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Background: The management of HER2+ BC has changed dramatically with the introduction and widespread use of HER2-targeted therapies, especially in the adjuvant setting. It is well-known that de novo metastatic HER2+ breast cancer patients have better outcomes that women with metastatic relapse. This could be related both to a lead time bias, as well as to an ATRESS (adjuvant therapy-related shortening of survival) phenomenon [1]. Indeed, cancer treatments induce increased both clonal selection, as well as globally tumor resistance and agressivity [2]. However, there is relatively limited real-world information on the impact of adjuvant and neoadjuvant anti-HER2 targeted treatments on patterns of recurrence and outcomes of HER2+ MBC. Thus, the purpose of this study was to determine how and how long anti-HER2 targeted treatment in early setting impact outcomes of patients with HER2+ recurring BC. Methods: Since 2014, the 18 French Cancer Centers launched the Epidemiological Strategy and Medical Economics (ESME) program to provide real-world data on MBC patients (pts). All pts who started a 1st-line treatment for MBC between 01-Jan-2008 and 31-Dec-2017 were included. We examined clinical characteristics and outcomes (overall survival [OS] and time to 1st metastasis [TTM]) in patients with HER2+ MBC pretreated with trastuzumab in the (neo)adjuvant setting (aT) compared with trastuzumab-naïve patients and patients with de novo HER2+ MBC. Multivariate analyses adjusted for baseline demographic, prognostic factors, adjuvant treatment received and time to MBC. Results: Among the 23698 pts of the ESME database, 4145 were women treated in 1st line of a HER2+ MBC: 1716 pts (41%) had de novo and 2429 pts (59%) recurrent and 65% had Hormone Receptor (HR) + MBC; 53%, 26% and 21% had respectively 1, 2, or > 2 metastatic sites (64% visceral and 11% brain). With a median follow-up of 60.7 m, median OS is 42.4 m (95% CI: 40.1-45.0) for patients who relapsed. OS is significantly longer in de novo MBC: 64.7 m (95% CI: 60.2-73) (HRadjusted=0.68, 95% CI: 0.62-0.76, p < 0.0001). Among pts with recurrent MBC, 56% (1343) had received adjuvant trastuzumab (aT). As 1st-line therapy for MBC, 86 % of pts received HER2-targeted agents (74% T-based, 24% T-pertuzumab-based). Median TTM was 46.9 months (m): 57.6 m in HR+ and 30.2 m in HR-. Among pts with HR- diseases, 38% relapsed during the first 2 years of follow-up and 30% after 4 years (14.8%% and 56.9% in HR+ respectively). Among pts with recurrent MBC, crude median OS is inferior in pts who received aT, as compared to those who did not: 37.2 m (95% CI: 34.4-40.3) vs. 53.5 m (95% CI: 47.6-60.1), but this difference does not persist after adjustment for age, performans status, disease-free interval and number and type of metastatic sites in the multivariate model (HR=1.05, 95% CI: 0.91-1.22). A short disease-free interval (6-24 months compared to >48) remains, however, a strong adverse prognostic factor (HR=2.1, 95% CI: 1.82-2.50). Conclusions: The receipt of adjuvant trastuzumab does not predict for worse outcomes when adjusted to the other prognostic factors, among patients who relapsed during the 2008-2017 period. An ATRESS phenomenon is not suggested, although we cannot rule it out for those who relapsed within the initial 2 years. The much better prognosis of de novo MBC may be largely linked to lead time biases. Citation Format: Fanny Le Du, Matthieu Carton, Mahasti Saghatchian, David Perol, Barbara Pistilli, Etienne Brain, Delphine Loirat, Laurence Vanlemmens, Thomas Vermeulin, Christelle Levy, Anthony Goncalves, Mony Ung, Marie Robert, Anne Jaffre, Mathieu Robain, Suzette Delaloge, Véronique Dieras. Impact of prior adjuvant trastuzumab (aT) on clinical characteristics, patterns of recurrence and outcomes in 4145 patients with Her2 positive (HER2+) metastatic breast cancer (MBC)- Results from the French ESME UNICANCER program [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P1-18-09.

Resume Introduction Chez les femmes considerees a haut risque de cancer du sein, la mastectomie est une alternative a la surveillance rapprochee. La chirurgie mammaire de reduction du risque (CMRR) presente des benefices et des risques, dont l’evaluation est particulierement importante car sa realisation depend du choix de la patiente. L’objectif de cette etude etait d’etudier les pratiques de la CMRR dans un centre francais de lutte contre le cancer et notamment d’evaluer la morbidite et le risque de decouverte fortuite de cancer. Methodes Il s’agit d’une etude retrospective, descriptive s’etendant de 2007 a 2017. Les dossiers de toutes les patientes ayant beneficie d’une CMRR bilaterale ou controlaterale ont ete analyses. Resultats Soixante-dix-neuf patientes ont ete operees sur la periode d’etude dont 58,2 % d’une mastectomie controlaterale. Le critere de recevabilite de la demande de mastectomie etait l’existence d’une mutation genetique dans 86,1 % des cas. Une complication postoperatoire est survenue chez 43,0 % des patientes et une reintervention a ete necessaire dans 72,1 % des cas. A l’analyse anatomopathologique, un cancer a ete decouvert dans 11,4 % des cas ; il s’agissait dans deux cas (2,5 %) d’un carcinome infiltrant de type triple negatif. Discussion La CMRR reste a ce jour la mesure la plus efficace de prevention du cancer du sein en France. Chaque femme doit, avant d’y recourir, etre clairement informee de la balance benefice–risque, en particulier de la forte probabilite de presenter une complication, de la necessite de plusieurs temps operatoires et de l’existence d’un risque de decouvrir un cancer a l’analyse anatomopathologique. L’accompagnement preoperatoire doit etre optimise afin de guider au mieux ces femmes dans leur processus decisionnel.

Background: Bone-only (BO) metastatic breast cancer (MBC), defined as bone as unique site of metastasis at MBC diagnosis, is thought to carry a better prognosis among MBC. However, only small retrospective series and data from selected randomized controlled trials have been reported so far. Based on a national database, we aimed at providing a large comprehensive analysis of BO MBC, and at evaluating its impact on clinical outcome. Methods: The ESME MBC platform (NCT03275311) is a French multicenter retrospective real-life database using a clinical trial-like methodology to collect data from 18 French Comprehensive Cancer Centers. It includes data from each newly diagnosed MBC patient having initiated at least one treatment between 2008 and 2016. BO cases occurring in women were retrieved and compared to the overall non-BO population, regarding treatment effects and survival. Results: Of the 22,463 women selected in the database, 5,041 (22.4%) patients with BO disease were identified. Most (N=4,102, 81.4%) had HR+/HER2- disease while 644 (12.8%) and 295 (5.9%) patients had HER2+ or HR-/HER2- disease, respectively. Compared to non-BO MBC, BO MBC patients were older in the global cohort and in HR-/HER2- patients (mean age 61.0y versus 59.5y, and 59.3y vs 56.4y, all p Conclusion: This large comprehensive study is the largest cohort of BO MBC to date. BO MBC has a distinct presentation from non-BO MBC and carry a better prognosis compared to non-BO MBC. A significant proportion of BO MBC patients have a very long survival and may benefit from aggressive local therapy, as stereotactic radiotherapy. Dedicated studies are warranted to tailor the management of these patients. Funding: This work was supported by UNICANCER. The ESME MBC database is supported by an industrial consortium (Roche, Pfizer, AstraZeneca, MSD, Eisai and Daiichi Sankyo). Data collection, analyses and publications are totally managed by R&D UNICANCER independently of the industrial consortium. TableBOBOBOBOnon-BOnon-BOnon-BOnon-BON (%)median OS monthsmedian PFS1 months5-year OS rate %N (%)median OS monthsmedian PFS1 months5-year OS rate %(95% CI)(95% CI)(95% CI)(95% CI)(95% CI)(95% CI)Overall population5,041 (100%)52.1 (50.3-54.1) 13.1 (12.6-13.8) 43.41 (41.66-45.15)15,054 (100%)34.7 (34.0-35.6) 8.5 (8.3-8.7) 30.55 (29.62-31.48)HR+/HER-4,102 (81.4%)52.6 (50.5-54.8)13.6 (13.0-14.3)43.52 (41.56-45.46)9,127 (60.6%) 39.0 (37.8-40.1)9.6 (9.3-9.9)32.69 (31.47-33.93)HER2+644 (12.8%)66.4 (59.8-71.9) 14.9 (12.9-17.3) 54.49 (49.54-59.16)3,265 (21.7%) 46.5 (44.2-48.9)10.6 (10.1-11.3)39.88 (37.77-41.98)HR-/HER2-295 (5.9%)20.8 (18.3-27.4) 5.6 (4.9-7.5)16.21 (11.21-22.02)2,662 (17.7%) 14.3 (13.6-15.1)4.8 (4.6-5.0)10.89 (9.4-12.5)De novo MBC patients1,909 (37.9%)58.6 (55.4-62.1)17.9 (17.0-18.9)48.24 (45.28-51.14)4,399 (29.2%) ---Relapsed MBC patients3,132 (62.1%)48.3 (46.5-50.5)10.7 (10.2-11.2)40.51 (38.34-42.67)10,655 (70.8%)--- Citation Format: Marion Bertho, Julien Fraisse, Anne Patsouris, Paul Cottu, Suzette Delaloge, David Pérol, Anne Jaffré, Anthony Goncalves, Marie-Paule Lebitasy, Véronique D'Hondt, Florence Dalenc, Jean-Marc Ferrero, Christelle Levy, Patrick Arveux, Roman Rouzier, Frédérique Penault-Llorca, Lionel Uwer, Jean-Christophe Eymard, Mathias Breton, Michaël Chevrot, Marianne Leheurteur, Michel Velten, Gaëtane Simon, Jean-Sébastien Frenel. Impact of bone-only metastatic breast cancer on outcome in a real-life setting: A comprehensive analysis of 5,041 women from the ESME database [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-19-01.

Background The impact of the first coronavirus disease 2019 (COVID-19) wave on cancer patient management was measured within the nationwide network of the Unicancer comprehensive cancer centers in France. Patients and methods The number of patients diagnosed and treated within 17 of the 18 Unicancer centers was collected in 2020 and compared with that during the same periods between 2016 and 2019. Unicancer centers treat close to 20% of cancer patients in France yearly. The reduction in the number of patients attending the Unicancer centers was analyzed per regions and cancer types. The impact of delayed care on cancer-related deaths was calculated based on different hypotheses. Results A 6.8% decrease in patients managed within Unicancer in the first 7 months of 2020 versus 2019 was observed. This reduction reached 21% during April and May, and was not compensated in June and July, nor later until November 2020. This reduction was observed only for newly diagnosed patients, while the clinical activity for previously diagnosed patients increased by 4% similar to previous years. The reduction was more pronounced in women, in breast and prostate cancers, and for patients without metastasis. Using an estimated hazard ratio of 1.06 per month of delay in diagnosis and treatment of new patients, we calculated that the delays observed in the 5-month period from March to July 2020 may result in an excess mortality due to cancer of 1000-6000 patients in coming years. Conclusions In this study, the delays in cancer patient management were observed only for newly diagnosed patients, more frequently in women, for breast cancer, prostate cancer, and nonmetastatic cancers. These delays may result is an excess risk of cancer-related deaths in the coming years., Highlights • A reduction of the number of cancer patients attending cancer centers was observed in France from January to July 2020. • This reduction was observed only for newly diagnosed patients. • The reduction of new diagnosis was more pronounced in women, for breast cancer, and prostate cancer, and nonmetastatic cancer. • No compensation was observed for the last months of 2020. The magnitude of delays may be larger in centers within the same country. • An estimation of the excess cancer death resulting from these delays is presented.

Background: Bone-only (BO) metastatic breast cancer (MBC) is considered a more favorable entity than other MBC presentations. However, only few retrospective series and data from selected randomized controlled trials have been reported so far. Methods: Using the French national multicenter ESME (Epidemiological Strategy and Medico Economics) Data Platform, the primary objective of our study was to compare the overall survival (OS) of patients with BO versus non-BO MBC at diagnosis, with adjustment on main prognostic factors using a propensity score. Secondary objectives were to compare first-line progression-free survival (PFS1), describe treatment patterns, and estimate factors associated with OS. Results: Out of 20,095 eligible women, 5041 (22.4%) patients had BO disease [hormone-receptor positive (HR+)/human epidermal growth-factor-receptor-2 negative (HER2−), n = 4 102/13,229 (31%); HER2+, n = 644/3909 (16.5%); HR−/HER2−, n = 295/2 957 (10%)]. BO MBC patients had a better adjusted OS compared with non-BO MBC [52.1 months (95% confidence interval (CI) 50.3–54.1) versus 34.7 months (95% CI 34.0–35.6) respectively]. The 5-year OS rate of BO MBC patients was 43.4% (95% CI 41.7–45.2). They also had a better PFS1 [13.1 months (95% CI 12.6–13.8) versus 8.5 months (95% CI 8.3–8.7), respectively]. This observation could be repeated in all subtypes. BO disease was an independent prognostic factor of OS [hazard ratio 0.68 (95% CI 0.65–0.72), p Conclusion: BO MBC patients have better outcomes compared with non-BO MBC, consistently, through all MBC subtypes.

Patients with metastatic breast cancer (MBC) often require inpatient palliative care (IPC). However, mounting evidence suggests age-related disparities in palliative care delivery. This study aimed to assess the cumulative incidence function (CIF) of IPC delivery, as well as the influence of age.The national ESME (Epidemio-Strategy-Medical-Economical)-MBC cohort includes consecutive MBC patients treated in 18 French Comprehensive Cancer Centres. ICD-10 palliative care coding was used for IPC identification.Our analysis included 12,375 patients, 5093 (41.2%) of whom were aged 65 or over. The median follow-up was 41.5 months (95% confidence interval [CI], 40.5-42.5). The CIF of IPC was 10.3% (95% CI, 10.2-10.4) and 24.8% (95% CI, 24.7-24.8) at 2 and 8 years, respectively. At 2 years, among triple-negative patients, young patients (65 yo) had a higher CIF of IPC than older patients after adjusting for cancer characteristics, centre and period (65+/65: β = -0.05; 95% CI, -0.08 to -0.01). Among other tumour sub-types, older patients received short-term IPC more frequently than young patients (65+/65: β = 0.02; 95% CI, 0.01 to 0.03). At 8 years, outside large centres, IPC was delivered less frequently to older patients adjusted to cancer characteristics and period (65+/65: β = -0.03; 95% CI, -0.06 to -0.01).We found a relatively low CIF of IPC and that age influenced IPC delivery. Young triple-negative and older non-triple-negative patients needed more short-term IPCs. Older patients diagnosed outside large centres received less long-term IPC. These findings highlight the need for a wider implementation of IPC facilities and for more age-specific interventions.

Background: The management of HER2+ BC has changed dramatically with the introduction and widespread use of HER2-targeted therapies, especially in the adjuvant setting. However, there is relatively limited real-world information on the impact of adjuvant Trastuzumab (aT) on patterns of recurrence and outcome of HER2+ MBC. Methods: In 2014, the 18 French Cancer Centers launched the Epidemiological Strategy and Medical Economics (ESME) program to provide real-world data on MBC patients (pts). All pts who started a 1st-line treatment for MBC between 01-Jan-2008 and 31-Dec-2014 were included. We examined clinical characteristics and outcomes (overall survival [OS] and time to next treatment [TNT]) in patients with HER2+ MBC pretreated with trastuzumab in the adjuvant setting (aT) compared with trastuzumab-naïve patients (nT) and patients with de novo HER2+ MBC (dn). Multivariate analyses adjusted for baseline demographic, prognostic factors and year of diagnosis (prior or after 2005, when aT was approved and widely administered in France for early HER2+ breast cancer). Results: Among the 15170 pts of the ESME database, 2863 (19%) were HER2+: 1093 pts (38%) had de novo and 1765 pts (62%) recurrent MBC; 63% were Hormone Receptor (HR) +; 54%, 25% and 21% had respectively 1, 2, or > 2 metastatic sites (68% visceral and 12% brain). Median time to 1st metastasis was 43.4 months (m) (95% CI: 24.6-84.4): 54 m in HR+ and 30 m in HR-. Among pts with recurrent MBC, 55% (995) had received aT. As 1st-line therapy for MBC, 90 % of pts received HER2-targeted agents (73% T-based). With a median follow-up of 46 m, median OS is 45 m (95% CI: 42.5-48). OS is significantly higher in de novo compared to recurrent MBC: 54 m (95% CI: 50.2-60.4) vs. 38.4 m (95% CI: 36.7-41.9), (p < 0.0001). Among pts with recurrent cancers, median OS is inferior in pts who had received aT, as compared to those who had not: 33.4 m (95% CI: 29.6-36.7) vs. 49.5 m (95% CI: 44.3-56.8), (p < 0.0001). Statistically significant differences persist after adjustment for age at MBC, disease-free interval, metastatic sites and RH status in the multivariate model (HR=1.45, 95% CI: 1.26-1.67) but not after adjustment for year of diagnosis (prior or after 2005) (HR=0.90, 95% CI: 0.70-1.15). Conclusions: These large-scale real-world data in patients with HER2+ MBC provide evidence that the survival outcome remain similar in patients with failure of adjuvant trastuzumab compared with trastuzumab-naïve patients after adjustment for year of diagnosis. De novo HER2+ MBC pts have the best outcomes. Data on clinical characteristics of metastasis and time to next treatment for the three subgroups will be presented at the meeting. Citation Format: Saghatchian M, Carton M, Piot I, Pérol D, Pistilli B, Brain E, Ghouadni A, Ricci F, Vanlemmens L, Loeb A, Levy C, Goncalves A, Dalenc F, Lefeuvre-Plesse C, Campone M, Jaffre A, Gourgou S, Cailliot C, Robain M, Dieras V. Impact of prior adjuvant trastuzumab (aT) on clinical characteristics, patterns of recurrence and outcome in 2863 patients with Her2 positive (HER2+) metastatic breast cancer (MBC)- Results from the French ESME UNICANCER program [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-20-03.

Women identified as high-risk for breast cancer may choose between close follow-up and radical mastectomy. Prophylactic mastectomy, as any other surgery, is associated with benefits and harms. The aim of this study was to assess the morbidity associated with prophylactic mastectomy and to evaluate the prevalence of occult cancers.All patients who underwent unilateral or bilateral prophylactic mastectomy between 2007 and 2017 in our institution were eligible for inclusion in this retrospective study. Medical history, type of surgery, occurrence of complication or reoperation and pathological reports were examined in medical charts.79 women underwent prophylactic mastectomy over the studied period of which 58.2% were contralateral after breast cancer. A genetic mutation was present in 86.1% of cases. Postoperative complications occurred in 43.0% of cases. An additional surgery for medical or esthetic purpose was needed in 72.1% of cases. Occult cancer was found in 11.4% of the pathological reports. Triple negative invasive ductal carcinoma was discovered in two cases (2.5%).Prophylactic mastectomy is the only effective preventive action against breast cancer. Women must be clearly informed of possible complications, high reoperation rate and potential pathological findings. Identifying women most at risk for breast cancer would help to better target those who will benefit most from surgery.

Introduction En oncologie, l’indice fonctionnel ECOG (PS), echelle de mesure de l’etat de sante general des patients, est un facteur pronostique systematiquement pris en compte dans les essais cliniques. Dans la pratique medicale courante, le PS est utilise par le medecin pour adapter la strategie therapeutique mais non systematiquement documente dans le dossier medical du patient. Le PS ne pouvant etre reporte retroactivement, la construction d’un substitut du PS permettrait de prendre en compte ce facteur dans les analyses sur donnees longitudinales retrospectives en vie reelle. L’objectif de ce travail etait de construire un substitut du PS a partir d’informations disponibles (âge, comorbidites, constantes biologiques) et decrire la performance du modele de prediction. Methodes A partir de la plateforme epidemio-strategie et medico-economique (ESME) des CLCCs sur le cancer du sein metastatique (CSM), les donnees de 865 patients traites dans quatre centres pour leur maladie metastatique a partir de 2014 ont ete extraites. Un recueil retrospectif a ete a ete organise concernant les comorbidites de Charslon et des valeurs biologiques (hematologie et biochimie). Un modele de regression logistique a ete utilise pour predire le substitut du PS. Les variables utilisees pour predire le PS etaient : l’âge, le statut menopausique, le score de Charslon, les transaminases, la bilirubine, la creatinine, les LDH, l’hemoglobine et les lymphocytes. Le PS a ete evalue selon deux seuils (PS > 0 et PS > 1). La performance du modele a ete utilisee par la methode de l’aire sous la courbe de ROC. Resultats Une mesure du PS au diagnostic de la maladie metastatique etait documentee chez 28 % seulement des 865 patients identifies. Les 619 patients sans mesure du PS ont ete exclus de l’analyse (316 patients sans aucune mesure du PS disponible dans le dossier medical et 303 patients avec une mesure du PS non disponible au diagnostic metastatique). Les patients exclus etaient un peu plus âges (63,2 versus 60,0, p 0 pour lequel l’âge (OR = 1,01 ; IC95 % [1,02–1,09]) et la bilirubine (OR = 8,01 ; [1,31–50,40]) etaient significativement associes. Les memes variables ont ete suggerees a partir d’une cohorte de validation externe comprenant 164 patients malgre une performance peu informative (AUC Conclusion Ce premier travail sur la prediction d’un substitut du PS suggere l’âge et un marqueur hepatique comme variables candidates pour integrer le modele de prediction. Malgre son utilisation courante dans le domaine de la prediction, le score de Charlson n’a pas ete retenu dans le modele final. L’evaluation de la performance du modele etait moyennement informative. Une etude prospective avec un effectif plus important et au diagnostic du cancer du sein metastatique, une mesure systematique du PS, l’administration d’un questionnaire de qualite de vie et la collecte de constantes biologiques permettrait de confirmer ces resultats.

The objective of our study is to describe the practices of breast reconstruction in patients aged 70 years and over undergoing a radical mastectomy at institut Bergonié.We performed a detailed single-site retrospective study from January 2005 to December 2015. Through a computerized review, we have identified and analyzed all patients aged 70 years and over who underwent a breast reconstruction.Five hundred and ninety patients underwent a radical mastectomy during the period. Twenty-eight patients (4.7%) benefited from a breast reconstruction. Nineteen patients (67.9%) had an immediate breast reconstruction and 9 patients (32.1%) had a delayed breast reconstruction, within an average time of 2 years. Sixteen patients (57.1%) benefited from the insertion of an expander replaced by a permanent implant. Five patients (17.9%) benefited from the immediate placement of an implant. Six patients (21.4%) had a reconstruction by autologous latissimus dorsi flap and 1 patient (3.6%) by exclusive lipofilling. Four patients (14.3%) presented postoperative complications without the need for removal of an implant or flap loss. Twenty patients (71.4%) were satisfied with their final reconstruction.Breast reconstruction in elderly patients is possible. Further studies are needed to better describe French practices.

Background Cancer registries cover 18% of the French population. A national surveillance might be warranted for some potentially environment-related cancers such as tumors of the central nervous system (CNS) to detect abnormal incidence variations. The PMSI database provides an interesting source of comprehensive, standardized and mandatory data collected from all health facilities. The aim of this work was to develop methods to identify incident CNS tumors using the PMSI database. Methods A selection of patients living in Gironde was made in the 2004 PMSI database of the hospital of Bordeaux, using the CNS tumors codification. Cases were validated via the CNS primary tumor registry of Gironde taken as the reference, or medical records. Various combinations of criteria were defined and tested. Results The first selection based on diagnoses identified patients with a sensitivity of 84% and a positive predictive value (PPV) of 34%. Patients wrongly identified by the PMSI were non-incident cases (49%) or patients without a CNS tumor (45%). Patients with a tumor not identified by the PMSI had been hospitalized in 2005 (44%) or had no code for CNS tumor (42%). According to the algorithms, the sensitivity ranged from 64% to 84%, and the PPV from 34% to 69%. The best combination had a sensitivity of 67% and a PPV of 69% and was obtained with codes for CNS tumor in 2004 associated with a diagnostic or therapeutic code for persons under 70 years without code for CNS tumor in previous years or code for metastasis in 2004. Conclusion According to these results, the PMSI database cannot be used alone to calculate the incidence of these complex tumors. However the PMSI database plays an important role in cancer surveillance, in combination with other information sources and the expertise of cancer registries. This role could increase with further reflection and improvement of data quality.

Resume Objectif L’objectif de cette etude etait d’evaluer l’impact diagnostique, therapeutique et economique des avis en cancerologie donnes par les pathologistes referents en Aquitaine. Materiel et methodes Une etude quantitative retrospective a ete effectuee sur tous les avis et relectures demandes dans deux centres pathologistes referents. Un echantillon des avis regionaux adresses pour tumeurs lymphoides, melaniques et conjonctives a ete selectionne. La proposition diagnostique du pathologiste initial a ete comparee au diagnostic du pathologiste expert. L’impact diagnostique etait determine majeur lorsque l’avis etait envoye pour tumeur maligne a typer ou a identifier, doute benin/malin, diagnostic non precise ou si les diagnostics etaient discordants (malin/benin). L’impact therapeutique etait juge fort si l’avis engendrait une modification radicale du traitement. Le cout des avis pour les deux structures et le cout de la prise en charge therapeutique pour un diagnostic discordant ont ete evalues. Resultats En 2006, les centres de reference ont recu 5077 dossiers, dont 3769 etaient des avis diagnostiques (75 %), 1324 avis provenaient de la region et parmi eux, 751 correspondaient a des tumeurs lymphoides (55 %), conjonctives (30 %) et melaniques (15 %). L’avis donne par l’expert a induit un impact diagnostique majeur dans 75 % des cas, un impact therapeutique fort dans 46 % des cas et un impact pronostique dans 38 % des cas. L’economie de sante realisee sur 53 cas discordants (malins diagnostiques benins) est estimee a environ 500 000 € en termes de prise en charge therapeutique. Conclusion Notre etude montre la necessite des avis diagnostiques non seulement pour la prise en charge du patient, mais egalement pour des raisons economiques.

Introduction Les donnees de vraie vie (RWD) ont un role important pour l’evaluation de l’efficience des medicaments et des strategies therapeutiques, et ce en complement des donnees provenant des essais cliniques controles. La methodologie de constitution de la plateforme de RWD ESME repose sur une approche multi sources pour centraliser et standardiser les donnees nationales relatives a la prise en charge (PEC) des patients dans les 18 centres de lutte contre le cancer. Methodes La plateforme ESME, geree par R&D Unicancer, integre des variables issues de bases de donnees structurees (donnees relatives aux sejours hospitaliers et donnees sur les medicaments dispenses dans les centres), ainsi que des donnees non structurees issues du dossier patient informatise (DPI). L’integration des donnees du DPI implique une relecture systematique par des techniciens d’etudes cliniques specifiquement formes, tenant compte si disponibles des donnees des bases locales (donnees des bases RCP, donnees issues de l’enquete permanente cancer si poursuivie…). La plateforme pour laquelle la gestion de l’anonymat est geree centre par centre, regroupe l’ensemble des donnees anonymisees consolidees des differentes sources. Cette methodologie fait l’objet de controles qualite, d’audit interne sur le recueil et de constitution de listes de preselection, ainsi que de controles de data-management systematiques. Les donnees collectees sont mises a jour annuellement et la plateforme integre les donnees des patients nouvellement diagnostiques. Resultats et discussion Le premier volet de ce programme concerne la plateforme ESME « Cancer du sein metastatique » (CSM) pour laquelle les dossiers de 16 736 patients ont ete selectionnes et valides. L’objectif final est de 25 000 dossiers completes valides attendus d’ici 2019. Il etait important de pouvoir capter les patients PEC pour un CSM non hospitalises et ne recevant pas de traitement dans le centre. Environ 12 % ont ainsi ete identifies comme etant exclusivement pris en charge par des therapies orales ou hormonotherapie avec un suivi en consultation dans les centres. Le controle qualite (CQ) sur site du processus de selection a ete realise chez environ 20 % des dossiers non selectionnes, et 13 % des dossiers selectionnes ont ete controles manuellement pour certains criteres majeurs. Ces criteres seront detailles avec les taux d’erreurs par critere et leurs implications pour l’exploitation des donnees. La plateforme ESME constitue une source unique en Europe de donnees en vie reelle pour la PEC du CSM. Elle est accessible a l’interrogation par des equipes de recherche ou des partenaires industriels, apres validation des questions de recherche par le comite scientifique ESME (CSE), sous le controle d’un comite de deontologie et d’un comite consultatif international (dix projets de recherche sont actuellement en cours). Conclusion La plateforme ESME constituera a terme une source unique et independante d’analyse de donnees dans une grande variete de pathologies d’organes ou de domaines therapeutiques en oncologie. Elle pourra contribuer a une meilleure comprehension de l’utilisation des strategies therapeutiques en vraie vie ainsi que leurs determinants. Ces donnees peuvent guider la communaute scientifique vers une prise de decision adaptee au contexte et ameliorer la PEC du patient en oncologie.

Background Colorectal cancer (CRC) care has improved considerably, particularly since the implementation of a quality of care program centered on national evidence-based guidelines. Formal quality assessment is however still needed. The aim of this research was to identify factors associated with practice variation in CRC patient care. Methods CRC patients identified from all cancer centers in South-West France were included. We investigated variations in practices (from diagnosis to surgery), and compliance with recommended guidelines for colon and rectal cancer. We identified factors associated with three colon cancer practice variations potentially linked to better survival: examination of ≥12 lymph nodes (LN), non-use and use of adjuvant chemotherapy for stage II and stage III patients, respectively. Results We included 1,206 patients, 825 (68%) with colon and 381 (32%) with rectal cancer, from 53 hospitals. Compliance was high for resection, pathology report, LN examination, and chemotherapy use for stage III patients. In colon cancer, 26% of stage II patients received adjuvant chemotherapy and 71% of stage III patients. 84% of stage US T3T4 rectal cancer patients received pre-operative radiotherapy. In colon cancer, factors associated with examination of ≥12 LNs were: lower ECOG score, advanced stage and larger hospital volume; factors negatively associated were: left sided tumor location and one hospital district. Use of chemotherapy in stage II patients was associated with younger age, advanced stage, emergency setting and care structure (private and location); whereas under-use in stage III patients was associated with advanced age, presence of comorbidities and private hospitals. Conclusions Although some changes in practices may have occurred since this observational study, these findings represent the most recent report on practices in CRC in this region, and offer a useful methodological approach for assessing quality of care. Guideline compliance was high, although some organizational factors such as hospital size or location influence practice variation. These factors should be the focus of any future guideline implementation.

The goal of this work was to evaluate the impact of expert pathological second opinion on the diagnosis and management of patients with cancer, in a French region (Aquitaine) and with an economic point of view.The study was first quantitative, performed retrospectively on all cases of cancer, voluntary sent for a second opinion to an expert pathologist of two centers. Secondly, we restricted the study to lymphoid, melanocytic and soft tissue tumors sent for second opinion. We considered that the expert review had an important diagnostic impact either when the initial pathologist sent the specimen to identify or classify malignant tumor or hesitated between benign and malignant tumor or had no hypothesis, or if there were discordant diagnoses (malignant/benign) between the two pathologists. We considered that the expert review had a high therapeutic impact if the disagreement between initial and expert diagnoses induced a complete modification in therapy. We evaluated the cost of second opinion for the expert centers and the cost of care management.Over the year 2006, the expert centers received 5077 lesions for consultation: 3769 specimens were sent by a pathologist for a second review, 1324 by pathologists of Aquitania and of these, 751 samples were submitted for lymphoid (55%), soft tissues (30%) or melanocytic tumors (15%). There was an important diagnostic impact for 75% of the samples; the impact of the expert review on patient management was considered high for 46% of specimens and the expert pathological diagnosis modified the clinical prognosis for 40% of the specimens. We estimated that for 53 discordant diagnoses (malignant/benign), second opinion allowed an economy of 500,000 euro.Expert second opinion is very important not only for diagnosis and management for patient with cancer but also for economic reasons.

International audience; We present the main results of the first population-based cancers survival study gathering all French registry data. Survival data on 205,562 cancer cases diagnosed between 01/01/1989 and 31/12/1997 were analysed. Relative survival was estimated using an excess rate model. The evolution of the excess mortality rate over the follow-up period was graphed. The analysis emphasised the effect of age at diagnosis and its variation with time after diagnosis. For breast and prostate cancers, the age-standardised five-year relative survivals were 84% and 77%, respectively. The corresponding results in men and women were 56% versus 58% for colorectal cancer and 12% versus 16% for lung cancer. For some cancer sites, the excess mortality rate decreased to low values by five years after diagnosis. For most cancer sites, age at diagnosis was a negative prognostic factor but this effect was often limited to the first year after diagnosis.

L’objectif du travail presente est l’analyse des determinants des couts de prises en charge des patientes atteintes de cancer du sein en Poitou-Charentes du diagnostic a la fin de la premiere annee de suivi.Le point de vue adopte est celui de l’assurance maladie. Les couts d’hospitalisation sont estimes a partir des donnees d’activite des etablissements, ceux des soins de ville sur les remboursements de l’assurance maladie et ceux du reseau sur le financement et l’activite des reseaux de cancerologie participants. Un recueil dans les dossiers a complete l’information. Le mode de facturation du secteur public a ete applique a toutes les hospitalisations. La recherche des determinants, influencant significativement les couts, a teste les indicateurs d’exposition au reseau, les caracteristiques des patientes, de leur cancer, de leur trajectoire de soins et de leur traitement.Sur les 296 patientes, le cout moyen de prise en charge est de 15 273 € (+/- 5 056 €). Les hospitalisations representent 82,5 % du cout, les soins de ville 16,9 % et le reseau 0,6 %. Les facteurs impactant de maniere significative le cout global ont ete identifies. La radiotherapie, la chimiotherapie, l’hormonotherapie, une comorbidite, un stade clinique de mauvais pronostic et le type de filiere « privee » augmentent les couts.Ces estimations mettent a disposition des elements nouveaux de comparaison avec la litterature. Les determinants des trajectoires et couts ainsi que les disparites de pratique sont un challenge pour les reseaux. Cette methode, combinant plusieurs bases, pourrait etre transposable a d’autres localisations cancereuses ou pathologies sous ALD.