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Purpose To describe the incidence, management, and survival outcomes of patients with muscle-invasive urothelial carcinoma (MIUC) undergoing radical surgery (RS) in France. Methods We relied on a non-interventional real-world retrospective study based on French National Hospitalization Database. Adults with MIUC with a first RS between 2015 and 2020 were selected. Subpopulations of patients with RS performed in 2015 and 2019 (pre-COVID-19) were extracted, according to cancer site: muscle-invasive bladder cancer (MIBC) or upper tract urothelial carcinoma (UTUC). Disease-free and overall survival (DFS, OS – Kaplan–Meier) were assessed on the 2015 subpopulation. Results Between 2015 and 2020, 21,295 MIUC patients underwent a first RS. Of them, 68.9% had MIBC, 28.9% UTUC, and 2.2% both cancers. Apart from fewer men among UTUC (70.2%) than MIBC patients (90.1%), patients’ demographic (mean age ~ 73 years) and clinical characteristics were similar whatever the cancer site or year of first RS. In 2019, RS alone was the most frequent treatment, occurring in 72.3% and 92.6% in MIBC and UTUC, respectively. Between 2015 and 2019, neoadjuvant use rate increased from 13.8% to 22.2% in MIBC, and adjuvant use rate increased from 3.7% to 6.3% in UTUC. Finally, median [95% confidence interval] DFS times were 16.0 [14.0–18.0] and 27.0 [23.0–32.0] months among MIBC and UTUC, respectively. Conclusion Among patients with resected MIUC annually, RS alone remained the main treatment. Neoadjuvant and adjuvant use increased between 2015 and 2019. Nonetheless, MIUC remains of poor prognosis, highlighting an unmet medical need, notably among patients at high risk of recurrence.

In advanced cancers, healthcare resource utilization (HCRU) and costs usually increase until death. However, few studies have measured HCRU over time in patients treated with immunotherapies. The objective was to describe the evolution of HCRU and costs over four years for patients with advanced non-small cell lung cancer (aNSCLC) initiating nivolumab. Based on the French hospital reimbursement database, all aNSCLC patients initiating nivolumab in the 2nd line or later in 2015 or 2016 were followed until 2019. HCRU (including hospitalizations and hospital visits) and costs (payer perspective) were described annually after nivolumab initiation. Trends in HCRU were analyzed with the Mann-Kendall test. As most patients did not reach the four-year follow-up, cost-analysis was performed without adjustment throughout, without adjustment in uncensored cases only or with adjustment using for all patients using the Bang&Tsiatis method. 10,452 patients initiating nivolumab were evaluated. The percentage of patients hospitalized or with hospital visits decreased (p p p per capita costs also decreased. The method without adjustment provided the lowest cost over time (€44,404 (Y1), €32,206 (Y2); €28,552 (Y3); €18,841(Y4)) while the Bang&Tsiatis method presented the highest cost (€45,002 (Y1), €36,330 (Y2); €35,080 (Y3); €28,931 (Y4)). HCRU and costs for NSCLC patients treated with nivolumab decreased over time. Cost estimates are dependent on the statistical method used to take into account uncertainty, but costs decreased over time whatever the method used.

Introduction The aim of the current study is to estimate the cost-effectiveness of adjuvant treatment with nivolumab relative to clinically relevant comparators in adult patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection from a French societal perspective. Methods The comparators were observation, low-dose interferon and pembrolizumab. A subgroup analysis was carried out in patients with BRAF mutation, adding dabrafenib plus trametinib. A three-state partitioned survival model was developed to project costs and health benefits over a 20-year time horizon. Extrapolation for recurrence-free survival (RFS) and overall survival (OS) was carried out using spline-based models. Because of the immaturity of OS data in pivotal trials for nivolumab and pembrolizumab, a predictive model of OS treatment effect based on RFS effect was developed using a correlation equation. Health state utilities and adverse events disutilities were derived from the CheckMate 238 trial and literature. Costs were estimated in 2019 euros. The model’s primary outcome was efficiency frontier. Deterministic and probabilistic sensitivity analyses were conducted to assess the robustness of results. Results Observation, low-dose interferon and nivolumab were on the efficiency frontier. The incremental cost–utility ratio of nivolumab versus low-dose interferon (closest therapy on the efficiency frontier) was €37,886/quality-adjusted life year (QALY). Probabilistic sensitivity analysis reported an 80% probability of nivolumab being a cost-effective strategy for a willingness-to-pay threshold of €52,000/QALY. In the subgroup with BRAF mutation, the efficiency frontier was not changed by the addition of dabrafenib plus trametinib. Conclusions Nivolumab is a cost-effective strategy as adjuvant treatment in adult patients with surgically resected melanoma in France. Electronic supplementary material The online version of this article (10.1007/s13555-020-00446-z) contains supplementary material, which is available to authorized users.

PURPOSE Immune checkpoint inhibitors substantially changed advanced non–small-cell lung cancer (aNSCLC) management and can lead to long-term survival. The aims of this study were (1) to use a machine learning method to establish a typology of treatment sequences on patients with aNSCLC who were alive 2 years after initiating a treatment with anti–programmed death-ligand 1 monoclonal antibody nivolumab and (2) to describe the patients' characteristics according to the typology of treatment sequences. MATERIALS AND METHODS This retrospective observational study was based on data from the comprehensive French hospital discharge database for all patients with lung cancer with at least one line of platinum-based chemotherapy, starting nivolumab between January 1, 2015, and December 31, 2016, and alive 2 years after nivolumab treatment initiation. Patients were followed until December 31, 2018. A typology of most common treatment sequences was established using hierarchical clustering with time sequence analysis. RESULTS Two thousand two hundred twelve study patients were, on average, 63.0 years old, 69.9% of them were men, and 61.9% had a nonsquamous cell carcinoma. During the 2 years after nivolumab treatment initiation, clusters of patients with four basic types of treatment sequences were identified: (1) almost continuous nivolumab treatment (44% of patients); (2) nivolumab most of the time followed by a treatment-free interval or a chemotherapy (15% of patients); and a short or medium nivolumab treatment, followed by (3) a long systemic treatment-free interval (17% of patients) or (4) a long chemotherapy (23% of patients). CONCLUSION This machine learning approach enabled the identification of a typology of four representative treatment sequences observed in long-term survival. It was noted that most long-term survivors were treated with nivolumab for well over 1 year.

In the context of health technologies assessment, patient-reported outcome measures (PROMs) have become assessment criteria that are expected by evaluation agencies along with the other usual clinical criteria. PROMs instruments measure all aspects of patient experience in connection with their health: symptoms, activities of daily living (physical function, sleep, etc.), various aspects of health-related quality of life (QoL), compliance, global impression of change in wellbeing. PROMs are useful both as 1) a primary or secondary efficacy endpoints, and 2) a tolerability criterion to supplement vigilance data reported by clinicians. Measurement of PROMs must be subject to methodological rigor that is identical to that of other assessment criteria measured by an observer. Scales must be validated, suitable for the objective, and where possible specific to a disease. In addition to standard measures of quality of life, PROMs are taken into consideration in the assessments performed by the HAS, even if their impact on the conclusions is difficult to isolate, as assessments are multifactorial and take into account all data available with regard to the medical context. The CEPS will indirectly take into account PROMs in the fixing of the price or tariff only if they have contributed to the award of the ASA/ASMR by the ad hoc committee of the HAS. The working group has formulated three recommendations which aim to further the implementation of patient-reported outcome measures: (1) Better information for all parties involved in a dossier for technology assessment, (2) Systematization of the collection of PROMs for evaluation of health products, (3) Improved quality of dossiers thanks to the use of relevant and validated tools.

Background The assessment of health-related quality of life (HRQoL) has seen exponential growth in oncology clinical trials. However, the measurement of HRQoL has yet to be optimised in routine clinical practice. This study aimed at exploring the operationalisation of HRQoL in clinical practice with the goal of reaching a consensus from a panel of physicians. Materials and methods Physicians involved in the management of lung cancer patients in France were recruited to participate in a Delphi study. The study involved three rounds of iterated queries to gain consensus on management aspects of HRQoL, including timing of discussion on HRQoL, which specific domains of HRQoL should be discussed, and what was the most appropriate method of assessment. The threshold adopted for consensus was at least 70% agreement among physicians. A scientific committee reviewed results following each round of the Delphi study. Results A representative panel of 60 physicians participated in this study. Consensus was obtained for HRQoL management at all time points in the patient care pathway. Panellists agreed that HRQoL discussions should occur during routine visits and hospitalisation. The involvement of patients' relatives was also recognised as important, except when discussing side-effects and involvement of a multidisciplinary team. There was a lack of consensus on a systematic assessment for all patients at each visit and no consensus on how HRQoL should be measured in clinical practice. Conclusions HRQoL discussions are considered an integral part in the management of lung cancer patients, and are deemed key to success in patient–physician interaction. Further research is required to harmonise how best to implement HRQoL assessment., Highlights • HRQoL was considered part of routine clinical visits in thoracic oncology by French physicians. • HRQoL was deemed key in the patient–physician interaction during the patient care pathway. • The implementation of the quality-of-life assessment is not yet in place, and the tools to assess it are not yet identified. • Further work should be conducted to harmonise how to best implement and use quality-of-life assessment in routine practice.

Aims: Overall survival (OS) of patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) is extremely poor. New therapeutic options emerge but need to establi...

BACKGROUND New cancer treatments, such as immune checkpoint inhibitors (ICIs), can improve survival and health-related quality of life (HRQoL) in patients with cancer. Although long-term monitoring of HRQoL has been shown to improve survival, integration of HRQoL into everyday practice remains poorly documented. OBJECTIVE This study describes experiences and expectations of patients treated with ICIs regarding a discussion of HRQoL with health care professionals (HCPs) in cancer management. METHODS This cross-sectional study was conducted in an online patient community (Carenity) in France. Patients treated with ICIs for cancer, included between September 2018 and January 2019, completed a questionnaire to assess the involvement of HCP in a discussion of HRQoL and when and what was discussed. RESULTS Of 82 patients included (mean age: 56.9 years, 95% CI 54.2-59.6; 46 [56%] male; 34 [41%] with lung cancer), 62 (76%) reported discussing HRQoL at least once with HCPs, mainly general practitioners (54/82, 66%), oncologists (53/82, 65%), and hospital nurses (50/82, 61%). Around half (45/82, 55%) of the patients were satisfied with these discussions. Discussions with the oncologist were at the patient’s initiative (34/53, 64%). Discussions occurred primarily during follow-up visits (40/62, 65%), when adverse events occurred (30/62, 48%), and at treatment initiation (27/62, 32%). The most discussed dimensions were symptoms (48/62, 77%) and physical well-being (43/62, 69%). With respect to expectations, 54/82 (66%) patients considered oncologists as the most important HCPs for discussing HRQoL. These discussions were desirable throughout the care pathway, particularly at diagnosis (63/82, 77%) and when treatment was initiated (75/82, 92%) or changed (68/82, 83%). All HRQoL dimensions were considered important to discuss. CONCLUSIONS With only around half of the patients satisfied with HRQoL discussions, impactful HRQoL integration in clinical practice is critical. According to patients, this integration should involve mainly oncologists and general practitioners, should happen at every step of the care pathway, and should be extended to dimensions that are currently rarely addressed.

Objective: To describe long-term outcomes of patients treated with nivolumab for advanced non-small cell lung cancer (aNSCLC) in everyday clinical practice in France, with a focus on patients aged ⩾80 years, patients with renal impairment and patients with brain metastases. Methods: The study included all patients with aNSCLC recorded in the French national hospital database, starting nivolumab in 2015–2016 and followed until December 2018. Patients were stratified by age, the presence of renal impairment and brain metastasis, as documented in the hospital discharge summaries. Information was retrieved on demographics, comorbidities and treatment history at baseline. Time to discontinuation of nivolumab treatment and overall survival were estimated using Kaplan–Meier survival analysis. Results: Overall, 10,452 patients were included, of whom 514 were octogenarians, 479 had renal impairment and 1800 had brain metastases at baseline. Median duration of nivolumab treatment was 2.8 months in the overall population and in both the octogenarian and renally impaired subgroups, and 2.3 months in patients with brain metastases. Median overall survival in these patient groups was 11.7 months (95% confidence interval: 11.3–12.2), 11.7 months (11.3–12.1), 11.7 months (11.3–12.2) and 9.9 months (9.0–10.9) respectively. Three-year overall survival rates were 19.1% (18.1–20.2) in the overall population, 16.5% (11.6–23.4) in octogenarians, 15.9% (11.8–21.4) in patients with renal impairment and 21.7% (19.4–24.2) in those with brain metastases. Conclusion: This large nationwide retrospective real-life cohort provided narrow estimates of long-term overall survival, which reached 19% at 3 years, consistent with data from phase III trials of nivolumab. Survival rates were comparable in the three special populations of interest and the overall population.

Background Immune checkpoint inhibitors (ICIs) are increasingly used to treat several types of tumors. Impact of this emerging therapy on patients’ health-related quality of life (HRQoL) is usually collected in clinical trials through standard questionnaires. However, this might not fully reflect HRQoL of patients under real-world conditions. In parallel, users’ narratives from social media represent a potential new source of research concerning HRQoL. Objective The aim of this study is to assess and compare coverage of ICI-treated patients’ HRQoL domains and subdomains in standard questionnaires from clinical trials and in real-world setting from social media posts. Methods A retrospective study was carried out by collecting social media posts in French language written by internet users mentioning their experiences with ICIs between January 2011 and August 2018. Automatic and manual extractions were implemented to create a corpus where domains and subdomains of HRQoL were classified. These annotations were compared with domains covered by 2 standard HRQoL questionnaires, the EORTC QLQ-C30 and the FACT-G. Results We identified 150 users who described their own experience with ICI (89/150, 59.3%) or that of their relative (61/150, 40.7%), with 137 users (91.3%) reporting at least one HRQoL domain in their social media posts. A total of 8 domains and 42 subdomains of HRQoL were identified: Global health (1 subdomain; 115 patients), Symptoms (13; 76), Emotional state (10; 49), Role (7; 22), Physical activity (4; 13), Professional situation (3; 9), Cognitive state (2; 2), and Social state (2; 2). The QLQ-C30 showed a wider global coverage of social media HRQoL subdomains than the FACT-G, 45% (19/42) and 29% (12/42), respectively. For both QLQ-C30 and FACT-G questionnaires, coverage rates were particularly suboptimal for Symptoms (68/123, 55.3% and 72/123, 58.5%, respectively), Emotional state (7/49, 14% and 24/49, 49%, respectively), and Role (17/22, 77% and 15/22, 68%, respectively). Conclusions Many patients with cancer are using social media to share their experiences with immunotherapy. Collecting and analyzing their spontaneous narratives are helpful to capture and understand their HRQoL in real-world setting. New measures of HRQoL are needed to provide more in-depth evaluation of Symptoms, Emotional state, and Role among patients with cancer treated with immunotherapy.

Objectif : Peu de donnees recentes sur l’incidence et la prevalence de l’hepatite C chronique (HCC) sont disponibles au niveau regional. De telles donnees sont indispensables afin de piloter efficacement une politique de sante publique sur la prise en charge de l’hepatite C. L’objectif de cette etude etait d’etablir la faisabilite de cartographier, a partir d’une base de donnees medico-administrative, d’eventuelles disparites regionales dans la prevalence de l’HCC et de ses complications. Methodes : La base PMSI MCO 2012 contient des informations sur la quasi-totalite des hospitalisations en France en termes de diagnostic et de consommation de soins. Les hospitalisations liees a une HCC ont ete identifiees grâce aux codes diagnostiques de la classification CIM-10. Les sejours retenus ont ete classes par stade de severite : hepatite non-cirrhotique, cirrhose compensee, cirrhose decompensee et carcinome hepatocellulaire (CHC). L’ensemble de ces informations a ete documente pour chaque region administrative en 2012. Resultats : Le nombre de patients hospitalises pour une HCC en France en 2012 a ete estime a 12 040 patients, correspondant a un taux national standardise de 19,3/100 000 personnes. La prevalence des patients hospitalises etait la plus elevee en Ile-de-France, Alsace et Provence-Alpes-Cote d’Azur, tout comme le taux standardise des patients ayant un CHC. Conclusions : Cette etude demontre la faisabilite d’utiliser la base PMSI pour identifier des disparites regionales dans la prevalence de l’hepatite C selon les stades de la maladie. Ces informations seront utiles pour adapter l’offre des soins au niveau local.

Resume L’acces au marche des medicaments innovants en France comporte une evaluation medico-economique (amelioration du service medical rendu/amelioration du service attendu [ASMR/ASA] I, II, III avec impacts significatifs sur les depenses d’assurance-maladie). En sus d’une analyse cout-resultat (ACR), des analyses d’impact budgetaire (AIB) peuvent etre produites d’autant plus que la soutenabilite du systeme d’assurance-maladie est une preoccupation croissante de l’ensemble des parties prenantes francaises. Les reflexions menees par les participants de la table ronde de Giens 2016 ont porte sur les analyses d’impact budgetaire et se sont basees sur une revue de litterature menee sur les modeles de diffusion, l’experience des participants dont celle liee aux modalites d’evaluation a l’hopital et des experiences etrangeres. La table ronde a permis de degager des recommandations sur 4 elements d’interet : 1 : l’utilisation des AIB tant d’un point de vue contractuel entre les industriels et le Comite economique des produits de sante (CEPS) a l’occasion des negociations prix que d’un point de vue de prospectives dans le cadre du suivi annuel des depenses budgetaires ; la definition de la population-cible et du rythme de diffusion du produit de sante etant aussi un element majeur ; 2 : l’interpretation des resultats des AIB au regard des resultats d’ACR, pour quels produits et a quel moment de leur cycle de vie ; 3 : l’integration du rythme de diffusion des produits de sante dans les AIB, et enfin 4 : la preoccupation de discuter le niveau d’implementation des produits de sante dans l’AIB tant en termes de cout d’opportunite, de qualite et d’organisation pour la promouvoir.

Introduction Les donnees en vie reelle peuvent completer celles des essais cliniques afin d’optimiser la prise en charge courante du CBNPC. Apres l’arret du nivolumab, peu de donnees existent concernant les pratiques, les options therapeutiques et leurs resultats. Methodes A partir des donnees du PMSI, une cohorte retrospective regroupant tous les patients atteints de CBNOC ayant initie nivolumab en 2015–2016 apres une chimiotherapie a ete suivie jusqu’au 31 decembre 2017 (suivi minimum de 12 mois). Les caracteristiques des patients (donnees demographiques, comorbidites, antecedents de traitement) ont ete recherchees. L’arret du nivolumab etait defini comme l’absence d’au moins 3 perfusions consecutives. Le temps avant arret du traitement (TTD) et la survie globale (SG) ont ete estimes par la methode de Kaplan–Meier. La SG des patients en re-challenge d’immunotherapie a ete analysee en fonction de la duree de leur traitement initial par nivolumab avec les intervalles suivants : Resultats Nous avons identifie 10 452 patients atteints de CBNPC initiant le nivolumab au cours de la periode d’inclusion (homme : 71 % ; âge moyen : 63,8 ± 9,6 ans ; histologie epidermoide : 44 % ; metastases cerebrales : 17,4 % ; anciennete mediane du CBNPC : 12,5 mois ; chirurgie curative anterieure : 15,6 % ; temps median depuis la premiere chimiotherapie : 10,5 mois ; dose moyenne du nivolumab : 213 ± 54 mg). Les medianes de TTD et de SG etaient de 2,8 mois et 11,6 mois. Les taux de SG a 1 an et 2 ans etaient de 48,8 % et 27,4 %. Au total, 5118 (53,4 %) patients ont recu un traitement systemique apres l’arret du nivolumab. Parmi eux, 1517 patients (29,6 %) ont ete traites a nouveau avec un anti-PD1 (nivolumab : 98,8 %) soit apres une pause therapeutique (groupe « reprise » : n = 1127 ; mTTD2 : 4,1 mois ; mSG2 : 14,9 mois a partir de la 2e sequence d’immunotherapie), soit apres une progression traitee par chimiotherapie (« groupe re-challenge » : n = 390 ; mTTD2 : 3,0 mois ; mSG2 : 18,2 mois a partir de la 2e sequence d’immunotherapie). La Fig. 1 presente les courbes de SG2 de l’immunotherapie du « groupe re-challenge » en fonction de la duree du traitement initial par nivolumab. Conclusion Parmi les patients recevant un traitement systemique apres l’arret du nivolumab, environ 30 % ont a nouveau recu une immunotherapie en reprise apres une pause ou en re-challenge apres une chimiotherapie. L’influence de la duree du traitement initial par nivolumab sur la survie en re-challenge doit etre etudiee davantage.

Introduction En France, environ 10 % des patients diagnostiques avec un cancer bronchique non a petites cellules (CBNPC) sont octogenaires. L’efficacite du nivolumab dans cette population specifique est peu connue et les donnees de vie reelle representent une source d’information pertinente. Le but de cette etude etait de decrire l’utilisation et l’efficacite du nivolumab chez les patients âges de 80 ans et plus. Methodes A partir des donnees hospitalieres du PMSI, une cohorte retrospective, regroupant tous les patients atteints de cancer bronchique (code CIM10 : C34*) et ayant initie nivolumab en 2015–2016 apres une chimiotherapie, a ete suivie jusqu’au 31 decembre 2017 (suivi minimum de 12 mois). Les caracteristiques des patients (donnees demographiques, comorbidites, antecedents de traitement) ont ete recherchees selon deux populations distinctes : ≥ 80 ans et Resultats Parmi les 10 452 patients atteints de CPNPC initiant nivolumab pendant la periode d’inclusion, 514 (4,9 %) etaient âges de 80 ans ou plus. L’âge moyen a l’initiation du groupe octogenaire etait de 82,5 ans (± 2,4) vs 62,8 ans (± 8,8) pour le reste de la cohorte. Les patients octogenaires etaient plus frequemment des hommes (p Tableau 1 . Conclusion Parmi les patients initiant nivolumab au cours de la periode d’etude, seul un faible pourcentage etaient âges de 80 ans ou plus (

Objectives Nivolumab is now a reference treatment for patients with advanced non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy. Little data are available on treatment approaches following discontinuation of nivolumab and on the interest of a second course of immunotherapy after nivolumab discontinuation. The aims of this study were to describe treatment pathways following nivolumab discontinuation and to describe survival following retreatment with immunotherapy. Materials and methods The analysis includes all patients with NSCLC recorded in a national hospital database, starting nivolumab in 2015-2016. Nivolumab treatment was considered discontinued if ≥3 infusions were missed. Patients starting a second course of PD-1 inhibitor following nivolumab discontinuation were analysed according to the duration of their initial nivolumab treatment course. Results 10,452 patients were included (71 % men; mean age: 63.8 ± 9.6 years; squamous histology: 44 %). Median nivolumab treatment duration was 2.8 months [IQR :1.4–6.9]. Median OS was 11.5 months [95 %CI: 11.1–11.9]; 5118 (53.4 %) patients received post nivolumab therapy lines: 1517 (29.6 %) of these received a second course of PD-1 inhibitor, either after a treatment-free interval (resumption: n = 1127) or after intervening chemotherapy (rechallenge: n = 390). Median OS after nivolumab discontinuation was 15.0 months [13.9–16.7] in the resumption group and 18.4 months [14.8–21.9] in the rechallenge group. Median OS was significantly longer in patients with an initial nivolumab treatment duration ≥3 months. Conclusion In this real-world setting, outcome after retreatment with a PD-1 inhibitor following a first course of nivolumab was significantly better in patients with a longer duration of initial nivolumab treatment.

Background Surrogate endpoints (SEs) for overall survival (OS) are specific to therapeutic class. The objective of this review was to document all alternative endpoints studied for their association with OS in Immune-Checkpoint Inhibitors (ICI)-treated patients. Methods We searched PubMed and Embase for publications reporting the association between a clinical endpoint and OS in ICI-treated populations from 01/01/2003 to 03/31/2018. Results Out of 6,335 references identified, 24 were selected. Only 3 studies assessed surrogacy at both the patient and trial levels. The main traditional alternative endpoints included progression-free survival (N = 10) and objective response rate (N = 8). New alternative endpoints, such as durable response rate (N = 1) and intermediate response endpoint (N = 1) statistically better correlate with OS in the cancer types analysed. Conclusion Based on the published evidence, there is insufficient data to support validated SE for OS. Adequate surrogacy assessment of promising composite endpoints which consider a duration component is encouraged.

Introduction Alors que l’evaluation de la QdV des patients est aujourd’hui commune dans les essais cliniques en oncologie, sa gestion dans la pratique courante reste sujette a de multiples questions. Cette etude vise a obtenir un consensus aupres de medecins impliques en oncologie thoracique sur les modalites de gestion de la QdV des patients dans la pratique courante. Methodes 747 medecins impliques dans la prise en charge du cancer du poumon en France ont ete invites a participer a une approche de type consensus fondee sur la methode Delphi. Organise en 3 tours, 7 aspects de la gestion de la QdV ont ete couverts, de l’identification des moments cles du parcours de soins (PDS) pour une prise en compte de la QdV, aux methodes d’evaluation. Un consensus a ete defini comme un point de vue partage par au moins 70% des panelistes. Resultats 60 medecins (13 oncologues, 43 pneumologues, 4 radiotherapeutes) ont participe a au moins un tour du Delphi (53 au tour 1, 46 au tour 2, 39 au tour 3). Des elements de consensus ont ete atteints pour 6 des 7 aspects couverts. Un consensus a ete obtenu sur l’importance de la gestion de la QdV tout au long du PDS des patients. Les panelistes ont selectionne les moments du diagnostic, de l’evaluation tumorale avec progression/Initiation d’un nouveau traitement et des soins palliatifs, comme les 3 moments les plus importants pour la prise en compte de la QdV en pratique clinique. Un consensus a ete atteint pour aborder la QdV de facon multidimensionnelle avec des specificites a des moments particuliers telles que la dimension spirituelle en soins palliatifs. Selon les panelistes, la discussion sur la QdV doit avoir lieu principalement pendant les visites de routine ou l’hospitalisation. La necessite d’associer les proches des patients a tout moment (sauf lors de la discussion d’effets secondaires) et d’impliquer une equipe multidisciplinaire a ete reconnue par plus de 70% des panelistes. Alors qu’un consensus a ete atteint sur l’importance d’une evaluation prealable de la QdV afin d’alimenter la discussion entre medecins et patients, aucun consensus n’a ete observe sur l’outil necessaire a sa realisation. Conclusion La prise en compte de la QdV pendant les visites de routine en oncologie thoracique fait l’objet d’un consensus entre cliniciens qui la considerent comme une composante essentielle dans l’interaction patient-medecin tout au long du PDS. Des travaux supplementaires restent necessaires pour harmoniser la mise en œuvre et l’utilisation de l’evaluation de la QdV.

Summary Background and objective This retrospective hospital database analysis aimed to determine the burden and cost of hospitalisations related to chronic hepatitis C (CHC) infections in France in 2012. Methods All hospital stays with CHC (ICD-10 code B18.2) coded as the principal, related or significantly associated diagnosis were extracted from the French National Hospital database 2012 (PMSI). Hospitalisations not directly related to CHC were excluded. Patients were assigned to a liver disease stage, namely non-cirrhotic liver disease, compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma or post-liver transplantation. Costing was performed using French national tariffs and expressed in 2013 Euros. We documented 22,056 hospital stays involving 12,040 patients who were considered to be directly related to CHC. Of these stays, 11,779 (53.4%) were documented in patients with severe complications (decompensated cirrhosis, hepatocellular carcinoma or liver transplantation). Results and conclusions The mean number and duration of hospital stays increased with disease severity. Overall, 1181 patients (9.8%) died during hospitalisation. The total cost of hospital stays for CHC was estimated to be € 61 million, of which 26.4% were attributable to hepatocellular carcinoma, 32.5% to post-liver transplantation and 21.0% to decompensated cirrhosis. Compared with a previous analysis in 2009, the number of patients hospitalised fell by 22%, although the patients hospitalised were overall more severely ill. The total cost of hospitalisation decreased by 8%, with a notably marked reduction in the number of biopsies performed (32%). This study illustrates the persistently high burden of CHC infections in France.

Resume L’evaluation medicoeconomique estime, pour une technologie de sante donnee, le surcout et le benefice clinique par rapport a une strategie de reference. L’objectif est d’analyser les criteres de mesure de benefice clinique qui fondent les decisions d’acces au marche et de remboursement des medicaments en oncologie, en France et en Europe. L’amelioration de la survie globale est le critere privilegie pour demontrer le benefice d’un medicament anti-cancereux ; un gain de survie de 2 a 3 mois ou plus serait considere comme pertinent pour un nouveau produit par rapport a un comparateur. En l’absence d’amelioration de la survie ou de donnees matures sur la survie, survie sans progression ou survie sans symptomes et la possibilite d’acceder a des alternatives therapeutiques a visee curative, la reduction des toxicites et l’amelioration de la qualite de vie peuvent etre prises en compte. Les differences d’appreciations du benefice clinique entre les agences d’evaluation et les payeurs ne sont pas specifiques pour la France. Les etudes de cas montrent qu’il est difficile de trouver une ligne claire dans les decisions de remboursement et de prix mais aussi qu’il est difficile d’identifier les facteurs qui expliquent les decisions de remboursement lorsque le benefice en survie globale n’est pas demontre.

Objectif La prise en charge au long cours des patients avec cancer bronchique non a petites cellules metastatique traite par nivolumab (immunotherapie anti-PD1) est peu documentee. L’heterogeneite des pratiques rend l’analyse des sequences de traitement complexe et propice a une approche par « Machine learning ». L’objectif de cette analyse est d’identifier des typologies de prise en charge des patients long-survivants apres l’initiation de nivolumab. Methode A partir des bases de donnees hospitalieres francaises (PMSI), les patients ayant initie nivolumab en 2015–2016 et en vie deux ans apres ont ete identifies. Un algorithme de « Machine learning » a permis de classer et regrouper automatiquement les patients en cluster presentant des sequences de traitement similaires en termes de duree et de succession des differentes options therapeutiques (nivolumab, chimiotherapies ou pause therapeutique). Resultats Parmi 10 452 patients ayant initie nivolumab sur la periode d’inclusion, 2212 (21,2 %) presentaient une survie d’au moins 24 mois. Quatre clusters ont ete identifies (Tableau 1): Cluster 1) Nivolumab est le traitement principal utilise presque en continu sur la periode avec une duree mediane cumulee (DMC) de 21,0 mois; Cluster 2) Nivolumab est le traitement majoritaire sur la periode (DMC: 16,5 mois), suivi d’une courte chimiotherapie (DMC: 2,5 mois) et/ou d’une pause therapeutique (DMC: 5,3 mois); Cluster 3) Le traitement par nivolumab est court (DMC: 6,4 mois), suivi d’une longue pause therapeutique (DMC: 14,4 mois); Cluster 4) Le traitement par nivolumab et court (DMC: 5,5 mois) suivi d’une ou plusieurs lignes de chimiotherapie (DMC: 9,5 mois). Les patients des clusters presentaient egalement des caracteristiques differentes en termes d’âge, de comorbidites et de prise en charge anterieure. Conclusion A partir d’un large echantillon de patients survivants deux ans apres l’initiation de nivolumab en deuxieme ligne ou plus, l’approche par « Machine learning » a permis de classer les patients ayant des sequences homogenes de traitement et d’identifier quatre groupes de patients a la prise en charge differente. Une etude approfondie de leur profil clinique pourrait permettre de mieux comprendre leur prise en charge.

Introduction L’anti-PD-1 nivolumab a demontre une superiorite en survie globale (SG) dans deux essais de phase III par rapport au docetaxel chez des patients pretraites atteints de CBNPC de type squameux (Sq) et non squameux (NSq) au stade avance. L’objectif etait de decrire, en vie reelle et selon l’histologie du CBNPC, les caracteristiques et la SG des patients francais traites par nivolumab. Methodes A partir des donnees hospitalieres du PMSI, une cohorte retrospective regroupant tous les patients atteints de CBNPC (CIM10 : C34*) pretraites par chimiotherapie ayant initie nivolumab en 2015–2016 a ete suivie jusqu’au 31 decembre 2017 (suivi minimum de 12 mois). Les caracteristiques des patients (demographiques, comorbidites, antecedents de traitement) ont ete recuperees selon le groupe histologique. Le temps avant arret du traitement (TTD) et la SG ont ete estimes par la methode de Kaplan–Meier. Resultats La cohorte globale comprenait 10 452 patients. Parmi eux, une majorite (n = 5805 ; 56 %) presentait une histologie NSq. Compares aux patients Sq (n = 4647), les patients NSq etaient plus jeunes (61,9 vs 66,1 ans ; p Conclusion Cette etude sur une large cohorte retrospective nationale a permis d’evaluer les caracteristiques des patients et la survie associee au nivolumab en pratique clinique. Pour les deux histologies, les resultats suggerent une similarite entre les SG en vie reelle et celles observees dans les essais.

International audience; Background: Territorial differences in the access to innovative anticancer drugs have been reported from many countries. The objectives of this study were to evaluate access to innovative treatments for metastatic lung cancer in France, and to assess whether socioeconomic indicators were predictors of access at the level of the municipality of residence.Methods: All incident cases of metastatic lung cancer hospitalised for a chemotherapy in public hospitals in 2011 were identified from the French National Hospital discharge database. Information on prescription of innovative drugs from an associated database (FICHCOMP) was crossed with the population density of the municipality and a social deprivation index based on national census data.Results: Overall, 21,974 incident cases of metastatic lung cancer were identified, all of whom were followed for 2 years. Of the 11,486 analysable patients receiving chemotherapy in the public sector, 6959 were treated with a FICHCOMP drug at least once, principally pemetrexed. In multivariate analysis, prescription of FICHCOMP drugs was less frequent in patients ≥66 years compared to those ≤55 years (odds ratio: 0.49 [0.44–0.55]), in men compared to women (0.86 [0.79–0.94]) and in patients with renal insufficiency (0.55 [0.41–0.73]) and other comorbidities. Prescription rates were also associated with social deprivation, being lowest in the most deprived municipalities compared to the most privileged municipalities (odds ratio: 0.82 [0.72–0.92]). No association was observed between the population density of the municipality and access to innovative drugs.Conclusion: Although access to innovative medication in France seems to be relatively equitable, social deprivation is associated with poorer access. The reasons for this need to be investigated and addressed.

Early market access of health products is associated with a larger number of requests for information by the health authorities. Compared with these expectations, the growing expansion of health databases represents an opportunity for responding to questions raised by the authorities. The computerised nature of the health system provides numerous sources of data, and first and foremost medical/administrative databases such as the French National Inter-Scheme Health Insurance Information System (SNIIRAM) database. These databases, although developed for other purposes, have already been used for many years with regard to post-registration studies (PRS). The use thereof will continue to increase with the recent creation of the French National Health Data System (SNDS [2016 health system reform law]). At the same time, other databases are available in France, offering an illustration of "product use under actual practice conditions" by patients and health professionals (cohorts, specific registries, data warehouses, etc.). Based on a preliminary analysis of requests for PRS, approximately two-thirds appeared to have found at least a partial response in existing databases. Using these databases has a number of disadvantages, but also numerous advantages, which are listed. In order to facilitate access and optimise their use, it seemed important to draw up recommendations aiming to facilitate these developments and guarantee the conditions for their technical validity. The recommendations drawn up notably include the need for measures aiming to promote the visibility of research conducted on databases in the field of PRS. Moreover, it seemed worthwhile to promote the interoperability of health data warehouses, to make it possible to match information originating from field studies with information originating from databases, and to develop and share algorithms aiming to identify criteria of interest (proxies). Methodological documents, such as the French National Authority for Health (HAS) recommendations on "Les etudes post-inscription sur les technologies de sante (medicaments, dispositifs medicaux et actes). Principes et methodes" [Post-registration studies on health technologies (medicinal products, medical devices and procedures). Principles and methods] should be updated to incorporate these developments.

Resume La mise sur le marche precoce de produits de sante s’accompagne d’une demande accrue d’informations par les autorites de sante. En regard de cette attente, l’enrichissement croissant des bases de donnees de sante represente une opportunite de reponse aux interrogations des autorites. L’informatisation du systeme de sante offre de nombreuses sources de donnees, en premier lieu avec les bases medico-administratives telles que le systeme national d’information inter-regimes de l’Assurance maladie (SNIIRAM). Ces bases de donnees, bien que developpees pour des objectifs autres, sont deja utilisees depuis de nombreuses annees a des fins d’etudes post-inscription (EPI). Leur utilisation n’ira que croissante avec la creation du systeme national des donnees de sante (SNDS) recemment etabli (loi de modernisation de notre systeme de sante de 2016). En parallele, il existe en France d’autres bases de donnees permettant d’approcher « l’utilisation en conditions reelles » des produits par les patients et les professionnels de sante (cohortes, registres specifiques, entrepots de donnees…). Sur la base d’une analyse preliminaire des demandes d’EPI, il apparait qu’environ deux tiers d’entre elles auraient trouve au moins en partie reponse dans les bases de donnees existantes. Le recours a ces bases comporte certains inconvenients, mais aussi de nombreux avantages qui sont listes. Afin d’en faciliter l’acces et d’en optimiser l’utilisation, il est apparu important d’exprimer des recommandations visant a faciliter cette evolution et a en garantir les conditions de validite technique. Parmi les recommandations formulees figure en particulier la necessite d’actions visant a favoriser la visibilite des travaux effectues dans le champ des EPI sur bases de donnees. En outre, il apparait utile de favoriser l’interoperabilite des entrepots de donnees de sante, de permettre l’appariement d’informations issues d’etudes de terrain avec celles provenant de bases de donnees, ou encore de developper et partager des algorithmes destines a identifier des criteres d’interet (proxies). Les documents methodologiques comme celui des recommandations de la Haute Autorite de sante (HAS) sur « les etudes post-inscription sur les technologies de sante (medicaments, dispositifs medicaux et actes). Principes et methodes » devraient, par leur actualisation, integrer ces evolutions.

Objectifs Dans de nombreux cancers, l’immunotherapie est devenue un standard de prise en charge au profil d’efficacite et de tolerance different de celui des chimiotherapies. Le vecu et la qualite de vie (QdV) des patients traites par immunotherapie en vie reelle restent meconnus. Les medias sociaux sont de plus en plus un moyen d’expression et d’echange des patients sur leur maladie et leurs preoccupations. L’objectif etait de decrire dans les medias sociaux les thematiques de discussion des patients traites ou ayant ete traites par immunotherapie et en particulier d’etudier les messages mentionnant leur QdV. Methode L’analyse portait sur les messages publies par des patients ou leurs proches entre janvier 2011 et aout 2018 sur de nombreux medias sociaux generalistes ou specialises en sante. Les messages d’interet ont ete identifies a l’aide d’une liste exhaustive de mots cles relatifs a l’immunotherapie (anti-CTLA4, anti-PD1, [noms des traitements et specialites], etc.) incluant les possibles fautes d’orthographes. Les thematiques des messages etaient analysees de deux manieres : – manuellement par deux relecteurs independants ; – automatiquement a l’aide d’un modele de sujet (topic model). Les mentions relatives a la QdV presentes dans les messages etaient classees selon huit dimensions predefinies a partir des principaux auto-questionnaires valides en oncologie (e.g. QLQ-C30, FACT-G). Resultats Au total, 267 messages ont ete identifies sur 19 sources differentes. Cela correspondait a 150 patients, dont une majorite de femmes (58 %). Le type de cancer etait disponible pour 123 patients et les localisations les plus frequents etaient le cancer du poumon (46 ; 37 %) et le melanome (41 ; 33 %). Pour 44 % des patients, les messages etaient postes par un proche, en majorite un conjoint ou un enfant. L’occurrence des messages a augmente de maniere importante a partir de l’annee 2017 (59 % des premiers messages de patients postes apres 2017). Les thematiques de discussion identifiees manuellement concernaient : l’acces a l’immunotherapie (modalite d’acces, essais cliniques et traitement a l’etranger), le contexte de la prise d’une immunotherapie (espoir, information et description du traitement) et les effets de l’immunotherapie (efficacite et effets indesirables). L’application d’un topic model a permis d’identifier automatiquement 10 thematiques. Certaines identifiees manuellement etaient retrouvees (acces, essais cliniques, effets secondaires, parcours therapeutique) alors que d’autres ont emerge (soutien des communautes de patients, frequence des soins, cancer d’un proche). Pour 137 patients (91 %), l’expression d’au moins une dimension predefinie de QdV a ete identifiee : la sante generale (115 ; 77 %), les symptomes (76 ; 51 %), l’etat emotionnel (49 ; 33 %), les activites courantes (22 ; 15 %), l’etat physique (13 ; 9 %), la situation professionnelle (9 ; 6 %), l’etat cognitif (2 ; 1 %) et la vie sociale (2 ; 1 %). Conclusion Cette etude montre la diversite des thematiques abordees sur les medias sociaux par les patients atteints de cancer et traites par immunotherapie ainsi que leurs proches. La QdV apparait comme un sujet central mentionne par la quasi-totalite des patients. L’ensemble des dimensions predefinies de QdV sont spontanement evoquees, en particulier la sante generale, les symptomes et l’etat emotionnel.

Background Management of metastatic melanoma is changing rapidly following the introduction of innovative effective therapies, with consequences for the allocation of healthcare resources. The objective of this study was to assess hospitalisation costs of metastatic melanoma in France from 2011 to 2013 from the perspective of the government payer. Methods The population studied corresponded to all adults with metastatic melanoma hospitalised in France between 1st January 2011 and 31st December 2013 who required chemotherapy, immunotherapy or radiotherapy due to tumour progression and unresectable Stage III or Stage IV melanoma. Metastatic melanoma was identified by ICD-10 codes documented in the hospital patient discharge records. For each patient, hospital stays were stratified into a pre- or post- progression health state using proxy variables for the RECIST criteria. All healthcare expenditure documented in the French national hospital claims system database and incurred between the index hospitalisation (or change of progression state) and the end of follow-up were analysed. For the principal analysis, valuation of healthcare resource consumption was performed using official national hospitalisation tariffs. Any expensive therapy administered during the stay was documented from a linked database of expensive drugs (FICHCOMP). Results Seventy-eight thousand seven hundred fifty hospital stays by 10,337 patients with metastatic melanoma were identified over the three-year study period. Annual per capita costs of hospitalisation were € 5046 in the pre-progression stage and € 19,006 in the post-progression stage. Hospitalisations attributed to adverse drug reactions to chemotherapy or immunotherapy were observed in 27% of patients. Annual per capita costs of these hospitalisations related to adverse drug reactions were € 3762 in the pre-progression stage and € 5523 in the post-progression stage. Conclusions Hospitalisation costs related to metastatic melanoma rise substantially as the disease progresses. Treatment strategies which slow down disease progression would be expected to reduce costs of hospitalisation for metastatic melanoma, although they may also entail significant acquisition costs. This will entail organisational changes of resource allocation for the treatment of metastatic melanoma in hospitals. Electronic supplementary material The online version of this article (doi:10.1186/s12913-017-2472-0) contains supplementary material, which is available to authorized users.

Objective: Only limited recent information is available concerning the regional incidence and prevalence of chronic hepatitis C (CHC), but this information is critical for optimal definition of public health policies for the management of hepatitis C. The objective of this study was to evaluate the feasibility of mapping potential regional differences in the prevalence of CHC and its complications using data from a health administrative database. Methods: The 2012 PMSI MCO hospital database contains information on diagnosis and healthcare resource use, essentially related to all hospitalisations in France. Hospital stays related to CHC were identified on the basis of ICD-10 disease codes. Hospital stays were classified according to stage of liver disease: non-cirrhotic liver disease, compensated cirrhosis, decompensated cirrhosis or hepatocellular carcinoma (HCC). All study variables were documented for each French administrative region in 2012. Results: In 2012, 12,040 patients were hospitalised in France for a reason related to CHC, corresponding to a standardised age- and gender- adjusted prevalence rate of 19.3/100,000 persons. The highest prevalences of CHC and HCC were observed in the Ile de France, Alsace and Provence-Alpes-Côte-d’Azur regions. Conclusions: This study demonstrates the feasibility of using the PMSI database to identify regional differences in the prevalence of CHC. This information may be useful for planning regional healthcare resource provision for CHC.

Brief description of the French health system. (PDF 401 kb)

International audience; The French healthcare system is a universal healthcare system with no financial barrier to access to health services and cancer drugs. The objective of the study is to investigate associations between, on the one hand, incidence and survival of patients diagnosed with lung cancer in France and, on the other, the socioeconomic deprivation and population density of their municipality of residence. A national, longitudinal analysis using data from the French National Hospital database crossed with the population density of the municipality and a social deprivation index based on census data aggregated at the municipality level. For lung cancer diagnosed at the metastatic stage, one-year and two-year survival was not associated with the population density of the municipality of residence. In contrast, mortality was higher for people living in very deprived, deprived and privileged areas compared to very privileged areas (hazard ratios at two years: 1.19 [1.13–1.25], 1.14 [1.08–1.20] and 1.10 [1.04–1.16] respectively). Similar associations are also observed in patients diagnosed with non-metastatic disease (hazard ratios at two years: 1.21 [1.13–1.30], 1.15 [1.08–1.23] and 1.10 [1.03–1.18] for people living in very deprived, deprived and privileged areas compared to very privileged areas). Despite a universal healthcare coverage, survival inequalities in patients with lung cancer can be observed in France with respect to certain socioeconomic indicators.

Background Stroke represents a major complication of atrial fibrillation (AF). The current anticoagulation options for stroke prevention increase hemorrhage risk. The objective of the study was to estimate the incidence and costs of hospitalization for stroke and hemorrhage in patients with AF who are eligible for stroke prevention. Methods Patients hospitalized for AF were identified from the French National hospital database (Programme Medicalise des Systemes d’Information) and a calculated stroke risk score (congestive heart failure, hypertension [blood pressure consistently >140/90 mm Hg], age ≥75 years, diabetes mellitus, and previous stroke, transient ischemic attack [CHADS2]). Adult patients eligible for stroke prevention (CHADS2 >0) were enrolled. The incidence of hospitalization for stroke and hemorrhage was calculated over a 2-year period. Costs of acute care were determined using diagnosis related groups (DRGs) and corresponding National Hospital Tariffs. Rehabilitation costs were analyzed for patients with strokes and classified by stroke severity. Results Sixty-one thousand five hundred eighty-two patients were identified with a mean age of 75.0 ± 11.0 years and a mean CHADS2 score of 1.90 ± 0.99. The 24-month cumulative incidence of any stroke was 32.1 cases/1,000 patients with AF (ischemic, 60%; hemorrhagic, 24%; unspecified, 16%), and that of hemorrhage was 53.1 cases/1,000 patients with AF (gastrointestinal, 26%; intracranial, 5%; other, 69%). The mean costs of ischemic and hemorrhagic strokes were €4,848 and €7,183 (mild), €10,909 and €14,298 (moderate), €29,065 and €29,701 (severe), and €6,035 and €4,590 (fatal), respectively. The mean costs of hemorrhage by type were €3,601 (gastrointestinal), €7,331 (intracranial), €3,941 (other major), and €2,552 (nonmajor). Conclusions The incidence and cost of hospitalization for hemorrhage should be considered in the global burden of AF. These data should be useful for pharmacoeconomic evaluation of new oral anticoagulant medications. Such real-world studies may be relevant for monitoring mid- to long-term morbidity and mortality in the AF population.

Objectif Indique en deuxieme ligne de traitement du cancer bronchique non a petites cellules (CBNPC) avance ou metastatique de type histologique epidermoide ou non epidermoide, nivolumab (immunotherapie anti-PD1) a ete mis a disposition en France dans le cadre d’une Autorisation temporaire d’utilisation (ATU) a partir de janvier 2015 jusqu’a son inscription au remboursement a la fin decembre 2016. L’objectif etait de decrire les caracteristiques des patients ayant recu nivolumab pendant cette periode, leur evolution entre 2015 et 2016, ainsi que la duree du traitement. Methode A partir des bases de donnees hospitalieres nationales du Programme de medicalisation du systeme d’information (PMSI), l’integralite des patients ayant recu nivolumab en 2015 et 2016 pour un cancer bronchique (code CIM-10 : C34) a ete incluse. Les variables recueillies etaient l’âge, le sexe, les comorbidites (hypertension arterielle, BPCO, diabete et insuffisance renale), le delai entre le diagnostic et l’initiation de nivolumab, le type d’etablissement et la dose. La prise en premiere ligne de pemetrexed et/ou bevacizumab etant specifique des CBNPC non epidermoides, les traitements anterieurs ont ete recherches afin d’identifier le type histologique. Les durees de traitement ont ete estimees par la methode de Kaplan–Meier. Les caracteristiques des patients ont ete comparees entre les annees 2015 et 2016 et entre les deux types d’histologies. Resultats Au total, 3120 patients ont recu nivolumab en 2015 et 7519 patients en 2016. Parmi eux, 1377 et 3402 patients presentaient un CBNPC de type epidermoide, respectivement. Toutes histologies confondues, l’âge moyen des patients etait de 63,8 ans (± 9,7) et le delai median entre le diagnostic de CBNPC et la premiere administration de nivolumab etait de 12,7 mois. La dose moyenne de nivolumab recue etait de 212 mg (± 57). La proportion de patients de sexe masculin et celle de patients âges de 70 ans ou plus etaient significativement plus elevees en 2016 par rapport a 2015 (respectivement, 28 % versus 25 % et 71 % versus 69 %). De meme, le delai median de recours a nivolumab depuis le diagnostic a ete significativement plus court en 2016 (11,9 mois versus 14,8 mois) et les patients ont ete plus frequemment inities dans des centres hospitaliers generaux (38 % versus 34 %) et des cliniques privees (18 % versus 14 %) plutot qu’en CHU (32 % versus 26 %) ou en CLCC (11 % versus 9 %). Pour l’ensemble des patients, la duree mediane de traitement avec nivolumab etait atteinte a 3,9 mois (Q1–Q3 : 1,8–10,1). Alors que 4433 patients etaient censures au 31 decembre 2016, la duree moyenne de traitement etait de 6,60 mois (± 0,08). Parmi les 6188 patients ayant arrete nivolumab, 44 % ont beneficie d’une chimiotherapie ulterieure. Conclusion Les donnees du PMSI permettent un suivi exhaustif du nombre de patients ayant recu nivolumab dans le cadre du systeme d’ATU. Ces donnees permettent de suivre son utilisation en vie reelle pour certaines variables importantes relatives au type d’initiation et au profil des patients. En termes de duree de traitement, ces resultats sont plutot conformes a ce qui etait attendu d’apres les essais cliniques et ceci quelle que soit l’histologie du CBNPC.

Background Immune-Checkpoint Inhibitors (ICI) treatments have specific Health Related Quality of Life (HRQoL) profiles. While HRQoL is central in the oncology patient experience, its integration into current practice remains poorly documented. The study objective was to describe patients' experience and expectations regarding HRQoL, in particular in their relationship with oncologists. Methods This research was a cross-sectional study within a French online patients’ community. Patients treated with ICI for cancer were recruited between Sep-18 and Jan-19. They answered to a questionnaire developed to assess health care practitioners (HCP) involvement in HRQoL, times of discussion and dimensions discussed. Importance of nine HRQoL dimensions were measured with a visual analog scale (VAS; 0–10 [low–high]). Results Over 82 patients included (median age: 59 years; 56% male, 41% with lung cancer), two third (53) mentioned a HRQoL discussion at least once with an oncologist. Half of them (39) discussed of HRQoL with oncologists and were mostly satisfied of this interaction. When occurred, discussions were mainly occasional during follow-up visits (64%), adverse event occurrence (57%), treatment initiation (43%) and were mostly on patients’ initiative (64%). The most discussed HRQoL dimensions were symptoms (85%) and physical well-being (74%). In terms of expectations, two thirds of patients (54) considered oncologists were one of the most important HCP to discuss HRQoL with. Among them, 85% to 98% considered that HRQoL discussion was important at all times of care considered in the study from diagnosis to palliative care. The most important discussion for patients were symptoms (8.7 SD ± 2.0), physical well-being (8.6 ±1.8) daily activities (8.1 ±2.2), family and social life (8.0 ± 1.8), work and leisure (7.9 ±2.1), cognition (7.8 ±2.5) and emotional state (7.7 ±2.7). Conclusion According to patients, HRQoL consideration mostly relies on oncologists. Integration of HRQoL in clinical practice could be optimized by increasing frequency of dedicated interactions and by extending discussions to the less often addressed dimensions. Legal entity responsible for the study Carenity. Funding Bristol-Myers Squibb. Disclosure O. Wilczynski: Honoraria (institution): Bristol-Myers Squibb. A. Boisbouvier: Honoraria (institution), Full / Part-time employment: Bristol-Myers Squibb. L. Radoszycki: Honoraria (institution): Bristol-Myers Squibb. F-E. Cotte: Full / Part-time employment: Bristol-Myers Squibb. A-F. Gaudin: Full / Part-time employment: Bristol-Myers Squibb. H. Lemasson: Full / Part-time employment: Bristol-Myers Squibb.