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1.
Ann Oncol ; 26(5): 865-872, 2015 May.
Article in English | MEDLINE | ID: mdl-25070543

ABSTRACT

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. The DATECAN initiative (Definition for the Assessment of Time-to-event End points in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for RCT in sarcomas and gastrointestinal stromal tumors (GIST). METHODS: We first carried out a literature review to identify TTE end points (primary or secondary) reported in publications of RCT. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points. Recommendations were developed through a validated consensus method formalizing the degree of agreement among experts. RESULTS: Recommended guidelines for the definition of TTE end points commonly used in RCT for sarcomas and GIST are provided for adjuvant and metastatic settings, including DFS, TTF, time to progression and others. CONCLUSION: Use of standardized definitions should facilitate comparison of trials' results, and improve the quality of trial design and reporting. These guidelines could be of particular interest to research scientists involved in the design, conduct, reporting or assessment of RCT such as investigators, statisticians, reviewers, editors or regulatory authorities.


Subject(s)
Endpoint Determination/standards , Gastrointestinal Stromal Tumors/therapy , Randomized Controlled Trials as Topic/standards , Research Design/standards , Sarcoma/therapy , Terminology as Topic , Consensus , Delphi Technique , Disease Progression , Disease-Free Survival , Endpoint Determination/classification , Gastrointestinal Stromal Tumors/diagnosis , Gastrointestinal Stromal Tumors/mortality , Humans , Randomized Controlled Trials as Topic/classification , Sarcoma/diagnosis , Sarcoma/mortality , Time Factors , Treatment Failure
2.
Eur J Cancer Care (Engl) ; 22(5): 638-47, 2013 Sep.
Article in English | MEDLINE | ID: mdl-23647444

ABSTRACT

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. The prognostic effect of NC on survival in BC patients was assessed with relative survival (RS) analyses. From 1982 to 2005, 210 patients with BC diagnosed in Côte d'Or were treated with NC followed by surgery and radiotherapy. For these patients, mean age at diagnosis was 50 (SD = 11). The main tumour characteristics were clinical AJCC stage 3 (46%) and an advanced Scarff Bloom and Richardson (SBR) stage (80%). Breast conserving surgery was performed in 84 patients (40%), 151 patients (72%) were treated with anthracyclines as the NC and the 5-year RS rate was 71%. Among these patients, 92 (37%) were matched. In this population, multivariate analyses showed that the use of NC did not independently influence RS: relative excess risk = 0.93 (0.50, 1.71).


Subject(s)
Breast Neoplasms/drug therapy , Adult , Aged , Breast Neoplasms/mortality , Breast Neoplasms, Male/drug therapy , Breast Neoplasms, Male/mortality , Case-Control Studies , Chemotherapy, Adjuvant/mortality , Female , France/epidemiology , Humans , Male , Mastectomy, Segmental/mortality , Mastectomy, Segmental/statistics & numerical data , Middle Aged , Neoadjuvant Therapy/mortality , Retrospective Studies , Survival Analysis , Treatment Outcome
3.
Qual Life Res ; 22(1): 1-11, 2013 Feb.
Article in English | MEDLINE | ID: mdl-22383104

ABSTRACT

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. The Ideal Scale Approach was also used to assess changes in standards by comparing health and QoL expectancies between baseline and the end of the first hospitalization. Successive Comparison Approach was used to assess changes in values through the longitudinal assessment of the relative importance of EuroQOL dimensions. RESULTS: The results of this study showed that recalibration RS effects occurred early after the first hospitalization for 6/15 dimensions of QLQ-C30 (emotional, cognitive, fatigue, insomnia, appetite loss, diarrhea) and 2/8 of BR-23 (future perspective, systemic therapy side effects). Moreover, health and QoL expectancies changed between the baseline and the end of the first hospitalization, and changes in values were seen for the self-care and usual activities dimensions of the EuroQOL-EQ-5D. CONCLUSIONS: The occurrence of RS early after the first hospitalization suggests that it needs to be taken into account to interpret QoL changes in BC.


Subject(s)
Breast Neoplasms/psychology , Health Status , Quality of Life , Surveys and Questionnaires , Adult , Aged , Breast Neoplasms/drug therapy , Fatigue , Female , France , Hospitalization , Humans , Middle Aged , Postoperative Period , Prospective Studies , Retrospective Studies , Self Care , Self Report , Statistics, Nonparametric , Visual Analog Scale
4.
Eur J Cancer Care (Engl) ; 21(6): 809-16, 2012 Nov.
Article in English | MEDLINE | ID: mdl-22642448

ABSTRACT

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. Data on male breast cancer diagnosed from 1982 to 2008 were provided. Relative survival rates were estimated at 5 years according to the characteristics of the patient and tumour, and treatment. Prognostic factors of survival in men with breast cancer were identified using a generalised linear model. Seventy-five men with invasive breast cancer were registered. Mean age at diagnosis was 66 years. The use of adjuvant chemotherapy (P= 0.013) and hormone therapy (P < 0.0001) increased over time. Relative survival rate at 5 years was 69% for the whole population. Analysis of relative survival according to the treatment showed that survival was longer for patients treated with surgery + radiotherapy + hormone therapy: 89% at 5 years. Scarff, Bloom and Richardson grade was independent prognostic factor of survival. Male breast cancer is a rare disease with a poor prognosis, and diagnosis is often made at an advanced stage. Early diagnosis and better knowledge of the disease would certainly lead to improvements in the prognosis.


Subject(s)
Breast Neoplasms, Male/mortality , Aged , Breast Neoplasms, Male/therapy , France/epidemiology , Humans , Male , Neoplasm Staging , Prognosis , Registries , Retrospective Studies , Rural Health , Survival Analysis , Treatment Outcome , Urban Health
5.
Ann Oncol ; 20(8): 1352-61, 2009 Aug.
Article in English | MEDLINE | ID: mdl-19468032

ABSTRACT

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. A mixed model analysis of variance for repeated measurements was then applied to assess the longitudinal effect of surgical modalities on QoL. RESULTS: Before surgery, GHS (P = 0.7807) and BRAS (P = 0.7688) QoL scores were similar whatever the surgical procedure: sentinel node biopsy (SLNB), axillary node dissection (ALND) or SLNB + ALND. As compared with other surgical groups, GHS 75.91 [standard deviation (SD) = 17.44, P = 0.041] and BRAS 11.39 (SD = 15.36, P < 0.0001) were better in the SLNB group 12 months after surgery. Whatever the type of surgery, GHS decreased after surgery (P < 0.0001), but increased 6 months later (P = 0.0016). BRAS symptoms increased just after surgery (P = 0.0329) and until 6 months (P < 0.0001) before decreasing (P < 0.0001). CONCLUSIONS: SLNB improved GHS and BRAS QoL in breast cancer patients. However, surgeons must be cautious, SLNB with ALND results in a poorer QoL.


Subject(s)
Breast Neoplasms/pathology , Breast Neoplasms/surgery , Lymph Nodes/pathology , Lymph Nodes/surgery , Cohort Studies , Female , Humans , Lymph Node Excision , Lymphatic Metastasis , Middle Aged , Prospective Studies , Quality of Life , Sentinel Lymph Node Biopsy
6.
Ann Oncol ; 19(2): 276-83, 2008 Feb.
Article in English | MEDLINE | ID: mdl-17962200

ABSTRACT

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. The effect of prognostic factors on survival was assessed with crude and relative multivariate survival analyses. RESULTS: Crude survival seemed to be worse in patients aged >60 years compared with those aged 45-60 (P > 0.0001), whereas relative survival did not differ. TNM stage, histological SBR grade, progesterone receptor status, tumour multifocal status, locoregional extension and the period of diagnosis were independent prognostic factors of crude and relative survival. CONCLUSION: Breast cancer is influenced by many factors. Despite the absence of any association between the number of examined nodes and overall survival in this study, the number of nodes removed, in conjunction with other prognostic factors, may be useful in selecting node-negative patients for systemic therapy.


Subject(s)
Breast Neoplasms/mortality , Breast Neoplasms/pathology , Carcinoma, Ductal, Breast/mortality , Carcinoma, Ductal, Breast/pathology , Cause of Death , Adult , Age Distribution , Aged , Aged, 80 and over , Breast Neoplasms/therapy , Carcinoma, Ductal, Breast/therapy , Combined Modality Therapy , Cross-Sectional Studies , Disease-Free Survival , Female , France/epidemiology , Humans , Middle Aged , Multivariate Analysis , Neoplasm Staging , Probability , Prognosis , Proportional Hazards Models , Risk Assessment , Survival Analysis
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