A collaboration between service users and professionals for the development and evaluation of a new program for cardiovascular risk management in persons with a diagnosis of severe mental illness: French multicenter qualitative and feasibility studies.

Background: Persons with a diagnosis of severe mental illness have a life expectancy that is 20 years lower than the general population, and they are disproportionately affected by cardiovascular disorders. Improving the management of cardiovascular risk is one of the main challenges for the public health system. In the care pathway of persons with a diagnosis of severe mental illness, a better understanding of limiting and facilitating factors is required.

Surveying End-of-Life Medical Decisions in France: Evaluation of an Innovative Mixed-Mode Data Collection Strategy.

Background: Monitoring medical decisions at the end of life has become an important issue in many societies. Built on previous European experiences, the survey and project Fin de Vie en France ("End of Life in France," or EOLF) was conducted in 2010 to provide an overview of medical end-of-life decisions in France.

Objective: To describe the methodology of EOLF and evaluate the effects of design innovations on data quality.

[The places of death of people aged 80 and over in France].

While the places and causes of death are the subject of abundant literature, the circumstances surrounding the end of life, the ultimate phase of existence, remain largely not explored in France. The pathways through different living places taken by people aged 80 and over during the last month of existence and the factors associated with them are described thanks to the unique information and data collected by the "End of Life in France" survey.

Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences.

The purpose of the study is to determine the effects of the BIG 1-98 treatments on bone mineral density. BIG 1-98 compared 5-year adjuvant hormone therapy in postmenopausal women allocated to four groups: tamoxifen (T); letrozole (L); 2-years T, 3-years L (TL); and 2-years L, 3-years T (LT). Bone mineral density T-score was measured prospectively annually by dual energy X-ray absorption in 424 patients enrolled in a sub-study after 3 (n = 150), 4 (n = 200), and 5 years (n = 74) from randomization, and 1 year after treatment cessation.

A longitudinal analysis of patient satisfaction with care and quality of life in ambulatory oncology based on the OUT-PATSAT35 questionnaire.

Background: In the oncology setting, there has been increasing interest in evaluating treatment outcomes in terms of quality of life and patient satisfaction. The aim of our study was to investigate the determinants of patient satisfaction, especially the relationship between quality of life and satisfaction with care and their changes over time, in curative treatment of cancer outpatients.

Methods: Patients undergoing ambulatory chemotherapy or radiotherapy in two centers in France were invited to complete the OUT-PATSAT35, at the beginning of treatment, at the end of treatment, and three months after treatment.

End-of-life medical decisions in France: a death certificate follow-up survey 5 years after the 2005 act of parliament on patients' rights and end of life.

Background: The "Patients' Rights and End of Life Care" Act came into force in France in 2005. It allows withholding/withdrawal of life-support treatment, and intensified use of medications that may hasten death through a double effect, as long as hastening death is not the purpose of the decision. It also specifies the requirements of the decision-making process.

[Safety and efficacy of bevacizumab combined with taxanes in the first-line treatment of metastatic breast cancer: ATHENA study-France].

The efficacy of the combination bevacizumab-chemotherapy in the first-line treatment of metastatic breast cancer (mBC) was demonstrated in several randomized clinical trials. However, limited safety data is available in daily medical practice. ATHENA is an international phase-IIIb study conducted in 2,251 patients with locally advanced or mBC, treated in first-line with bevacizumab combined with taxanes-based chemotherapy.

Determinants of patient satisfaction in ambulatory oncology: a cross sectional study based on the OUT-PATSAT35 questionnaire.

Background: The aim of this study was to identify factors associated with satisfaction with care in cancer patients undergoing ambulatory treatment. We investigated associations between patients' baseline clinical and socio-demographic characteristics, as well as self-reported quality of life, and satisfaction with care.

Methods: Patients undergoing ambulatory chemotherapy or radiotherapy in 2 centres in France were invited, at the beginning of their treatment, to complete the OUT-PATSAT35, a 35 item and 13 scale questionnaire evaluating perception of doctors, nurses and aspects of care organisation.

FACE: the barefaced facts of AI potency.

The use of third-generation aromatase inhibitors (AIs), such as anastrozole and letrozole, as initial adjuvant hormonal therapy in postmenopausal women (PMW) with hormone receptor-positive (HR+) breast cancer offers a significant benefit over tamoxifen for reducing recurrence risk. Clinical studies, including the Arimidex Tamoxifen Alone or in Combination (ATAC) and the Breast International Group (BIG) 1-98 trials, have proven that both anastrozole and letrozole are, respectively, superior to tamoxifen in improving disease-free survival. Although differing in design, objectives, and follow-up time, these trials offer some insight into the comparative clinical efficacy of these two nonsteroidal AIs.

Long-term efficacy and safety of letrozole for the adjuvant treatment of early breast cancer in postmenopausal women: a review.

Aromatase inhibitors (AIs) are becoming more widely used than tamoxifen as adjuvant hormonal therapy for postmenopausal women (PMW) with early breast cancer (EBC). It is clear that these drugs offer important efficacy benefits over tamoxifen and differ from tamoxifen in their safety profile. The accepted strategies for adjuvant AI therapy include initial adjuvant treatment following surgery, switching and/or sequencing from prior tamoxifen, and extended adjuvant therapy following the full 5 years of tamoxifen treatment.

Effective inhibition of aromatase inhibitor-associated bone loss by zoledronic acid in postmenopausal women with early breast cancer receiving adjuvant letrozole: ZO-FAST Study results.

Background: Letrozole is safe and effective in postmenopausal women with estrogen receptor-positive early breast cancer, but long-term aromatase inhibitor use may cause bone loss and increase fracture risk. This study evaluated an immediate or delayed strategy of bone protection therapy with zoledronic acid.

Methods: A total of 1065 patients who were receiving adjuvant letrozole were randomized to immediate-start or delayed-start zoledronic acid (4 mg intravenously biannually for 5 years).

Rurality and survival differences in lung cancer: a large population-based multivariate analysis.

Several studies have suggested rural health disadvantages. In France, studies on rural-urban patterns of lung cancer survival have yielded conflicting results. The aim of this analysis was to determine whether rural residence was associated with poor survival in three French counties.

Comparison of docetaxel- and vinca alkaloid-based chemotherapy in the first-line treatment of advanced non-small cell lung cancer: a meta-analysis of seven randomized clinical trials.

Introduction: To compare the impact on overall survival (OS) of docetaxel-based chemotherapy versus vinca alkaloid-based regimens for first-line therapy of advanced non-small cell lung cancer.

Methods: A meta-analysis of all randomized, controlled trials comparing docetaxel- and vinca alkaloid-based chemotherapy was undertaken using MEDLINE, CANCERLIT, MEDSCAPE, Google Scholar, the Cochrane Library, the National Institutes of Health randomized, controlled trials register, and conference proceedings, supplemented by information from clinical study reports. All published and unpublished randomized, controlled trials (in any language) were included.

Assessment of care by breast cancer patients participating or not participating in a randomized controlled trial: a report with the Patients' Committee for Clinical Trials of the Ligue Nationale Contre le Cancer.

Purpose: Cancer patients participating in randomized controlled trials (RCTs) have not been found to have better clinical outcomes than other patients. Our objective was to assess the impact of RCTs on patients' satisfaction with care.

Patients And Methods: A prospective study was carried out in a cohort of women with breast cancer (N = 455) divided into those invited to participate in an RCT (201 acceptances, 66 refusals) and a comparable control group not invited to participate (n = 188).

The Breast International Group 1-98 trial: big results for women with hormone-sensitive early breast cancer.

As there is a risk for relapse in early breast cancer, especially at 1-3 years post surgery, the need for adjuvant therapy is clear. In terms of disease-free survival, aromatase inhibitors have emerged as superior to tamoxifen for the adjuvant treatment of hormone-sensitive breast cancer in several Phase III clinical trials. Of these trials, the Breast International Group (BIG) 1-98 trial stands out as unique in design, as it is the only trial to address whether an aromatase inhibitor is more effective as initial adjuvant therapy or as sequential therapy with an aromatase inhibitor and tamoxifen in either order and in rigor of end points and safety evaluations.

Decision-making and breast cancer clinical trials: how experience challenges attitudes.

Objective: The aim of this study was to measure women's preferences about decision-making and their impact to participate or not to a hypothetical randomised controlled trial (RCT).

Methods: We surveyed prospectively breast cancer patients invited to participate in a clinical RCT (group 1a=201 acceptances, group 1b=66 refusals) or not invited (group 2=188). All women had the same treatment.

Effects of adjuvant aromatase inhibitor therapy on lipid profiles.

How aromatase inhibitors affect lipids is of great interest. Compared with tamoxifen, adjuvant anastrozole and letrozole are associated with increased incidences of hypercholesterolemia, while similar data are lacking for exemestane in the adjuvant setting. No significant differences in lipid profiles occurred with extended adjuvant exemestane compared with placebo, but total cholesterol and low-density lipoprotein levels increased significantly above baseline in both groups over 6 months.

Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial.

Purpose: The PACS 01 trial compared six cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) with a sequential regimen of three cycles of FEC followed by three cycles of docetaxel (FEC-D) as adjuvant treatment for women with node-positive early breast cancer.

Patients And Methods: Between June 1997 and March 2000, 1,999 patients with operable node-positive breast cancer were randomly assigned to either FEC every 21 days for six cycles, or three cycles of FEC followed by three cycles of docetaxel, both given every 21 days. Hormone-receptor-positive patients received tamoxifen for 5 years after chemotherapy.

Epirubicin-based chemotherapy as adjuvant treatment for poor prognosis, node-negative breast cancer: 10-year follow-up results of the French Adjuvant Study Group 03 trial.

We evaluated the contribution of an epirubicin-based adjuvant chemotherapy on disease-free survival (DFS) in poor prognosis, node-negative breast cancer (BC) patients. Poor prognostic factors were defined as: pathologic tumor size >or= 4 cm, estrogen-receptor negative, and progesterone-receptor negative. Scarff-Bloom Richardson grade 2 tumors must have two of these factors, and only one in case of grade 3.

Refining the postmenopausal breast cancer treatment paradigm: the FACE trial.

It is clear that letrozole and anastrozole provide significant benefits for patients with breast cancer. However, possible differences in efficacy have been suggested by varying degrees of aromatase inhibition and effectiveness in the neoadjuvant and first-line settings. Analyses of aromatase inhibitor-treated patient subgroups within the Arimidex, Tamoxifen, Alone or in Combination trial and Breast International Group 1-98 trial, and the National Cancer Institute of Canada Clinical Trials Group's MA.

Adjuvant trials: Aromatase inhibitors in early breast cancer--are they alike?

Tamoxifen has been a standard therapy for breast cancer, but its use is complicated by serious events, including endometrial cancer and thromboembolism. Tamoxifen therapy beyond the recommended 5 years fails to improve disease outcomes, leaving many patients without a treatment option and susceptible to relapse. While all third-generation aromatase inhibitors have proven to be more effective than tamoxifen in reducing recurrence risk, in a variety of settings, there may be some differences in efficacy.

[Influence of the delay between conservative surgery and radiation therapy on local relapse in node-positive breast tumor].

It has been shown that a delay in radiotherapy (RT) initiation resulted in a higher local relapse (LR) rate. The present analysis investigated retrospectively if the RT-adjuvant therapy sequence modified local-disease-free survival (L-DFS) after breast-conserving surgery (BCS) in node-positive (N +) breast cancer patients. Among seven French Adjuvant Study Group trials, 1,831 patients were assessable: 475 received RT directly after BCS, 567 after the 3rd chemotherapy (CT) cycle, and 789 after the 6th CT cycle.

Influence of intravenous amifostine on xerostomia, tumor control, and survival after radiotherapy for head-and- neck cancer: 2-year follow-up of a prospective, randomized, phase III trial.

Purpose: To evaluate chronic xerostomia and tumor control 18 and 24 months after initial treatment with amifostine in a randomized controlled trial of patients with head-and-neck cancer; at 12 months after radiotherapy (RT), amifostine had been shown to reduce xerostomia without changing tumor control.

Methods And Materials: Adults with head-and-neck cancer who underwent once-daily RT for 5-7 weeks (total dose, 50-70 Gy) received either open-label amifostine (200 mg/m2 i.v.

Intravenous amifostine during chemoradiotherapy for head-and-neck cancer: a randomized placebo-controlled phase III study.

Purpose: Clinical trials demonstrated the efficacy and safety of intravenous (i.v.) or subcutaneous (s.

Influence of the time between surgery and radiotherapy on local recurrence in patients with lymph node-positive, early-stage, invasive breast carcinoma undergoing breast-conserving surgery: results of the French Adjuvant Study Group.

Background: Radiotherapy (RT) after breast-conserving surgery (BCS) has produced significant reductions in ipsilateral breast carcinoma (BC) recurrence. It was shown previously that a delay in the initiation of RT resulted in a higher local recurrence (LR) rate. In the current retrospective analysis, the authors investigated whether the RT-adjuvant therapy sequence modified local-disease-free survival (L-DFS) after BCS in patients with early-stage, lymph node-positive BC.