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Pascal Piedbois

Publications and source records attributed to Pascal Piedbois.

11 recordsLinked to original sources
PubMed2006

A randomized multi-center phase II trial of the angiogenesis inhibitor Cilengitide (EMD 121974) and gemcitabine compared with gemcitabine alone in advanced unresectable pancreatic cancer.

BACKGROUND: Anti-angiogenic treatment is believed to have at least cystostatic effects in highly vascularized tumours like pancreatic cancer. In this study, the treatment effects of the angiogenesis inhibitor Cilengitide and gemcitabine were compared with gemcitabine alone in patients with advanced unresectable pancreatic cancer. METHODS: A multi-national, open-label, controlled, randomized, parallel-group, phase II pilot study was conducted in 20 centers in 7 countries. Cilengitide was administered at 600 mg/m2 twice weekly for 4 weeks per cycle and gemcitabine at 1000 mg/m2 for 3 weeks followed by a week of rest per cycle. The planned treatment period was 6 four-week cycles. The primary endpoint of the study was overall survival and the secondary endpoints were progression-free survival (PFS), response rate, quality of life (QoL), effects on biological markers of disease (CA 19.9) and angiogenesis (vascular endothelial growth factor and basic fibroblast growth factor), and safety. An ancillary study investigated the pharmacokinetics of both drugs in a subset of patients. RESULTS: Eighty-nine patients were randomized. The median overall survival was 6.7 months for Cilengitide and gemcitabine and 7.7 months for gemcitabine alone. The median PFS times were 3.6 months and 3.8 months, respectively. The overall response rates were 17% and 14%, and the tumor growth control rates were 54% and 56%, respectively. Changes in the levels of CA 19.9 went in line with the clinical course of the disease, but no apparent relationships were seen with the biological markers of angiogenesis. QoL and safety evaluations were comparable between treatment groups. Pharmacokinetic studies showed no influence of gemcitabine on the pharmacokinetic parameters of Cilengitide and vice versa. CONCLUSION: There were no clinically important differences observed regarding efficacy, safety and QoL between the groups. The observations lay in the range of other clinical studies in this setting. The combination regimen was well tolerated with no adverse effects on the safety, tolerability and pharmacokinetics of either agent.

Adult↗
PubMed2006

Multicenter randomized trial of adjuvant fluorouracil and folinic acid compared with surgery alone after resection of colorectal liver metastases: FFCD ACHBTH AURC 9002 trial.

PURPOSE: Complete resection of liver metastases of colorectal origin is the only potentially curative treatment. In order to decrease recurrences, the use of adjuvant systemic chemotherapy after liver resection is controversial because no randomized study demonstrated its benefit. PATIENTS AND METHODS: In a multicenter trial, we randomly assigned 173 patients with completely resected (R0) hepatic metastases from colorectal cancer to surgery alone and observation (87 patients) or to surgery followed by 6 months of systemic adjuvant chemotherapy with a fluorouracil and folinic acid monthly regimen (86 patients). The main outcome criterion was disease-free survival. Secondary outcome measures were overall survival and treatment-related toxicity. RESULTS: The intention-to-treat analysis was based on 171 patients, after a median follow-up of 87 months (SE = 5.8). The 5-year disease-free survival rate, after adjustment for major prognostic factors, was 33.5% for patients in the chemotherapy group and 26.7% for patients in the control group (Cox multivariate analysis: odds ratio for recurrence or death = 0.66; 95% CI, 0.46 to 0.96; P = .028). With regard to secondary outcome measures, a trend towards increased overall survival was observed but did not reach statistical significance (5-year overall survival: chemotherapy group, 51.1% v control group, 41.1%; odds ratio for death, 0.73; 95% CI, 0.48 to 1.10; P = .13). CONCLUSION: Despite a suboptimal regimen, which was the standard at the beginning of the study, adjuvant intravenous systemic chemotherapy provided a significant disease-free survival benefit for patients with resected liver metastases from colorectal cancer.

Adult↗
PubMed2006

Adenocarcinomas of unknown primary (ACUP) of the mediastinum mimicking lymphoma: CT findings at diagnosis and follow-up.

OBJECTIVE: To describe the computed tomography (CT) features at diagnosis and after treatment of adenocarcinoma of unknown primary (ACUP) mimicking lymphoma of the mediastinum. METHODS: Fifteen patients with pathologically proven ACUP and with primarily mediastinal involvement were initially referred to the Hematologic Department of our institution with a suspected diagnosis of lymphoma, and accounted for our study population. Presenting symptoms and baseline biological values were analyzed. All thoraco-abdominal CT studies were reviewed for the location and size of the mediastinal involvement and associated findings. Follow-up chest CT was performed in 14 patients after radiotherapy, chemotherapy or surgical treatment. RESULTS: The most frequent CT feature was a large anterior and middle mediastinal mass (67%), with no calcification. Associated findings included the presence of lung nodules (40%), compression of large mediastinal vessels (33%) and pleural effusion (27%). Follow-up CT, performed in 14 cases, suggested partial or complete responses in 7 patients (50%) 4 weeks after the treatment onset. CONCLUSIONS: Mediastinal ACUP is a differential diagnosis of large mediastinal masses and is frequently associated with lung nodules and mediastinal vascular compression.

Adenocarcinoma↗
PubMed2005

Meta-analysis when only the median survival times are known: a comparison with individual patient data results.

BACKGROUND: The hazard ratio (HR) is the most appropriate measure for time to event outcomes such as survival. In systematic reviews, HRs can be calculated either from the raw trial data obtained as part of an individual patient data (IPD) meta-analysis or from the appropriate trial-level summary statistics. However, the information required for the latter are seldom reported in sufficient detail to allow reviewers to calculate HRs. In contrast, the median survival and survival rates at specific time points are frequently presented. We aimed to evaluate retrospectively the performance of meta-analyses using median survival times and survival rates by comparing them with meta-analyses using IPD to calculate HRs. METHODS: IPD from thirteen published meta-analyses (MAs) in cancers with high mortality rates were used. Median survival and survival rates were calculated from the IPD rather than taken from publications so that the same trials, patients, and extended follow-up are used in each analysis. RESULTS AND CONCLUSIONS: We show that using median survival times or survival rates at a particular point in time are not reasonable surrogate measures for meta-analyses of survival outcomes and that, wherever possible, HRs should be calculated. Individual trial publications reporting on time to event outcomes, therefore, should provide more detailed statistical information, preferably logHRs and their variances, or their estimators.

Data Interpretation, Statistical↗
PubMed2005

FDG PET in patients with cancer of an unknown primary.

BACKGROUND: This prospective study was undertaken to address the capacity of positron emission tomography (PET) with 2-[18F]fluoro-2-deoxy-D-glucose (18F-FDG) to determine the primary tumour site of carcinomas with unknown primary site. PATIENTS AND METHODS: Twenty-five patients with metastases from adenocarcinoma or undifferentiated carcinoma of unknown primary site (CUP) were included prospectively. For all patients, extensive imaging was unsuccessful in localizing the primary site. Patients received 370 MBq of 18F-FDG intravenously, and whole-body images were acquired 60 min after injection. All hot spots that could not be attributed to a metastatic site were considered as the primary tumour. The evaluation of FDG PET data was based on clinical and radiological outcome or surgery if indicated. RESULTS: Twenty-four patients were eligible for analysis. All known metastases were visualized. In six patients, FDG PET showed a primary tumour site which was confirmed by follow-up or surgery. In five patients, the primary tumour site was suggested by FDG PET but not confirmed by clinical outcome. No primary tumour was found in the other patients, with a mean follow-up of 15 months. CONCLUSION: In our series, FDG PET allowed the identification of primary tumour site in one quarter of patients with CUP (6/24). We conclude that FDG PET has a place in the initial staging of these patients.

Adenocarcinoma↗
PubMed2004

Efficacy of oral adjuvant therapy after resection of colorectal cancer: 5-year results from three randomized trials.

PURPOSE: Adjuvant therapy of colorectal cancer with oral fluorinated pyrimidines is attractive because of its ease of administration and good tolerability. The purpose of this meta-analysis is to assess the survival and disease-free survival benefits of treating patients after surgical resection of a primary colorectal tumor with oral fluoropyrimidines for 1 year. PATIENTS AND METHODS: This meta-analysis was performed on individual data from three randomized trials conducted by the Japanese Foundation for Multidisciplinary Treatment for Cancer involving a total of 5,233 patients with stages I to III colorectal cancer. RESULTS: The overall hazard ratio in favor of oral therapy was 0.89 for survival (95% CI, 0.80 to 0.99; P =.04), and 0.85 for disease-free survival (95% CI, 0.77 to 0.93; P <.001). Thus oral therapy reduced the risk of death by 11% and the risk of recurrence or death by 15%. There was no significant heterogeneity between trials, nor did the benefit of oral therapy depend on tumor stage (I, II, or III), tumor site (rectum or colon), patient age, or patient sex. CONCLUSION: Oral fluoropyrimidines improve disease-free survival and survival of patients after resection of early-stage colorectal cancer. These observations support the use of these agents alone after resection of early-stage disease, as well as further testing of oral agents in combination with new drugs that have recently shown antitumor activity in advanced colorectal cancer.

Administration, Oral↗
PubMed2003

Semimonthly versus monthly regimen of fluorouracil and leucovorin administered for 24 or 36 weeks as adjuvant therapy in stage II and III colon cancer: results of a randomized trial.

PURPOSE: This randomized, 2 x 2 factorial study compared a semimonthly (LVFU2) with a monthly (FULV) regimen of fluorouracil and leucovorin and 24 versus 36 weeks of each regimen as adjuvant treatment of patients with stage II (Dukes' B2) and III (Dukes' C) colon cancer. PATIENTS AND METHODS: LVFU2 was administered semi-monthly for 2 consecutive days as dl- or l-leucovorin (200 or 100 mg/m2, respectively) as a 2-hour infusion, followed by a 400 mg/m2 FU bolus and 600 mg/m2 of FU as a 22-hour continuous infusion. FULV was administered monthly for 5 consecutive days as a 15-minute infusion of dl- or l-leucovorin, followed by 400 mg/m2 of FU as a 15-minute infusion. RESULTS: A total of 905 patients were randomly assigned. The median follow-up was 41 months. Disease-free survival was similar between the LVFU2 and FULV groups (127 v 124 events; hazard ratio [HR] = 1.04; P =.74) and between 24 and 36 weeks of therapy (128 v 123 events; HR = 0.94; P =.63). Analysis of overall survival showed a slight excess in the number of deaths in LVFU2 compared with FULV (73 v 59), but this difference was not statistically significant (HR = 1.26; 95% confidence interval, 0.90 to 1.78; P =.18). The most commonly observed grade 3 to 4 toxicities were neutropenia, diarrhea, and mucositis. Toxicities were significantly lower in the LVFU2 group (all toxicities, P <.001). CONCLUSION: Our data confirm that LVFU2 is less toxic than FULV. At a median follow-up of 41 months, no statistically significant difference could be detected in disease-free or overall survival between the treatment groups or treatment durations.

Adenocarcinoma↗
PubMed2003

Progress in the medical treatment of advanced colorectal cancer.

Despite recent progress made in screening, prevention and adjuvant treatment of colorectal cancer, a large proportion of patients with this disease develop local recurrences or distant metastases. The management of these patients requires a multidisciplinary approach. Surgery must be performed whenever possible for metastases confined to the liver or lung. However, in most cases, chemotherapy and supportive care are the only feasible treatments. This review describes the research carried out in this field through randomized trials and meta-analyses aimed at optimizing the efficacy of front-line chemotherapy.

Administration, Oral↗
PubMed2003

Direct treatment costs for patients with lung cancer from first recurrence to death in france.

OBJECTIVE: To determine the direct treatment cost of lung cancer management from progression to death from the viewpoint of the hospital. METHODS: A retrospective descriptive study was performed. Data from 100 patients who died of lung cancer and who had received treatment from four different types of hospital were used; the hospitals were public hospitals (teaching and non-teaching), private not-for-profit cancer centres, and private hospitals. Resource utilisation/cost data collected included the cost of diagnosis of the recurrence, the cost of hospitalisations or day care treatments and ambulatory surgery. All resources were valued in 2001 euros. RESULTS: In France, the average cost per patient was euro12 518 for the whole group (78% with non-small cell lung cancer [NSCLC], and 22% with small cell lung cancer [SCLC]), euro13 969 for patients with NSCLC and euro7369 for patients with SCLC. The higher cost of treatment in patients with NSCLC is explained by longer survival and duration of chemotherapy. In patients with NSCLC, 51% of the total cost corresponded to terminal care, with up to seven lines of chemotherapy. In patients with SCLC, the costs of diagnosis and terminal care each represented 41% of the total cost. CONCLUSIONS: The cost of treatment of recurrence of lung carcinoma is high, and is related to the number of lines of chemotherapy and the use of radiotherapy and surgery.

Antineoplastic Agents↗
PubMed2002

Contribution of meta-analyses to the evaluation of treatments for advanced colorectal cancer.

In the last decade, the Meta-Analysis Group in Cancer (formerly Advanced Colorectal Cancer Meta-Analysis Project) has systematically used a meta-analytic to reassess the efficacy and toxicity of various fluoropyrimidine regimens in advanced colorectal cancer, as well as to investigate related questions, such as the relation between tumor response and survival. In this paper, the basic methodology of meta-analysis is reviewed and the findings of seven successive meta-analyses conducted between 1989-2000 by the Meta-Analysis Group in Cancer are summarized. The interested reader can refer to the statistical appendix for details on the methodology used for all meta-analyses.

Antidotes↗