Genomic signature to guide adjuvant chemotherapy treatment decisions for early breast cancer patients in France: a cost-effectiveness analysis.

Introduction: Chemotherapy (CT) is commonly used as an adjuvant treatment for women with early breast cancer (BC). However, not all patients benefit from CT, while all are exposed to its short- and long-term toxicity. The Oncotype DX® test assesses cancer-related gene expression to estimate the risk of BC recurrence and predict the benefit of chemotherapy. The aim of this study was to estimate, from the French National Health Insurance (NHI) perspective, the cost-effectiveness of the Oncotype DX® test compared to standard of care (SoC; involving clinicopathological risk assessment only) among women with early, hormone receptor-positive, human epidermal growth factor receptor 2-negative BC considered at high clinicopathological risk of recurrence. Methods: Clinical outcomes and costs were estimated over a lifetime horizon based on a two-component model that comprised a short-term decision tree representing the adjuvant treatment choice guided by the therapeutic decision support strategy (Oncotype DX® test or SoC) and a Markov model to capture long-term outcomes. Results: In the base case, the Oncotype DX® test reduced CT use by 55.2% and resulted in 0.337 incremental quality-adjusted life-years gained and cost savings of €3,412 per patient, compared with SoC. Being more effective and less costly than SoC, Oncotype DX® testing was the dominant strategy. Discussion: Widespread implementation of Oncotype DX® testing would improve patient care, provide equitable access to more personalized medicine, and bring cost savings to the health system.

[Episode-based bundled payment model: evaluation of medical costs for early operable breast cancer]. / Financement à l'épisode de soins : évaluation du coût d'une chirurgie première pour cancer du sein précoce.

INTRODUCTION: Episode-based bundled payment model is actually opposing to fee-for-service model, intending to incentivize coordinated care. The aims of these study were to determine episode-based costs for surgery in early breast cancer patients and to propose a payment model. METHODS: OPTISOINS01 was a multicenter prospective study including early breast cancer patients from diagnosis to one-year follow up. Direct medical costs, quality and patient reported outcomes were collected. RESULTS: Data from 604 patients were analyzed. Episode-based costs for surgery were higher in case of: planned radical surgery (OR=9,47 ; IC95 % [3,49-28,01]; P<0,001), hospitalization during more than one night (OR=6,73; IC95% [2,59-17,46]; P<0,001), home hospitalization (OR=11,07 ; IC95 % [3,01-173][3,01-54][3,01-543][3,01-54,33]; P<0,001) and re-hospitalization (OR=25,71 ; IC95 % [9,24-89,17; P<0,001). The average cost was 5 268 € [2 947-18 461] when a lumpectomy was planned and 7408 € [4 222-22 565] in case of radical mastectomy. Bootstrap method was applied for internal validation of the cost model showing the reliability of the model with an area under the curve of 0,83 (95 % CI [0,80-0,86]). Care quality and patient reported outcomes were not related to the costs. DISCUSSION: This is the first report of episode-based costs for breast cancer surgery. An external validation will be necessary to validate our payment model.

Absenteeism and indirect costs during the year following the diagnosis of an operable breast cancer: A prospective multicentric cohort study.

BACKGROUND: Diseases consequence on individual work as much as consequences of being absent from work are matters of interest for decision makers. METHODS: We analyzed lengths of absenteeism and related indirect costs for patients with a paid activity in the year following the diagnosis of early stage breast cancer, in the prospective OPTISOINS01 cohort. Both human capital and friction costs approach were considered for the valuation of lost working days (LWD). For the analysis, the friction period was estimated from recent French data. The statistical analysis included simple and multiple linear regression to search for the determinants of absenteeism and indirect costs. RESULTS: 93 % of the patients had at least one period of sick leave, with on average 2 period and 186 days of sick leave. 24 % of the patients had a part-time resumption after their sick leave periods, during 114 days on average (i.e. 41 LWD). Estimated indirect costs were 22,722.00 € and 7,724.00 € per patient, respectively for the human capital and the friction cost approach. In the multiple linear regression model, factors associated with absenteeism were: the invasive nature of the tumor (p = .043), a mastectomy (p = .038), a surgery revision (p = .002), a chemotherapy (p = .027), being a manager (p = .025) or a craftsman (p = .005). CONCLUSION: Breast cancer lead to important lengths of absenteeism in the year following the diagnosis, but almost all patients were able to return to work. Using the friction cost or the human capital approach in the analysis led to an important gap in the results, highlighting the importance of considering both for such studies.

Direct medical and non-medical costs of a one-year care pathway for early operable breast cancer: Results of a French multicenter prospective study.

INTRODUCTION: The organization of health care for breast cancer (BC) constitutes a public health challenge to ensure quality of care, while also controlling expenditure. Few studies have assessed the global care pathway of early BC patients, including a description of direct medical costs and their determinants. The aims of this multicenter prospective study were to describe care pathways of BC patients in a geographic territory and to calculate the global direct costs of early stage BC during the first year following diagnosis. METHODS: OPTISOINS01 was a multicenter, prospective, observational study including early BC patients from diagnosis to one-year follow-up. Direct medical costs (in-hospital and out-of-hospital costs, supportive care costs) and direct non-medical costs (transportation and sick leave costs) were calculated by using a cost-of-illness analysis based on a bottom-up approach. Resources consumed were recorded in situ for each patient, using a prospective direct observation method. RESULTS: Data from 604 patients were analyzed. Median direct medical costs of 1 year of management after diagnosis in operable BC patients were €12,250. Factors independently associated with higher direct medical costs were: diagnosis on the basis of clinical signs, invasive cancer, lymph node involvement and conventional hospitalization for surgery. Median sick leave costs were €8,841 per patient and per year. Chemotherapy was an independent determinant of sick leave costs (€3,687/patient/year without chemotherapy versus €10,706 with chemotherapy). Forty percent (n = 242) of patients declared additional personal expenditure of €614/patient/year. No drivers of these costs were identified. CONCLUSION: Initial stage of disease and the treatments administered were the main drivers of direct medical costs. Direct non-medical costs essentially consisted of sick leave costs, accounting for one-half of direct medical costs for working patients. Out-of-pocket expenditure had a limited impact on the household.

Multidimensional impact of breast cancer screening: Results of the multicenter prospective optisoins01 study.

Breast cancer (BC) screening has been developed to detect earlier stage tumors associated with better prognosis. The aim of study was to evaluate the impact of BC screening on therapeutic management of patients with first operable BC, and on costs, patients' needs, and working life. OPTISOINS01 was a multicenter, prospective observational study which aimed to identify the main care pathway of early BC. Among patients aged from 50 to 74 years-old, 2 groups were defined: the "Clinical signs" group and the "Screening" group (national organized screening and individual screening). We compared between these 2 groups: locoregional and systemic treatments, direct medical and non-medical costs from a National Health Insurance perspective, patients' needs assessed by the validated SCNS-BR8 "breast cancer" module of the SCNS-SF34 supportive care needs survey and the duration of sick leave. The "Clinical signs" group included 89 patients, while the"Screening" group included 290 patients. More axillary lymph node dissections and radical breast surgery were performed in the "Clinical signs". The rate of adjuvant chemotherapy was dramatically higher in the "Clinical signs" group. The median direct medical costs of the "Screening" group were €11,860 (€3,643-€41,030) per year and per patient, much lower than in the "Clinical signs" group (€14,940; €5,317-€41,070). Finally, needs specifically assessed by the SCNS-BR8 questionnaire were significantly higher for the postoperative and post-adjuvant periods in the "Clinical signs" group. This study highlighted the benefit of BC screening in terms of reduced therapies and positive impact on work and social life.

Determinants of return at work of breast cancer patients: results from the OPTISOINS01 French prospective study.

INTRODUCTION: Return to work (RTW) after breast cancer (BC) is still a new field of research. The factors determining shorter sick leave duration of patients with BC have not been clearly identified. The aim of this study was to describe work during BC treatment and to identify factors associated with sick leave duration. MATERIALS AND METHODS: An observational, prospective, multicentre study was conducted among women with operable BC. A logbook was given to all working patients to record sociodemographic and work-related data over a 1-year period. RESULTS: Work-related data after BC were available for 178 patients (60%). The median age at diagnosis was 50 years (27-77), 87.9% of patients had an invasive form of BC and 25.3% a lymph node involvement. 25.9% had a radical surgery and 24.2% had an axillary dissection. Radiotherapy was performed in 90.9% of patients and chemotherapy in 48.1%. Sick leave was prescribed for 165 patients (92.7%) for a median of 155 days. On univariate analysis, invasive BC (p=0.025), lymph node involvement (p=0.005), radical surgery (p=0.025), axillary dissection (p=0.004), chemotherapy (p<0.001), personal income <€1900/month (p=0.03) and not having received the patient information booklet on RTW (p=0.047) were found to be associated with a longer duration of sick leave. On multivariate analysis, chemotherapy was found to be associated with longer sick leave (OR: 3.5; 95% CI 1.6 to 7.9; p=0.002). The cost of sick leave to French National Health Insurance was fourfold higher in the case of chemotherapy (p<0.001). CONCLUSION: Advanced disease and chemotherapy are major factors that influence sick leave duration during the management of BC. TRIAL REGISTRATION NUMBER: NCT02813317.

Preoperative clinical pathway of breast cancer patients: determinants of compliance with EUSOMA quality indicators.

BACKGROUND: The European Society of Breast Cancer Specialists (EUSOMA) has defined quality indicators for breast cancer (BC). The aim of this study was to describe the preoperative clinical pathway of breast cancer patients and evaluate the determinants of compliance with EUSOMA quality indicators in the Optisoins01 cohort. METHODS: Optisoins01 is a prospective, multicentric study. Data from operable BC patients were collected, including results from before surgery to 1 year follow-up. Seven preoperative EUSOMA quality indicators were compared with the clinical pathways Optisoins01. RESULTS: Six hundred and four patients were included. European Society of Breast Cancer Specialists targets were reached for indicator 1 (completeness of clinical and imaging diagnostic work-up), 3 (preoperative definitive diagnosis) and 5 (waiting time). For indicator 8 (multidisciplinary discussion), the minimum standard of 90% of the patients was reached only in general hospitals and comprehensive cancer centres. Having more than 1 medical examination within the centre was associated with an increased waiting time for surgery, whereas it was reduced by having an outpatient breast biopsy. The comprehensive cancer centre type was the only parameter associated with the other quality indicators. CONCLUSIONS: European Society of Breast Cancer Specialists quality indicators are a useful tool to evaluate care organisations. This study highlights the need for a standardised and coordinated preoperative clinical pathway.

Determinants of geographic inequalities in HPV vaccination in the most populated region of France.

BACKGROUND: In France, there are recommendations and reimbursements for human papillomavirus (HPV) vaccination but no HPV vaccination programs. Therefore, vaccination is largely determined by parents' initiative, which can lead to inequalities. The objective of this study was to determine the factors associated with poorer vaccination coverage rates in the most populated region of France. METHODS: The data of this study were obtained from the National Health Insurance between 2011 and 2013. Correlations between vaccination initiation rate (at least 1 dose reimbursed) and socio-demographic/cultural factors were assessed using Pearson's product-moment correlation coefficient. Multivariate analyses were performed using logistic regression. RESULTS: In total, 121,636 girls received at least one HPV vaccine dose. The vaccination rate for girls born from 1996 to 1999 was 18.7%. Disparities in vaccination coverage rates were observed between the 8 departments of the region, ranging from 12.9% to 22.6%. At the department level, unemployment, proportion of immigrants and foreigners, and coverage by CMU health insurance ("Couverture Maladie Universelle", a health insurance plan for those who are not otherwise covered through business or employment and who have a low income) were significantly inversely correlated with vaccination rates, whereas urban residence, medical density, income and use of medical services were not related to coverage. In the multivariate model, only the percentage of foreigners remained independently associated with lower vaccination coverage. At the individual level, the use of medical services was a strong driver of HPV vaccination initiation. CONCLUSION: We observed geographic disparities in HPV vaccination initiation coverage. Even if no clear factor was identified as a vaccination determinant, we observed a failure of vaccination only based on parents' initiative. Therefore, an organized policy on HPV vaccination, such as school-based programs, can help improve coverage rates.

Surgical management modifications following systematic additional shaving of cavity margins in breast-conservation treatment.

BACKGROUND: Positive wide local excision margins are the most important risk factor of local breast-carcinoma recurrence. Shaving additional margins could lower the need for re-excisions when wide local excision margins are positive and cavity margins are negative. MATERIALS AND METHODS: This retrospective study, from January 2007 to December 2008, included 99 women with breast carcinomas who underwent wide local excision with 4 additional, systematically shaved, surgical cavity margins. All therapeutic decisions concerning post-wide local excision treatment were made by consensus during multidisciplinary meetings. RESULTS: This systematic cavity-shaving strategy avoided 25 re-excisions (25.3%), and 6 patients required new surgery because of carcinoma found in the additional cavity-shaving margins, despite negative wide local excision margins. No preoperative factor predictive of positive cavity margins was identified. CONCLUSIONS: Systematic shaving of additional cavity margins changed the surgical management after breast-conservation treatment.