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A Vergnenegre

Publications and source records attributed to A Vergnenegre.

At least 19 recordsLinked to original sources

Cost-minimization analysis of a phase III trial comparing concurrent versus sequential radiochemotherapy for locally advanced non-small-cell lung cancer (GFPC-GLOT 95-01).

BACKGROUND: We conducted an economic analysis of a phase III clinical trial comparing sequential radiochemotherapy (RT-CT) with concurrent RT-CT in patients with locally advanced non-small-cell lung cancer. PATIENTS AND METHODS: The trial was a randomized multicenter study comparing three cycles of chemotherapy (arm A) followed by radiotherapy against an RT-CT combination (two cycles of platinum etoposide) followed by two cycles of platinum-vinorelbine (arm B). The economic analysis adopted the payer's perspective and only included direct costs. Costs (euro, 1996-2003) were recorded until the cut-off date. A cost minimization analysis and a sensitivity analysis were carried out. RESULTS: Data from 173 patients were used in the economic study. Protocol costs tended to be higher in arm B, while relapse costs were significantly higher in arm A. The total number of hospital days was higher in arm B. The average total cost per patient was euro16,074 in arm A and euro15,245 in arm B (P=0.15). The cost minimization analysis favored arm B. This advantage persisted in the sensitivity analysis. CONCLUSIONS: Concurrent RT-CT was not the more costly strategy in this phase III trial, despite lengthier hospitalization for toxicity. Other studies of similar design are needed to confirm these results in future randomized trials.

Adolescent↗

Randomized multicentric phase II study of carboplatin/gemcitabine and cisplatin/vinorelbine in advanced non-small cell lung cancer GFPC 99-01 study (Groupe français de pneumo-cancérologie).

PURPOSE: To evaluate the efficacy and safety of gemcitabine and carboplatin in the treatment of previously untreated patients with advanced non-small cell lung cancer (NSCLC). METHODS: A randomized phase II study was conducted by the Groupe Français de Pneumo-Cancérologie (GFPC) in 15 centers. The patients were randomized in either arm A (GC): gemcitabine 1250 mg/m2 on days 1 and 8+carboplatin AUC 6 mg/(mLmin) on day 1; or in arm B (VP): vinorelbine 30 mg/m2 weekly+cisplatin 80 mg/m2 on day 1. Treatment cycles were repeated every 3 weeks. RESULTS: A total of 100 patients were randomized with stage IV or stage III NSCLC with malignant pleural effusion: 51 patients in arm A and 49 patients in arm B. A total of 190 cycles were administered in the GC arm and 172 cycles in the VP arm, with a median of four cycles per patient in each arm. The dose intensity was 84.9% for gemcitabine, 99.8% for carboplatin, 97.7% for cisplatin and 67.7% for vinorelbine. The objective response rates were 19.6% (95% CI, 9.8-33.1) for GC and 29.2% (95% CI, 17.0-44.1) for VP in an ITT analysis. The response duration was 169 days in arm A and 226 days in arm B. The TTP was similar with 140 days (GC) and 148 days (VP), respectively. Overall survival rates were 334 days in the GC combination and 304 days in the VP combination. Overall, the treatment was safe and toxicities observed were different in each arm: neutropenia was the most common toxicity in the VP treatment, whereas thrombocytopenia was more frequent in the GC combination. Anemia was similar in both arms. Non-haematologic toxicity was mild. One toxic death in arm A and three toxic deaths in arm B were observed. CONCLUSION: In terms of response rate, the gemcitabine-carboplatin combination was not efficient enough to allow further phase III study. Survival data are in the same range as the standard arm. This chemotherapy is feasible and may represent an alternative to a standard cisplatin-based regimen, allowing treatment in an outpatient setting.

Adult↗

[Indoor radon exposure and lung cancer risk. Results of an epidemiological study carried out in France].

INTRODUCTION: Several epidemiological studies have indicated an increased risk of lung cancer associated with indoor radon exposure. As part of a large European project, a hospital based case-control study was carried out in four regions of France: Auvergne, Brittany, Languedoc-Roussillon and Limousin. MATERIAL AND METHODS: Individual data on demographic characteristics, residential history, smoking and occupational exposures were collected during face-to-face interviews. Radon concentrations were measured in each dwelling occupied by the subject during the 30-year period prior to the interview. RESULTS: 486 cases and 984 controls were included in the study. After adjustment for age, sex, region, smoking history and occupational exposure, the risk of lung cancer increased by 4% per 100 Bq/m(3), when considering cumulative exposure in the 30 years prior to diagnosis. CONCLUSION: The study indicates a positive association between lung cancer risk and indoor radon exposure. The risk estimate per unit of exposure is in agreement with other recently published indoor case-control studies.

Aged↗

Randomised, multicentre phase II study assessing two doses of docetaxel (75 or 100 mg/m2) as second-line monotherapy for non-small-cell lung cancer.

BACKGROUND: The survival benefit associated with first-line chemotherapy in advanced lung cancer led to the need for second-line chemotherapy. Docetaxel (Taxotere) has proven efficacy in both settings. This study evaluated the safety and efficacy of two doses of docetaxel in patients with non-small-cell lung cancer who had failed first-line platinum-based chemotherapy. PATIENTS AND METHODS: In total, 182 patients from 24 French centres were randomised and treated with either docetaxel 75 mg/m(2) (arm A) or 100 mg/m(2) (arm B) every 3 weeks. Baseline characteristics were well balanced, except more patients in arm A had metastatic disease (91.4% versus 78.7%) and therefore the median number of sites involved for arm A was three compared with two for arm B. RESULTS: Median time to treatment failure was 1.34 months [95% confidence interval (CI) 1.28-1.64] for arm A and 1.64 months (95% CI 1.34-2.62) for arm B. Median overall survival was 4.7 months (95% CI 3.8-5.9) for arm A versus 6.7 months (95% CI 4.8-7.1) for arm B. According to a blinded expert panel, disease control was achieved in 35 (43.8%) patients in arm A and 39 (49.4%) patients in arm B. More patients in arm B experienced grade 3-4 neutropenia (B: 72.7% versus A: 44.0%), asthenia (B: 20.2% versus A: 10.8%) and infection (B: 6.7% versus A: 2.2%). Three treatment-related deaths were reported in each arm. CONCLUSIONS: The optimal docetaxel dosage in this second-line setting is 75 mg/m(2), as it has a more favourable safety profile and on balance a similar efficacy to the 100 mg/m(2) dose.

Adult↗

[Prevalence of exercise-induced asthma in school children].

BACKGROUND: Although asthma is the most common pulmonary condition in pediatrics, the incidence of exercise-induced asthma (EIA) in school children is not well documented and few studies have been devoted to the condition. There are considerable variations in morbidity and mortality between countries. This study was designed to evaluate the prevalence of EIA in children in the 6th grade (11-14 year-olds) in one French department (Haute-Vienne) and to identify undiagnosed cases. METHODS: The representative sample was obtained over a period of 28 days (February 2(nd) to April 10(th) 1998) by cluster sampling method, stratified by size of the schools. The number of subjects planned was 891. The selected children filled in a questionnaire on their asthma history and were subjected to an outdoor exercise test (6 minute run). Respiratory function was measured with a peak flow-meter. RESULTS: Seven hundred and eighty two school children were included in this survey. Participation rate was 87.8%. The prevalence of asthma from the questionnaire was 10.7% (CI 95%: 8.7 - 12.8). After exercise, 68 school children presented exercise-induced bronchospasm: the prevalence of the EIA was 8.7% (CI 95%: 6.9 - 10.5). Among these 68 school children, 27 were known asthmatics and 41 were not. With the 10 treated asthmatics, the overall prevalence of EIA was therefore estimated at 9.9% (CI 95%: 8.2 - 11.7). CONCLUSION: The prevalence of asthma and EIA was close to that found in other studies using a similar methodology. EIA remains under-diagnosed since 41 undeclared asthmatic school children were identified in our population. Nurses'information is necessary to initiate the use of systematically testing respiratory function (with a peak flow meter) at least once a year. Efficient management of the asthmatic child requires cooperation between the various professionals dealing with school children.

Adolescent↗

[Value of 18FDG-CDET in the evaluation of operable bronchial cancer].

The purpose of this study was to investigate the utility of 18fluorodeoxyglucose (FDG) coincidence detection position emission tomography (CDET) in the evaluation of metastatic mediastinal lymph nodes in patients with potentially operable non-small-cell lung cancer (NSCLC). A prospective study was performed in thirty patients with newly suspected NSCLC. Thoracic computed tomography (CT), FDG CDET, and invasive surgical staging were performed in patients. Blinded prospective interpretation was performed for each test and compared to pathological staging obtained by mediastinoscopy and/or by thoracotomy. Patients were followed for six months to detect occult metastases. The sensitivity and specificity of CDET for the detection of mediaStinal lymph nodes were 75% and 94.4% respectively. The corresponding value for CT were 50% and 80.9%. Three patients with N1 disease were classified as N0 by CDET. With regard to definitive surgical node staging, CDET could identify nodal disease in 26 patients and CT only in 18 patients (n = 30). FDG full-ring positron emission tomography (PET) is the most accurate non-invasive method for the detection and staging of lung cancer. In addition, FDG CDET shows high accuracy for the detectability of pulmonary lesions with a diameter at least 2 cm and the evaluation of lymph node in NSCLC.

Carcinoma, Non-Small-Cell Lung↗

[Phase II study of docetaxel in inoperable advanced non small cell lung cancer].

The purpose is to determine the response to, and toxicity of docetaxel (Taxotère) in patients with inoperable non small cell lung cancer (NSCLC), previously untreated. Seventy patients with stage IIIB or IV NSCLC were treated by 100 mg/m2/ 3 weeks of docetaxel until tumor progression or severe toxicity. Premedication with diosmine and prednisolone was given in all patients: 66/70 were eligible and 55/70 were assessable for antitumoral activity. Median age: 63 years, WHO performans status 0-1: 83%, stage IV: 96%. For eligible patients, 17/66 (26%) achieved an objective response: 1 complete response and 16 partial response (IC 95% = 15-36). With a median follow-up of 23.4 months (range 14.9-28.7), for evaluable patients, the median response duration was 8 months, the median time to progression 4 months, and the median survival time 10 months. The median number of administered cycles is 5 (range 1-12). The estimate one year survival rate was 47%. Seventy-six patients presented neutropenia (grade 3-4); febrile neutropenia was observed in 7% of cycles. Non haematological toxicities are: fluid retention related to docetaxel (2.9%), diarrhea (6%), nausea-vomiting (4%), asthenia (3%), nail changes (6%). Docetaxel (Taxotère) administered at 100 mg/m2/3 weeks has relevant clinical activity in previously untreated NSCLC with a acceptable toxicity.

Adult↗

[Medical-economic evaluation of lung cancers. Theoretical approaches and practical applications].

There has been an increasing number of publications dealing with the assessment of treatments or medical strategies. Chronic diseases like lung cancer require such an analysis, in relation to their costs and their poor efficacy. In its first part, this review shows the theoretical basis of economic assessment, the available tools and the limits of these methods. The second part points out their use in lung cancer: cost evaluation of these cancers for the society, economic assessment of new chemotherapic drugs, cost-effectiveness analysis in randomized trials. These methods give to the clinicians complementary results for their final decision.

Antineoplastic Agents↗

[Explanatory factors of length of stay at the diagnosis-related group 129: common pneumonia and pleurisy, aged over 69 and/or associated co-morbidities].

BACKGROUND: Utilization of diagnosis related groups (DRGs) for hospital comparison, based on length of stay (LOS). OBJECTIVES: Inside a DRG (Pneumonia and pleurisy > 69 and/or associated comorbidities), to point out the explicative factors of LOS and the variables which could be recorded for a better description of these patients. SETTING: Pneumologic unit of Limoges' teaching hospital. METHODS: From 01-01-94 to 31-12-94, the DRG 129 was studied through the medical unit summary, the performance status at entrance, the social complexity, the characteristics of pneumonia (symptoms, temperature, arterial pressure...), the severity by American Thoracic Society (ATS) criteria, the procedures (chest X-ray, biology, fibroscopy...), the antibiotic treatments (intravenous and oral). Statistical tests associated univariate analysis, linear and logistic regressions. RESULTS: LOS was 15.53 d +/- 8.57 (m +/- SD). The mathematical model explains 69% of the variance of LOS logarithm. The logistic regression found 5 variables with a significant odds-ratio (OR) for an increased LOS: a high ATS score, repeated laboratory tests, a complex social situation, an increase length of antibiotic treatment (intravenous and oral). CONCLUSION: A better description of LOS, inside a DRG, needs supplementary variables. For pneumonia admitted in Limoges' hospital, the severity of the disease, the number of laboratory tests, the antibiotic treatment, the social complexity are the more significant indicators.

Age Factors↗

Work related distal airway obstruction in an agricultural population.

OBJECTIVE: To assess the prevalence of distal airway obstruction and its risk factors in agricultural areas. METHODS: A cross sectional study of respiratory symptoms and lung function was performed among French farmers and their spouses (1122 subjects) who came for preventive medicine examinations. They answered a respiratory questionnaire and performed pulmonary function tests on a portable spirometer. Diagnoses of chronic bronchitis were made on the basis of reported chronic respiratory symptoms. Airway obstruction was determined from predicted values. Odds ratio (OR) and linear regression coefficients were calculated after stratification by smoking and history of cardiac and other respiratory diseases. RESULTS: Of respiratory symptoms prevalence of chronic cough was 8.47%, and chronic bronchitis 7.66%. Prevalence of distal airway obstruction was 11.4%, and overall airflow obstruction 3.2%. Smokers were 20.2% men, and 5.7% women. Linear regressions showed high association between pack-years in smokers or exsmokers and forced expiratory volume in one second/forced vital capacity (FEV1/VC) and forced expiratory flow between 25% and 75% of vital capacity (FEF25-75). In non-smokers without any history of cardiac or respiratory diseases, age and the size of farms had the highest correlations with these variables. OR for distal airway obstruction was 2.1 in subjects > 50 years old v the younger ones and 3.02 in the smaller farms v the larger ones. CONCLUSION: After stratification by smoking and history of cardiac and respiratory diseases, distal airway obstruction is present in agricultural areas. The age, and the size of farm are the highest respiratory risk factors in non-smokers.

Adolescent↗

[Carboplatin-VP16 combination in non small cell lung cancers in the aged patient. A study of the French group in pneumology (GFPC)].

UNLABELLED: Between February 1992 and May 1993, 22 patients older than 75 years, with non small cell lung cancer, were treated with carboplatin and oral etoposide. There were 18 men and four women with a median age of 79 years. Fourteen patients had an epidermoid carcinoma: four had an adenocarcinoma and four had an undifferentiated carcinoma. Carboplatin was administered intravenously on day 1 at a dose of 300 mg/m2; oral etoposide was administered at a dose of 600 mg/m2 (two capsules daily) for 9, 10, 11, or 12 days according to body surface. Courses were repeated every 28 days for a total of three courses. TOXICITY: 15 patients (68%) had received previous chemotherapy. Myelosuppression was the main problem with one grade IV and five grade III hematologic toxicities. We observed one mild neurologic toxicity. RESULTS: 19 patients were evaluable for response. We observed one complete response (5%), five disease stabilizations (26%) and 13 disease progressions. Median survival was 5 months. These results led to discontinue this study.

Aged↗

Is Navoban (tropisetron) as effective as Zofran (ondansetron) in cisplatin-induced emesis? The French Navoban Study Group.

The purpose of this study was to evaluate and compare the antiemetic effectiveness and tolerability of Navoban (tropisetron) and Zofran (ondansetron) following high-dose (> or = 50 mg/m2) cisplatin chemotherapy. In a randomised, multi-centre, double-blind, double-dummy, parallel group study, 117 evaluable chemotherapy-naive patients who received Navoban were compared with 114 who received Zofran. Patient diary cards were used to assess both acute (Day 1) and delayed (Days 2-6) nausea and vomiting. Total control of acute vomiting was achieved in 54% of Navoban and 65% of Zofran patients (p = 0.052), and total control of acute nausea in 66% and 62% respectively (p = 0.655). Total control of delayed vomiting was achieved in 44% of Navoban patients and 46% of Zofran patients (p = 0.765), and of delayed nausea in 56% and 47% respectively (p = 0.207). Both reactions combined were totally prevented during the entire 6-day trial period in 22% of Navoban and 24% of Zofran patients (NS), while a further 42% of patients in both groups remained largely free from both nausea and emesis. The few adverse reactions (e.g. headache, constipation, diarrhoea) were mainly mild and typical of the 5-HT3-receptor antagonists. In conclusion, there were no significant differences in efficacy and tolerability between Navoban 5 mg once daily and the highest recommended dose of Zofran (32 mg on Day 1, followed by 8 mg three times a day).

Antiemetics↗

[Vaginal trial or repeat cesarean in a woman with a previous cesarean section? An example of analysis of medical decision making].

Decision making analysis is a probability-based quantitative method used for decision making in particularly uncertain circumstances. Such analysis can be used to develop a model for medical decision making and help to determine the best strategy for a given clinical situation. A decision tree includes all the necessary choices and the corresponding consequences. Statistical analysis of the decisional tree orients the decision to the one with the smallest risk and the greatest advantages. This work describes the basis of the methodology and the decision analysis using a simple example in obstetrics: repeat cesarean or uterus trial in women with a history of cesarean section. The analysis of the decision, based on data in the literature, demonstrates the choice for the uterin trial because of the lower maternal morbidity.

Cesarean Section↗