IntroductionWith stressors that are often associated with suicide increasing during the coronavirus disease 2019 (COVID-19) pandemic, there has been concern that suicide mortality rates may also be increasing. Our objective was to determine whether suicide mortality rates increased during the COVID-19 pandemic.With stressors that are often associated with suicideincreasing during the coronavirus disease 2019 (COVID-19) pandemic,there has been concern that suicide mortality rates may alsobe increasing.ObjectivesOur objective was to determine whether suicidemortality rates increased during the COVID-19 pandemic.MethodsWe conducted an interrupted time-series study using data from January 2019 through December 2020 from 2 large integrated health care systems. The population at risk included all patients or individuals enrolled in a health plan at HealthPartners in Minnesota or Henry Ford Health in Michigan. The primary outcome was change in suicide mortality rates, expressed as annualized crude rates of suicide death per 100,000 people in 10 months following the start of the pandemic in March 2020 compared with the 14 months prior. We conducted an interrupted time-series study using data fromJanuary 2019 through December 2020 from 2 large integrated health care systems. The population at risk included all patients or individuals enrolledin a health plan at HealthPartners in Minnesota or Henry Ford HealthSystem in Michigan. The primary outcome was change in suicide mortality rates, expressed as annualized crude rates of suicide death per 100,000 people in 10 months following the start of the pandemic in March2020 compared with the 14 months prior.ResultsThere were 6,434,675 people at risk in the sample, with 55% women and a diverse sample across ages, race/ethnicity, and insurance type. From January 2019 through February 2020, there was a slow increase in the suicide mortality rate, with rates then decreasing by 0.45 per 100,000 people per month from March 2020 through December 2020 (SE= 0.19, P=0.03). There were 6,434,675 people at risk in the sample, with 55% women and a diverse sample across ages, race/ethnicity, and insurance type. From January 2019 through February 2020, there was a slow increase in the suicide mortality rate, with rates then decreasing by 0.45 per 100,000 people per month from March 2020 through December 2020 (SE= 0.19, P=0.03).ConclusionsOverall suicide mortality rates did not increase with the pandemic, and in fact slightly declined from March to December 2020. Our findings should be confirmed across other settings and, when available, using final adjudicated state mortality data. Overall suicide mortality rates did not increase with the pandemic, and in fact slightly declined from March to December 2020. Our findings should be confirmed across other settings and,when available, using final adjudicated state mortality data.Disclosure of InterestNone Declared

CHAPTER SECTIONS Contributors James Fraser Rachael Moloney, MHS Ellen Tambor, MA Leah Tuzzio, MPH Gregory Simon, MD, MPH Rachel Hays, MPH Lorella Palazzo, PhD Contributing Editors Karen Staman, MS Gina […]

Les données de résultats cliniques en vie réelle avec le pembrolizumab en monothérapie chez des patients avec cancer bronchique non à petites cellules (CBNPC) avancé précédemment traités restent limitées. Notre objectif était d’estimer la survie globale (SG) et la survie sans progression en vie réelle (SSPvr) en France avec le pembrolizumab en monothérapie chez des patients avec CBNPC avancé antérieurement traités par chimiothérapie, exprimant PD-L1, après l’autorisation donnée à la suite de l’étude de phase III KEYNOTE-010 (KN010), dans laquelle une SG médiane de 11,8 mois (IC 95 % : 10,4–13,1) et un taux de SG à 12 mois de 48,9 % (IC 95 % : 45,1–52,6) ont été rapportés. À l’aide de la plateforme de données ESME CBP (Epidémio-STRATEGIE médico-économique/Cancer Broncho-Pulmonaire ; NCT03848052), nous avons identifié des patients adultes avec CBNPC confirmé histologiquement, à un avancé (stade IIIB ou IV), dont la tumeur exprime PD-L1 (TPS ≥ 1 %), traités avec au moins une ligne de chimiothérapie et ayant initié pembrolizumab en monothérapie entre le 12 mai 2017 et le 31 décembre 2018. Les patients présentant des mutations tumorales d’EGFR ou d’ALK devaient avoir reçu une thérapie ciblée appropriée avant de recevoir pembrolizumab. Les patients ayant déjà reçu pembrolizumab dans un essai clinique étaient exclus. Cette analyse intermédiaire était prévue dans un plan d’analyse statistique avec une extraction des données au 31 août 2019. La SG et la SSPvr ont été estimées par la méthode de Kaplan–Meier. Trois cent quatre patients ont été inclus avec un suivi médian par patient de 5,9 mois (intervalle : 0–24). Les caractéristiques des patients et les résultats de SG/SSPvr sont présentés dans le Tableau 1. Les résultats cliniques du pembrolizumab dans les CBNPC avancés exprimant PD-L1 et antérieurement traités par chimiothérapie ont été similaires à ceux des essais cliniques, confirmant ainsi l’efficacité du pembrolizumab en vie réelle en France.

Pembrolizumab a été le premier traitement anti-PD-1 autorisé en Europe dans le traitement de première ligne du cancer bronchique non à petites cellules métastatique (CBNPCm) non précédemment traité, à partir des résultats de l’étude KEYNOTE-024 démontrant une survie globale (SG) à 12 mois de 70,3 %. Notre objectif était d’estimer la SG et la survie sans progression en vie réelle (SSPvr) en France avec pembrolizumab en monothérapie en première ligne du CBNPCm dont les tumeurs expriment PD-L1 avec un score de proportion tumoral (TPS) ≥ 50 %). En utilisant la plateforme de données ESME CBP (Epidémio-Stratégie Médico-Economique/Cancer Broncho-Pulmonaire; NCT03848052), nous avons identifié des patients adultes atteints d’un CBNPCm PD-L1-positif (TPS ≥ 50 %) confirmé histologiquement et ayant initié un traitement de première ligne avec pembrolizumab en monothérapie entre le 12 mai 2017 et le 31 décembre 2018. Les patients mutés EGFR/ALK ou ayant participé à un essai clinique ont été exclus. Cette analyse intermédiaire était prévue dans un plan d’analyse statistique avec une extraction des données au 31 août 2019. La SG et la SSPvr ont été estimées par la méthode de Kaplan-Meier. 164 patients ont été inclus avec un suivi médian par patient de 8 mois (intervalle : 0–24). Le score de performance ECOG au début du traitement était de 0–1 (n = 86; 68,3 %), 2 (n = 25 ; 19,8 %), 3–4 (n = 15 ; 11,9 %) ou manquant (n = 38). Des informations complémentaires sur les caractéristiques des patients et les résultats d’efficacité sont présentés dans le Tableau 1. Les résultats cliniques des patients avec un CBNPCm exprimant fortement PD-L1 ont été conformes à ceux de l’étude clinique KEYNOTE-024, soutenant l’efficacité de pembrolizumab en vie réelle, en France.

CHRYSALIS is an open-label, single arm phase 1b/2 clinical trial conducted to assess safety and efficacy of amivantamab in patients with EGFR Ex20ins advanced NSCLC, after progressing on platinum doublet chemotherapy (CT). In absence of a comparator arm in CHRYSALIS, comparison of trial outcomes versus an external cohort of similar patients allows to quantify clinical benefits relative to treatments used in current clinical practice. Individual patient data for baseline risk factors and outcomes on OS, PFS and TTNT were available for patients from CHRYSALIS (median follow-up 12.5 m) and for a cohort of similar patients treated with real-world clinical practice (RWCP) from the Epidemio-Strategy and Medical Economics (ESME) advanced lung cancer database (NCT03848052). All treatment lines for patients fulfilling the CHRYSALIS eligibility criteria with at least 1 subsequent therapy after CT progression were selected from ESME. Comparative analyses were adjusted for imbalances on baseline characteristics, including number of prior treatment lines and metastatic sites, brain metastasis, liver metastasis, age, gender, smoking status and ECOG. Inverse probability weighting. Hazard ratios (HR) for amivantamab versus RWCP were estimated for OS, PFS and TTNT using IPW weighted proportional hazards regression. Multivariable regression including baseline characteristics as covariates was done as a confirmatory analysis. 114 pts from CHRYSALIS and 52 treatment lines from 44 patients from ESME were included in the comparative analyses. Following adjustment, amivantamab was significantly superior to RWCP across all endpoints and methods.Table: 1122POutcomeAmivantamab median [95% CI]RWCPMedian [95% CI]ATT-adjustment HR [95% CI] (p-value)Covariate adjustment HR [95% CI] (p-value)OS22.8 [17.5 – NE]13.0 [7.9 –17.3]0.49 [0.29 – 0.82] (p = 0.007)0.46 [0.25 – 0.83] (p = 0.011)PFS6.9 [5.6 – 8.6]5.7 [2.8 –7.9]0.56 [0.37 – 0.85] (p < 0.001)0.46 [0.31 – 0.69] (p < 0.001)TTNT12.4 [8.3 – 18.8]7.8[4.4 – 8.3]0.48 [0.32 – 0.72] (p < 0.001)0.41 [0.27 – 0.62] (p < 0.001) Open table in a new tab These findings suggest that amivantamab is an effective treatment option associated with significantly better OS, PFS, and TTNT for EGFR ex20ins advanced NSCLC compared with current clinical practice in France.

Contributors Douglas Zatzick, MD Beverly Green, MD, MPH Miguel Vazquez, MD Contributing EditorKaren Staman, MS Case Example: The Trauma Survivors Outcomes & Support (TSOS) Pragmatic Trial Research Team: Rapid […]

ContexteLa « matching-adjusted indirect comparisons » (MAIC) est une méthode permettant de comparer les effets absolus des traitements lorsque la disponibilité des données individuelles des patients est limitée. Dans les études de vie réelle, la présence de données manquantes est un problème fréquent. L'imputation multiple (IM) est souvent utilisée pour remplacer les valeurs manquantes par un ensemble de valeurs plausibles qui représentent l'incertitude sur la bonne valeur à imputer. Dans le contexte de petits échantillons, les deux processus de MAIC et IM combinés soulèvent des questionnements méthodologiques et peuvent conduire à des problèmes de convergence des modèles. L'objectif du présent travail était de développer une méthodologie prédéfinissant les différentes étapes de l'analyse jusqu'à l'obtention d'un modèle satisfaisant. Cette approche a été appliquée aux patients atteints de cancer du poumon non à petites cellules métastatique ROS1-positif, avec la comparaison des données agrégées de 3 essais cliniques mono-bras randomisés d'entrectinib et des données de la cohorte observationnelle française, nationale et multicentriques du Cancer du Poumon Avancé ou Métastatique du programme Épidémio-Stratégie Médico-Economique (ESME)[1].MéthodesCette étude a été menée selon trois phases (go/no go) : 1) évaluation de la faisabilité, 2) estimation des poids et 3) analyse des résultats et inférence. Ce résumé se concentre sur la phase 2. Les facteurs pronostiques clés étaient l'âge, le sexe, l'ECOG (∼45 % manquant), l'histologie de la tumeur, le statut tabagique (∼6 % manquant), les métastases cérébrales et le nombre de lignes de traitement précédentes. La méthodologie développée est une implémentation séquentielle en 4 étapes pour calculer pour chaque jeu de données imputé les poids en utilisant une régression logistique (méthode des moments) [2], résumée ci-après :1- Modèles initiaux sur toutes les variables pronostiques ;2- Si les modèles ne convergent pas pour tous les jeux de données, simplification en appliquant des étapes prédéfinies englobant a) la suppression des variables ayant une catégorie excessivement majoritaire dans les deux groupes de traitement, b) le recodage des variables ;3- Troncature des poids inférieurs à 0,01 ;4- Procédure « pas à pas » descendante (backward) sur les variables avec déséquilibre jusqu'à ce que les moyennes sur les jeux de données des différences moyennes normalisées par variable soient toutes inférieures à 0,15, avec pour chaque variable sélectionnée a) son recodage, b) sa suppression si cela permet l'équilibre sur d'autres variables.RésultatsCinq populations de la base de données ESME ont été considérées (entre 19 et 70 patients), deux d'entre elles reflétant les comparateurs français reconnus par la Haute Autorité de santé (HAS), les trois autres la pratique clinique. La méthodologie a permis de sélectionner, pour chaque population, le modèle qui convergeait pour tous les jeux de données imputés, avec des caractéristiques équilibrées entre les groupes de traitement. La taille effective des échantillons après pondération était comprise entre 10 (-47 % par rapport à la taille initiale de l'échantillon) et 60 (-14 %).ConclusionCette approche, développée dans un cas spécifique en oncologie, peut être extrapolée à d'autres études.Mots clésComparaisons indirectes, données manquantes ; Imputation ; Faibles échantillons ; Données de vie réelle ; MAICDéclaration de liens d'intérêtsLes auteurs n'ont pas précisé leurs éventuels liens d'intérêts.

Background: Primary inflammatory breast cancer (IBC) is a rare and aggressive entity whose prognosis has been improved by multimodal therapy. However, 5-year overall survival (OS) remains poor. Given its low incidence, the prognosis of IBC at metastatic stage is poorly described. Materials and methods: This study aimed to compare OS calculated from the diagnosis of metastatic disease between IBC patients and non-IBC patients in the Epidemiological Strategy and Medical Economics database (N = 16 702 patients). Secondary objectives included progression-free survival (PFS) after first-line metastatic treatment, identification of prognostic factors for OS and PFS, and evolution of survival during the study period. Results: From 2008 to 2014, 7465 patients with metastatic breast cancer and known clinical status of their primary tumor (T) were identified (582 IBC and 6883 non-IBC). Compared with metastatic non-IBC, metastatic IBC was associated with less hormone receptor-positive (44% versus 65.6%), more human epidermal growth factor receptor 2-positive (30% versus 18.6%), and more triple-negative (25.9% versus 15.8%) cases, more frequent de novo M1 stage (53.3% versus 27.7%; P < 0.001), and shorter median disease-free interval (2.02 years versus 4.9 years; P < 0.001). With a median follow-up of 50.2 months, median OS was 28.4 months [95% confidence interval (CI) 24.133.8 months] versus 37.2 months (95% CI 36.1-38.5 months) in metastatic IBC and non-IBC cases, respectively (P < 0.0001, log-rank test). By multivariate analysis, OS was significantly shorter in the metastatic IBC group compared with the metastatic non-IBC group [hazard ratio = 1.27 (95% CI 1.1-1.4); P = 0.0001]. Survival of metastatic IBC patients improved over the study period: median OS was 24 months (95% CI 20-31.9 months), 29 months (95% CI 21.7-39.9 months), and 36 months (95% CI 27.9-not estimable months) if diagnosis of metastatic disease was carried out until 2010, between 2011 and 2012, and from 2013, respectively (P = 0.003). Conclusion: IBC is independently associated with adverse outcome when compared with non-IBC in the metastatic setting.

Metastatic non-small cell lung cancer is a disease with a poor prognosis and things may improve with the rise of immunotherapy. Clinical trials proved that immunotherapy had better results on survival than chemotherapy as first-line treatment for patients with metastatic lung cancer (MLC). Although clinical trials have strong internal validity, they suffer from restrictive selection criterions and it can be difficult to generalize to real-life patients. We aimed to evaluate if the results of survival when comparing immunotherapy with chemotherapy as first-line therapy for MLC in real-life data are similar to those from clinical trials. All consecutive patients included in the retrospective Epidemio-Strategy Medico Economic (ESME-AMLC–NCT03848052) program with a non-small cell MLC treated with a systemic treatment (either chemotherapy alone or immunotherapy alone) between January 2015 and December 2018. Patients diagnosed with a tumor with EGFR, KRAS, ROS or BRAF mutation were excluded. Confounding and indication biases were taken account by analyzing causal relation between treatment allocation and survival by constructing a directed acyclic graph. Progression-free survival was analyzed as secondary outcome. ESME database included 21,169 patients and 5,255 individuals were included in the study: 5055 treated with chemotherapy, 200 treated with immunotherapy. Median age at diagnosis was 63 years and male represented 67.7% of the population. Median OS in immunotherapy group was 16.4 months (95% CI = [14.1–NR]) and was higher than in chemotherapy group (11.6 months; 95% CI = [11.0–12.2]). In Cox models analyzes, immunotherapy group had better results after 3 months for subjects with performance status (PS) 0–1 (HR = 0.59; 95% CI = [0.42–0.83], P = 0.003) but had poor results before 3 months for subjects with 2, 3 or 4 PS (HR = 2.28; 95% CI = [1.17–4.47], P = 0.016). Our results were in favor of benefits on survival of the immunotherapy as first-line treatment for MLC after 3 months for patients in good health condition, as found in clinical trials.

Background: Information on real-world clinical outcomes for pembrolizumab monotherapy among patients with previously treated advanced NSCLC remains limited. Our aim was to estimate overall survival (OS) and real-world progression-free survival (rwPFS) in France for pembrolizumab monotherapy in previously treated, PD-L1-expressing advanced NSCLC patients following approval based on the phase III trial KEYNOTE-010 (KN010), where a 11.8 month median OS (95% CI: 10.4 to 13.1) and a 48.9% 12-month OS rate (95% 45.1, 52.6) were reported. Methods: Using the Epidemiological Strategy Medical Economics Advanced or Metastatic Lung Cancer (ESME-AMLC) Data Platform [NCT03848052], we identified adult patients with histologically confirmed, PD-L1 TPS ≥1%, advanced (stage IIIB or IV) NSCLC treated with at least one prior chemotherapy regimen and who initiated pembrolizumab monotherapy between 12 May 2017 and 31 December 2018. Patients with EGFR/ALK genomic aberration were required to have been treated with an appropriate targeted therapy prior to pembrolizumab. Patients who received pembrolizumab in a clinical trial were excluded. This planned interim analysis was based on a prespecified statistical analysis plan, with data cut-off on August 31, 2019. OS and rwPFS were estimated using the KM method. Results: A total of 304 patients were identified, with a median follow-up of 5.9 months (range: 0, 24). Patient characteristics and OS/rwPFS results are shown below. Table 110POverallECOG 0–1ECOG ≥2N30413163Age, median (range), yr62.5 (37, 92)62 (37, 92)63 (42, 85)Current/former smoker, n (%)276 (90.8)122 (93.1)55 (87.3)Non-squamous histology, n (%)261 (85.9)112 (85.5)54 (85.7)History of brain metastasis, n (%) TPS120 (39.5)49 (37.4)25 (39.7)1–49%147 (51.0)56 (43.8)29 (50.9)≥50%141 (49.0)72 (56.3)28 (49.1)NR1636Median OS, mos. (95% CI) OS rate, % (95% CI)13.7 (9.9, NR)16.2 (10.2, NR)5.4 (2.8, NR)12 mos52.9 (45.9, 59.5)55.5 (44.7, 65.0)38.0 (24.1, 51.7)Median rwPFS, mos. (95% CI) rwPFS rate, % (95% CI)2.8 (2.1, 3.7)3.3 (2.3, 5.7)1.4 (1.4, 2.6)12 mos21.6 (16.3, 27.4)24.3 (16.1, 33.3)12.1 (4.1, 24.8) Open table in a new tab Conclusions: Clinical outcomes among previously treated advanced, PD-L1 expressing NSCLC patients were consistent with clinical trial results thus supporting the effectiveness of pembrolizumab in the real-world setting in France. Clinical trial identification: ESMECSM2019–24. Legal entity responsible for the study: UNICANCER. Funding: MSD. Disclosure: M. Pérol: Advisory/Consultancy, Advisory Boards/Symposium/Institutional grants: Roche; Advisory/Consultancy, Advisory Boards/Symposium: Eli Lilly; Advisory/Consultancy, Advisory Boards/Symposium: Novartis; Advisory/Consultancy, Advisory Boards/Symposium/Institutional grants: AstraZeneca; Advisory/Consultancy, Advisory Boards/Symposium/Institutional grants: Takeda; Advisory/Consultancy, Advisory Boards/Symposium: MSD; Advisory/Consultancy, Advisory Boards/Symposium: Bristol-Myers Squibb; Advisory/Consultancy, Advisory Boards/Symposium/Institutional grants: Boehringer-Ingelheim; Advisory/Consultancy, Advisory Boards/Symposium: Pfizer; Advisory/Consultancy, Symposium: Amgen; Advisory/Consultancy, Symposium/Institutional grants: CHUGAU; Advisory/Consultancy, Symposium: Illumina. T. Filleron: Research grant/Funding (institution): BMS. All other authors have declared no conflicts of interest.

Background: Taxanes are one of the most effective chemotherapies (CT) in breast cancer (BC), but the efficacy of taxanes rechallenge in early metastatic relapse has been poorly studied in patients previously treated by taxanes in the (neo)adjuvant setting. Our study aimed to analyse the efficacy of taxane rechallenge in case of early metastatic relapse in a multicentre retrospective observational study compared with other chemotherapies. Methods: We analysed the French national ESME metastatic BC (MBC) database and selected HER2- MBC patients who received CT in first-line treatment for a metastatic relapse occurring 3-24 months after previous (neo) adjuvant taxanes treatment. Results: Of 23,501 female patients with MBC in ESME, 1057 met the selection criteria. 58.4% received a taxanebased regimen (75.4% concomitant bevacizumab) and 41.6% received other CT. In hormone-receptor positive (HR+)/HER2- MBC, multivariate analysis showed no difference in OS between taxanes without bevacizumab compared to other CT (HZR = 1.3 [0.97; 1.74], but taxanes was significantly associated with worse PFS (HZR = 1.48 [1.14; 1.93]). In TNBC, taxanes without bevacizumab and carboplatin/gemcitabine were not superior to other CT for OS (HZR = 1.07 [0.79; 1.44] and HZR = 0.81 [0.58; 1.13], respectively), while for PFS, taxanes was inferior (HZR = 1.33 [1.06-1.67]) and carboplatin plus gemcitabine was superior to other CT (HZR = 0.63 [0.46; 0.87]). For both subtypes, the worse outcome observed with paclitaxel was no longer observed with the addition of bevacizumab. Conclusions: With the limitation of retrospective design, taxanes rechallenge in early metastatic relapse of BC may result in a worse PFS in TNBC and HR+/HER2- MBC, which was not observed with the addition of bevacizumab.

In the last years, tumor genomic testing has drastically changed the prognosis of patients especially in those treated for an advanced/metastatic nonsquamous non–small-cell lung cancer (NSCLC). Lung cancer is associated with older age. However considering the heterogeneity of this population it remains unclear whether older patients are screened in the same proportion as younger patients. This study aims to compare the proportion of molecular testing performed in advanced or metastatic nonsquamous NSCLC at diagnosis between patients aged ≥ 70 years old, and their younger counterparts.

PurposeThe Time to First Metastatic Recurrence (TFMR) could be considered as an indirect reflection of the tumour growth kinetics which plays an important role in cancer. Molecular subtypes such as expression of estrogen receptor are known predictive factors of TFMR. The CinéBreast study aimed to identify predictive factors of the time to TFMR.MethodsThe French Epidemiological Strategy and Medical Economics (ESME) Metastatic Breast Cancer (MBC) Database (NCT03275311) was used, which contains data from a cohort of metastatic breast cancer patients from 2008 to 2016 using retrospective data collection. It is a national multi-centre database. The impact of TFMR on overall survival (OS) since first metastasis was also evaluated.ResultsAmong 16 702 patients recorded in the ESME MBC database, 10 595 had an initially localised breast cancer with hormone receptor (HR) and HER2 status available, with a metastatic recurrence. Median follow up was 56 months. Median TFMR was 59 months (<24: 20%, 24–60: 31%, 60–120: 25%, >120: 24%). HER2+ and TNBC were respectively 4 times and 12 times (p < 0.0001) more likely to have a recurrence within 2 years when compared to the luminal subgroup. Short TFMR and HR-/HER2-subtype significantly correlated with a poor OS in multivariate analysis.Some patients with MBC (20% in HER2+, 10% in ER+/HER2-and <5% in the ER-/HER2-) were long-term survivors in all 3 subgroups.ConclusionsIn this large-scale real-life data study, patients with a TNBC metastatic recurrence had a shorter TFMR. Short TFMR significantly correlated with worse overall survival.

Back to table of contents Previous article Next article LettersFull AccessSelf-Reported Suicidal Ideation as a Predictor of Suicidal BehaviorGregory E Simon, M.D., M.P.H.Gregory E SimonSearch for more papers by this author, M.D., M.P.H.Published Online:1 Jul 2019https://doi.org/10.1176/appi.ps.70704AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinked InEmail IN REPLY: Our data are certainly not adequate to assess the accuracy or utility of item 9 of the nine-item Patient Health Questionnaire (PHQ-9) to identify risk of suicide death for people with psychotic disorders.But we believe that PHQ-9 item 9 can be useful in identifying risk of suicide attempt—in the general population of mental health outpatients and for people with psychotic disorders. Among people with a diagnosis of psychotic disorder, a response of “nearly every day” to item 9 at an outpatient visit identifies persons with a 3.5% risk of suicide attempt in the following 90 days. In general medicine, we routinely use and act on risk prediction tools with lower positive predictive value. For example, the U.S. Preventive Services Task Force recommends tamoxifen for women with a predicted risk of breast cancer exceeding 3% over 5 years (1) and recommends statins for people with predicted risk of a cardiovascular event exceeding 10% over 10 years (2).The practical question for clinicians is not “Will this patient attempt suicide in the next 90 days?” but “Is this patient’s risk of self-harm high enough that I should ask additional questions?” We believe a predicted risk of 3.5% within 90 days is high enough to justify that extra attention.References1 Moyer VA: Medications to decrease the risk for breast cancer in women: recommendations from the US Preventive Services Task Force recommendation statement. Ann Intern Med 2013; 159:698–708Medline, Google Scholar2 Bibbins-Domingo K, Grossman DC, Curry SJ, et al.: Statin use for the primary prevention of cardiovascular disease in adults: US Preventive Services Task Force recommendation statement. JAMA 2016; 316:1997–2007Crossref, Medline, Google Scholar FiguresReferencesCited byDetailsCited byNone Volume 70Issue 7 July 01, 2019Pages 637-638 Metrics PDF download History Published online 1 July 2019 Published in print 1 July 2019

Abstract Background:Primary inflammatory breast cancer (IBC) is a rare and aggressive form of breast cancer. Survival of IBC patients has been improved by multimodal therapy. However 5-year overall survival (OS) still remains close to 50-60%, due to high risk of disseminated disease. Given the low incidence, prognosis of metastatic cases stages is poorly described. Methods:This study aimed to describe OS of IBC (T4d AJCC TNM classification) with upfront or recurrent metastatic disease compared with non-IBC patients in the ESME database (N=16,702 patients). OS was calculated from the diagnosis of metastasis to the date of death (from any cause), or censored to date of latest news. Secondary objectives included progression-free survival (PFS). Results:From 2008 to 2014, 7,465 patients with diagnosis of MBC and known clinical status of their primary tumor (T) were identified, including 582 IBC (T4d) and 6,883 non-IBC. As expected, metastatic IBC was associated with pejorative features compared to non-IBC, with less hormonal receptors-positive tumors (44% vs 65.6%), more HER2-positive (30% vs 18.6%) or triple-negative (25.9% vs 15.8%) cases (p<0.001), more frequent upfront M1 stage (53.3% vs 27.7%; p<0.001), and shorter median disease-free interval (2.02 years vs. 4.9 years; p<0.001). With a median follow-up of 50.2 months (0-104), median OS was 28.4 [95%CI 24-33.8] versus 37.2 months [95%CI 36.1-38.5] in metastatic IBC and non-IBC cases respectively (p<0.0001, log-rank test). By multivariate Cox model with adjustment for major prognostic factors [including age, disease-free interval, type of relapse, visceral metastases, molecular subtype, grade], OS was significantly shorter in the metastatic IBC group compared with non-IBC group (HR 1.25 [95%CI 1.1-1.4], p=0.0002). Of note, survival of metastatic IBC patients improved over the last years: median OS 24 months [95%CI 20-31.9], 29 months [95%CI 21.7-39.9] and 36 months [95%CI 27.9-NE] if diagnosed before 2011, between 2011 and 2012, or after 2012 respectively (p=0.003). Such improvement was not observed in non-IBC patients. IBC was associated with shorter median PFS under first line systemic treatment compared with non-IBC (7.2 months [95%CI 6.6-8.3] vs 9.5 months [95%CI 9.1-9.8] respectively, p=0.0136). This was maintained in a multivariate Cox model adjusting for same factors as for OS (HR 1.15 [95%CI 1-1.3], p=0.0050). Compared with non-IBC, synchronous metastatic IBC showed worse median OS and PFS (39.9 months [95%CI 34.2-45.3] vs 48.4 months [95%CI 46.3-50.8], p=0.0035; 10 months [95%CI 8.8-12.7] vs 14.5 months [95%CI 13.6-15.7], p=0.0027, respectively. Similar results were obtained in metachronous metastatic cases (20.01 months [95%CI 17.1-21.2] vs 32.8 months [95%CI 31.5-34.3], p<0.0001; 5.1 months [95%CI 4.1-6] vs 7.9 months [95%CI 7.6-8.3], p<0.0001, respectively). Conclusion:In this large national and multicentric study, IBC is a major and independent factor associated with adverse outcome in metastatic setting. Of note, the independent adverse impact on PFS identified in this study may suggest a lower sensitivity of metastatic IBC to available therapeutics. However, results seem to improve in the last years. Detailed analysis according to phenotype will be available. Citation Format: Monneur A, Bertucci F, Lardy-Cleaud A, Augereau P, Debled M, Levy C, Mouret-Reynier MA, Coudert B, Mailliez A, Bachelot T, Ferrero J-M, Guiu S, Uwer L, Campone M, Cottu P, Jouannaud C, De la Motte Rouge T, Leheurteur M, Petit T, Pistilli B, Dalenc F, Simon G, Robain M, Viens P, Lerebours F, Gonçalves A. Metastatic inflammatory breast cancer: Clinical features and outcomes in the national, multicentric, real-life ESME cohort [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-17-04.