lung function parameters in omalizumab responder patients: An interesting tool?

BACKGROUND: Omalizumab, an anti-IgE antibody, is used to treat patients with severe allergic asthma. The evolution of lung function parameters over time and the difference between omalizumab responder and nonresponder patients remain inconclusive. The objective of this real-life study was to compare the changes in forced expiratory volume in 1 second (FEV1) of omalizumab responders and nonresponders at 6 months. METHODS: A multicenter analysis was performed in 10 secondary and tertiary institutions. Lung function parameters (forced vital capacity (FVC), pre- and postbronchodilator FEV1, residual volume (RV), and total lung capacity (TLC) were determined at baseline and at 6 months. Omalizumab response was assessed at the 6-month visit. In the omalizumab responder patients, lung function parameters were also obtained at 12, 18, and 24 months. RESULTS: Mean prebronchodilator FEV1 showed improvement in responders at 6 months, while a decrease was observed in nonresponders (+0.2±0.4 L and -0.1±0.4 L, respectively, P<.01). After an improvement at 6 months, pre- and postbronchodilator FEV1 remained stable at 12, 18, and 24 months. The FEV1/FVC remained unchanged over time, but the proportion of patients with an FEV1/FVC ratio <0.7 decreased at 6, 12, 18, and 24 months (55.2%, 54.0%, 54.0%, and 44.8%, respectively, P<.05). Mean RV values decreased at 6 months but increased at 12 months and 24 months (P<.05). Residual volume/total lung capacity (RV/TLC) ratio decreased at 6 months and remained unchanged at 24 months. CONCLUSION: After omalizumab initiation, FEV1 improved at 6 months in responder patients and then remained stable for 2 years. RV and RV/TLC improved at 6 months.

[Features of asthma in women: what is the relationship with hormonal status?]. / Particularités de l'asthme de la femme: quelle relation avec le statut hormonal?

INTRODUCTION: The prevalence and control of asthma are modulated by hormonal changes in women, suggesting an influence of sex hormones on the airways. BACKGROUND: The blood levels of both oestrogens and progesterone can modulate airway tone and inflammation. Asthma prevalence changes at puberty and the menopause, events also associated with modifications of adipose tissue and behaviour. Changes in lung function and asthma control are well documented during the menstrual cycle. However, an effect of hormone therapy on asthma control has not been demonstrated. PERSPECTIVE: The effect of a targeted hormonal therapeutic intervention in menopausal asthma, a phenotype, which is frequently particularly severe, or in premenstrual asthma, should be evaluated by randomized trials. CONCLUSION: Involvement of sex hormones and their cyclical variations in the characteristics of asthma in women is probable, despite lack of convincing data. However, no definitive protective or deleterious effect can be assigned. Complex interactions with adipose tissue, airways anatomy and the domestic or working environment must be taken into account to explain these differences.

Quality of life in lung cancer: does disclosure of the diagnosis have an impact?

BACKGROUND: Quality of life (QOL) is an important component of evaluation in oncology. Usually, QOL is used in phase III studies to compare two treatments. The aim of this trial was to evaluate the impact of the disclosure of the diagnosis of cancer on QOL by using the European Organisation for Research and Treatment of Cancer core Quality of Life Questionnaire (EORTC QLQ)-C30 questionnaire and the supplemental lung cancer-specific module QLQ-LC13. PATIENTS AND METHODS: Patients hospitalised for exploration of an abnormal chest X-ray, with no previous history of cancer, a performance status < or =2, and able to fulfil the questionnaire were eligible. The patients answered the questionnaire two times: before (Q1) and after (Q2) the disclosure of the diagnosis. RESULTS: Seventy patients answered at Q1 and Q2. After the disclosure, some scores deteriorated: arm pain (P=0.009), physical functioning (P=0.01), role functioning (P=0.008), emotional functioning (P=0.0001) and social functioning (P=0.012), whereas the patients' own assessment of global QOL (item global QOL in functioning scales) did not show the same evolution. CONCLUSION: Disclosure of the diagnosis had an impact on social and emotional QOL. Patients with lung cancer need psychological support at the beginning of their disease.

Unexpected effects of inhaled fluticasone in an HIV patient with asthma.

International guidelines recommend prescription of inhaled corticosteroids to improve asthma control. Chronic secondary adrenal suppression due to inhaled corticosteroids has been described. We report a case of acute adrenal suppression due to drug interaction between Fluticasone and antiretroviral therapy in a HIV patient. Seeing an increased prevalence of hyperresponsiveness among HIV-infected men, we conclude that coprescription of Fluticasone and highly active antiretroviral therapy must be carefully controlled.

[Validation of an asthma knowledge questionnaire]. / Validation d'un questionnaire de connaissances sur l'asthme.

INTRODUCTION: A patient's knowledge of his disease and its treatment is an essential part of the evaluation of an educational process. It is useful therefore to use a rapid, easy and valid means of collecting the information necessary to produce an educational programme adapted to the needs of the patient. METHODS: Following a review of the literature an initial questionnaire was constructed. It included four domains: biomedical, signs and symptoms of severity, general knowledge and treatment. The questionnaire was administered to 73 asthmatics in order to assess its clarity and comprehensibility. It was then reviewed and modified in both format and content by 10 French experts. The revised questionnaire was completed by 108 asthmatics distributed throughout 10 French respiratory centres, a group of 83 non-asthmatic subjects and 203 sixth year medical students at the Bordeaux University School of Medicine. RESULTS: The mean scores were: 19 for the non-asthmatics (range 2-36), 25.7 for the asthmatics (range 4-38) and 32.9 for the students (range 17-40), p 0.0001. The questionnaire was shown to be discriminating with good reliability and reproducibility: alpha Cronbach coefficient=0.82; intra-class correlation coefficient=0.70. CONCLUSIONS: This study has validated a French language asthma knowledge questionnaire.

[Mediastinal sarcoidosis and vascular thrombosis: a fortuitous association?]. / Sarcoïdose médiastinale et thrombose vasculaire: association fortuite?

A 43-year-old woman presented with a recent history of intermittent dyspnea with wheezing. The chest x-ray evidenced mediastinal nodes. A CT scan showed vascular embolism. Mediastinoscopy was performed and pathology examination of the node confirmed the diagnosis of sarcoidosis. The patient responded to corticosteroid and anticoagulation therapy. Is this a fortuitous association? A vascular localization of sarcoidosis? Thrombosis by compression?