Patients with non-small-cell lung cancer harbouring a BRAF mutation: a multicentre study exploring clinical characteristics, management, and outcomes in a real-life setting: EXPLORE GFPC 02-14.

Background: Mutations in BRAF are rare oncogene mutations, found in 2% of non-small-cell lung cancers (nsclcs). Little information is available about the management of patients with BRAF-mutated nsclc, except for those included in clinical trials. We undertook the present study to assess the clinical characteristics, management, and outcomes of those patients in a real-life setting. Methods: This retrospective multicentre observational study included all patients with BRAF-mutated nsclc diagnosed between January 2012 and December 2014. Results: Patients (n = 59) from 24 centres were included: 57.6% men; mean age: 64.5 ± 14.5 years; 82% with a performance status of 0-1 at diagnosis; smoking status: 40.3% current, 32.6% former; 93% with adenocarcinoma histology; 75% stage iv; 78% with V600E mutations; 2 with EGFR and 2 with ALK co-mutations. Of the stage iv patients, 79% received first-line therapy (14.2% anti-BRAF), and 48% received second-line treatment (23.8% anti-BRAF). Response rate and progression-free survival were, respectively, 51.7% and 8.7 months [95% confidence interval (ci): 6.4 months to 15.2 months] for first-line therapy and 35.3% and 4.1 months (95% ci: 2 months to 10.9 months) for second-line treatments. The 2-year overall survival was 58.5% (95% ci: 45.8% to 74.8%). Outcomes in patients with stage iv nsclc harbouring BRAF V600E mutations (n = 32) did not differ significantly from those of patients with other BRAF mutations. Conclusions: In this real-world analysis, most nsclc patients with a BRAF mutation were men and current or former smokers. Survival appears to be better in these BRAF-mutated patients than in nsclc patients without an oncogenic driver.

Impact of Continuing First-Line EGFR Tyrosine Kinase Inhibitor Therapy Beyond RECIST Disease Progression in Patients with Advanced EGFR-Mutated Non-Small-Cell Lung Cancer (NSCLC): Retrospective GFPC 04-13 Study.

UNLABELLED: Retrospective studies suggested a benefit of first-line tyrosine kinase inhibitor (TKI) treatment continuation after response evaluation in solid tumors (RECIST) progression in epidermal growth factor receptor (EGFR)-mutated non-small-cell lung cancer (NSCLC) patients. The aim of this multicenter observational retrospective study was to assess the frequency of this practice and its impact on overall survival (OS). The analysis included advanced EGFR-mutated NSCLC patients treated with first-line TKI who experienced RECIST progression between June 2010 and July 2012. Among the 123 patients included (67 ± 12.7 years, women: 69 %, non smokers: 68 %, PS 0-1: 87 %), 40.6 % continued TKI therapy after RECIST progression. There was no difference between the patients who did and did not continue TKI therapy with respect to progression-free survival (PFS1: 10.5 versus 9.5 months, p = 0.4). Overall survival (OS) showed a non-significant trend in favor of continuing TKI therapy (33.0 vs. 21.2 months, p = 0.054). Progressions were significantly less symptomatic in the TKI continuation group than in the discontinuation group (18 % vs. 37 %, p < 0.01). Univariate analysis showed a higher risk of death among patients with PS >1 (HR 4.33, 95 %CI: 2.21-8.47, p = 0.001), >1 one metastatic site (HR 1.96, 95 %CI: 1.06-3.61, p = 0.02), brain metastasis (HR 1.75, 95 %CI: 1.08-2.84, p = 0.02) at diagnosis, and a trend towards a higher risk of death in cases of TKI discontinuation after progression (HR 1.62, 95 %CI: 0.98-2.67, p = 0.056 ). In multivariate analysis only PS >1 (HR 6.27, 95 %CI: 2.97-13.25, p = 0.00001) and >1 metastatic site (HR 2.54, 95 %CI: 1.24-5.21, p = 0.02) at diagnosis remained significant. This study suggests that under certain circumstances, first-line TKI treatment continuation after RECIST progression is an acceptable option in EGFR-mutated NSCLC patients. CLINICAL TRIAL INFORMATION: NCT02293733.

Management of malignant pleural mesothelioma: a French multicenter retrospective study (GFPC 0802 study).

BACKGROUND: Malignant pleural mesothelioma (MPM) is a rare disease with poor prognosis in spite of significant improvement in survival, due to new chemotherapy regimens. We describe here patients' profiles and management in daily practice in France. METHODS: Observational retrospective study. Data were collected from medical files. All patients with histologically proven MPM diagnosed from January 2005 to December 2008 were included in the participating sites. RESULTS: Four hundred and six patients were included in 37 sites: mean age 68.9 ± 9.8 years, male predominance (sex ratio 3.27), latency of the disease 45.7 years, epithelioïd type 83 %. Diagnosis was made using thoracoscopy in 80.8 % of patients. Radical surgery was performed in 6.2 % of cases. Chemotherapy was administered to 74.6 % of patients. First line regimens consisted mainly of platinum + pemetrexed (91 %) or pemetrexed alone (7 %). Objective response rate was 17.2 % and another 41.6 % of patients experienced disease stabilization. Half of these patients underwent second line chemotherapy (platinium + pemetrexed 31.6 %, pemetrexed alone 24.6 %), resulting in a 6 % response rate. Third-line chemotherapy (56 patients) yielded disease control in 5.4 % of cases. CONCLUSIONS: The management of MPM in France is usually in accordance with guidelines. Response rates are somewhat lower than those described in clinical trials.

Randomized open-label non-comparative multicenter phase II trial of sequential erlotinib and docetaxel versus docetaxel alone in patients with non-small-cell lung cancer after failure of first-line chemotherapy: GFPC 10.02 study.

BACKGROUND: Concomitant administration of erlotinib with standard chemotherapy does not appear to improve survival among patients with non-small-cell lung cancer (NSCLC), but preliminary studies suggest that sequential administration might be effective. OBJECTIVE: To assess the efficacy and tolerability of second-line sequential administration of erlotinib and docetaxel in advanced NSCLC. METHODS: In an open-label phase II trial, patients with advanced NSCLC, EGFR wild-type or unknown, PS 0-2, in whom initial cisplatin-based chemotherapy had failed were randomized to sequential erlotinib 150 mg/d (day 2-16)+docetaxel (75 mg/m(2) d1) (arm ED) or docetaxel (75 mg/m(2) d1) alone (arm D) (21-day cycle). The primary endpoint was the progression-free survival rate at 15 weeks (PFS 15). Secondary endpoints included PFS, overall survival (OS), the overall response rate (ORR) and tolerability. Based on a Simon optimal two-stage design, the ED strategy was rejected if the primary endpoint was below 33/66 patients at the end of the two Simon stages. RESULTS: 147 patients were randomized (median age: 60±8 years, PS 0/1/2: 44/83/20 patients; males: 78%). The ED strategy was rejected, with only 18 of 73 patients achieving PFS15 in arm ED at the end of stage 2 and 17 of 74 patients in arm D. In arms ED and D, respectively, median PFS was 2.2 and 2.5 months and median OS was 6.5 and 8.3 months. CONCLUSION: Sequential erlotinib and docetaxel was not more effective than docetaxel alone as second-line treatment for advanced NSCLC with wild-type or unknown EGFR status.

Two biomarker-directed randomized trials in European and Chinese patients with nonsmall-cell lung cancer: the BRCA1-RAP80 Expression Customization (BREC) studies.

BACKGROUND: In a Spanish Lung Cancer Group (SLCG) phase II trial, the combination of BRCA1 and receptor-associated protein 80 (RAP80) expression was significantly associated with outcome in Caucasian patients with nonsmall-cell lung cancer (NSCLC). The SLCG therefore undertook an industry-independent collaborative randomized phase III trial comparing nonselected cisplatin-based chemotherapy with therapy customized according to BRCA1/RAP80 expression. An analogous randomized phase II trial was carried out in China under the auspices of the SLCG to evaluate the effect of BRCA1/RAP80 expression in Asian patients. PATIENTS AND METHODS: Eligibility criteria included stage IIIB-IV NSCLC and sufficient tumor specimen for molecular analysis. Randomization to the control or experimental arm was 1 : 1 in the SLCG trial and 1 : 3 in the Chinese trial. In both trials, patients in the control arm received docetaxel/cisplatin; in the experimental arm, patients with low RAP80 expression received gemcitabine/cisplatin, those with intermediate/high RAP80 expression and low/intermediate BRCA1 expression received docetaxel/cisplatin, and those with intermediate/high RAP80 expression and high BRCA1 expression received docetaxel alone. The primary end point was progression-free survival (PFS). RESULTS: Two hundred and seventy-nine patients in the SLCG trial and 124 in the Chinese trial were assessable for PFS. PFS in the control and experimental arms in the SLCG trial was 5.49 and 4.38 months, respectively [log rank P = 0.07; hazard ratio (HR) 1.28; P = 0.03]. In the Chinese trial, PFS was 4.74 and 3.78 months, respectively (log rank P = 0.82; HR 0.95; P = 0.82). CONCLUSION: Accrual was prematurely closed on the SLCG trial due to the absence of clinical benefit in the experimental over the control arm. However, the BREC studies provide proof of concept that an international, nonindustry, biomarker-directed trial is feasible. Thanks to the groundwork laid by these studies, we expect that ongoing further research on alternative biomarkers to elucidate DNA repair mechanisms will help define novel therapeutic approaches. TRIAL REGISTRATION: NCT00617656/GECP-BREC and ChiCTR-TRC-12001860/BREC-CHINA.

Clinical management patterns and treatment outcomes in patients with non-small cell lung cancer (NSCLC) across Europe: EPICLIN-Lung study.

BACKGROUND: Throughout Europe, physicians face similar challenges in non-small cell lung cancer (NSCLC) management, but comprehensive international information on usual clinical practice is lacking so the burden of NSCLC is not fully understood. METHODS: This multinational, multicentre, non-interventional study (NCT00831909) was conducted in eight European countries. Patients with confirmed NSCLC were consecutively enrolled from January to March 2009 and followed for 12 months or until death. Information was collected on patient and disease characteristics, diagnosis and treatment patterns, and clinical outcomes. Spontaneously reported adverse events (AEs) were also recorded. RESULTS: Data were available for 3508 patients. Most patients (77.5%) were male, median (range) age was 65.0 years (21.6-90.7), the majority of patients had a World Health Organization performance status of ≤1 (74.7%), and 10.8% were never smokers. The most prevalent histologies were adenocarcinoma (43.8%) and squamous-cell carcinoma (29.4%). Most patients presented with advanced disease (11.6% with stage IIIA, 18.7% with stage IIIB, 48.6% with stage IV). In stage IV disease, median progression-free survival and overall survival (months) by first-line treatment cluster were platinum regimens: 6.5, 10.8; non-platinum regimens: 4.3, 8.5; regimens with bevacizumab 8.7, 12.9; investigational regimens: 5.6, 10.8; best supportive care: 5.4, 6.6. The most frequently reported severe (Common Terminology Criteria for Adverse Events v3.0>2) AEs were blood/bone marrow (16.0%) and pulmonary/upper respiratory (7.8%). Key limitations of this study related to its non-interventional nature and wide regional focus; for example, achieving a representative sample of the overall NSCLC population, variation in recruitment between countries, and data based on information from medical records derived from routine visits. CONCLUSIONS: The Epidemiological Study to Describe NSCLC Clinical Management Pattern in Europe-Lung (EPICLIN-Lung) study provides new insights into the descriptive patterns and clinical management strategies for NSCLC across Europe, and how they affect patient outcomes.

Real-world healthcare resource utilization in a European non-small cell lung cancer population: the EPICLIN-Lung study.

BACKGROUND: There is a lack of data on health resource assessment in non-small cell lung cancer (NSCLC) to inform clinical decision-making. The Epidemiological Study to Describe NSCLC Clinical Management Pattern in Europe-Lung (EPICLIN-Lung) study provides information on healthcare resource utilization associated with different NSCLC treatment strategies in real-life clinical settings. METHODS: This multinational, multicenter, non-interventional study (NCT00831909) was conducted in eight European countries in 2009-2010. Patients with confirmed NSCLC were enrolled and followed for 12 months or until death. Information was collected on patient and disease characteristics, diagnosis and treatment patterns. Healthcare resource utilization was described in relation to diagnostic patterns and treatment received. RESULTS: Data were available for 3508 patients (median age=65.0 years, male=77.6%, Caucasian=98.4%, adenocarcinoma=43.8%, stage IV=48.6%, 10.8% never smoked). The overall mean number of hospitalization days was 16.4 (standard deviation (SD)=18.42). Patients were followed up for a mean of 245.8 (131.4) days. Most patients (96.0%) underwent imaging procedures, most commonly scanning (93.9%). Surgery was associated with a mean of 12.5 (9.33) hospitalization days, with lobectomy and extended procedures (20.3%) being the most common surgery types. Radiotherapy resulted in a mean of 11.6 (14.12) hospitalization days. The majority of radiotherapy was palliative (56.0%), which resulted in fewer (mean 9.5 [11.12]) hospitalization days. Administration of systemic treatment resulted in a mean of 6.5 (8.04) hospitalization days, 1.7 (3.59) visits for disease-related events, 2.3 (1.83) adverse events and 5.4 (5.86) blood-specific resources. The key limitations of this study are those inherent to its non-interventional nature and wide regional focus, and the lack of cost-effectiveness data. CONCLUSIONS: EPICLIN-Lung provides important, Europe-wide information on drivers of healthcare resource use in different treatment strategies for NSCLC.

Update on the treatment of non-small-cell lung cancer: focus on the cost-effectiveness of new agents.

BACKGROUND: The incidence of lung cancer and the cost of drug treatment have increased dramatically in the last decade. This article examines the costs of new target agents, such as tyrosine kinase inhibitors (TKIs) and anti-angiogenic drugs. METHODS: This study uses PubMed research to focus on the topics of lung cancer, economics, and new targeted therapies. RESULTS: The published papers only addressed TKIs and anti-angiogenic antibodies. For gefitinib, the results favored a clinical-based selection, despite the low number of studies. Erlotinib was studied in second line and as a maintenance treatment (with the studies reaching opposite conclusions in terms of cost-effectiveness). Economic analyses were not in favor of bevacizumab, but the studies on this topic were very heterogeneous. CONCLUSION: The economic impact of a drug depends on the health care system organization. Future clinical trials must include economic analyses, particularly with TKIs in the first line.

[Supportive, palliative care in lung cancer]. / Les soins de support dans les cancers bronchopulmonaires (CBP).

BACKGROUND: Despite recent advances, the prognosis of lung cancer (LC) remains poor and justifies the early introduction of palliative care (PC) and supportive care (SC). The objective of this paper is to describe the published data in this field. METHODS: After definitions of PC and SC, the different types of study are depicted: randomized clinical trials (RCT) and observational studies. RESULTS: All the RCT (most often performed in the USA) have emphasised the importance of the early introduction of PC and SC (less aggressive treatments at the end of life, better quality of life). Observational studies are scarce. The one performed in France (ETOBSUP study) showed that PC and SC, in real life, have not reached the objectives of the National Cancer Institute. CONCLUSION: All the studies agreed that PC and SC should be introduced as early as possible in patients with LC.

Multicentre phase II study of cisplatin-etoposide chemotherapy for advanced large-cell neuroendocrine lung carcinoma: the GFPC 0302 study.

BACKGROUND: The optimal treatment of large-cell neuroendocrine carcinoma (LCNEC) of the lung remains unclear. Here, our primary objective was to assess the efficacy of cisplatin-etoposide doublet chemotherapy in advanced LCNEC. Accuracy of the pathological diagnosis and treatment toxicity were assessed as secondary objectives. PATIENTS AND METHODS: Prospective, multicentre, single-arm, phase II study with a centralised review of treatment-response and pathological data. Patients had untreated performance status (PS) 0/1 stage IV/IIIB LCNEC and received cisplatin (80 mg/m22 d1) and etoposide (100 mg/m22 d1-3) every 21 days. RESULTS: Eighteen centres included 42 patients (mean age, 59 ± 9 years; 69% men; median of four cycles/patient). At least one grade-3/4 toxicity occurred in 59% of patients (neutropaenia, thrombocytopaenia, and anaemia in 32%, 17%, and 12%, respectively). The median progression-free survival (PFS) and overall survival (OS) were 5.2 months (95% confidence interval, CI, 3.1-6.6) and 7.7 months (95% CI, 6.0-9.6), respectively. The centralised pathologist review reclassified 11 of 40 (27.5%) patients: 9 as small-cell lung cancer, 1 as undifferentiated non-small-cell lung cancer, and 1 as atypical carcinoid. Survival data were not significantly changed by excluding the reclassified patients. CONCLUSIONS: The pathological diagnosis of LCNEC is difficult. The outcomes of advanced LCNEC treated with cisplatin-etoposide doublets are poor, similar to those of patients with advanced small-cell lung carcinoma (SCLC).

[The Lady Windermere syndrome: clinical and bacteriological data and progress in seven cases]. / Le syndrome de Lady Windermere : données cliniques, bactériologiques et évolutives.

Described by Reich and Johnson in 1992 [2], the Lady Windermere syndrome occurs exclusively in non-smoking women over the age of 60 years, without significant pre-existing pulmonary disease. It comprises bronchial dilatation, typically in the middle lobe and lingula, together with secondary infection by atypical mycobacteria (Mycobacterium avium in the first cases). Among the 17 cases of atypical mycobacterial infection that we have seen in the past 14 years, there were seven cases of this syndrome. It was associated with cough, sputum, sometimes haemoptysis, febrile episodes and deterioration of general health. The diagnostic criteria and treatment were defined by the American Thoracic Society. The pathophysiological hypothesis proposed by Reich and Johnson was that voluntary suppression of the cough led to congestion of the bronchi and secondary infection with atypical mycobacteria. Currently it is thought more likely that the following factors are involved: progressive increase in dilatation of small bronchi, delayed diagnosis, morphological abnormalities of the thorax, hormonal factors, immune deficiency, genetic neutrophil dysfunction, and even heterozygous forms of cystic fibrosis.

A multicenter phase II randomized trial of gemcitabine followed by erlotinib at progression, versus the reverse sequence, in vulnerable elderly patients with advanced non small-cell lung cancer selected with a comprehensive geriatric assessment (the GFPC 0505 study).

BACKGROUND: The aim of this randomized phase II trial was to evaluate the feasibility and activity of weekly gemcitabine (G) followed by erlotinib at disease progression (arm A) versus erlotinib followed by G at progression (arm B) in vulnerable elderly patients with advanced non small-cell lung cancer (NSCLC), selected on the basis of a comprehensive geriatric assessment (CGA). METHODS: Vulnerable elderly chemotherapy-naive patients with stage IIIB/IV NSCLC were selected after a CGA (socioeconomic, cognitive and emotional status, depression, nutritional status, ADL and IADL assessments). The primary endpoint was the time to second progression (TTP2). Overall survival (OS), time to first progression (TTP1) and safety were secondary endpoints. RESULTS: Between May 2006 and January 2010, 21 centers enrolled 100 patients, of whom 94 were eligible. TTP2 was 4.3 and 3.5 months in arm A and arm B, respectively; TTP1 was 2.5 and 2.2 months; and the median OS time was 4.4 and 3.9 months. The respective one-year survival rates were 27.3% and 20%. There was no major unexpected toxicity. CONCLUSION: In vulnerable elderly patients with NSCLC not selected for EGFR expression, both strategies were feasible but had modest efficacy. Further studies are needed to identify elderly patients who should receive palliative care only.

[Geriatric assessment contribution to treatment decision-making in thoracic oncology]. / Impact de l'évaluation gériatrique sur la décision de traitement en oncologie thoracique.

BACKGROUND: Lung cancer is a frequently occurring disease among elderly people. The objective of this study was to search for a relationship between multimodal geriatric assessment and a decision-making in the treatment of patients with this condition. METHODS: Forty-nine elderly patients (aged 70 years and over) diagnosed with a primary lung cancer underwent a geriatric assessment before decision for treatment was made in a multidisciplinary meeting. We described the impact of the geriatric assessment on the management decisions made. RESULTS: Almost half of treatment (44.9%) decisions were modified by the geriatric assessment. For patients with so called "pre-frailty" according to Balducci's criteria, 60% of treatment decisions were modified by the results of geriatric assessment (use of only one chemotherapeutic drug, dose disease or best supportive care). For this group of patients, Folstein MMSE and IADL were predictive of change in decision-making, with the threshold estimated to be 26 points. Only the MMSE was significantly associated with the medical decision in multivariate analysis. CONCLUSION: Geriatric assessment should be integrated into treatment decision-making for patients with primary lung cancer aged more than 70 years, particularly those where frailty is a concern. Folstein's MMSE was predictive in our study for changes in decision-making.

A multicentre phase II randomised trial of weekly docetaxel/gemcitabine followed by erlotinib on progression, vs the reverse sequence, in elderly patients with advanced non small-cell lung cancer selected with a comprehensive geriatric assessment (the GFPC 0504 study).

BACKGROUND: Elderly cancer patients form a heterogeneous population in which therapeutic decision-making is often difficult. The aim of this randomised phase II trial was to evaluate the feasibility and activity of weekly docetaxel/gemcitabine (DG) followed by erlotinib after progression (arm A) vs erlotinib followed by DG after progression (arm B) in fit elderly patients with advanced non small-cell lung cancer (NSCLC). METHODS: Elderly chemotherapy-naive patients with stage IIIB/IV NSCLC were selected after a comprehensive geriatric assessment (socioeconomic, cognitive, depression, ADL and IADL assessments). The primary endpoint was the time to second progression (TTP2). Overall survival (OS), the time to first progression (TTP1) and safety were secondary endpoints. RESULTS: Between July 2006 and November 2008, 22 centres enrolled 100 patients. TTP2 was 7.5 and 5.8 months in arm A and arm B, respectively; TTP1 was 4.7 and 2.7 months; and the median OS time was 9.4 and 7.1 months; the respective 1-year survival rates were 36.2 and 31.4%. There was no major unexpected toxicity. CONCLUSION: These results suggest that weekly DG, followed by erlotinib, is a promising treatment for fit elderly patients with NSCLC; the efficacy of the reverse sequence was insufficient to recommend it for EGFR-non-selected patients.

Multicenter observational study of erlotinib therapy (OBSTAR) for non small-cell lung cancer: a GFPC study.

CONTEXT: Erlotinib therapy for non small-cell lung cancer (NSCLC) has mainly been evaluated in randomized trials. METHOD: OBSTAR was a multicenter, retrospective, observational study involving all patients treated with erlotinib in 18 French centers between June 2005 and September 2007. The analyses focused on the patients' characteristics, previous treatments, and treatment efficacy during a three-year follow-up period. RESULTS: 534 patients were included in this study. The median survival times were respectively 5.2 [3.7-7.4] and 4.7 [4.1-5.7] months, depending to whether erlotinib was used as second- (n=190), or ≥ third-line treatment (n=305). The disease control rate were 39.1% [30.2-48.7] and 29.9% [29.6-36.9] according to the line of treatment. Factors predictive of an objective response were gender, age, and smoking status. Factors predictive of progression were age, sex, smoking status, the line of treatment, and the number of metastases. Treatment had to be interrupted for toxicity in 8.5% of cases. CONCLUSION: This study of erlotinib therapy in 2005-2007 confirms, in the general NSCLC patient population, the results of pivotal trials.

[The costs of asthma in France and the economic implications of its level of control]. / Le coût de l'asthme en France et les implications économiques du niveau de contrôle.

INTRODUCTION: The prevalence of asthma is increasing in France and the proportion of patients with poorly controlled or uncontrolled asthma remains significant. The economic impact of this public health issue is still poorly documented and this is addressed in the present literature review. STATE OF THE ART: Older identified studies aimed to estimate the use of asthma-related health care resources according to the asthma severity. Only more recent studies have taken into account the level of control of the disease as well. A consistent finding was that asthma-related medical costs were highly dependent both on the degree of severity and level of control. PERSPECTIVES: Studies identified in this review used the recommendations current at the time of their publication to define severity or levels of control in connection to asthma-related medical consumption, which leads to important methodological variation among them. Economic evaluation which is generally based on annual consumption estimates is hampered by the fact that the level of control reflects only a short-term situation. CONCLUSIONS: Although data in the literature are consistent in showing that improved control of the disease significantly reduces the costs of its management, there is a need for economic studies based on recent definitions of control and using appropriate methodology.

[A phase II study of weekly cisplatine plus oral vinorelbine with concomittant radiotherapy in non-dependent elderly patients with localized inoperable non small cell lung carcinoma (Essai GFPC 08-06, Raccosa)]. / Radio-chimiothérapie concomitante chez le sujet âgé indépendant (Essai GFPC 0806 RACCOSA).

UNLABELLED: A phase II study of weekly cisplatine plus oral vinorelbine with concomittant radiotherapy in non-dependent elderly patients with localized inoperable non small cell lung carcinoma (Essai GFPC 08-06, Raccosa). BACKGROUND: Non small cell lung cancer (NSCLC) in elderly patients is an important problem because of the increasing incidence of NSCLC and the aging of the population. Elderly patients constitute a heterogeneous population including a significant group of relatively fit patients who ought to benefit from the conventional treatment. The standard treatment for a locally advanced NSCLC (inoperable IIIA and IIIB) is concomitant radiochemotherapy, however studies evaluating this treatment to the old subject are few. METHODS: This phase II study aims to evaluate tolerance of concomitant radiochemotherapy in fit elderly patients (more than 70 years old) with locally advanced NSCLC (inoperable IIIAN2 or IIIB). The treatment is oral vinorelbine (30 mg/m(2) per week) and intravenous cisplatine (30 mg/m(2) per week) during 6 weeks in conjunction with radiotherapy (66 Gy, 33 fraction, six and a half weeks). The main criterion of evaluation is acute toxicity. Late toxicity, quality of life, global response, time to progression and overall survival will also be estimated. With a Simon's optimal plan in two steps, the total number of patients to be included is 59 with an intermediate analysis after the inclusion of 19 patients. EXPECTED RESULTS: Our study aims to demonstrate that fit elderly patients can benefit from concomitant radiochemotherapy. It will permit an improvement in the care available for fit elderly patients with locally advanced NSCLC by allowing them to benefit from the reference treatment.

Randomized follow-up study of resected NSCLC patients: conventional versus 18F-DG coincidence imaging.

The aim of this study was to compare the utility of gamma camera using a coincidence detection system imaging (CDET) with 18-fluorodeoxyglucose to conventional imaging techniques in the detection of recurrence of non-small cell lung cancer. Sixty-nine patients were randomized into two groups for follow-up after surgery from October 2000 to December 2002. Each patient was evaluated every 6 months by conventional technique imaging in group A (n=33) or CDET imaging in group B (n=36) over two years. The direct costs of each procedure were evaluated. The major endpoint was the number of recurrences or new tumours detected. The two groups were similar. A total of 25 recurrences was detected (9 in group A and 16 in group B). Overall survival was similar in the two groups. CDET imaging was more expensive. CDET imaging provides earlier detection of recurrence, but does not modify survival outcome. Further studies are necessary to demonstrate the impact, if any, of 18-FDG imaging.

[Chronic bronchitis: prevalence and quality of life. Analysis of data from the French Health Interview Survey 2002-2003]. / Bronchite chronique: prévalence et qualité de vie.

INTRODUCTION: Chronic bronchitis is associated with an increased risk of COPD and health-related quality of life (HRQoL) impairment. The objectives of the study were to estimate the prevalence of chronic bronchitis and to describe its relations with quality of life. METHODS: The French Health Interview Survey was conducted in 2003 in a representative sample of households. Data were collected during an interviewer's visits to the home. Respiratory symptoms and HRQoL (SF-36) were assessed in 9,050 adults aged 45 years and older using a self-administered questionnaire. RESULTS: The prevalence of chronic bronchitis was estimated at 3.5%. Chronic bronchitis was associated with an impaired physical component summary score after adjusting for sex, age and dyspnoea. It was associated with a reduced mental component summary score (MCS) among men. In women, this association was only significant in the absence of dyspnoea. CONCLUSION: The prevalence of chronic bronchitis was 3.5% among adults aged 45 years and older. Chronic bronchitis was associated with impairment in health-related quality of life.

[Economic impact of second- and third-line erlotinib treatment of non small-cell lung cancer]. / Conséquences économiques de l'erlotinib dans le traitement des cancers bronchopulmonaires non à petites cellules.

OBJECTIVE: This study examined care consumption and management costs among patients who received second- or third-line oral erlotinib therapy for non small-cell lung cancer (NSCLC). METHODS: The study involved two observational cohorts of NSCLC second- or third-line treated patients. In the first, patients received IV chemotherapy alone (233 patients), while patients in the second cohort, received oral erlotinib (166 patients). Only direct costs were taken into account. The analysis adopted the payer's perspective. RESULTS: The treatments lasted a similar length in the second- line setting (respectively 94,5+/-67,5 and 105+/-79,4 days for the IV and erlotinib cohorts) but was significantly longer in the erlotinib cohort during third-line therapy (76.6+/-96.5 versus and 114.4+/-74.5 days, p<0.008). In the erlotinib cohort, there were more women (p=0.023), a higher rate of adenocarcinoma (p=0.0043), a similar rate of conventional hospitalization, but less daycare clinics (p<0.001). The erlotinib cohort received significantly less antiemetic treatment (p<0.0001), erythropoietin stimulating agents (p<0.005) and G-CSF (p<0.001). Monthly management costs per patient in the IV and erlotinib cohorts were respectively 3126 +/-1904 and 2750+/-1450 euros during second-line treatment, and 3026+/-1029 and 2823+/-1490 euros during third-line treatment (no significant difference). These results must be validated by prospective observational studies focusing on quality of life and the time spent in hospital.