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Introduction: Routine Electronic Monitoring of Health-Related Quality of Life (HRQoL) (REMOQOL) in clinical care with real-time feedback to physicians could help to enhance patient-centered care. We evaluated the feasibility of REMOQOL in the French context in the QOLIBRY study. The primary objective was to assess the patients' compliance with REMOQOL. Methods: The QOLIBRY study was a single-center, prospective study conducted in the University Hospital of Besançon (France). Eligible patients were those treated with systemic therapies for breast, lung or colorectal cancer at any stage. Patients were invited to complete the EORTC QLQ-C30 questionnaire and cancer-site-specific modules before each visit on tablets and/or computers in the hospital or at home. During the consultation, physicians had real-time access to visual summaries of HRQoL scores. Compliance was assessed as adequate if at least 66% of HRQoL assessments were completed during the 4 months of follow-up. Results: Between March 2016 and October 2018, 177 patients were included in the QOLIBRY study. Median age was 64 years (IQR 54–71). The proportion of patients with an adequate compliance rate was 95.5% (n = 63) in the breast cancer cohort, 98.2% (n = 55) in the colorectal cancer cohort, and 90.9% (n = 50) in the lung cancer cohort. The physicians checked the HRQoL results in 73.1% of visits and prescribed supportive care and adapted patient management in 8.3% and 5.2% of visits, respectively. Conclusion & perspectives: The results of QOLIBRY study suggest that REMOQOL is feasible in the French context. However, information about HRQoL monitoring, training of the physicians in the use of the software, and recommendations for using HRQoL results to guide care are essential and must be improved. [ABSTRACT FROM AUTHOR]

Background: In 2013, the interim analysis of the Protocol for Herceptin as Adjuvant therapy with Reduced Exposure (PHARE) trial could not show that 6 months of adjuvant trastuzumab was non-inferior to 12 months. Here, we report the planned final analysis based on the prespecified number of occurring events.Methods: PHARE is an open-label, phase 3, non-inferiority randomised trial of patients with HER2-positive early breast cancer comparing 6 months versus 12 months of trastuzumab treatment concomitant with or following standard neoadjuvant or adjuvant chemotherapy. The study was undertaken in 156 centres in France. Eligible patients were women aged 18 years or older with non-metastatic, operable, histologically confirmed adenocarcinoma of the breast and either positive axillary nodes or negative axillary nodes but a tumour of at least 10 mm. Participants must have received at least four cycles of a chemotherapy for this breast cancer and have started receiving adjuvant trastuzumab-treatment. Eligible patients were randomly assigned to either 6 months or 12 months of trastuzumab therapy duration between the third and sixth months of adjuvant trastuzumab. The randomisation was stratified by concomitant or sequential treatment with chemotherapy, oestrogen receptor status, and centre. The primary objective was non-inferiority in the intention-to-treat population in the 6-month group in terms of disease-free survival with a prespecified hazard margin of 1·15. This trial is registered with ClinicalTrials.gov, number NCT00381901.Findings: 3384 patients were enrolled and randomly assigned to either 12 months (n=1691) or 6 months (n=1693) of adjuvant trastuzumab. One patient in the 12-month group and three patients in the 6-month group were excluded, so 1690 patients in each group were included in the intention-to-treat analysis. At a median follow-up of 7·5 years (IQR 5·3-8·8), 704 events relevant to disease-free survival were observed (345 [20·4%] in the 12-month group and 359 [21·2%] in the 6-month group). The adjusted hazard ratio for disease-free survival in the 12-month group versus the 6-month group was 1·08 (95% CI 0·93-1·25; p=0·39). The non-inferiority margin was included in the 95% CI. No differences in effects pertaining to trastuzumab duration were found in any of the subgroups. After the completion of trastuzumab treatment, rare adverse events occurred over time and the safety analysis remained similar to the previously published report. In particular, we found no change in the cardiac safety comparison, and only three additional cases in which the left ventricular ejection fraction decreased to less than 50% have been reported in the 12-month group.Interpretation: The PHARE study did not show the non-inferiority of 6 months versus 12 months of adjuvant trastuzumab. Hence, adjuvant trastuzumab standard duration should remain 12 months.Funding: The French National Cancer Institute. [ABSTRACT FROM AUTHOR]

Abstract Adjuvant chemotherapy shows clear benefits in HER2-positive and triple-negative breast cancer (BC). Its benefits are less universal in BCs expressing hormone receptors. The 21-gene Oncotype DX® Breast Recurrence Score test was designed for HR+, HER2– early-stage BC before decision on adjuvant chemotherapy. Its validity and utility was demonstrated prospectively across multiple studies. The observational study PONDx characterized the use of Oncotype DX® Breast in routine practice in France and evaluated its decision impact. Of 882 ER-positive BC patients (67% postmenopausal), most (79%) had N0/Nmic node involvement, grade 2 tumors (68%), tumor size 1–5 cm (88%), and ductal histology (78%). BCs with histopathologically elevated recurrence risk included grade 3: 18%; N1: 21%; Ki67 > 20%: 31%. Recurrence Score results by prognostic category were: <18: 54%, 18–30: 36%; >30: 10%. Compared to recommendations before individual availability of the score, results prompted net absolute reductions in chemotherapy recommendations of 36% (total population), and 29% (grade 3 and/or Ki67 > 20% histologies). Decisions reflected prognostic implications: in the Recurrence Score <18 category, 95% of patients received recommendations of hormonal therapy only, in the >30 category, 97.5% were recommended additional chemotherapy; 95% followed the final recommendations of their physicians. The Recurrence Score provides independent predictive and prognostic information in ER + N0/N1 early BC, including high-risk subgroups. PONDx further characterizes the population where the test is beneficial in real-life use and fits current clinical needs. Oncotype DX® Breast enables relevant net reductions in chemotherapy use, sparing patients from serious toxicities. Its therapeutic implications are highly accepted by physicians and patients. Highlights • The results of PONDx confirm a pronounced decision impact in early breast cancer and define the relevant target population for the use of the test in real-life practice according to physician's appraisal. • The test leads to a relevant net reduction in adjuvant chemotherapy recommendations. [ABSTRACT FROM AUTHOR]

Background. The 21-gene Oncotype DX Recurrence Score assay is a validated assay to help decide the appropriate treatment for estrogen receptor-positive (ER 1 ), early-stage breast cancer (EBC) in the adjuvant setting. The choice of adjuvant treatments might vary considerably in different countries according to various treatment guidelines. This prospective multicenter study is the first to assess the impact of the Oncotype DX assay in the French clinical setting. Methods. A total of 100 patients with ER+, human epidermal growth factor receptor 2-negative EBC, and node-negative (pN0) disease or micrometastases in up to 3 lymph nodes (pN1mi) were enrolled. Treatment recommendations, physicians' confidence before and after knowing the Recurrence Score value, and physicians' perception of the assay were recorded. Results. Of the 100 patients, 95 were evaluable (83 pN0, 12 pN1mi). Treatment recommendations changed in 37% of patients, predominantly from chemoendocrine to endocrine treatment alone. The proportion of patients recommended chemotherapy decreased from 52% pretest to 25% post-test. Of patients originally recommended chemotherapy, 61% were recommended endocrine treatment alone after receiving the Recurrence Score result. For both pN0 and pN1mi patients, post-test recommendations appeared to follow the Recurrence Score result for low and high values. Physicians' confidence improved significantly. Conclusion. These are the first prospective data on the impact of the Oncotype DX assay on adjuvant treatment decisions in France. Using the assay was associated with a significant change in treatment decisions and an overall reduction in chemotherapy use. These data are consistent with those presented from European and non-European studies. [ABSTRACT FROM AUTHOR]

Background. The Oncotype DX recurrence score (RS) assay has been validated for prediction of 10-year risk of distant recurrence and likelihood of benefit from chemotherapy in patients with estrogen receptor (ER)-positive, HER2-negative early breast cancer. Patients with high RS tumors have substantial benefit, and patients with low RS tumors have minimal if any benefit from chemotherapy. Tumor size is used as a key parameter when selecting patients for neoadjuvant chemotherapy. The aim of this study was to assess the distribution of RS in patients selected for neoadjuvant chemotherapy primarily according to tumor size. Patients and Methods. Patients with ER-positive and HER2-negative tumors that were node-negative or had no more than 1 positive node from three trials were included in this study. Oncotype DX was performed at Genomic Health, Inc., blinded to the clinical data. Descriptive statistics were calculated for distribution of RS for all cases. Results. Of 277 patients, 96 met eligibility criteria, and 81 had sufficient material for analysis. Median tumor size was 40 mm (interquartile range [IQR], 30-50 mm). Grade I, II, and III were observed in 13,49, and 17cases, respectively. There was a wide distribution of RS with a median of 21.4 (IQR, 16.05-26.75). In total, 23 (28.3%) had high, 28 (34.6%) intermediate, and 30 (37%) low RS results. Conclusion. The RS may provide relevant information for neoadjuvant treatment decisions in select patients both in clinical practice and in studies. Inclusion of low RS disease patients in neoadjuvant trials will likely only dilute the ability to look at treatment effects. [ABSTRACT FROM AUTHOR]

Aim: To carry out a cost-minimization analysis including a comparison of the costs arising from first-line treatment by trastuzumab plus docetaxel versus trastuzumab plus paclitaxel in patients with metastatic breast cancer. Methods: All consecutive patients with human epidermal growth receptor 2-postive metastatic breast cancer who were treated at Besanc¸on University Hospital and Saint Vincent private hospital between 2001 and 2010 by first-line therapy containing trastuzumab plus taxane were retrospectively studied. Economic analysis took into account costs related to drugs, hospitalization, and healthcare travel. Results: Progression-free survival difference between the two treatments was not significant (p¼0.65). First-line treatment by trastuzumab plus taxane was estimated at approximately E68,000 (p¼0.74). The drug costs represented around 70–75% of the total cost, mainly related to the use of trastuzumab. Conclusion: Our economic analysis shows that although the costs of the two trastuzumab plus taxane regimens are similar, they may contribute to the on-going debate about the availability and use of innovative chemotherapy drugs, in particular in human epidermal growth factor receptor 2-positive metastatic breast cancer with new therapies such as trastuzumab-DM1 and pertuzumab. [ABSTRACT FROM AUTHOR]

Purpose: Colorectal cancer (CRC) screening has been shown to decrease CRC mortality. Organised mass screening programs are being implemented in France. Its perception in the general population and by general practitioners is not well known. Methods: Two nationwide observational telephone surveys were conducted in early 2005. First among a representative sample of subjects living in France and aged between 50 and 74 years that covered both geographical departments with and without implemented screening services. Second among General Practionners (Gps). Descriptive and multiple logistic regression was carried out. Results: Twenty-five percent of the persons(N = 1509) reported having undergone at least one CRC screening, 18% of the 600 interviewed GPs reported recommending a screening test for CRC systematically to their patients aged 50-74 years. The odds ratio (OR) of having undergone a screening test using FOBT was 3.91 (95% CI: 2.49-6.16) for those living in organised departments (referent group living in departments without organised screening), almost twice as high as impact educational level (OR = 2.03; 95% CI: 1.19-3.47). Conclusion: CRC screening is improved in geographical departments where it is organised by health authorities. In France, an organised screening programs decrease inequalities for CRC screening. [ABSTRACT FROM AUTHOR]

The article focuses on the increase rates of coverage for mammographic screening in France for older women. It notes that the generations Baby boomers and Silent generation are very concerned with breast cancer screening. It cites seven surveys in France which targeted women aged between 50-74 years old and had shown an increase in the said disease.

Background: There is a growing need for real-world data on cancer treatments usage, especially to assess compliance with recommendations. We developed a French project using hospital data to analyse evolution in the therapeutic strategies implemented in patients with human epidermal growth factor receptor 2 (HER2)-overexpressed (HER2+) breast cancer (BC) and exposed to injectable HER2-targeted therapies, i.e. trastuzumab, pertuzumab or trastuzumab emtansine (T-DM1)., Patients and Methods: Data from 26,350 women with BC were extracted in September 2018 from the Electronic Pharmacy Record systems of 120 French randomly recruited hospitals. Evolution in the treatments used, and combination regimens were described from 2011, in accordance with the BC stage and treatment line., Results: Overall, 21,119 patients treated since 2011 were analysed: 16,398 patients with early BC (eBC) and 6030 patients with metastatic BC (mBC) including patients treated at both stages. In eBC, 89.2% of patients received trastuzumab combined with at least taxanes (trastuzumab-taxane-anthracycline: 62.6%). Patients with mBC were treated in the first line (80.3%) and/or the second line (40.1%) and/or ≥ the third line (28.3%). After its approval in 2014, pertuzumab was first used in first-line therapy combinations in 67.4% of the total cases, while trastuzumab-taxane decreased from 47.2% to 9.2%. Similarly, T-DM1 was used as the second-line treatment in 53.8% of cases., Conclusions: Given recent changes in available treatments for patients with HER2+ BC, this large French project provides robust information on real-world evolution in therapeutic strategies. Our data suggest there is room for significant improvement in optimal drug utilisation. Such data will be useful to build drug-related indicators for future value-based pricing solutions., Competing Interests: Conflict of interest statement PC reports grants, personal fees and non-financial support from Roche during the conduct of the study; grants, personal fees and non-financial support from Pfizer; grants from Novartis; and personal fees from Lilly outside the submitted work. BC reports personal fees from Roche during the conduct of the study and personal fees from Roche, BMS and AstraZeneca outside the submitted work. DP reports grants and non-financial support from Roche during the conduct of the study; personal fees from Roche, Pierre Fabre, Novartis, BMS, Eli-Lilly and Ipsen; personal fees and non-financial support from AstraZeneca; and grants from MDS Avenir outside the submitted work. JM reports grants and personal fees from Roche during the conduct of the study and non-financial support from Roche and Amgen outside the submitted work. OA reports personal fees and non-financial support from Roche during the conduct of the study and personal fees from Roche outside the submitted work. NC and LS report being Roche employees. XP reports personal fees from Roche during the conduct of the study and personal fees from Samsung BioEpis and Prestige Pharma outside the submitted work. Other authors declare no conflict of interest., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Adjuvant chemotherapy shows clear benefits in HER2-positive and triple-negative breast cancer (BC). Its benefits are less universal in BCs expressing hormone receptors. The 21-gene Oncotype DX ® Breast Recurrence Score test was designed for HR+, HER2- early-stage BC before decision on adjuvant chemotherapy. Its validity and utility was demonstrated prospectively across multiple studies. The observational study PONDx characterized the use of Oncotype DX ® Breast in routine practice in France and evaluated its decision impact. Of 882 ER-positive BC patients (67% postmenopausal), most (79%) had N0/Nmic node involvement, grade 2 tumors (68%), tumor size 1-5 cm (88%), and ductal histology (78%). BCs with histopathologically elevated recurrence risk included grade 3: 18%; N1: 21%; Ki67 > 20%: 31%. Recurrence Score results by prognostic category were: <18: 54%, 18-30: 36%; >30: 10%. Compared to recommendations before individual availability of the score, results prompted net absolute reductions in chemotherapy recommendations of 36% (total population), and 29% (grade 3 and/or Ki67 > 20% histologies). Decisions reflected prognostic implications: in the Recurrence Score <18 category, 95% of patients received recommendations of hormonal therapy only, in the >30 category, 97.5% were recommended additional chemotherapy; 95% followed the final recommendations of their physicians. The Recurrence Score provides independent predictive and prognostic information in ER + N0/N1 early BC, including high-risk subgroups. PONDx further characterizes the population where the test is beneficial in real-life use and fits current clinical needs. Oncotype DX ® Breast enables relevant net reductions in chemotherapy use, sparing patients from serious toxicities. Its therapeutic implications are highly accepted by physicians and patients., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Purpose: Eribulin is approved for advanced breast cancers refractory to anthracyclines and taxanes. Efficacy according to sensitivity to previous therapies has been poorly explored., Materials and Methods: Safety data were collected prospectively and we retrospectively collected efficacy data from the five French centres that participated in the Eribulin E7389-G000-398 expanded access program. Our main objectiveswere exploration of safety and analysis of eribulin efficacy (progression-free survival [PFS] and overall survival [OS]) according to sensitivity to the last microtubule-inhibiting agent administered., Results: Median eribulin treatment duration was 3.3 months for the 250 patients included in this prospective single-arm study. Two hundreds and thirty-nine patients (95.6%) experienced an adverse event (AE) related to treatment including 129 (51.6%) with grade ≥ 3 AEs. The most frequently observed toxicities were cytopenias (59.6% of included patients), gastrointestinal disorders (59.2%), and asthenia (56.4%). The most frequent grade 3-4 AE was neutropenia (37.2% with 4.8% febrile neutropenia). Median PFS and OS were 4.6 and 11.8 months, respectively. Patients classified as responders to the last microtubule-inhibiting therapy had a longer OS (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.51 to 0.94; p=0.017), and tended to display a better PFS (HR, 0.78; 95% CI, 0.58 to 1.04; p=0.086). OS improvement was still significant in multivariate analysis (adjusted HR, 0.53; 95% CI, 0.35 to 0.79; p=0.002)., Conclusion: This work based on a prospective study suggests that identification of patients likely to be more sensitive to eribulin could be based on their previous response to microtubules inhibitors.

Background: The EDIFICE surveys have assessed cancer screening behavior in the French population since 2005., Methods: The 2016 edition was conducted among a representative sample of 1501 individuals (age, 50-75 years). The current analysis focuses on breast, colorectal, prostate, lung, and cervical cancer screening., Results: The rate of women (50 to 74 years) declaring having had at least one breast cancer screening test in their lifetime remained stable and high between 2005 and 2016. Compliance with recommended screening intervals improved between 2005 and 2011 from 75 to 83%, respectively, then decreased significantly to 75% in 2016 (P = 0.02). Uptake of at least one lifetime colorectal cancer screening test procedure declared (individuals aged 50-74 years) increase from 25% in 2005 to 59% in 2011, stabilized at 60% in 2014, then reached 64% in 2016. Opportunistic prostate cancer screening (men aged 50-75 years) rose between 2005 and 2008 from 36 to 49%, plateaued until 2014 then dropped to 42% in 2016. The proportion of women aged 50-65 declaring having undergone one cervical cancer screening test dropped significantly between 2014 and 2016 from 99 to 94% (P < 0.01). Lastly, 11% of our survey population in 2014 and 2016 (55-74 years) declared having already undergone lung cancer screening., Conclusion: Cancer screening behavior fluctuates in France, regardless of the context, i.e., organized programs or opportunistic screening. This observation highlights the need for constant analysis of population attitudes to optimize public awareness campaigns.

The prognosis of infracentimetric breast cancers (BC) is heterogeneous. The EURISTIC survey describes how French oncology specialists perceive the prognosis of pT1a,b pN0 BCs. A self-administered questionnaire has been sent to over 2000 French BC specialists. Six hundred and sixty-three physicians responded. Fifty-eight percent do not consider tumor size as a key prognostic criterion. They consider that the cutoff for poor prognosis is 22mm, 10mm and 7mm for hormone receptors (HRs)+, HER2+ and triple-negative (TN) tumors respectively. Eighty-three percent of respondents consider that a HR+ pT1a,b tumor has a good prognosis (21% and 8% for HER2+ and TN respectively). Factors perceived as most detrimental are: HER2 overexpression (29% of respondents); HR- (20%); high grade (20%); TN status (14%); high KI67 (5%); presence of lymphovascular invasion (3%); young age (2%) and high mitotic index (1%). For French specialists, immunohistochemical characteristics, in particular hormone and HER2 status, are strong prognostic factors in BCs below 1cm., (Copyright © 2015 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

Background: This article reports, the cardiac toxicity according to 6- versus 12-month durations of adjuvant trastuzumab in PHARE randomised trial (NCT00381901)., Patients and Methods: Cardiac follow-up and Left Ventricular Ejection Fraction (LVEF) assessment by echocardiography or multigated acquisition scan were performed every 3 months while patients received trastuzumab and after completion of treatment over the first 2 years and every 6 months afterwards. The primary cardiac end-point was Cardiac Heart Failure (CHF) defined as New York Heart Association (NYHA) class III or IV. The secondary cardiac end-points were: cardiac events, cardiac dysfunctions defined by NYHA class I and II; LVEF decreases, cardiac recoveries. The cardiac subcommittee reviewed cardiac events and assessed if patients had favourable outcomes or not on the basis of trends from LVEF measurements., Results: Among 3380 patients the cardiac dysfunction assessment included 14,055 and 13,218 LVEF measurements in the 12- and 6-month arms. The overall incidences of CHF were 0.65% (11/1690) and 0.53% (9/1690) in the 12 and 6 month arms, respectively (p>0.05). Cardiac dysfunction occurred in 5.9% (100/1690) and 3.4% (58/1690) of patients in the 12 and 6 month arms, respectively (p=0.001). Recoveries were observed for the majority patients and 0.79% (27/3380) of patients experienced an unfavourable cardiac outcome., Conclusion: PHARE confirm that the incidence of cardiac end-points remains low and mostly reversible after trastuzumab. Identification at baseline of cardiac risk categories of patients should be of interest to provide an optimal adaptation of adjuvant modalities and a shorter duration might be an option., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

The EDIFICE programme began in 2005 and set out to provide a clearer insight over time into the participation of the French population in cancer screening. EDIFICE 3 was conducted in 2011 by phone interviews among a representative sample of 1603 individuals aged between 40 and 75 years using the quota method. The analysis focused on the target populations (50-74 years) of the national screening programmes for breast and colorectal cancer. The same populations were also assessed with respect to prostate cancer screening. In 2005, 93% of the sample population had undergone at least one mammogram in their lifetime; this figure reached 94% in 2008 and 95% in 2011. Compliance with recommended intervals improved between 2005 and 2011, and significantly so for women aged 65-74 years. In 2005, 25% of respondents reported having undergone at least one colorectal cancer screening test; this figure reached 38% in 2008 and 59% in 2011. Recommended intervals were respected by 30 and 51% in 2008 and 2011, respectively. In 2005, 2008 and 2011, a total of 36, 49 and 50% of men reported having undergone at least one prostate cancer screening test. This rate decreased significantly in men aged 50-59 years between 2008 and 2011 (44 vs. 37%, P≤0.05). Attendance rates in national screening programmes are high and stable for breast cancer, and although currently improving for colorectal cancer, the European guideline target has not yet been reached. Despite the absence of recommendations for prostate cancer screening, participation remains constant.

The Cochrane analysis exploring the risk/benefit ratio of breast cancer screening resulted in a controversy worldwide spread by the mass media. Our survey sought to assess the impact of this controversy in terms of breast cancer screening awareness and attendance. A nationwide observational study, recorded in the EDIFICE iterative surveys, with a representative sample of 451 women aged 40-75 years, living in France, was carried out in the 3 months after the start of the controversy in January 2013. Of the 405 women with no personal history of cancer, 69 (17%) declared having heard of the controversy (aware group). Women remembering the controversy were more likely to belong to higher socioprofessional categories and to have a higher level of education. The most frequently remembered issues were overdiagnosis (38%), unreliability (16%) and radiation risk (9%). Compared with women who were unaware of the controversy, the aware group knew more about the limits of breast cancer screening (undiagnosed cancers, 20 vs. 7%, P<0.05 and risk of false positives, 20 vs. 2%, P<0.05) and were more likely to change their opinion for the worse over the mass media debate (8.7 vs. 1.2%, P<0.05). Nevertheless, only 1% of the aware-group declared their intention to subsequently undergo screening less frequently. The low impact of the controversy on the behaviour of women with respect to screening suggests that it should not be seen as a threat to screening attendance rates, but more as an opportunity to improve awareness.

This analysis aimed to assess the extent to which exposure to cancer risk factors and attendance of screening programmes are influenced by social characteristics. The validated Evaluation of deprivation and health inequalities in public health centres (EPICES) index was used to measure social deprivation. A sample of the general population (N=1603) was assessed to search for potential correlations between screening attendance, risk factors and any components of the EPICES score. In 2011, 33% of the population studied was classified as 'vulnerable'. Sex had no significant impact on this rating (32% men, 35% women), whereas occupational status did. Vulnerable individuals were more likely already to have cancer (10 vs. 7%; nonsignificant difference; odds ratio 1.43 [0.98-2.10]). The mean BMI was 26.0 kg/m (SD 4.9) for the vulnerable population versus 24.8 kg/m (SD 3.9) in the nonvulnerable population (P<0.01). The prevalence of current smoking was higher in the vulnerable group (38 vs. 23%, odds ratio 2.03 [1.61-2.56]). In contrast, no statistically significant difference was observed between attendance rates for nationwide organized cancer screening programmes (breast and colorectal; target age group 50-74 years) by the vulnerable and nonvulnerable groups. Social indicators of vulnerable populations are associated with increased rates of risk factors for cancer, but not with screening attendance. Our data support the previously reported marked impact of organized programmes that reduce or even remove inequalities in access to cancer screening. However, although the organized programmes have indeed enabled population-wide, nonselective access to screening, primary prevention as it stands today remains inadequate in the underserved population and further improvements are warranted.

Background: One of the main measures of the French national cancer plan is to encourage physicians to work collectively, and to minimize territorial inequities in access to care by rethinking the geographical distribution of oncologists. For this reason, cancer care services are currently being reorganized at national level. A new infrastructure for multidisciplinary cancer care delivery has been put in place in our region. Patients can receive multidisciplinary health care services nearer their homes, thanks to a mobile team of oncologists. The objective of our study was to assess, using a quality approach, the impact on medical management and on the costs of treating early breast cancer, of the new regional structure for cancer care delivery., Methods: Before-and-after study performed from 2007 to 2010, including patients treated for early breast cancer in three hospitals in the region of Franche-Comté in Eastern France. The main outcome measures were quality criteria, namely delayed treatment (>12 weeks), dose-intensity and assessment of adjuvant chemotherapy. Other outcomes were 24-month progression-free survival (PFS) and economic evaluation., Results: This study included 667 patients. The rate of chemotherapy tended to decrease, but not significantly (49.3% before versus 42.2% after, p=0.07), while the use of taxanes increased by 38% across all centres (59.6% before versus 98.0% after, p < 0.0001). There was a non-significant reduction in the time between surgery and adjuvant chemotherapy (6.0 ± 3.0 weeks before versus 5.6 ± 3.6 weeks after, p=0.11). Dose-dense chemotherapy improved slightly, albeit non significantly (86.3% versus 91.1% p=0.22) and time to treatment tended to decrease. The new regional infrastructure did not change 24-month PFS, which remained at about 96%. The average cost of treatment was estimated at € 7000, with no difference between the two periods., Conclusions: Despite a shortage of oncologists, the new organization put in place in our region for the provision of care for early breast cancer makes it possible to maintain local community-based treatment, without negative economic consequences. This new structure for cancer care delivery offers cancer services of similar quality with no modification of 24-month PFS in early breast cancer.

Oncotype DX® has been validated as quantifying the likelihood of distant recurrence at 10 years and overall chemotherapy benefit in patients with estrogen-receptor-positive and HER-2-negative early breast cancer. In 2012, this genomic signature was routinely available for patients in Franche-Comté, France. Patients eligible for Oncotype DX(®) testing had a ER-positive, HER-2-négative early breast cancer with a nodal involvement limited to 0 or 1 positive-node without extracapsular spread; an adjuvant chemotherapy was indicated based on usual prognostic factors. The aim was to assess the economic impact of Oncotype DX(®) testing in a French region. A cost-minimisation analysis from the French Public Healthcare System perspective was performed. The availability of Oncotype DX(®) in Franche-Comté, France, and its use in clinical routine allowed a decrease of 73 % of adjuvant chemotherapy without increase of the cost of the patients' management and with a potential reduction of the cost for the French Public Healthcare System. This strategy was successful and may allow the reimbursement of this test in France for patients with early breast cancer.

Background: Since 2005, 12 months of adjuvant trastuzumab has been the standard treatment for patients with HER2-positive early-stage breast cancer. However, the optimum duration of treatment has been debated. We did a non-inferiority trial of a shorter exposure of 6 months versus the standard 12 months of trastuzumab for patients with early breast cancer., Methods: We did an open-label, randomised, phase 3 trial in 156 centres in France. Patients with HER2-positive early breast cancer who had received at least four cycles of chemotherapy, had breast-axillary surgery, and had received up to 6 months of trastuzumab (administered by intravenous infusions over 30-90 min every 3 weeks; initial loading dose 8 mg/kg; 6 mg/kg thereafter) before randomisation were eligible. Patients were randomly assigned via central randomisation procedure with web-based software to continue trastuzumab for another 6 months (12 months total duration; control group) or to discontinue trastuzumab at 6 months (6 months total duration; experimental group). Randomisation was stratified by concomitant or sequential administration of trastuzumab with chemotherapy, oestrogen-receptor status, and centre using a minimisation algorithm. The primary endpoint was disease-free survival, with a prespecified non-inferiority margin of 1·15. Analyses were done in the intention-to-treat population. This study is registered at ClinicalTrials.gov, number NCT00381901., Findings: 1691 patients were randomly assigned to receive 12 months of trastuzumab and 1693 to receive 6 months of trastuzumab; 1690 patients in each group were included in the intention-to-treat analyses. After a median follow-up of 42·5 months (IQR 30·1-51·6), 175 disease-free survival events were noted in the 12-month group and 219 in the 6-month group. 2-year disease-free survival was 93·8% (95% CI 92·6-94·9) in the 12-month group and 91·1% (89·7-92·4) in the 6-month group (hazard ratio 1·28, 95% CI 1·05-1·56; p=0·29). 119 (93%) of the 128 cardiac events (clinical or based on assessment of left ventricular ejection fraction) occurred while patients were receiving trastuzumab. Significantly more patients in the 12-month group experienced a cardiac event than did those in the 6-month group (96 [5·7%] of 1690 patients vs 32 [1·9%] of 1690 patients, p<0·0001)., Interpretation: After 3·5 years follow-up, we failed to show that 6 months of treatment with trastuzumab was non-inferior to 12 months of trastuzumab. Despite the higher rates of cardiac events, 12 months of adjuvant trastuzmab should remain the standard of care., Funding: French National Cancer Institute., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Purpose: The treatment of patients with advanced cancer is becoming increasingly aggressive near the end of life, whereas poor literature is available. This study analyzes the management of patients with a solid cancer in their last 3 months of life in the Centre Hospitalier Universitaire de Besançon, France., Methods: This retrospective study includes all adult patients with a solid tumor who died in medical oncology or radiotherapy unit in 2005, 2006, and 2007. Group A had received at least one specific anticancer treatment at the end of life, while group B did not., Results: Of 167 included patients, 139 (83.2 %) received a specific treatment during the last 3 months of life. The reference unit was medical oncology for 76 % and radiotherapy for 24 % patients; overall survival was 18 and 9 months, and median age of metastatic evolution was 59 and 71 in group A and B, respectively. The number of previous lines of chemotherapy was on average 1.96 and 0.39, respectively. In a univariate analysis, differences appear for reference unit, age of death, and number of previous lines of chemotherapy, with a trend for chemosensitivity of the tumor in this small-sized study. No significant difference was found for sex, life-threatening metastases, or performance status., Conclusion: These preliminary data suggest that when evaluating the utilization of care at the end of life, one needs to take into account factors such as the age of the patient and the chemosensitivity of the tumor.

Breast cancer incidence remains the highest among gynaecologic neoplasms. Once they have achieved their treatments, patients should undergo careful follow-up. It aims at detecting early local recurrence or controlateral breast cancer. Based on large cohorts, clinical and radiological follow-up procedures come from guidelines realised by scientific organisations. We evaluated our regional practices in Franche-Comté and compared them to current guidelines. Patients with early breast cancer positive for hormonal receptors filled a questionnaire concerning their follow-up. It included patients treated from 1999 to 2005. When frequency of consultation is evaluated, only half of the patients undergo what is recommended. Whereas mammography and non-validated complementary exams are more regularly realised. Patients consulting more one practician have a better compliance. Our study underlines significant disparities among patients follow-up. Better interactions between physicians and a greater implication of patients in their follow-up would increase its quality.

In France, mammography screening is offered to women aged between 50 and 74 years. EDIFICE, the iterative nationwide survey, collected data on a national level about consumers utilization of available cancer screening procedures. This analysis compared data from a subset of 241 women aged between 40 and 50 years with that of 488 women aged between 50 and 74 years. Multivariate analysis showed the following significant factors to be linked with screening attendance for women younger than 50 years: age, with a threshold value at 44 years; awareness of the recommended screening period (2 years); consultation within the last 12 months with a general practitioner or a gynaecologist; and long standing local programme for colon cancer screening. Notwithstanding the debate on risk/benefit of breast cancer screening for women in their 40s, we observed more differences with regard to attendance between women aged 40-45 years versus that of 46-74 years than between women aged 40-49 years versus that of 50-74 years. The issue that is unanswered as yet is, do women make a kind of heuristic for starting breast cancer screening, leading them to a threshold choice of 45 years or alternatively to a collective answer of standard age minus 5 years!

In France, free faecal occult blood testing is offered to individuals aged between 50 and 74 years every 2 years as a method of screening for colorectal cancer (CRC). To assess how a proposed organized programme of CRC screening would be perceived among a representative sample of individuals living in France, aged between 40 and 75 years, and by a representative sample of general practitioners, two nationwide observational telephone surveys were carried out in 2005 (EDIFICE 1; 1601 individuals) and 2008 (EDIFICE 2; 1801 individuals). In 2008, 38% of individuals aged between 50 and 74 years reported undergoing screening for CRC; this corresponded to a statistically significant 13% increase in CRC screening rate compared with 2005 (P=0.01). When asked whether it was possible to screen for CRC, 94% of individuals who had undergone screening (N=350) responded positively compared with 87% of individuals who had not been screened. The main reason for individuals not to undergo screening was a lack of awareness (35% of men and 37% of women, P=not significant); the second reason was lack of advice and referral from their general practitioner (21% of women versus 15% of men, P=0.03). The French population is aware of the potential benefit of CRC screening; however, many do not undergo regular screening. It is therefore important to identify the hurdles associated with CRC screening.

In France, no official recommendations for or against systematic screening for prostate cancer have been issued yet. Therefore, individuals' choices with regard to screening or non-screening, and general practitioners' (GPs) recommendations for or against systematic screening should reflect personal preferences. Four nationwide observational studies (surveys) were conducted in France, two in 2005 and two in 2008, on a representative sample of participants aged between 40 and 75 years and a representative sample of GPs. In 2005, 36% of the male population interviewed, and aged between 50 and 75 years declared having undergone a screening test, compared with 49% in 2008 [odds ratio (OR)=1.63; 95% confidence interval (CI)=1.25-2.12]. In 2008, the number of men interviewed who reported having undergone screening less than 1 year earlier increased from 51% in 2005 to 74% (OR=2.18; 95% CI=1.40-3.40). The screening rate for young men (45-49 years) was only 7% in 2008 (data not available in 2005). In 2005, 58% of GPs systematically recommended prostate cancer screening for their patients aged 50-74 years, whereas in 2008, the figure was 65% (OR=1.32; 95% CI=1.04-1.66). The sex or age of the GPs had no significant impact on this rate. In France, we have observed a highly significant increase in prostate cancer screening: more men are screened, more often, at a younger age and more frequently using a prostate-specific antigen blood test. In our surveys, the observed threshold age for onset of prostate cancer screening is 50 years, almost the same as that for approved organized breast and colorectal screening programmes.

Colorectal cancer (CRC) is an important public health issue in France, justifying a screening policy adapted to individual risk. The general practitioner (GP) is most commonly the initiator of CRC screening. The EDIFICE 2 survey, carried out in 2008 among 600 GPs, showed that 83% of GPs were convinced of the importance of screening, but that only 30% of GPs systematically recommended the procedure. The main underlying reasons were that only 50% of GPs declared themselves sufficiently trained, GPs needed clear guidelines and information supports for patients and a better implication in the programme's overall organization. This important role was confirmed by patients as the second most important reason for not undergoing screening: the absence of recommendation from their treating physician. The optimization of the screening procedure thus requires a stronger implication of GPs, by confirming their pivotal role in CRC screening and by relying on clear reference documentation guaranteeing quality assurance of a national organized screening programme.

Regular mammography screening has been available in France, free of charge, for all women aged 50-74 years since 2005. Two nationwide surveys [EDIFICE 1 (507 women interviewed; age 50-74 years) and EDIFICE 2 (488 women)] recently collected data on individuals' access to cancer screening procedures. Two further surveys interviewed 600 general practitioners (GPs) each to determine their attitudes towards screening in general and screening for breast cancer in particular. The method of quotas ensured the populations surveyed were representative. In 2005, 93%, and in 2008, 94% of women reported having undergone a screening mammography. Anage-related effect was apparent in the 70-74 year subgroup in 2005, whereas in 2008, over 90% of women aged 50-74 years had had a mammography in their lifetime. In 2008, 66% of women had undergone a mammography as a part of an organized screening programme, versus 45% in 2005. In 2005, 15% of women reported having received no recommendation from their GP, whereas this figure fell to 4% in 2008. In both EDIFICE surveys, two thirds of GPs systematically recommended breast cancer screening to female patients aged 50-74 years; however, female GPs were more likely to systematically recommend this screening. In 2008, 77% of the GPs questioned were aware of the recommended frequency for breast cancer screening, compared with 71% in 2005. Results of studies such as EDIFICE may help increase the proportion of women who undergo breast cancer screening. Successful implementation of organized screening relies heavily on treating physicians. The impact of mammography in breast cancer screening may be further improved by systematic organized screening, by encouraging regular examination and by targeting women who give up screening.

In France, the age range for organized screening for breast cancer is 50-74 years. From a layperson's perspective, the public health message focusing on a specific target population may be difficult to understand. The aim of this study is to assess how women aged over 75 years deal with this absence of screening recommendations for their age group. The population-based survey, EDIFICE, was carried out by telephone in 2008. Women were interviewed with regard to their behaviour, and in particular relating to breast cancer screening. For 136 breast cancer-free women, aged 75 and above and who had undergone at least one mammography in their lifetime, the test had been done within the last 2 years for only 62 (51%) of them. In a multiregression analysis, only one item (i.e. already having undergone at least five mammographies) was statistically associated with a higher rate of attendance (odds ratio=3.3, 95% confidence interval=1.03-11.1). According to our data, for women aged 75 and above, an estimated 17,000,000 Euros are spent each year on breast cancer screening in France, the net benefit of which is still unknown.

Background: Intraperitoneal (i.p.) epinephrine was shown to increase the accumulation of i.p. cisplatin in tumours, and thus its antitumour effect in a model of peritoneal carcinomatosis in rats., Methods: To determine the tolerance to i.p. epinephrine with cisplatin, 18 patients with recurrent ovarian carcinoma were intraoperatively treated in this phase 1 study. After maximal cytoreductive surgery, the peritoneal cavity was filled twice for 1 h with 30 mg/l of cisplatin and increasing concentrations of epinephrine (0, 1, 2, 3 mg/l) in 3 l of saline solution at 37 degrees C., Results: No deaths occurred. Three patients were treated at each of the 0, 1 and 2 mg/l epinephrine levels without adverse events. Two of the three patients who received 3 mg/l epinephrine experienced cardiac intolerance. Six additional patients received 2 mg/l of epinephrine without toxicity. A relationship between the serum concentration of epinephrine and occurrence of cardiac toxicity was established. A 60% decrease in serum area under the curve of platinum was calculated in patients receiving i.p. epinephrine compared with i.p. cisplatin alone. Renal toxicity from cisplatin was not increased by epinephrine. No haematological or neurological toxicity was recorded. The other grade 3-4 adverse events [thromboembolism (5), peritonitis (1), abdominal bleeding (1), bowel fistula (1)] occurred as often as usually reported for this heavy surgical procedure., Conclusion: The combination of i.p. epinephrine with cisplatin as intraoperative chemotherapy after optimal cytoreductive surgery is feasible. The recommended concentration for further studies is 2 mg/l for i.p. epinephrine.

Introduction: Anaemia is a common toxicity in cancer patients and epoetins (EPOs) are now an established treatment. The economic profile of EPO treatment was assessed in patients with breast cancer treated by adjuvant-chemotherapy., Materials and Methods: Two strategies were compared: without treatment by EPO and with the possible use of treatment by EPO (epoetin alfa) when required. The clinical effectiveness criterion was time adjusted to quality of life and economic data included only direct medical costs., Main Results: One hundred ninety-two patients were included. In the group with the strategy containing the possible use of EPO, 45.5% of patients effectively received EPO. A significant difference in the haemoglobin level profile over time was observed which provided a significant overall benefit of 0.0052 (p<10(-4)) quality-adjusted life year (QALY) associated with an extra cost of 1,615 (p<10(-4)). In the base case analysis, the cost per added QALY was estimated as 310,577 with the strategy containing the possible use of EPO., Conclusion: This robust result seems to be unacceptable, but the only relevant point of discussion might be the level of acceptable incremental cost-effectiveness ratio (ICER) for a patient.

The aim of the present prospective study was to determine if malnutrition, measured using a simple validated score, is an independent risk factor for nosocomial infections (NI) in non-selected hospital in-patients. Between 29 and 31 May 2001, a survey on the prevalence of NI was conducted on all 1637 in-patients (61 (SD 25) years old) in a French university hospital as part of a national survey. Actual and usual body weights were recorded in all in-patients, and serum albumin levels were measured on all blood samples taken during the week before the study. Nutritional status was evaluated by using the nutritional risk index (NRI). Albumin values were obtained in 1084 patients, and complete weight information was obtained in 911. Therefore, NRI was calculated in 630 patients (61 (SD 20) years old): 427 (67.8 %) were malnourished. NI prevalence was 8.7 %: 4.4 % in non-malnourished patients, 7.6 % in moderately malnourished patients and 14.6 % in severely malnourished patients. In univariate analysis, the odds ratios for NI were 1.46 (95 % CI 1.2, 2.1) in moderately malnourished patients and 4.98 (95 % CI 4.6, 6.4) in severely malnourished patients. In multivariate analysis, age, immunodeficiency and NRI class influenced NI risk. Vascular and urinary catheters, and surgical intervention, were the extrinsic factors associated with NI, with odds ratios ranging from 2.0 (95 % CI 1.8, 2.6) for vascular catheters to 10.8 (95 % CI 8.8, 12.6) for association of the three factors. In conclusion, in non-selected hospitalized patients, malnutrition assessed with a simple and objective marker is an independent risk factor for NI. An early screening for malnutrition may therefore be helpful to reduce the high prevalence of NI.