Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)†.

Background: The use of potential surrogate end points for overall survival, such as disease-free survival (DFS) or time-to-treatment failure (TTF) is increasingly common in randomized controlled trials (RCTs) in cancer. However, the definition of time-to-event (TTE) end points is rarely precise and lacks uniformity across trials. End point definition can impact trial results by affecting estimation of treatment effect and statistical power.

Influence of geriatric oncology consultation on the management of breast cancer in older women: a French population-based study.

Aim: The objective of the present population-based study was to assess the impact of geriatric oncology consultation on the management of elderly patients with breast cancer and to identify the predictive factors of breast cancer treatment in this population.

Methods: A total of 206 women aged 75 years and older with breast cancer, diagnosed from January 2007 to December 2009 were included. The independent impact of geriatric oncology consultation on treatment was analyzed using multivariate logistic regression with adjustment for the other predictive factors of treatment.

Impact of neoadjuvant chemotherapy on survival in breast cancer patients in daily practice: a population-based study.

This population-based study aimed to describe the effects of neoadjuvant chemotherapy (NC) on survival in breast cancer (BC) patients in daily practice. BC patients treated with NC followed by surgery and radiotherapy, were retrospectively selected from 1982 to 2005 using the Côte d'Or BC registry. These patients were matched for the baseline AJCC (American Joint Committee on Cancer) stage, age at diagnosis, date of diagnosis and oestrogens receptors status to those who had undergone surgery followed by adjuvant chemotherapy and radiotherapy.

Protocol of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project: formal consensus method for the development of guidelines for standardised time-to-event endpoints' definitions in cancer clinical trials.

Introduction: In randomised phase III cancer clinical trials, the most objectively defined and only validated time-to-event endpoint is overall survival (OS). The appearance of new types of treatments and the multiplication of lines of treatment have resulted in the use of surrogate endpoints for overall survival such as progression-free survival (PFS), or time-to-treatment failure. Their development is strongly influenced by the necessity of reducing clinical trial duration, cost and number of patients.

Population-based study of breast cancer in older women: prognostic factors of relative survival and predictors of treatment.

Background: A large proportion of women with breast cancer (BC) are elderly. However, there is a lack of information regarding BC prognostic factors and care in this population. The aims of this study were to assess the prognostic factors of relative survival (RS) among women with BC aged ≥ 75 years old and to identify the predictive factors of treatments administered to this population.

Gemcitabine plus oxaliplatin in advanced hepatocellular carcinoma: a large multicenter AGEO study.

Background & Aims: The current standard treatment for advanced hepatocellular carcinoma (HCC) is sorafenib. This drug is effective but generally does not induce tumor shrinkage and other treatment options are still needed.

Methods: This retrospective multicenter study included all consecutive patients with advanced HCC treated with gemcitabine and oxaliplatin (GEMOX) between 2001 and 2010.

Attending breast cancer screening alone does not explain the detection of tumours at an early stage.

The goal of a screening programme is to allow tumour detection at an early stage when treatments are more effective and less invasive. We examined whether attending breast cancer (BC) screening alone can explain the discovery of tumours at an early stage. Women aged 50-74 years, with a first BC diagnosed from January 2006 to December 2008, were eligible.

Breast cancer in men in Cote d'Or (France): epidemiological characteristics, treatments and prognostic factors.

Breast cancer in men is rare, and clinical trials are thus not feasible. This study aimed to describe the epidemiological characteristics, treatment and prognostic factors of breast cancer in men. A population-based study was performed using data from the Cote d'Or breast and gynaecological cancer registry.

Response shift effects on measuring post-operative quality of life among breast cancer patients: a multicenter cohort study.

Purpose: To characterize response shift effects in patients with breast cancer (BC).

Methods: The QLQ-C30, BR23, and EurQOL-EQ-5D were assessed at baseline and at the end of the first hospitalization. We used the then-test approach to characterize changes in internal standards by calculating the mean difference between the then-test (retrospective measure) and pre-test baseline QoL assessments.

Population-based study of breast cancer screening in Côte d'Or (France): clinical implications and factors affecting screening round adequacy.

Factors affecting the adequacy of breast cancer screening rounds and the clinical implications of screening have been investigated in women aged 50-74 years. Questionnaires were sent to all eligible patients and to the family doctor of those patients who had died or were lost to follow-up at the time of the study. Unlike the tumour characteristics the patients' personal and family characteristics were also collected before the diagnosis.

Impact of response shift on longitudinal quality-of-life assessment in cancer clinical trials.

The assessment of longitudinal change in subjective patient-reported outcomes such as health-related quality of life (HRQoL) is a key component of many clinical and research evaluations. A major goal of measuring patient-reported HRQoL is to determine to what extent changes in HRQoL reports over time represent true changes in HRQoL due to treatment or cancer and to what extent they reflect measurement error. Indeed, the subjective assessment of HRQoL change is subject to response-shift effects, whereby health changes lead to shifts in internal standards (i.

Time to deterioration in quality of life score as a modality of longitudinal analysis in patients with breast cancer.

Purpose: This prospective multicenter study explored different definitions of time to deterioration (TTD) in quality of life (QoL) scores, according to different cutoffs of the minimal clinically important difference (MCID) as a modality for longitudinal QoL assessment in breast cancer patients.

Methods: QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and BR-23 before surgery, after surgery, and 6 and 12 months later. The global health score, arm symptoms score (BRAS), and breast symptoms score were analyzed.

Population-based study of ovarian cancer in Côte d'Or: prognostic factors and trends in relative survival rates over the last 20 years.

Background: The aim of this population-based study was to assess independent prognostic factors in ovarian cancer using relative survival (RS) and to investigate changes in RS rates from 1982 to 2005.

Methods: Data on 748 patients with ovarian cancer were provided by the Côte d'Or gynaecologic cancer registry. The RS was estimated using a generalized linear model with a Poisson error structure.

A multicenter cohort study to compare quality of life in breast cancer patients according to sentinel lymph node biopsy or axillary lymph node dissection.

Background: This prospective multicenter study assessed and compared the impact of different surgical procedures on quality of life (QoL) in breast cancer patients.

Patients And Methods: The EORTC QLQ-C30 and the EORTC QLQ-BR-23 questionnaires were used to assess global health status (GHS), arm (BRAS) and breast (BRBS) symptom scales, before surgery, just after surgery and 6 and 12 months later. The Kruskal-Wallis test with the Bonferroni correction was used to compare scores.

Population-based study of breast cancer survival in Cote d'Or (France): prognostic factors and relative survival.

Background: Few population-based studies have reported jointly analyses of relative survival according to the following prognostic factors: tumour-node-metastasis (TNM) stage, age, number of examined and positive nodes, hormonal status, histological Scarff, Bloom and Richardson (SBR) grade, tumour extension, hormone receptor status and tumour multifocal status.

Patients And Methods: Data on female invasive breast cancer were provided by the Cote d'Or breast cancer registry. The Kaplan-Meier method and log-rank test were used to estimate and compare the survival probability at 1, 5, 10 and 15 years.