Publications by authors named "Bernard Asselain"

128 Publications

Two-year survival with nivolumab in previously treated advanced non-small-cell lung cancer: A real-world pooled analysis of patients from France, Germany, and Canada.

Lung Cancer 2021 07 30;157:40-47. Epub 2021 Apr 30.

University Hospital, Goethe-University Frankfurt, Department of Hematology and Medical Oncology, Frankfurt, Germany. Electronic address:

Objectives: Immune checkpoint inhibitors have become the standard of care for metastatic non-small-cell lung cancer (NSCLC) progressing during or after platinum-based chemotherapy. Real-world clinical practice tends to represent more diverse patient characteristics than randomized clinical trials. We sought to evaluate overall survival (OS) outcomes in the total study population and in key subsets of patients who received nivolumab for previously treated advanced NSCLC in real-world settings in France, Germany, or Canada.

Materials And Methods: Data were pooled from two prospective observational cohort studies, EVIDENS and ENLARGE, and a retrospective registry in Canada. Patients included in this analysis were aged ≥18 years, had stage IIIB/IV NSCLC, and received nivolumab after at least one prior line of systemic therapy. OS was estimated in the pooled population and in various subgroups using the Kaplan-Meier method. Timing of data collection varied across cohorts (2015-2019).

Results: Of the 2585 patients included in this analyses, 1235 (47.8 %) were treated in France, 881 (34.1 %) in Germany, and 469 (18.1 %) in Canada. Median OS for the total study population was 11.3 months (95 % CI: 10.5-12.2); this was similar across France, Germany, and Canada. The OS rate was 49 % at 1 year and 28 % at 2 years for the total study population. In univariable Cox analyses, the presence of epidermal growth factor receptor mutations in nonsquamous disease, liver, or bone metastases were associated with significantly shorter OS, whereas tumor programmed death ligand 1 expression and Eastern Cooperative Oncology Group performance status 0-1 were associated with significantly prolonged OS. Similar OS was noted across subgroups of age and prior lines of therapy.

Conclusion: OS rates in patients receiving nivolumab for previously treated advanced NSCLC in real-world clinical practice closely mirrored those in phase 3 studies, suggesting similar effectiveness of nivolumab in clinical trials and clinical practice.
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http://dx.doi.org/10.1016/j.lungcan.2021.04.022DOI Listing
July 2021

Efficacy of extracranial stereotactic body radiation therapy (SBRT) added to standard treatment in patients with solid tumors (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases: study protocol for a randomised phase III trial (STEREO-OS).

BMC Cancer 2021 Feb 4;21(1):117. Epub 2021 Feb 4.

Academic Radiation Oncology & Brachytherapy Department, Lorraine Institute of Cancerology - Alexis-Vautrin Comprehensive Cancer Center, 6 avenue de Bourgogne, 54519, Vandœuvre-lès-Nancy, France.

Background: Stereotactic Body Radiation Therapy (SBRT) is an innovative modality based on high precision planning and delivery. Cancer with bone metastases and oligometastases are associated with an intermediate or good prognosis. We assume that prolonged survival rates would be achieved if both the primary tumor and metastases are controlled by local treatment. Our purpose is to demonstrate, via a multicenter randomized phase III trial, that local treatment of metastatic sites with curative intent with SBRT associated of systemic standard of care treatment would improve the progression-free survival in patients with solid tumor (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases compared to patients who received systemic standard of care treatment alone.

Methods: This is an open-labeled randomized superiority multicenter phase III trial. Patients with up to 3 bone-only metastases will be randomized in a 1:1 ratio.between Arm A (Experimental group): Standard care of treatment & SBRT to all bone metastases, and Arm B (Control group): standard care of treatment. For patients receiving SBRT, radiotherapy dose and fractionation depends on the site of the bone metastasis and the proximity to critical normal structures. This study aims to accrue a total of 196 patients within 4 years. The primary endpoint is progression-free survival at 1 year, and secondary endpoints include Bone progression-free survival; Local control; Cancer-specific survival; Overall survival; Toxicity; Quality of life; Pain score analysis, Cost-utility analysis; Cost-effectiveness analysis and Budget impact analysis.

Discussion: The expected benefit for the patient in the experimental arm is a longer expectancy of life without skeletal recurrence and the discomfort, pain and drastic reduction of mobility and handicap that the lack of local control of bone metastases eventually inflicts.

Trials Registration: ClinicalTrials.gov NCT03143322 Registered on May 8th 2017. Ongoing study.
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http://dx.doi.org/10.1186/s12885-021-07828-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7863429PMC
February 2021

Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study.

Oncoimmunology 2020 04 12;9(1):1744898. Epub 2020 Apr 12.

Department of Medical Oncology, Centre Léon Bérard, Lyon, France.

EVIDENS is an ongoing, prospective, non-interventional study evaluating the effectiveness and safety of nivolumab in lung cancer patients in France (ClinicalTrials.gov NCT03382496). Adults with a pathologically confirmed diagnosis of lung cancer and initiating treatment with nivolumab were recruited from 146 sites in France. This analysis included only patients with non-small cell lung cancer (NSCLC) who received ≥1 nivolumab infusion, and evaluated patient characteristics at the time of nivolumab initiation and its effectiveness and safety after a median follow-up of 18 months. A total of 1,420 patients with NSCLC were included, most of whom had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 (82.9%), non-squamous histology (69.2%) and stage IV disease (91.4%). Brain metastases were present in 19.9% of patients. Nivolumab was a second-line or ≥third-line regimen in 73.6% and 26.1% of patients, respectively. Almost all patients had prior chemotherapy (99.7%). Median overall survival was 11.2 months (95% confidence interval [CI]: 10.0-12.4). ECOG PS, smoking status, corticosteroids at baseline, epidermal growth factor receptor mutation status, presence of symptomatic brain metastases and treatment-related adverse events (TRAEs) were independent predictors of survival. Grade 3 and 4 TRAEs were reported in 105 (7.4%) and 12 (0.8%) patients, respectively; no treatment-related deaths were reported. Preliminary results of the EVIDENS study confirm the effectiveness and safety of nivolumab, mostly in pre-treated advanced NSCLC patients, with similar benefits to those observed in the phase III randomized clinical trials, despite a broader study population.
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http://dx.doi.org/10.1080/2162402X.2020.1744898DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7790497PMC
April 2020

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

J Gynecol Obstet Hum Reprod 2021 Jun 13;50(6):101871. Epub 2020 Jul 13.

Curie Institute, Surgical Oncology Department, Saint-Cloud, France.

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.
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http://dx.doi.org/10.1016/j.jogoh.2020.101871DOI Listing
June 2021

[Epidemiology and socio-cultural specificities of young women with breast cancer].

Bull Cancer 2019 Dec;106(12S1):S4-S9

Service d'oncologie médicale, hôpital Hôtel-Dieu, 1, place du Parvis Notre-Dame, 75004 Paris, France.

Breast cancer, with 58,459 new cases in France in 2018, is the most common cancer among women. Breast cancer, of young women, defined by consensus as women under 40 years of age, represents only 5% of breast cancer cases in France and 7% worldwide. Epidemiology: The incidence rate of breast cancer increased in France between 1990 and 2018, with an average increase of +1.1% per year. An overall upward trend is also found in Europe and the United States. The mortality rate (MPR) follows an inverse trend with an average decrease of -1.3% per year between 1990 and 2018. Survival is 90% at 5 years for young women, slightly lower than for women aged 45 to 74 (92-93%). Socio-cultural specificities The testimonies collected in the Meeting and Information Spaces show that young women experience the disease in a very different way from women usually affected by the disease. The consequences of cancer and treatment have a strong impact on their lives as women, couples, mothers, but also on their social, professional and civic lives. Returning to work is particularly difficult for young women, who are often away from the company for more than 10 months and 1 in 5 of whom report feeling penalized in their careers because of the disease. This aspect of the post-disease period, although crucial, is often overlooked and underestimated.
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http://dx.doi.org/10.1016/S0007-4551(20)30041-2DOI Listing
December 2019

Comedications influence immune infiltration and pathological response to neoadjuvant chemotherapy in breast cancer.

Oncoimmunology 2020 14;9(1):1677427. Epub 2019 Nov 14.

Residual Tumor & Response to Treatment Laboratory, RT2Lab, Translational Research Department, U932, Immunity and Cancer, Institut Curie, PSL Research University, Paris, France.

Immunosurveillance plays an important role in breast cancer (BC) prognosis and progression, and can be geared by immunogenic chemotherapy. In a cohort of 1023 BC patients treated with neoadjuvant chemotherapy (NAC), 40% of the individuals took comedications mostly linked to aging and comorbidities. We systematically analyzed the off-target effects of 1178 concurrent comedications (classified according to the Anatomical Therapeutic Chemical (ATC) Classification System) on the density of tumor-infiltrating lymphocytes (TILs) and pathological complete responses (pCR). At level 1 of the ATC system, the main anatomical classes of drugs were those targeting the nervous system (class N, 39.1%), cardiovascular disorders (class C, 26.6%), alimentary and metabolism (class A, 16.9%), or hormonal preparations (class H, 6.5%). At level 2, the most frequent therapeutic classes were psycholeptics (N05), analgesics (N02), and psychoanaleptics (N06). Pre-NAC TIL density in triple-negative BC (TNBC) was influenced by medications from class H, N, and A, while TIL density in HER2 BC was associated with the use of class C. Psycholeptics (N05) and agents acting on the renin-angiotensin system (C09) were independently associated with pCR in the whole population of BC or TNBC, and in -positive BC, respectively. Importantly, level 3 hypnotics (N05C) alone were able to reduce tumor growth in BC bearing mice and increased the anti-cancer activity of cyclophosphamide in a T cell-dependent manner. These findings prompt for further exploration of drugs interactions in cancer, and for prospective drug-repositioning strategies to improve the efficacy of NAC in BC.
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http://dx.doi.org/10.1080/2162402X.2019.1677427DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6959439PMC
July 2021

Improving breast cancer sensitivity to paclitaxel by increasing aneuploidy.

Proc Natl Acad Sci U S A 2019 11 4;116(47):23691-23697. Epub 2019 Nov 4.

INSERM U981, LabEx LERMIT, Department of Molecular Medicine, Gustave Roussy Research Center, Université Paris Saclay, 94800 Villejuif, France;

Predictive biomarkers for tumor response to neoadjuvant chemotherapy are needed in breast cancer. This study investigates the predictive value of 280 genes encoding proteins that regulate microtubule assembly and function. By analyzing 3 independent multicenter randomized cohorts of breast cancer patients, we identified 17 genes that are differentially regulated in tumors achieving pathological complete response (pCR) to neoadjuvant chemotherapy. We focused on the gene, whose major product, ATIP3, is a microtubule-associated protein down-regulated in aggressive breast tumors. We show here that low levels of ATIP3 are associated with an increased pCR rate, pointing to ATIP3 as a predictive biomarker of breast tumor chemosensitivity. Using preclinical models of patient-derived xenografts and 3-dimensional models of breast cancer cell lines, we show that low ATIP3 levels sensitize tumors to the effects of taxanes but not DNA-damaging agents. ATIP3 silencing improves the proapoptotic effects of paclitaxel and induces mitotic abnormalities, including centrosome amplification and multipolar spindle formation, which results in chromosome missegregation leading to aneuploidy. As shown by time-lapse video microscopy, ATIP3 depletion exacerbates cytokinesis failure and mitotic death induced by low doses of paclitaxel. Our results favor a mechanism by which the combination of ATIP3 deficiency and paclitaxel treatment induces excessive aneuploidy, which in turn results in elevated cell death. Together, these studies highlight ATIP3 as an important regulator of mitotic integrity and a useful predictive biomarker for a population of chemoresistant breast cancer patients.
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http://dx.doi.org/10.1073/pnas.1910824116DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6876190PMC
November 2019

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

PLoS One 2019 10;14(7):e0210917. Epub 2019 Jul 10.

Health Economics Department, Institut Curie, Paris, France/CEMKA-EVAL, Bourg-La-Reine, France.

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.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0210917PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6619952PMC
February 2020

Evidence of slight improvement in five-year survival in non-small-cell lung cancer over the last 10 years: Results of the French KBP-CPHG real-world studies.

Bull Cancer 2019 Apr 23;106(4):283-292. Epub 2019 Feb 23.

Hôpital de Meaux, respiratory medicine department, 6-8, rue Saint-Fiacre, BP 218, 77104 Meaux cedex, France.

Background: Although improved during the last decades, the prognosis of lung cancer is poor. In 2000, the French College of general hospital respiratory physicians, conducted KBP-2000-CPHG, a prospective multicenter epidemiological study including all volunteer adult patients diagnosed for primary lung cancer; with the five-year survival as primary endpoint. The primary objective of KBP-2010-CPHG was to compare overall five-year survival data with KBP-2000-CPHG ones.

Material And Methods: All consecutive patients≥18 years of age with primary lung cancer diagnosed between 1st January and 31st December 2010 were included. The KBP-2010-CPHG protocol was approved by the advisory committee on research information processing in the health field (CCTIRS) on November 19, 2009.

Results: Respectively, 5667 and 7051 patients were included in KBP-2000-CPHG and KBP-2010-CPHG. Five-year survival was improved: 12.7% [11.9%-13.5%] in 2010 versus 10.0% [9.2%-10.9%] in 2000 (P<0.001). Non-small-cell lung cancer showed improvement (13.8% [13.0%-14.8%] in 2010 versus 11.4% [10.5%-12.4%] in 2000; P<0.001); but not small-cell lung cancer (5.7% [4.4%-7.4%] in 2010 versus 3.3% [2.3%-4.7%] in 2000; P=0.56). The KBP-2010-CPHG study showed an overall 6% reduction in risk of death (HR=0.94 [0.89-0.98]; P=0.004).

Conclusions: Survival of patients with lung cancer improved over a 10-year period. This improvement was slight and limited to non-small-cell lung cancer, possibly partly because of 2010 advances in diagnosis and targeted therapy.
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http://dx.doi.org/10.1016/j.bulcan.2019.01.010DOI Listing
April 2019

The ongoing French metastatic breast cancer (MBC) cohort: the example-based methodology of the Epidemiological Strategy and Medical Economics (ESME).

BMJ Open 2019 02 21;9(2):e023568. Epub 2019 Feb 21.

R&D UNICANCER, Paris, France.

Purpose: The currently ongoing Epidemiological Strategy and Medical Economics (ESME) research programme aims at centralising real-life data on oncology care for epidemiological research purposes. We draw on results from the metastatic breast cancer (MBC) cohort to illustrate the methodology used for data collection in the ESME research programme.

Participants: All consecutive ≥18 years patients with MBC treatment initiated between 2008 and 2014 in one of the 18 French Comprehensive Cancer Centres were selected. Diagnostic, therapeutic and follow-up data (demographics, primary tumour, metastatic disease, treatment patterns and vital status) were collected through the course of the disease. Data collection is updated annually.

Finding To Date: With a recruitment target of 30 000 patients with MBC by 2019, we currently screened a total of 45 329 patients, and >16 700 patients with a metastatic disease treatment initiated after 2008 have been selected. 20.7% of patients had an hormone receptor (HR)-negative MBC, 73.7% had a HER2-negative MBC and 13.9% were classified as triple-negative BC (ie, HER2 and HR status both negative). Median follow-up duration from MBC diagnosis was 48.55 months for the whole cohort.

Future Plans: These real-world data will help standardise the management of MBC and improve patient care. A dozen of ancillary research projects have been conducted and some of them are already accepted for publication or ready to be issued. The ESME research programme is expanding to ovarian cancer and advanced/metastatic lung cancer. Our ultimate goal is to achieve a continuous link to the data of the cohort to the French national Health Data System for centralising data on healthcare reimbursement (drugs, medical procedures), inpatient/outpatient stays and visits in primary/secondary care settings.

Trial Registration Number: NCT03275311; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2018-023568DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6398702PMC
February 2019

Celecoxib With Neoadjuvant Chemotherapy for Breast Cancer Might Worsen Outcomes Differentially by COX-2 Expression and ER Status: Exploratory Analysis of the REMAGUS02 Trial.

J Clin Oncol 2019 03 31;37(8):624-635. Epub 2019 Jan 31.

1 Institut Curie, Université Paris Descartes, Paris, France.

Purpose: The overexpression of cyclooxygenase 2 (COX-2) gene, also known as prostaglandin-endoperoxide synthase 2 ( PTGS2), occurs in breast cancer, but whether it affects response to anticox drugs remains unclear. We investigated the relationships between PTGS2 expression, celecoxib use during neoadjuvant chemotherapy (NAC), and both event-free survival (EFS) and overall survival (OS).

Materials And Methods: We analyzed a cohort of 156 patients with human epidermal growth factor receptor 2 -negative breast cancer from the REMAGUS02 (ISRCTN Registry No. 10059974) trial with pretreatment PTGS2 expression data. Patients were treated by sequential NAC (epirubicin plus cyclophosphamide followed by docetaxel with or without celecoxib). Experimental validation was performed on breast cancer cell lines. The Cancer and Leukemia Group B (CALGB) 30801 ( ClinicalTrials.gov identifier: NCT01041781) trial that tested chemotherapy with or without celecoxib in patients with lung cancer served as an independent validation cohort.

Results: After 94.5 months of follow-up, EFS was significantly lower in the celecoxib group (hazard ratio [HR], 1.7; 95% CI, 1 to 2.88; P = .046). A significant interaction between PTGS2 expression and celecoxib use was detected ( P = .01). In the PTGS2-low group (n = 100), EFS was lower in the celecoxib arm (HR, 3.01; 95% CI, 1.45 to 6.24; P = .002) than in the standard treatment arm. Celecoxib use was an independent predictor of poor EFS, distant relapse-free survival, and OS. Celecoxib in addition to docetaxel enhanced cell viability in PTGS2-low cell lines but not in PTGS2-high cell lines. In CALGB 30801, a trend toward poorer progression-free survival was observed in the patients with low urinary metabolite of prostaglandin E2 who received celecoxib (HR = 1.57; 95% CI, 0.87 to 2.84; P = .13).

Conclusion: Celecoxib use during chemotherapy adversely affected survival in patients with breast cancer, and the effect was more marked in PTGS2-low and/or estrogen receptor-negative tumors. COX-2 inhibitors should preferably be avoided during docetaxel use in patients with breast cancer who are undergoing NAC.
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http://dx.doi.org/10.1200/JCO.18.00636DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6804843PMC
March 2019

Prediagnosis weight loss, a stronger factor than BMI, to predict survival in patients with lung cancer.

Lung Cancer 2018 12 5;126:55-63. Epub 2018 Jul 5.

Service de Pneumologie, Groupe Hospitalier Régional Mulhouse-Sud Alsace (GHRMSA), Hôpital Emile Muller, 20 rue du Dr Laënnec, BP 1370, 68070 Mulhouse, France. Electronic address:

Objectives: Recent studies have demonstrated that elevated BMI is associated with improved survival in patients with lung cancer. According to the authors, this "obesity paradox" could be a true benefit or a spurious relationship. In this context, data from the French KBP-2010-CPHG cohort (7,051 patients followed up for primary lung cancer diagnosed in 2010 in the respiratory medicine departments of 104 nonacademic hospitals) were analyzed.

Methods: Patients were stratified according to BMI at diagnosis using the definition of the French-Speaking Society of Clinical Nutrition and Metabolism (Société Francophone de Nutrition Clinique et Métabolisme). Survival was analyzed using log-rank and a univariate Cox model. Prognostic factors were identified using a multivariate Cox model with backward elimination procedure, and with or without inclusion of prediagnosis weight loss in the model.

Results: Patients were followed for a median 20.2 months. At diagnosis, respectively 12%, 28%, 45%, and 15% of the 6,595 patients with BMI data were obese, overweight, normal-weight, and underweight; 35%, 43%, 57%, and 75% reported prediagnosis weight loss (i.e., weight loss within the 3 months prior to diagnosis). One-year survival (% [95% CI]) was 53% [50%-57%], 50%, [48%-52%], 43%, [42%-45%], and 32% [29%-35%] in obese, overweight, normal-weight, and underweight patients, respectively (p < 0.001). It was particularly low in underweight patients with prediagnosis weight loss: 27% [24-30%]. BMI did not remain an independent prognostic factor associated with survival when prediagnosis weight loss was introduced in the Cox model. Risk of death was increased by 17%, 23%, and 46% in patients with <5 kg, 5-10 kg, or ≥10 kg prediagnosis weight loss, respectively (p < 0.001).

Conclusion: BMI is an easy but crude assessment tool. Other variables should be used to improve management of patients, and understanding of how prediagnosis body size and nutritional status are associated with cancer survival.
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http://dx.doi.org/10.1016/j.lungcan.2018.07.005DOI Listing
December 2018

UCBG 2-08: 5-year efficacy results from the UNICANCER-PACS08 randomised phase III trial of adjuvant treatment with FEC100 and then either docetaxel or ixabepilone in patients with early-stage, poor prognosis breast cancer.

Eur J Cancer 2018 11 26;103:184-194. Epub 2018 Sep 26.

Institut Claudius Regaud, IUCT Oncopole, Toulouse, France.

Purpose: UNICANCER-PACS08 compared adjuvant FEC (5-FU; epirubicin; cyclophosphamide) then docetaxel to FEC then ixabepilone in poor prognosis early breast cancer (BC). We evaluated whether replacing docetaxel with ixabepilone would increase 5-year disease-free survival (DFS).

Patients And Methods: Triple-negative breast cancer (TNBC) or oestrogen receptor (ER)+/progesterone receptor (PR)-/HER2- BC patients were randomised to receive standard FEC (3 cycles) followed by 3 cycles of either docetaxel (100 mg/m) or ixabepilone (40 mg/m). Radiotherapy was mandatory after conservative surgery; ER+ patients received endocrine therapy.

Results: Seven hundred sixty-two patients were enrolled between October 2007 and September 2010. Baseline characteristics were balanced between arms. Median follow-up was 66.7 months. Median DFS was not reached; 5-year DFS rate was 76% with docetaxel and 79% with ixabepilone (hazard ratio [HR] = 0.80; 95% confidence interval [CI] = 0.58-1.10; p = 0.175). Median overall survival (OS) was not reached; 5-year OS rate was 86% versus 84% (HR = 0.97; 95% CI = 0.66-1.42; p = 0.897). TNBC patients treated with ixabepilone had a 23% lower risk of relapse compared to docetaxel (HR for DFS = 0.77; 95% CI = 0.53-1.11; p = 0.168). DFS was longer with ixabepilone than docetaxel in patients with grade II-III lymphocytic infiltration (HR = 0.55; 95% CI = 0.29-1.05; p = 0.063). All patients experienced ≥1 adverse events (AEs): 75% reported grade III-IV AEs and two (<1%) had grade V AEs (both with neutropenia and infection receiving ixabepilone).

Conclusion: After adjuvant FEC, ixabepilone was comparable to docetaxel for treating poor prognosis early BC patients. The benefit of ixabepilone in subgroups (patients with TNBC and grade II-III lymphocytic infiltration) requires further evaluation.
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http://dx.doi.org/10.1016/j.ejca.2018.06.025DOI Listing
November 2018

[Adaptive designs for innovative therapies assessment: New methodological challenges].

Authors:
Bernard Asselain

Bull Cancer 2018 Sep 23;105(9):741-742. Epub 2018 Aug 23.

Hôpital hôtel Dieu, service d'oncologie médicale, 1, place du Parvis-de-Notre-Dame, 75004 Paris, France. Electronic address:

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http://dx.doi.org/10.1016/j.bulcan.2018.07.002DOI Listing
September 2018

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

BMJ Open 2018 05 18;8(5):e020276. Epub 2018 May 18.

Department of Surgical Oncology, Institut Curie-Centre René Huguenin, Paris, France.

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.
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http://dx.doi.org/10.1136/bmjopen-2017-020276DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5961575PMC
May 2018

The 21-gene Recurrence Score® assay predicts distant recurrence in lymph node-positive, hormone receptor-positive, breast cancer patients treated with adjuvant sequential epirubicin- and docetaxel-based or epirubicin-based chemotherapy (PACS-01 trial).

BMC Cancer 2018 May 4;18(1):526. Epub 2018 May 4.

Department of Medical Oncology, Institut Claudius Régaud, Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse, France.

Background: The 21-gene Recurrence Score (RS) result predicts outcome and chemotherapy benefit in node-negative and node-positive (N+), estrogen receptor-positive (ER+) patients treated with endocrine therapy. The purpose of this study was to evaluate the prognostic impact of RS results in N+, hormone receptor-positive (HR+) patients treated with adjuvant chemotherapy (6 cycles of FEC100 vs. 3 cycles of FEC100 followed by 3 cycles of docetaxel 100 mg/m) plus endocrine therapy (ET) in the PACS-01 trial (J Clin Oncol 2006;24:5664-5671).

Methods: The current study included 530 HR+/N+ patients from the PACS-01 parent trial for whom specimens were available. The primary objective was to evaluate the relationship between the RS result and distant recurrence (DR).

Results: There were 209 (39.4%) patients with low RS (< 18), 159 (30%) with intermediate RS (18-30) and 162 (30.6%) with high RS (≥ 31). The continuous RS result was associated with DR (hazard ratio = 4.14; 95% confidence interval: 2.67-6.43; p <  0.001), adjusting for treatment. In multivariable analysis, the RS result remained a significant predictor of DR (p <  0.001) after adjustment for number of positive nodes, tumor size, tumor grade, Ki-67 (immunohistochemical status), and chemotherapy regimen. There was no statistically significant interaction between RS result and treatment in predicting DR (p = 0.79).

Conclusions: After adjustment for clinical covariates, the 21-gene RS result is a significant prognostic factor in N+/HR+ patients receiving adjuvant chemoendocrine therapy.

Trial Registration: Not applicable.
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http://dx.doi.org/10.1186/s12885-018-4331-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5936023PMC
May 2018

Expression Is Predictive of Response to Neoadjuvant Celecoxib in -negative Breast Cancer Patients.

Anticancer Res 2018 03;38(3):1485-1490

Pharmacogenomics Unit, Curie Institute, Paris, France.

Background: The prognostic and predictive role of cyclo-oxygenase-2 (COX2) in breast cancer is still debated, and in particular, its role as a target of COX2 inhibitor (celecoxib) in neoadjuvant setting.

Materials And Methods: We analyzed a series of 156 breast cancer samples from patients of the COX2 inhibitor-treated arm included in the REMAGUS-02 randomized phase II trial. COX2 gene expression was assessed by reverse transcription and quantitative polymerase chain reaction using ribonucleic acid from frozen biopsies. Pathological complete response (pCR) was the surrogate end-point.

Results: Significantly higher rates of grade 3, and estrogen and progesterone receptor negativity were observed in tumors with the highest expression of COX2. pCR rates were significantly higher in COX2-overexpressing tumors in patients receiving celecoxib. The test for interaction between COX2 gene expression and the celecoxib effect was statistically significant (p<0.01), but was not retained in the multivariate analysis.

Conclusion: COX2 overexpression is predictive of pCR in patients with celecoxib-treated tumors. The efficacy of celecoxib in breast cancer might be improved by quantification of COX2 gene expression.
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http://dx.doi.org/10.21873/anticanres.12375DOI Listing
March 2018

Can we trust the calculation of texture indices of CT images? A phantom study.

Med Phys 2018 Apr 13;45(4):1529-1536. Epub 2018 Mar 13.

IR4M-UMR8081, CNRS, Univ Paris Sud, University Paris Saclay, Orsay Cedex, France.

Purpose: Texture analysis is an emerging tool in the field of medical imaging analysis. However, many issues have been raised in terms of its use in assessing patient images and it is crucial to harmonize and standardize this new imaging measurement tool. This study was designed to evaluate the reliability of texture indices of CT images on a phantom including a reproducibility study, to assess the discriminatory capacity of indices potentially relevant in CT medical images and to determine their redundancy.

Methods: For the reproducibility and discriminatory analysis, eight identical CT acquisitions were performed on a phantom including one homogeneous insert and two close heterogeneous inserts. Texture indices were selected for their high reproducibility and capability of discriminating different textures. For the redundancy analysis, 39 acquisitions of the same phantom were performed using varying acquisition parameters and a correlation matrix was used to explore the 2 × 2 relationships. LIFEx software was used to explore 34 different parameters including first order and texture indices.

Results: Only eight indices of 34 exhibited high reproducibility and discriminated textures from each other. Skewness and kurtosis from histogram were independent from the six other indices but were intercorrelated, the other six indices correlated in diverse degrees (entropy, dissimilarity, and contrast of the co-occurrence matrix, contrast of the Neighborhood Gray Level difference matrix, SZE, ZLNU of the Gray-Level Size Zone Matrix).

Conclusions: Care should be taken when using texture analysis as a tool to characterize CT images because changes in quantitation may be primarily due to internal variability rather than from real physio-pathological effects. Some textural indices appear to be sufficiently reliable and capable to discriminate close textures on CT images.
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http://dx.doi.org/10.1002/mp.12809DOI Listing
April 2018

Prognostic Biomarkers Used for Localised Prostate Cancer Management: A Systematic Review.

Eur Urol Focus 2018 12 7;4(6):790-803. Epub 2017 Mar 7.

Service d'Urologie, Clinique BeauSoleil, Montpellier, France.

Context: Prostate cancer stratification is based on tumour size, pretreatment PSA level, and Gleason score, but it remains imperfect. Current research focuses on the discovery and validation of novel prognostic biomarkers to improve the identification of patients at risk of aggressive cancer or of tumour relapse.

Objective: This systematic review by the Intergroupe Coopérateur Francophone de Recherche en Onco-urologie (ICFuro) analysed new evidence on the analytical validity and clinical validity and utility of six prognostic biomarkers (PHI, 4Kscore, MiPS, GPS, Prolaris, Decipher).

Evidence Acquisition: All available data for the six biomarkers published between January 2002 and April 2015 were systematically searched and reviewed. The main endpoints were aggressive prostate cancer prediction, additional value compared to classical prognostic parameters, and clinical benefit for patients with localised prostate cancer.

Evidence Synthesis: The preanalytical and analytical validations were heterogeneous for all tests and often not adequate for the molecular signatures. Each biomarker was studied for specific indications (candidates for a first or second biopsy, and potential candidates for active surveillance, radical prostatectomy, or adjuvant treatment) for which the level of evidence (LOE) was variable. PHI and 4Kscore were the biomarkers with the highest LOE for discriminating aggressive and indolent tumours in different indications.

Conclusions: Blood biomarkers (PHI and 4Kscore) have the highest LOE for the prediction of more aggressive prostate cancer and could help clinicians to manage patients with localised prostate cancer. The other biomarkers show a potential prognostic value; however, they should be evaluated in additional studies to confirm their clinical validity.

Patient Summary: We reviewed studies assessing the value of six prognostic biomarkers for prostate cancer. On the basis of the available evidence, some biomarkers could help in discriminating between aggressive and non-aggressive tumours with an additional value compared to the prognostic parameters currently used by clinicians.
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http://dx.doi.org/10.1016/j.euf.2017.02.017DOI Listing
December 2018

Optimal duration of adjuvant chemotherapy for high-risk node-negative (N-) breast cancer patients: 6-year results of the prospective randomised multicentre phase III UNICANCER-PACS 05 trial (UCBG-0106).

Eur J Cancer 2017 07 11;79:166-175. Epub 2017 May 11.

Institut Claudius Regaud, Institut Universitaire Cancer Toulouse-Oncopole, 1 avenue Irèle joliot-Curie, 31059 Toulouse Cedex 9, France. Electronic address:

Purpose: Optimal duration of adjuvant chemotherapy in the treatment of early-stage breast cancer remained to be investigated rigorously for the standard regimens in widespread use in North America (doxorubicin/cyclophosphamide, AC) and Europe (5-fluorouracil/epirubicin/cyclophosphamide, FEC). Whether six cycles of FEC 100 present an advantage, or not, compared with only four cycles was tested directly in a phase III prospective multicentre trial.

Patients And Methods: Between 2002 and 2006, 1515 women between 18 and 65°years of age, with node negative N(-) high-risk early-stage breast cancer, were included in the study following breast surgery and axillary lymph node dissection or procedure by sentinel node technique. Inclusion in the study required tumour size T ≥ 1 cm and at least one of the high-risk factors: T > 2 cm, negative oestrogen receptor/progesterone receptor (ER- and PR-), Scarff-Bloom-Richardson (SBR) grade II or III and age ≤ 35°years. Patients were randomly assigned to either six FEC 100 (Arm A) or four FEC 100 (Arm B). The trial was powered to detect an absolute difference ≥6% in disease-free survival (DFS) at 5°years.

Results: At 6.1°years median follow-up, with 91 (12%) events recorded in Arm A versus 106 (14%) in Arm B, no statistically significant risk increase was associated with four versus six FEC 100: DFS (hazard ratio (HR) = 1.18; CI 95% [0.89-1.56], P = .24) and overall survival (OS) (HR = 1.39; CI 95% [0.91-2.13], P = .12).

Conclusion: Differences in chemotherapy duration did not induce notably different outcomes in our cohort of high-risk patients.

Clinical Trial Registry Number: NCT00055679, Agence National de Sécurité du Médicament (ANSM) - France.
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http://dx.doi.org/10.1016/j.ejca.2017.03.004DOI Listing
July 2017

First-line Bevacizumab and Paclitaxel for HER2-negative Metastatic Breast Cancer: A French Retrospective Observational Study.

Anticancer Res 2017 03;37(3):1403-1407

Department of Medical Oncology, Curie Institute, PSL Research University, Paris, France.

Aim: To assess outcomes in patients treated with first-line bevacizumab-containing therapy for human epidermal growth factor receptor (HER)2-negative metastatic breast cancer (mBC) at a single centre with a homogenous standard-of-care.

Patients And Methods: Information on patient and disease characteristics, efficacy, and safety was extracted from computer-based records of all patients receiving first-line bevacizumab-paclitaxel at the Curie Institute, Paris, France, between 2008 and 2011.

Results: Median progression-free survival in the 116 treated patients was 13.2 months; median overall survival was 38.4 months. Corresponding values were 9.0 and 18.8 months, respectively, in patients with triple-negative mBC, and 19.4 and 58.8 months, respectively, in patients receiving maintenance endocrine therapy. No new safety signals were seen.

Conclusion: Outcomes in patients treated with bevacizumab-paclitaxel at our center were consistent with efficacy in prospective clinical trials, with notable activity in poor-prognosis disease. Maintenance endocrine or oral therapy with bevacizumab after paclitaxel discontinuation was associated with long-term disease control.
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http://dx.doi.org/10.21873/anticanres.11462DOI Listing
March 2017

Long-term outcome of the REMAGUS 02 trial, a multicenter randomised phase II trial in locally advanced breast cancer patients treated with neoadjuvant chemotherapy with or without celecoxib or trastuzumab according to HER2 status.

Eur J Cancer 2017 04 7;75:323-332. Epub 2017 Mar 7.

Medical Oncology Department, Institut Curie, Saint Cloud, Paris, France; Université Paris Descartes, Sorbonne Paris Cite, Paris, France.

Background: The REMAGUS-02 multicenter randomised phase II trial showed that the addition to neoadjuvant chemotherapy (NAC) of trastuzumab in patients with localised HER2-positive breast cancer (BC) increased the pathological complete response (pCR) rate and that the addition of celecoxib in HER2-negative cases did not increase the pCR rate. We report here the long-term follow-up results for disease-free survival (DFS) and overall survival (OS).

Patients And Methods: From 2004 to 2007, 340 stage II-III BC patients were randomly assigned to receive neoadjuvant EC-T (four cycles of epirubicin-cyclophosphamide followed by four cycles of docetaxel) +/- celecoxib in HER2-negative cases (n = 220) and ± trastuzumab in HER2-positive cases (n = 120). From September 2005, all patients with HER2-positive BC received adjuvant T (n = 106).

Results: Median follow-up was nearly 8 years (94.4 months, 20-127 m). In the HER2-negative subgroup, addition of celecoxib was not associated with a DFS benefit. Favourable factors were smaller tumour size, expression of progesterone receptor status (PgR) and pCR. In the HER2-positive population, neoadjuvant trastuzumab was not associated with a DFS benefit. Axillary pCR was the only prognostic factor associated with DFS in this group [HR = 0.44, 95% CI = 0.2-0.97], p = 0.035]. To note, DFS and OS were significantly higher in the HER2-positive than in HER2-negative BC patients (HR = 0.58 [0.36-0.92], p = 0.021).

Conclusion: Celecoxib combined with NAC provided neither pCR nor survival benefit in patients with HER2-negative BC. Absence of PgR is a major prognostic factor. Neoadjuvant trastuzumab increased pCR rates without translation into a DFS or OS benefit compared with adjuvant trastuzumab only. Axillary pCR could be a more relevant surrogate of survival than in the breast in HER2-positive population. A retrospective comparison shows that patients with HER2-positive tumours have a better outcome than HER2-negative BC patients showing the impact of trastuzumab on the natural history of BC.
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http://dx.doi.org/10.1016/j.ejca.2017.01.008DOI Listing
April 2017

Observational Cohort Study of Patients With Metastatic Colorectal Cancer Initiating Chemotherapy in Combination With Bevacizumab (CONCERT).

Clin Colorectal Cancer 2017 06 9;16(2):129-140.e4. Epub 2016 Aug 9.

Gustave Roussy Institute, Villejuif and Paris Sud University, Le Kremlin Bicêtre, France.

Background: The CONCERT study (observational cohort study of patients with metastatic colorectal cancer initiating chemotherapy in combination with bevacizumab) aimed to describe patient characteristics, bevacizumab use, its efficacy in terms of progression-free survival (PFS) and overall survival (OS), and its safety in patients with metastatic colorectal cancer (mCRC) treated in daily medical practice.

Patients And Methods: CONCERT was an observational, prospective, multicenter, cohort study conducted in France. Patients with mCRC initiating bevacizumab combined with chemotherapy were included and followed up for ≤ 36 months.

Results: Overall, 737 evaluable patients were assessed, and 71%, 21%, and 8% initiated bevacizumab as first-, second-, or third-line therapy or more, respectively. Their mean age was 64.5 years (range, 25-88 years), and 60% were men. Bevacizumab was mainly started at 5 mg/kg every 2 weeks (95%) and mostly combined with FOLFIRI (leucovorin, 5-fluorouracil, irinotecan; 68.0%) or FOLFOX (leucovorin, 5-fluorouracil, oxaliplatin; 22.0%). The median PFS was 10.4 months (95% confidence interval [CI], 9.6-11.3) in first-line, 8.5 months (95% CI, 7.0-9.2) in second-line, and 6.3 months (95% CI, 4.5-8.9) in third-line or beyond. The corresponding median OS was 25.3 months (95% CI, 21.5-28.6), 19.1 months (95% CI, 15.7-22.6), and 14.9 months (95% CI, 11.6-20.4). In first-line treatment, primary tumor resection and oxaliplatin-based chemotherapy were prognostic of a longer PFS. Eastern Cooperative Oncology Group performance status ≥ 2, > 1 metastatic sites, and intermediate or high risk using the Köhne prognostic index were associated with shorter PFS. The safety profile of bevacizumab combined with chemotherapy was comparable to that found by other observational studies of mCRC.

Conclusion: The efficacy and safety results of bevacizumab plus chemotherapy as first- and second-line treatment of mCRC in daily practice in the CONCERT observational, prospective study were in line with those from randomized clinical studies.
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http://dx.doi.org/10.1016/j.clcc.2016.07.013DOI Listing
June 2017

Letter on the article "The BIAL/Biotrial case of death of a human volunteer in the first-in-human study of BIA 10-2474: Are we missing the fundamentals?"

Presse Med 2017 03 21;46(3):349-352. Epub 2017 Feb 21.

Institut Gustave-Roussy, 114, rue Edouard-Vaillant, 94807 Villejuif, France.

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http://dx.doi.org/10.1016/j.lpm.2017.01.007DOI Listing
March 2017

Study of Intrapatient Variability and Reproducibility of Quantitative Tumor Perfusion Parameters Evaluated With Dynamic Contrast-Enhanced Ultrasonography.

Invest Radiol 2017 03;52(3):148-154

From the *Gustave Roussy and IR4M, Centre National de la Recherche Scientifique, Université Paris-Sud, Université Paris-Saclay; †Service Biostatistique et Épidémiologie, Gustave Roussy and CESP Centre for Research in Epidemiology and Population Health, INSERM U1018, Université Paris-Sud; and ‡Radiology Department, Gustave Roussy, Villejuif, France.

Objectives: Dynamic contrast-enhanced (DCE) ultrasonography (US) is a functional imaging technique enabling quantitative assessment of solid tumor perfusion in metastatic patients treated with antiangiogenic therapies.The objective of this prospective single-center study was to evaluate in real-life conditions (in routine clinical practice) the intrapatient variability and reproducibility of DCE-US parameters.

Materials And Methods: Each patient provided written informed consent and had 2 DCE-US examinations (preprandial and postprandial) at baseline, day 15, and 1 month after treatment initiation. Perfusion curves were recorded after Sonovue injections to determine 7 perfusion parameters. Dynamic contrast-enhanced US examinations were analyzed in pairs: preprandial and postprandial. Log transformed values were used to determine the variability of the pairs (within-subject coefficient of variation) and their reproducibility (Spearman correlation coefficient).

Results: We included 60 patients (23 colon cancers, 36 kidney cancers, and 1 breast cancer) treated with axitinib (26 patients), sunitinib (27 patients), and other antiangiogenic treatments (7 patients). The 60 patients included 38 men (63%) and 22 women (37%) with a median age of 62 (range, 25-82 years). Thirty patients had hepatic and 30 had extrahepatic target lesions. Data were analyzed for 128 pairs of DCE-US: 45 (baseline), 45 (day 15), and 38 (1 month). Preprandial and postprandial values were not significantly different. For area under the curve and area under the washout, the correlation coefficient between preprandial and postprandial values was 0.89; the associated within-subject coefficients of variation were 61% and 64%, respectively. However, the range of individual variations (postprandial value/preprandial value) was less than 2 logs for a range of parameter values of about 4 logs. Variability was independent of the metastatic site.

Conclusions: This study showed that area under the curve and area under the washout are the 2 most reproducible DCE-US parameters.
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http://dx.doi.org/10.1097/RLI.0000000000000324DOI Listing
March 2017

Choroidal melanoma and pregnancy.

Acta Ophthalmol 2016 Nov 24;94(7):e652-e660. Epub 2016 Mar 24.

Institut Curie, Paris Descartes University, Paris, France.

Purpose: Choroidal melanoma is a rare tumour in adults. The mean age at diagnosis is 60, but the tumour can affect women of childbearing age. A negative effect of pregnancy on patients' survival has not been formally excluded to date. The aim of the present study is to evaluate the effect of pregnancy on the prognosis of choroidal melanoma.

Methods: We conducted a single-centre retrospective study at the Institut Curie on the population of women of childbearing age who were diagnosed with choroidal melanoma between June 1980 and October 2013. We took a particular interest in the prognosis of those who were pregnant at the time of diagnosis and in the prognosis of those who chose to get pregnant after the treatment.

Results: We found 27 pregnant patients at the time of diagnosis and 13 patients who became pregnant after the treatment. There was no difference in the survival between these two groups of patients and the group of other women of childbearing age diagnosed with choroidal melanoma (p = 0.52). There was also no difference in metastasis-free survival (p = 0.91). Most women were able to carry their pregnancies to term (67% had a term pregnancy, and only 7% had an abortion). For women who were pregnant when they were diagnosed with choroidal melanoma, a conservative treatment was chosen in 85% of cases, and proton beam therapy was the most widely used treatment.

Conclusions: Survival in women of childbearing age does not appear to be influenced by pregnancy. We show that proton beam therapy can be used to treat women who are pregnant at the time of choroidal melanoma diagnosis.
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http://dx.doi.org/10.1111/aos.12984DOI Listing
November 2016

[Breast cancer screening: On our way to the future].

Bull Cancer 2016 09 26;103(9):753-63. Epub 2016 Jul 26.

Université de recherche Paris, sciences et lettres, institut Curie, 26, rue d'Ulm, 75005 Paris, France.

Breast cancer remains a potentially lethal disease, which requires aggressive treatments and is associated with long-term consequences. Its prognosis is linked to both tumor biology and burden at diagnosis. Although treatments have allowed important improvements in prognosis over the past 20 years, breast cancer screening remains necessary. Mammographic screening allows earlier stage diagnoses and a decrease of breast cancer specific mortality. However, breast cancer screening modalities should be revised with the objective to address demonstrated limitations of mammographic screening (limited benefit, imperfect sensitivity and specificity, overdiagnoses, radiation-induced morbidity). Furthermore, both objective and perceived performances of screening procedures should be improved. Numerous large international efforts are ongoing, leading to scientific progresses that should have rapid clinical implications in this area. Among them is improvement of imaging techniques performance, development of real time diagnosis, and development of new non radiological screening techniques such as the search for circulating tumor DNA, development of biomarkers able to allow precise risk evaluation and stratified screening. As well, overtreatment is currently addressed by biomarker-based de-escalation clinical trials. These advances need to be associated with strong societal support, as well as major paradigm changes regarding the way health and cancer prevention is perceived by individuals.
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http://dx.doi.org/10.1016/j.bulcan.2016.06.005DOI Listing
September 2016

[First outpatient satisfaction questionnaire with day-surgery in a French comprehensive cancer center].

Bull Cancer 2016 Apr 26;103(4):330-5. Epub 2016 Feb 26.

Institut Curie, département d'oncologie chirurgicale, 26, rue d'Ulm, 75005 Paris, France.

Introduction: To assess the patient's satisfaction in a day-surgery unit in oncology for a surgical diagnosis or therapeutic act.

Methods: Between October 2013 and February 2014, we conducted a satisfaction survey from the validated questionnaire COPS-D. This questionnaire analyse the patient's stages in the care system, from the preoperative consultation to the return home: 9 stages with 23 items rated 1 (bad) to 5 (excellent). It was sent by postmail 3 weeks after their hospitalization.

Results: Four hundred and sixty-seven questionnaires were mailed, with a response's rate to 38% (172/467). Participant's characteristics: 88% are women, 45% are full time workers, 54% of senology. Two-third of the assessments were rated 4 or 5. Five percent were rated 1 or 2. The patient's exit is the least preferred step. The operating room's assessment is the most preferred by patients. Sixty-one percent of participants have written a free comment, 31% are positives, 36% are negatives, and 32% are mixed. The wait was the negative recurrent comment (21%).

Discussion: Most participants are very satisfied. Improving the wait before the operation and output is already underway. Studies are now needed to assess the care's safety and the economic aspect of day-surgery.
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http://dx.doi.org/10.1016/j.bulcan.2016.01.018DOI Listing
April 2016
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