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Biomedical subjects

P Fournel

Publications and source records attributed to P Fournel.

At least 19 recordsLinked to original sources
PubMed2006

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↗
PubMed2005

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↗
PubMed2005

Docetaxel and concurrent radiotherapy after two cycles of induction chemotherapy with cisplatin and vinorelbine in patients with locally advanced non-small-cell lung cancer. A phase II trial conducted by the Groupe Francais de Pneumo-Cancerologie (GFPC).

CONTEXT: The most satisfactory treatment for patients with locally advanced non-small-cell lung cancer (NSCLC) is combination chemotherapy-radiotherapy (CT-RT). The optimal treatment modalities remain to be determined. OBJECTIVE: We conducted a multicenter phase II trial of the docetaxel-radiotherapy combination after induction chemotherapy with cisplatin-vinorelbine. The main endpoint was the objective response rate. PATIENTS AND METHODS: Patient with inoperable stage locally advanced NSCLC received induction chemotherapy consisting of two cycles of cisplatin 100 mg/m2 on D1 and vinorelbine 25 mg/m2 on D1, D8, D15 and D22. Patients with responses or stable disease then received concurrent RT-CT consisting of 25 mg/m2/week docetaxel and single-fraction radiotherapy (66 grays (Gy) in 33 fractions) over 6.5 weeks. RESULTS: Fifty-six patients were enrolled from 1 July 2000 to 31 December 2001. Sixteen patients left the trial after induction chemotherapy, eight for progression, five for toxicity, and two for intercurrent events. One patient underwent surgery after induction chemotherapy. In total, 40 of the 56 patients received RT-CT. Twelve (30%) of these 40 patients experienced grade III or IV pulmonary or esophageal toxicity. In the intention-to-treat analysis, the objective response rate was 46.4% (95% CI 33.0-60.2). The median time to progression was 6.2 months [1.1-26.0]. The median survival time was 13 months [0.3-44.9 months]. Nine patients progressed during RT-CT, six with brain metastases. CONCLUSION: Weekly docetaxel with concurrent radiotherapy, following chemotherapy is acceptable. The tumor response rate is moderate. Further trials are required to determine the risk-benefit relationship of this treatment schedule, and the possible benefit of adding other cytotoxic drugs.

Adult↗
PubMed2004

[Medical-surgical treatment of pulmonary infection with Mycobacterium malmoense].

CASE REPORT: We report the case of a patient with chronic obstructive pulmonary disease in whom pulmonary infection due to mycobacterium malmoense was discovered unexpectedly. A diagnostic and therapeutic surgical resection was performed. CONCLUSION: The non-tuberculous mycobacterium was identified by culture of the specimen. Surgery was followed by empirical antibiotic treatment with rifampicin and pyrazinamide for two and a half months. Isoniazid was withdrawn rapidly on account of hepatitis and the treatment was supplemented later with clarithromycin, leading to a total duration of treatment of seven and a half months. This case is unusual because of its medico-surgical management that led to assessment and appropriate treatment of this infection.

Anti-Bacterial Agents↗
PubMed2004

[Treatment of non-resectable stage III non-small cell lung cancer].

The prognosis of locally advanced and non-resectable non-small cell lung cancers (NSCLC) remains poor, despite the therapeutic progress made over the past few years. The best therapeutic strategy is currently the concomitant association of chemotherapy and radiotherapy. Such treatment must be reserved for patients in general state of good health. Oesophagitis is the principle limiting toxicity. The objectives for the years to come are to improve the results and to reduce the toxicity by optimising radiotherapy, using new chemotherapy drugs, and by pinpointing the therapeutic strategy. The sequential association of chemotherapy and radiotherapy still retains its place for the other patients.

Carcinoma, Non-Small-Cell Lung↗
PubMed2002

Carboplatin-etoposide combination in small cell lung cancer patients older than 70 years: a phase II trial.

BACKGROUND: No standard treatment is defined for elderly patients with small cell lung cancer (SCLC). Carboplatin and etoposide are highly active agents against SCLC. In this study, we evaluated the activity and toxicity of a combination of these two agents. PATIENTS AND METHODS: Thirty-four untreated patients with limited or extensive SCLC and median age of 73.9 years entered the study. Chemotherapy consisted of carboplatin i.v. on day 1 (AUC 5 using Calvert's formula) and etoposide 100 mg/m(2) given orally on days 1-5, every 4 weeks, and thoracic irradiation was given to limited disease patients after chemotherapy. RESULTS: The overall response rates was 59% (95% CI: 43-76). The median survival for all patients was 37 weeks (range 3-76 weeks). The toxicity was mainly haematological with grade 3-4 neutropenia in 59% of courses, febrile neutropenia in 15% of courses, and toxic death in 9% of patients. CONCLUSION: The results of this regimen are disappointing with worse response and survival, and more haematological toxicity than expected and previously reported, despite the use of Calvert's formula. Possible explanations are the use of etoposide per os rather than i.v., the frequent comorbidities of older patients and the inclusion of patients with poor prognosis factors.

Administration, Oral↗
PubMed2002

Phase II randomized multicenter study evaluating a treatment regimen alternating docetaxel and cisplatin-vinorelbine with a cisplatin-vinorelbine control group in patients with stage IV non-small-cell lung cancer: GFPC 97.01 study.

BACKGROUND: The potential absence of cross-resistance between cisplatin and docetaxel in non-small-cell lung cancer (NSCLC) suggests that alternating regimens of cisplatin-based chemotherapy and docetaxel might increase the activity of chemotherapy in stage IV NSCLC. PATIENTS AND METHODS: Randomized, multicenter, non-comparative phase II study in patients with stage IV NSCLC (Eastern Cooperative Oncology Group performance status of 0-2). Patients randomized to alternating treatment group (A) received docetaxel 100 mg/m2 on days (D) 1 and 43 alternating with cisplatin 100 mg/m2 on D22 and vinorelbine 30 mg/m2 on D22, D29 and D36. Those randomized to the control group (B) received cisplatin 80 mg/m2 on D1, D22 and D43 and vinorelbine 30 mg/m2 once a week from D1 to D57. Treatment was continued for a further 6 weeks in the event of objective response or stabilization. RESULTS: Seventy patients were enrolled (group A: 38, group B: 32). More premature treatment discontinuations due to toxicity were observed in group A (median number of cycles: 3) than in group B (median number of cycles: 5). The intention-to-treat objective response rate was 10.8% [95% confidence interval (CI) 0.8% to 20.8%] in group A compared with 25% (95% CI 10% to 40%) in group B, the median time to treatment failure being 10.2 weeks and 17.3 weeks, respectively. The median survival and 1-year survival were 29.1 weeks and 39% in group A compared with 41.6 weeks and 42% in group B. Febrile neutropenia occurred in 5.9 and 4.9% of the cycles in group A and group B, respectively. Non-hematological toxicity was moderate in the two groups. CONCLUSIONS: The addition of docetaxel alternating with cisplatin-vinorelbine did not enhance the activity of this combination. The development of sequential regimens might be a more promising way of exploiting the absence of cross-resistance between these two drugs.

Adult↗
PubMed2002

[Exercise test and evaluation of exertional dyspnoea in former coal miners].

The decrease in pulmonary function tests (PFTs) in retired coal miners who complain of increased exercise dyspnoea does not precisely reflect exercise tolerance. PFTs and a maximal cardiopulmonary exercise test in order to determine peak were performed in thirty-eight patients (69.7 +/- 6.7 years old). They also completed a six-minute walk test (6MWD) in order to evaluate its sensibility to detect a limitation of peak. Quality of life was assessed by the Saint George's Hospital Respiratory Questionnaire (SGRQ). PFTs were within normal values in 21 patients whereas 8 patients showed an obstructive pattern, 4 a restrictive one and 5 gas exchange abnormalities only. We found a mild decrease in peak at 70.4 +/- 15.9% of reference value. Exercise limitation was explained by a poor ventilatory adaptation in 36.8% of cases, cardiac abnormalities in 23.7% and both in 7.7%. 6MWD was within normal at 83.7 +/- 15.6% of reference value. Neither peak, maximal workload nor 6MWD correlated with the results of PFTs. In patients with normal pulmonary function, the 6MWD had an 80% sensitivity at predicting a decrease in peak. The total SGRQ index of 51% represents the effect of dyspnoea on quality of life. We conclude that there is moderate impairment of maximal exercise capacity in one third of retired coal miners complaining of exercise dyspnoea, irrespective of PFTs results. We suggest that 6MWD could be used to detect a decreased exercise tolerance in these patients with normal PFTs, but should be followed up with a maximal cardiopulmonary exercise test if found to be abnormal.

Aged↗
PubMed2001

Results of a phase III study of early versus delayed whole brain radiotherapy with concurrent cisplatin and vinorelbine combination in inoperable brain metastasis of non-small-cell lung cancer: Groupe Français de Pneumo-Cancérologie (GFPC) Protocol 95-1.

PURPOSE: To determine if the timing of whole brain radiotherapy (WBRT) with respect to chemotherapy with cisplatin and vinorelbine would influence survival in patients with non-small-cell lung cancer (NSCLC) and concurrent brain metastasis. PATIENTS AND METHODS: One hundred seventy-six patients with brain metastasis from NSCLC were included in the study between July 1995 and October 1997. All patients received chemotherapy with cisplatin 100 mg/m2 on day 1 and vinorelbine 30 mg/m2 on days 1, 8, 15, 22. Cycles were repeated every four weeks. Evaluation of response was performed after two, four or six cycles. After two cycles, chemotherapy was administered to the responders to a maximum of six cycles. Patients were randomised to receive WBRT 30 Gy/10 fx/12 days and delayed corticosteroids. (arm A) for the intracranial nonresponders, or early on day 1 to 12 during the first cycle of chemotherapy (arm B). RESULTS: One hundred seventy-one patients were eligible: eighty-six in arm A and eighty-five in arm B; none had received prior chemotherapy; seventy-six and seventy-three, respectively, were assessable for response. There was a 21% overall objective response rate (OR) (with 1 complete response and 17 partial responses) after two cycles of chemotherapy alone (arm A) and a 20% OR (with 17 partial responses) to chemotherapy and early WBRT (arm B). The intracranial OR was 27% and 33%, respectively (P = 0.12). The six months survival rate (46% and 40%) and the median survival duration (24 and 21 weeks, respectively) were not significantly different between the two arms (P = 0.83, log-rank test). The major toxicity was severe or life-threatening neutropenia (grade 4), which occurred in 35% of arm A patients and 36% of arm B patients. There were thirteen treatment-related deaths (six in arm A and seven in arm B). There was no difference between the arms for haematological and neuro-toxicities. CONCLUSIONS: These results confirm the efficacy of chemotherapy in brain metastases of NSCLC and suggest that the timing (early or delayed) of WBRT did not influence survival of NSCLC with brain metastasis treated with concurrent chemotherapy.

Adult↗
PubMed2001

Invasive thymoma: a clinical study of 23 cases.

BACKGROUND: Invasive thymoma is a rare mediastinal tumor. Clinicopathological characteristics that influence survival of patients with this tumor are under debate. Treatment is based on tumor resection. The benefice of therapies, such as radiation therapy (RT) and/or chemotherapy (CT) as adjuvant treatments to surgery, or palliative therapy to unresectable or recurrent thymoma are discussed. OBJECTIVES: The aim of this study was to assess patients with invasive thymoma, with specific emphasis on factors predicting survival. METHODS: We studied retrospectively 23 patients with invasive thymoma. Parameters assessed were age, presenting symptoms, histological features, stage at diagnosis, treatment modalities and survival. All patients received primary therapy: 11 patients (48%) had tumor resection associated with CT and/or RT, while 12 patients had palliative therapy including RT and/or CT. Regimens for CT were based on cisplatin. RESULTS: Patients' mean age was 58 years. Three patients had stage II disease at diagnosis (13%), 8 patients had stage III (35%) and 12 patients had stage IV (52%). Median overall survival was 20 months (range: 4-160) and five-year survival rate was 43.5% (10 patients). Surgical resection had a significant impact on survival (p < 0.0001). Survival was also related to stage of the disease at diagnosis (p = 0.006), but not to histology of the tumor (p = 0.12). Salvage treatment was of clinical importance: 5 out of 15 patients (33.3%) who relapsed during a 5-year follow-up responded to a multimodality therapeutic approach that affected survival (p = 0.019). CONCLUSION: Factors determining the outcome of these tumors are the stage of the disease at diagnosis, and the adequacy of surgical removal. Salvage treatment of recurrent thymoma may give a moderate response rate and improve survival.

Combined Modality Therapy↗
PubMed2000

[Lemierre syndrome: clinical and radiological characteristics of a rare disease].

A benign oropharyngial infection without appropriate treatment can be complicated by a jugular vein thrombosis and disseminated septic embolies with deleterious pulmonary effects. This septic clinical picture most commonly known as Lemierre syndrome is attributed to Fusobacterium necrophorum, a Gram negative anaerobic bacilli. We describe a case of a young patient who has presented this syndrome accompanied by typical pulmonary manifestations. Adequate antibiotic treatment for 3 weeks associated with anticoagulant treatment for about 3 months duration have allowed a complete recovery without sequel.

Adult↗
PubMed1998

Microsatellite instability and loss of heterozygosity at chromosomes 9 and 17 in non-small cell lung cancer.

BACKGROUND: Microsatellite instability (MI) and loss of heterozygosity (LOH) are described in lung cancer specimens. However, their importance in tumorigenesis remains unknown. The aim of this study was to identify the presence of MI and LOH in human tumor and normal bronchial mucosa DNA. METHODS: We performed biopsies with fiberoptic bronchoscopy and took specimens from the tumor and from the opposite site normal bronchial mucosa in 20 patients with non-small-cell lung cancer (NSCLC). Four patients had an adenocarcinoma, while 16 had a squamous cell carcinoma. Also, 6 patients had an early-stage disease (stages I and II), while 14 patients had an advanced-stage disease (stages III and IV). All paired specimens were studied for MI and LOH on chromosome 17p, 17q, 9p, and 9q, with 10 polymorphic markers. RESULTS: Sixteen of 20 tumors displayed genetic alterations (80%). Six tumors (30%) exhibited MI, five tumors (25%) exhibited LOH, while five tumors exhibited MI and LOH concurrently. The marker HBX had the most frequent incidence of LOH (4/20, 20%), indicating that the hbx gene becomes a strong candidate tumor suppressor gene, whereas of MI it was D17S515 (4/20, 20%). No relationship was observed between the presence of LOH or MI and the histologic subtype of NSCLC or the stage of the disease. CONCLUSION: Results suggest that genetic alterations exist in tumor, compared with the normal mucosa DNA. They may have a role in carcinogenesis as they exist in all stages and in both NSCLC histologic subtypes studied.

Adenocarcinoma↗