Search

The management of patients with metastatic hormone-sensitive prostate cancer (mHSPC) has been significantly modified by the availability of innovative but expensive treatments, increasing the economic burden of prostate cancer. Here, we aimed to systematically identify and review published economic evaluations (EEs) related to the treatment of mHSPC and assess their quality. A systematic search was performed of the PubMed and Cochrane databases. Three reviewers independently selected EEs by defined inclusion and exclusion criteria. They extracted all data from each EE (general information, study population, data about the EE, interventions and comparators, and outcomes). They also assessed the quality of the selected EEs according to Drummond's checklist. Fourteen EEs published between 2016 and 2021 were eligible for the systematic review. The EEs found ADT + docetaxel to be the most cost-effective of all available treatments as a first-line strategy for mHSPC (abiraterone acetate plus prednisone, enzalutamide, and apalutamide). Five EEs showed that a simple price reduction of abiraterone acetate of 50% to 75% could change the results to render this treatment also cost-effective relative to that with docetaxel. Twelve EEs were of high quality, with a Drummond score ≥ 7. Analysis of the 14 EEs identified by our systematic review, amongst which 78.6% met high quality standards, showed that ADT + docetaxel tends to be the most cost-effective alternative for mHSPC. These results were assessed by sensitivity analysis. The data provided by this systematic review help to provide a better understanding of these treatments and the better use of healthcare resources.

The potential effects of breast cancer (BC) on health-related quality of life (HRQoL) should be considered in clinical and policy decision-making, as the economic burden of BC management is currently assessed. In the last decades, time-to-HRQoL score deterioration (TTD) has been proposed as an approach to the analysis of longitudinal HRQoL in oncology. The main objectives of the current study were to investigate the evolution of the utility values in BC patients after diagnosis and during follow-ups and to evaluate the TTD in utility values among women in all stages of BC.Health-state utility values (HSUV) were assessed using the EuroQol 5-Dimension 3-Level at diagnosis, at the end of the first hospitalization and 3 and 6 months after the first hospitalization. For a given baseline score, HSUV was considered to have deteriorated if this score decreased by ≥ 0.08 points of the EQ-5D utility index score and ≥ 7 points of the EQ visual analogue scale. TTD curves were calculated using the Kaplan-Meier estimation method.Overall 381 patients were enrolled between February 2006 and February 2008. The highest proportions of respondents at the baseline and all follow-ups reporting some and extreme problems were in pain discomfort and anxiety/depression dimensions; more than 80% of patients experienced a deterioration in EQ-5D utility index score and EQ VAS score with a median TTD of 3.15 months and 6.24 Months, respectively.BC patients undergoing therapy need psychological support to cope with their discomfort, pain, depression, anxiety, and fear during the process of diagnosis and treatment to improve their QoL.

Introduction: Soft tissue sarcomas (STSs) are a rare and heterogenous group of tumors, with poor prognostic, judging from their frequency to relapse. Few drugs are available after the conventional first-line regimen. Since 2007, trabectedin got approval after failure of anthracyclines and ifosfamide, for advanced or metastatic STS. This led to a FDA approval in 2015, but real-world evidence is still required, complementary to the pivotal phase II and III trials. Methods: One hundred twenty-six patients with STS, treated by trabectedin between 2002 and 2019, were analyzed in this retrospective study, in two French centers. The effects of trabectedin on survival, response, and toxicity were described. All patients were tested for toxicities, and efficacy was assessed in patients exposed to at least 2 cycles of trabectedin. Results: Three median cycles were administered per patient (1–79). Among the 113 patients analyzed for efficacy, the median progression-free survival was 3.0 months (95% CI: 2.3–4.8), with an overall survival of 12.3 months (95% CI: 10.2–16.9). The rate of disease control was 46% at the end of treatment. Myxoid liposarcoma (n = 11) was the histology subtype that benefited most from this chemotherapy with median progression-free survival and overall survival of 13.3 months (95% CI: 2.3–18.7) and 27.8 months (95% CI: 3.2–64.7), respectively. Adverse events were manageable. Discussion and Conclusion: Efficacy of trabectedin is confirmed in terms of clinical benefit and low toxicity, especially for myxoid liposarcoma. Combinatory regimens are under clinical trials to optimize the place of this chemotherapy.

BACKGROUND No study has focused on the economic burden in non-Hodgkin lymphoma (NHL) survivors, even though this knowledge is essential. This study reports on health care resource use and associated health care costs as well as related factors in a series of 1671 French long-term NHL survivors. METHODS Health care costs were measured from the payer perspective. Only direct medical costs (medical consultations, outpatient treatments, hospitalizations, and medical transport) in the past 12 months were included (reference year 2015). Multiple linear regression was used to search for explanatory factors of health care costs. RESULTS In total, 1100 survivors (66%) reported having used at least 1 health care resource, and 867 (52%) reported having used at least 1 outpatient treatment. After the authors accounted for missing data, the mean health care cost was estimated at €702 ± €2221. Hospitalizations and outpatient treatments were the main cost drivers. Sensitivity analyses confirmed the robustness of the results. For the 1100 survivors who reported using at least 1 health care resource, the mean health care cost was €1067 ± €2268. Several factors demonstrated statistically significant relationships with health care costs. For instance, cardiovascular disorders increased costs by 66% ± 16%. In contrast, rituximab or autologous stem cell transplantation as initial therapy had no effect on health care costs. CONCLUSIONS The consideration of economic constraints in health care is now a reality. This retrospective study reports on a better understanding of health care resource use and associated health care costs as well as related factors. It may help health care professionals in their ongoing efforts to design person-centered health care pathways.

Background The optimal therapeutic strategies for patients with metastatic hormone-sensitive prostate cancer (mHSPC) followed by metastatic castrate-resistant prostate cancer (mCRPC), in terms of cost and effectiveness remains unknown. This study aims to compare the cost-effectiveness of various potential strategies, from the start of first-line treatment in mHSPC to the death of the patients. Methods Two Markov decision-analysis models were developed, one for cohort A “asymptomatic/mildly symptomatic patients in mCRPC” and one for cohort B “symptomatic patients in mCRPC”. Each strategy reflects daily practice for mHSPC until progression in mCRPC from the start of first treatment regimen with either docetaxel or abiraterone acetate plus prednisone (AA) in mHSPC to the death of the patient. The cost-effectiveness analysis was performed from the French public healthcare system perspective. Only direct medical costs were included. Survival data were extracted from results of published randomized clinical trials. Results For cohort A, docetaxel followed by AA is the most cost-effective therapeutic strategy (€96,925 for 4.24 life-years). For cohort B, docetaxel followed by docetaxel is the most cost-effective therapeutic strategy (€81,463 for 4.05 life-years). Sensitivity analyses confirmed the robustness of our results except for a price reduction of 70% for AA or enzalutamide. Conclusions Our approach is innovative to the extent that our analysis takes into account various potential strategies for mPC. Our economic evaluation suggests that a price reduction of AA or enzalutamide impacts on the results. This approach must continue, including new drugs for patients with mPC. MICRO-ABSTRACT This study aims to define optimal sequencing for patients moving from mHSPC to mCRPC based on their cost and effectiveness through literature publications. The results add useful information to clinician and patients facing treatment decisions in the real world.

Resume Introduction Depuis le dernier plan cancer 2014–2019, l’evaluation des repercussions de la maladie chez les aidants est devenue essentielle. En effet, la qualite de la relation d’aide participe a la qualite de vie du malade. Dans ce contexte, l’objectif principal de cette etude etait de decrire l’evolution de l’attachement de l’aidant de patients ayant un cancer pendant les trois premieres annees d’accompagnement de la maladie. Methode Les aidants ont ete recrutes dans le cadre de l’etude ICE (Informal Carers of Elderly) et accompagnaient un proche, âge de plus de 60 ans, atteint d’un cancer colorectal, du sein ou de la prostate. Ils ont ete rencontres a domicile dans les trois mois suivant l’inclusion dans l’etude puis tous les six mois pendant trois ans pour un entretien semi-directif enregistre et la passation d’une echelle (RSQ) qui evaluait le style d’attachement secure ou insecure de type detache, preoccupe et craintif. Resultats L’evolution de l’attachement traduit des strategies relationnelles differentes chez les 33 aidants inclus dans les quatre premiers temps du suivi. Les trois premiers temps sont marques par une insecurite. Selon l’etape de la maladie, le style d’attachement de l’aidant peut etre different. Discussion Un style d’attachement detache permet de minimiser les signaux de detresse dans les premiers temps de la maladie. A l’inverse, en periode de remission, l’attachement preoccupe traduit l’anxiete de l’aidant. Il semble necessaire d’envisager un accompagnement specifique des aidants dans le cancer avec des besoins differencies selon les etapes du parcours de l’aidant.

Scientific advances in the last decade have highlighted the use of immunotherapy, especially immune checkpoint inhibitors, to be an effective strategy in cancer therapy. However, these immunotherapeutic agents are expensive, and their use must take into account economic criteria. Thus, the objective of the present study was to systematically identify and review published EE related to the use of ipilimumab, nivolumab or pembrolizumab in melanoma, lung cancer, head and neck cancer or renal cell carcinoma, and to assess their quality. The systematic literature research was conducted on Medline via PubMed and the Cochrane Central Register of Controlled Trials to identify economic evaluations published before July 2018. The quality of each selected economic evaluation was assessed by two independent reviewers using the Drummond checklist. Our systematic review was based on 32 economic evaluations using different methodological approaches, different perspectives and different time horizons. Three-quarters of the economic evaluations are full (n = 24) with a Drummond score ≥ 7, synonymous of “high quality”. Among them, 66% reported a strategy that was cost-effective. The most assessed immunotherapeutic agent was nivolumab. In patients with renal cell carcinoma or head and neck cancer, it was less likely to be cost-effective than in patients with melanoma or lung cancer. Whether or not these findings will be confirmed remains to be seen when market approval to cover more indications is extended and new effective immunotherapeutic agents become available.

The EORTC Quality of Life Utility Measure-Core 10 Dimensions (QLU-C10D) is a new multi-attribute utility instrument derived from the EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30), a widely used cancer-specific quality-of-life questionnaire. It covers ten dimensions: physical, role functioning, social, emotional functioning, pain, fatigue, sleep, appetite, nausea and bowel problems. To allow national health preferences to be reflected, country-specific valuations are being performed through collaboration between the Multi-Attribute Utility Cancer (MAUCa) Consortium and the EORTC. The aim of this study was to determine the utility weights for health states in the French version of the QLU-C10D. Valuations were run in a web-based setting in a general population sample of 1033 adults. Utilities were elicited using a discrete-choice experiment (DCE). Data were analyzed by conditional logistic regression and mixed logits. The sample was representative of the general French population in terms of gender and age. Dimensions with the largest impact on utility weights were, in this order: physical functioning, pain and emotional functioning. The impact on utilities was lower for role functioning, nausea, bowel problems and social functioning. The dimensions of sleep, fatigue and lacking appetite were associated with the smallest utility decrement. The results of the present study provide utility weights for the QLU-C10D and offer interesting prospects, as some cancer-specific dimensions also received sizeable utility weights (nausea and bowel problems). In fact, the EQ-5D and the HUI 3 are recommended in France and commonly used for cancer-related CUA; however, both these instruments are generic. The availability of a new cancer-specific utility instrument, such as the QLU-C10D, could improve the quality and the pertinence of future CUA in oncology

Mobilization of peripheral blood stem cells (PBSC) can be performed using plerixafor, which is expensive, or high-dose cyclophosphamide (HDCy). We hypothesized that the overall cost of mobilization with plerixafor might not be greater if the cost of complication management was considered. We performed a cost analysis of these two strategies. This multicentric observational study recruited patients with myeloma who underwent a first PBSC mobilization. We considered direct medical costs, including hospitalization, mobilization agents, apheresis, and supportive treatments. We included 111 patients, 54 and 57 in the HDCy and plerixafor groups, respectively. Cost of mobilization with HDCy was 5097 ± 2982€ vs. 10958 ± 1789€ for plerixafor (p

Background. Better knowledge on caregivers is required to address their needs with dedicated support. The results from the ICE study explored the health-related quality of life (HRQoL) in caregivers of elderly with chronic disabilities, after social intervention or not.Methods. Caregivers of patients (≥60 years) with cancer, neurodegenerative disease, stroke, or age-related macular degeneration were randomized 1:1 in the supportive intervention group (support from social workers and information booklet) or in the control group (information booklet only), and completed questionnaires (short form-36 questionnaire (SF-36), Hospital Anxiety Depression Scale (HADS), and Zarit Burden Interview (ZBI) quarterly (6-monthly for ZBI) during two years. Caregiver characteristics, and caregiver HRQoL assessment through SF-36, HADS, ZBI scores at baseline, at 12 months (M12) and 24 months (M24) on an individual and an aggregate level, were described using paired-t test comparisons, and minimal important difference. Longitudinal assessments of caregiver HRQoL over the two first years were reported.Results. From 2015 to 2019, 179 caregivers supported patients with cancer (n=92, 52%), Alzheimer (n=46, 26%), Parkinson (n=20, 11%) were randomized. No evidence differences in SF-36 PCS and MCS summary scores mean change over time, neither in HADS anxiety and burden ZBI scores were shown. However, HADS depression mean changes showed a clinically significant increase of 1.4 (4.0) at M12, and 1.7 (4.1) at M24 in control group. Conclusion. Appropriate support need to be proposed to improve the global caregiver HRQoL, and reduce depression at 1 and 2 years.Trial registration number: This study was registered retrospectively with ClinicalTrials.gov NCT02626377 on 9th December 2015.

Serious adverse drug reactions account for 3.6% of French hospital admissions. Of these, 48.5% are, at least potentially, preventable. The first aim of post-marketing pharmacovigilance is to detect adverse drug reactions as a safety signal to improve patients' safety. Thus, this study describes the epidemiology of "serious" adverse drug reactions reported between 2015 and 2018 to a regional pharmacovigilance centre and assesses their economic burden.All "serious" adverse drug reactions reported to a regional pharmacovigilance centre during the four-year study period were collected and cost associated. Only congenital anomalies related to "serious" adverse drug reactions were excluded.All 2585 "serious" adverse drug reactions reported are related to 1242 "serious" individual case safety reports. Among 58.1% of them, patients required hospital admission or a visit to the emergency room with a median cost estimated to €3725 per "serious" individual case safety report. The most "serious" adverse drug reactions reported involved gastrointestinal disorders. Fifteen percent of the imputed drugs had a narrow therapeutic index and the most frequently drug was fluindione. Finally, high relationships with an economic burden were observed for ages over or equal to 65, and imputed drugs from "Blood and Blood-Forming Organs" and "Anti-infectives for systemic use" therapeutic groups.This study provides news data on epidemiology and cost of "serious" adverse drug reactions completing the existing literature. On a regional scale, pharmacovigilance real world data could be interesting for pharmacist clinicians in common practice to improve the good use of drugs.

Resume Objectifs La mise en place des bilans partages de medication a l’officine en 2018 encourage le pharmacien a une cooperation accrue avec les professionnels de sante. Cette mission permet une diminution de l’iatrogenie chez le sujet âge. Cela necessite une reorganisation des formations universitaires (initiale et continue). L’objectif est de presenter les resultats d’une experimentation pedagogique. Methodes Un enseignement a ete cree pour permettre aux etudiants de realiser une analyse pharmaceutique adaptee au sujet âge, mettre en place et realiser un bilan partage de medication a l’officine. L’experimentation a ete realisee sur 2 annees (2017–2018 et 2018–2019). Les etudiants devaient pendant leur stage de 6e annee realiser au moins un bilan partage de medication mensuel. Un suivi etait organise grâce a une saisie en ligne des informations. Resultats Soixante-quatre etudiants et 35 maitres de stage ont participe. Les etudiants ont ameliore leur aisance pour l’utilisation d’outils de pharmacie clinique (analyse pharmaceutique, interventions pharmaceutiques, observance…). Ils ont realise 345 bilans partages de medication. Dans 24,3 % des cas, une amelioration de la prescription etait proposee au medecin (generaliste ou specialiste). Pour 80 % des maitres de stage, la formation des etudiants a aide la mise en place de cette nouvelle activite officinale. Conclusions Cet enseignement est apprecie par les etudiants et les maitres de stage. Il a permis une appropriation des differents outils indispensables a la realisation des bilans partages de medication a l’officine. Les bilans partages de medication viennent conforter le travail pluridisciplinaire des pharmaciens, notamment avec les medecins generalistes.

Resume Introduction Depuis le plan cancer, l’evaluation des pratiques professionnelles est indispensable pour s’assurer de la mise en œuvre de soins de haute qualite. Evaluer la satisfaction des patients est un des piliers pour des soins de haute qualite. L’objectif principal de l’etude etait d’evaluer la satisfaction de patientes atteintes d’un cancer du sein de stade precoce traitees par hormonotherapie, l’objectif secondaire etant d’identifier les facteurs associes a la satisfaction. Methode Le questionnaire EORTC OUT-PATSAT 35 modifie a ete envoye a un echantillon de patientes franc-comtoises afin d’evaluer neuf dimensions de satisfaction parmi lesquelles les qualites relationnelles, les informations fournies, la satisfaction globale. Pour chaque dimension, un score de satisfaction compris entre 0 (satisfaction nulle) et 100 (satisfaction elevee) a ete mesure. Des modeles de regression logistique ont permis d’etudier les facteurs associes a la satisfaction. Resultats Le score moyen de satisfaction globale des 280 patientes ayant repondu etait de 73 [0–100]. Pratiquer une activite extra-professionnelle etait associe a une satisfaction plus elevee pour plusieurs dimensions (odds ratio entre 2,80 et 4,12 ; p Discussion Les patientes etaient satisfaites et plusieurs facteurs impactant leur satisfaction ont ete identifies, sur la base d’un questionnaire qui doit evoluer pour prendre en compte l’aspect ambulatoire de leur prise en charge. Lors des consultations, une attention particuliere sera portee sur ces facteurs.

Introduction Influenza vaccination coverage currently remains below the 75% recommended threshold by the World Health Organization. To correct this situation, experiments have been successively carried out in France to enable community pharmacists to vaccinate at-risk populations. In this context, a study was conducted with pharmacists from the French Franche-Comte region to evaluate their positioning, needs and expectations regarding influenza vaccination at community pharmacies. Materials and methods A survey was created and sent to licensed pharmacists in March of 2018. This consisted of 4 parts: characteristics of the community pharmacy; positioning of the pharmacist regarding vaccinations carried out at the pharmacy; training needs and expectations; and willingness to implement vaccinations. Results The participation rate in this survey was 32% (137/427). More than 90% of the pharmacists agreed that community pharmacies’ assets were adequate for the implementation of these vaccinations (accessibility and availability), although 52% considered this complicated. Their main fears were reluctance from patients and conflicts of interest with other health professionals authorized to vaccinate (58%). The needs and expectations regarding pharmacy student training were essential for 94% of them as well as continuous training of practicing pharmacists (96%). The willingness of pharmacists to vaccinate stemmed from the fact that influenza vaccination coverage would increase for at-risk subjects (36%). Conclusion This survey allowed us to assess the favorable positioning and the real interest of pharmacists from Franche-Comte regarding the influenza vaccination done at community pharmacies, given the proviso that they were given relevant training and allocated adequate resources.

BACKGROUND In the past few decades, Lebanon has witnessed a significant increase in the incidence rates of women diagnosed with breast cancer. This increase, which is associated with the advancements in treatment modalities, emphasizes the need to evaluate the health-related quality of life (HRQoL) of women with breast cancer and to compare its patterns before and after breast-conserving surgery (BCS). OBJECTIVE This study aims to describe changes in HRQoL according to body image pre- and post-BCS and just before initiation of adjuvant therapy in newly diagnosed patients with breast cancer in Lebanon. METHODS A prospective cohort study targeting Lebanese women newly diagnosed with breast cancer and who have an indication for BCS will be conducted in 2 health care facilities. Baseline characteristics and clinical data will be collected. The European Organization for Research and Treatment of Cancer Quality-of-Life cancer-specific and breast cancer–specific questionnaires will be used to assess HRQoL. The outcomes will be measured at baseline and 1 day after breast surgery. The primary outcome will be the body image dimensions of the Quality-of-Life breast cancer–specific questionnaire. Statistical analyses will include descriptive statistics, paired 2-tailed t test, and stepwise multiple regression. A total of 120 patients will be required. RESULTS A total of 120 patients were enrolled in the study. Future outcomes will be published in professional peer-reviewed health-related research journals. CONCLUSIONS This study is strengthened by its follow-up nature, allowing us to draw conclusions about causality. The results of this study will identify the most affected components of HRQoL, as well as the factors that could play a role in improving HRQoL among women undergoing BCS. The findings of this study will help decision makers, physicians, and social workers to design a comprehensive program with multidisciplinary components for the management and care of patients with breast cancer in Lebanon. CLINICALTRIAL INTERNATIONAL REGISTERED REPORT DERR1-10.2196/27893

Background The perceptions of healthcare students of vaccines have been poorly explored and appropriate training strategies to address possible confidence gaps concerning vaccination for these future professionals is still a subject of debate. Methods A questionnaire to assess the perceptions of vaccination and the feeling of preparedness to address patient concerns was submitted to 874 multidisciplinary healthcare students enrolled in the French program “Service Sanitaire des Etudiants en Sante” (SSES). The evolution of their perceptions during the year and the impact of having performed a primary prevention intervention in the context of the SSES program were assessed. Results In total, 530 students of nursing (42.5%), medicine (31.5%), physiotherapy (11.3%), pharmacy (10.9%), and midwifery (3.8%) completed the questionnaires. Among them, 7.0% carried out an intervention within the topic “vaccination and hygiene” and 93.0% within another topic (“nutrition and physical activity” or “addiction”). A portion of the students showed traits of vaccine hesitancy, including specific concerns about side effects (61.5%) or the number of vaccines in the vaccination schedule (30.0%). They felt ill prepared to address vaccine-hesitant patients, with poor confidence of their knowledge about vaccines (52.5%), their ability to inform patients about the side effects (42.5%), the benefit/risk of adjuvants (51.7%), and the rules for introducing a new vaccine (51.9%). They showed significant differences in perception depending on their curriculum. Misconceptions and hesitancy concerning vaccines were significantly improved after the students had performed the primary prevention intervention, regardless of the topic. Conclusions A portion of French healthcare students show traits of vaccine hesitancy, with significant differences depending on the courses attended. Programs of health promotion, such as the French SSES program, which includes a primary prevention intervention conducted by multidisciplinary groups of students, may improve the global confidence of healthcare students concerning vaccination.

International audience

Background:Fecal microbiota transplantation (FMT) is an effective therapy in recurrentClostridium difficileinfection (rCDI). It is only recommended for this indication by European and American guidelines. Other indications of FMT are being studied, such as inflammatory bowel disease (IBD), and they have shown promising results.Objectives:To identify and review published FMT-related economic evaluations (EEs) to assess their quality and the economic impact of FMT in the treatment of these diseases.Data sources:The systematic literature research was conducted in both PubMed and Cochrane to identify EEs published before July 1, 2019.Study eligibility criteria:Articles were included if they concerned FMT (whatever the disease and its line of treatment), if they reported full or partial EEs, and if they were written in English. Articles were excluded if they did not concern FMT; if they did not report an EE; or if they were a systematic review, editorial, comment, letter to the editor, practice point, or poster.Methods:A measurement tool, AMSTAR, was used to optimize the quality of this systematic review. Based on the CHEERS checklist, data were identified and extracted from articles. The quality of each EE was assessed using the Drummond checklist.Results:Overall, 9 EEs were included: all EEs were full evaluations and 8 were cost-utility analyses (CUAs). All EEs had a Drummond score ≥ 7, which indicated high quality. All CUAs related to rCDI and IBD concluded that FMT was cost-effective compared with other reference treatments, at a threshold ≤$50,000/QALY. One EE about initial CDI showed that FMT was dominated by metronidazole.Conclusions:Despite a limited number of EEs, FMT seems to be a promising and cost-effective treatment for rCDI. More EE studies on other diseases like IBD are necessary to address FMT efficiency for new indications. Therefore, our systematic review provides a framework for healthcare decision making.

Resume Introduction Le ciblage des patients candidats a la conciliation medicamenteuse (CM) est une des strategies de deploiement a moyens humains constants. Dans cet objectif, les facteurs predictifs d’erreurs medicamenteuses (EM) de notre etablissement ont ete etudies. Materiels et methodes Une etude prospective est realisee en court sejour geriatrique du 1er decembre 2015 au 30 juin 2017. Le risque d’EM a ete evalue a partir des caracteristiques epidemiologiques, cliniques et medicamenteuses des patients concilies. Resultats Sur 658 patients, 161 presentaient une divergence non intentionnelle a l’admission. En analyse multivariee, l’hospitalisation pour desordres hydro-electrolytiques (p = 0,0110) et le seuil de polymedication superieur a neuf (p = 0,0085) sont des facteurs predictifs significatifs de divergences non intentionnelles. Discussion En complement de la CM d’entree, ces resultats renforcent la necessite d’une securisation de la sortie quel que soit le traitement ambulatoire initial des patients. Conclusion Notre etude a permis d’etendre la CM au second service de court sejour geriatrique. L’analyse de risque a priori des patients non concilies demontre la robustesse de l’outil propose en lien avec l’organisation des etablissements de court sejour.

Purpose To describe factors associated with overall survival (OS) among patients with metastatic clear-cell renal-cell carcinoma (mccRCC) in regard to evolution of systemic therapies. Patients and Methods Two hundred twenty-four consecutive patients with histologically confirmed mccRCC who received targeted therapy on first-line treatment between January 2007 and March 2015 were included. The primary end point was OS for metastatic first-line or second-line treatment. An analysis of prognostic factors of long survival was performed using a 2-step approach: univariate, then multivariate analysis. Results Median OS [95% confidence interval] was 19.4 months [16.1-24.9]. Three prognostic factors were identified in first-line treatment: Memorial Sloan Kettering Cancer Center (MSKCC) favorable and intermediate risks (hazard ratio [95% confidence interval] = 0.362 [0.207-0.630] and 0.561 [0.393-0.801], respectively, P = 4.10−4), metastasectomy (0.667 [0.468-0.951], P = .03), and lack of lymph node metastasis (0.715 [0.513-0.994], P = .049). In second-line treatment, median OS [95% confidence interval] was 11.0 months [8.9-14.4] for 167 patients. Three different prognostic factors predicted long survival: toxicity for first-line treatment discontinuation (HR [95% confidence interval] = 0.298 [0.180-0.493], P Conclusion These real-life data confirm the positive impact of targeted therapy in the mccRCC setting. Moreover, it emphasizes the importance of considering many factors in order to better estimate prognosis in patient pretreated with systemic therapy.

Resume Introduction Depuis la tarification a l’activite, la cotation des actes est un enjeu majeur pour les hopitaux. Par son activite de pharmacie clinique, la pharmacie hospitaliere peut etre un atout ; un medicament pouvant etre caracteristique d’une comorbidite medicale associee (CMA). L’objectif est d’evaluer un modele d’identification des CMA a travers les prescriptions medicales. Materiels et methodes Une extraction des sejours ou les prescriptions contenaient un ou plusieurs medicaments d’un referentiel associant medicaments–CMA a ete realisee sur 10 mois. Deux axes ont ete etudies : une etude theorique comparant les donnees extraites avec celles du departement d’information medicale puis une analyse de robustesse du modele sur un echantillon. Resultats L’ajout d’une comorbidite permet d’augmenter le niveau du sejour dans 28 % des cas pour un gain theorique annuel de 869 000 €. L’analyse en vie reelle (n = 15) montre une concordance de 53 % dans la cotation des sejours pour une valorisation reelle de 10 777 € soit une extrapolation a 460 534 € pour un an (soit 767 557 € si 100 % de services informatises). Discussion/Conclusion Ce projet s’inscrit dans une logique d’amelioration de cotation des sejours et constitue une etude originale de collaboration entre la pharmacie et le departement d’information medicale. La variabilite des pratiques et les utilisations hors AMM constituent les principaux freins et l’absence de donnees dans le dossier medical empeche une cotation ideale.

© 2017, Springer Science+Business Media New York. Purpose: To review the data sources of health-state utility values (HSUVs), as well as their elicitation and use, in 140 breast cancer-related cost–utility analyses (CUAs), and to provide a critical appraisal of these. Methods: A checklist was developed to guide the process of the critical appraisal. It is divided into three parts: the data source (three questions), elicitation method (four questions), and use (ten questions) of HSUVs in CUAs. Two independent reviewers performed the data extraction. A consensus was reached in case of disagreements. Data sources were categorized as “original study,” “derived from the literature,” or “other.” Results: The data source of HSUVs was always specified. When HSUVs were derived from the literature (90% of cases), the authors referred to a median number of two references as data sources. The critical appraisal of the elicitation of HSUVs in CUAs revealed considerable variability in terms of the quality of the reporting of the data source selection of HSUV. More details were provided by authors when HSUVs were elicited from an original study rather than derived from the literature. The use of HSUVs elicited from an original study was generally better described in terms of the checklist than were those derived from the literature. Conclusions: Based on the developed checklist, we were able to highlight the challenges that authors are facing when trying to adequately report HSUV used in CUAs. Our proposed checklist offers a good starting point for encouraging more explicit and comprehensive reporting of HSUVs in CUAs.

Since the introduction of targeted therapies, specific lymphoma mortality has decreased. Possible long-term toxicities, however, are not known yet. This article describes the implementation of the SIMONAL study that investigates the hypothesis of an overconsumption of care after lymphoma treatment with a 10-year follow-up.

© 2019, The Author(s). Purpose: The EORTC QLU-C10D is a new multi-attribute utility instrument derived from the EORTC QLQ-C30, a widely used cancer-specific quality of life questionnaire. It covers ten dimensions: physical, role, social, emotional functioning, pain, fatigue, sleep, appetite, nausea, and bowel problems. To allow national health attitudes to be reflected, country-specific valuations are being performed by collaboration of the Multi-Attribute Utility Cancer (MAUCa) Consortium and the EORTC. The purpose of this paper is to provide German value sets (utility weights) for the QLU-C10D. Methods: Valuations were run in a web-based setting in two general population samples of approximately 2000 adults in total. As the German version of the QLQ-C30 is presently undergoing a revision of the wording of one response category, valuations for both the current and the new version were performed (Germany 1 and 2). Utilities were elicited using a discrete choice experiment (DCE). Data were analyzed by conditional logistic regression and mixed logits. Results: Completion rates were 88.3% (1002/1135) and 90.4% (1016/1124) for Germany 1 and Germany 2 valuations, respectively. Dimensions with the largest impact on utility weights were, in this order: physical functioning, pain, role functioning, social functioning and nausea (same ordering for both German versions). Several violations of the logical ordering of levels were observed for Germany 1; this was largely improved for Germany 2. Conclusion: This study established German utility weights for the cancer-specific utility instrument QLU-C10D.

Summary The immunotherapies known as “inhibitors of checkpoint” (ICP) are monoclonal antibodies used since 2010 and have dramatically modified the management of the advanced or metastatic melanomas. By reactivating the anti-tumoral immune response, these antibodies can activate the immune system in all the tissues with a risk to induce immune related adverse events (IrAE). Thus, the adverse effect's profile of ICP is considered as very different from that usually associated with conventional chemotherapies. The objectives of our retrospective monocentric study were the evaluation of the real life's safety and efficiency of the ipilimumab and the pembrolizumab in patients with an advanced melanoma. Seventy-two patients treated by ipilimumab and\or pembrolizumab between August 1st, 2008 and December 31st, 2016 were investigated. The main IrAE occurring involved the gastro- intestinal, skin, and the endocrine systems. The average onset time of IrAE was 39, 104 and 68 days, respectively and their respective duration was of 67, 50 and 111 days. There were 13 events of grade III and IV along with one death. The overall survival was 5 months for the patients treated in monotherapy with ipilimumab, and 14 months for those treated by pembrolizumab. Our real life's study tends to confirm the current safety profile of ICP treatment. Moreover and according to our analyses, the drug sequence seems to have a global survival impact.

Cancer is becoming more prevalent in elderly patient. Due to polypharmacy, older adults with cancer are predisposed to drug-drug interactions. There is also an increasing interest in the use of complementary and alternative medicine (CAM). Thirty to seventy percent of patients with cancer have used CAM. Through pharmaceutical counseling sessions, we can provide advices on herb-drug interactions (HDI). All the patients seen in pharmaceutical counseling sessions were prospectively included. Information was collected during these sessions: prescribed medication (oral anticancer agents (OAA) and other drugs), CAM (phytotherapy especially), and use of over-the-counter (OTC) drugs. If pharmacist considered an interaction or an intervention clinically relevant, the oncologist was notified. Then, a literature review was realized to identify the potential HDI (no interactions, precautions for use, contraindication). Among 201 pharmacist counseling sessions, it resulted in 104 interventions related to 46 HDI, 28 drug-drug interactions and 30 others (wrong dosage, omission…). To determine HDI, we review 73 medicinal plants which are used by our patients with cancer and 31 OAA. A total of 1829 recommendations were formulated about 59 (75%) medical plants and their interaction with an OAA. Herb-drug interactions should not be ignored by healthcare providers in their management of cancer patients in daily practice.

Since the cancer plan, evaluation of professional practices is essential to ensure the implementation of high-quality health care. Assess patient satisfaction is one of the pillars of high-quality health care. The main objective of the study was to assess the satisfaction of patients with early breast cancer taking a hormonal therapy, the secondary objective was to identify factors associated with their satisfaction.The modified EORTC OUT-PATSAT-35 questionnaire was sent to a sample of patients in Franche-Comté in order to evaluate nine dimensions of satisfaction among which interpersonal skills, provided information, and overall satisfaction. For each dimension, a satisfaction score between 0 (no satisfaction) and 100 (highest satisfaction) was measured. Logistic regression analyses were used to study the factors associated with satisfaction.The mean overall satisfaction score for the 280 patients who answered was 73 [0-100]. Practicing an extra-professional activity was associated with higher satisfaction for several dimensions (odds ratio between 2.80 and 4.12, P0.05) whereas it was decreased in the case of a modified appetite (odds ratio between 0.27 and 0.52, P0.05). No link has been shown between satisfaction and adherence.The patients were satisfied and several factors impacting their satisfaction were identified, based on a questionnaire that must evolve to take into account the ambulatory aspect of their care. During the consultations, particular attention will be paid to these factors.

Background Targeted therapies have transformed the treatment of metastatic clear-cell renal cell carcinoma (mccRCC). Despite the importance of mccRCC, studies on its economic burden in daily practice are sparse. The purpose of this retrospective study was to evaluate cost of illness for 224 patients with mccRCC included in the cohort published by Thiery-Vuillemin et al (Factors influencing overall survival for patients with metastatic clear-cell renal cell-carcinoma in daily practice. Clin Genitourin Cancer 2018; 16:e297-305), and then to determine the explanatory factors of cost of illness. Patients and Methods The study was performed from the French Public Healthcare System perspective with lifetime horizon. Only direct medical costs were included. Multiple linear regression was used to search for explanatory factors of cost of illness. The robustness of results was assessed. Results The mean cost of illness was estimated at €71,185 ± 52,683. Outpatient/inpatient treatment and hospitalization represented 76.0% and 19.7% of this cost, respectively. After adjustment, 5 explanatory factors were identified: time of disease control for the metastatic first-line treatment ≥6 months, number of lines of treatment >2, nephrectomy at metastatic stage, lack of metastases at presentation, and age at metastatic diagnosis younger than 65 years. Individually, they increased cost of illness by 128%, 95%, 53%, 53%, and 23%, respectively. Conclusion Although it is difficult to transpose our economic evaluation results to those obtained in other countries, it should be noted that our findings were consistent with them and robust. To our knowledge, our study was the first to accurately identify explanatory factors of cost of illness. Identifying them could enable us to predict the budgetary effect on a regional level of managing patients who began their first-line treatment with a targeted therapy.

Background: Post-transplant diabetes is a frequent and serious complication of kidney transplantation. There is currently no treatment to prevent or delay the disease. Nevertheless, identification of risk factors make possible to target a population at risk to develop de novo diabetes. We hypothesized that a short term treatment with Vildagliptin may prevent new onset diabetes after transplantation (NODAT) in high-risk patients. Methods: This is a multicenter double-blind placebo-controlled randomized clinical trial. Patients undergoing first kidney transplantation will be included in 10 French transplant center. Included patients will be randomized (1:1) to receive either vildagliptin 100 or 50 mg/day (depending on glomerular filtration rate) during 2 months (the first dose being administered before entering the operating blocks) or placebo. Additional antidiabetic therapy could be administered according to glycemic control. The primary outcome is the proportion of diabetic patients 1 year after transplantation, defined as patients receiving a diabetic treatment, or having a fasting glucose above 7 mmol/l, or/and with an abnormal oral glucose tolerance test. Secondary outcomes include the glycated hemoglobin, the occurrence of acute rejection, infection, graft loss and patient death at 3 months, 6 months and 12 months after transplantation. The results will be correlated to clinical and general characteristics of the patient, cardiovascular history, nephropathy, dialysis history, transplantation data, biological data, the health-related quality of life and the cost-effectiveness of prevention of diabetes with vildagliptin. Discussion: There are only few data concerning pharmacological prevention of post-transplant diabetes. If our hypothesis is verified, our results will have a direct application in clinical practice and could limit diabetes-associated morbidity, reduce cardiovascular complications, increase quality of life of renal transplant patients, and consequently promote graft and patient survival. Our results may possibly serve for non-transplant patients carrying a high-risk of diabetes associated with other co-morbidities. Trial registration: ClinicalTrials.gov, NCT02849899 Registered on 8 February 2016. Keywords: Diabetes prevention; Vildagliptin; kidney transplantation; randomized controlled trial.

Resume Introduction La prise en charge de la douleur est un enjeu de sante publique important, particulierement en cancerologie. Dans une demarche d’evaluation des pratiques professionnelles, l’IRFC-FC a realise une enquete chez des patients presentant une tumeur solide metastatique osteophile en Franche-Comte. Les objectifs etaient d’evaluer la prevalence de la douleur, ses caracteristiques, sa prise en charge et son impact sur la qualite de vie. Methode Une enquete observationnelle, prospective et multicentrique a ete realisee via un questionnaire d’autoevaluation. Ont ete inclus les patients presentant un cancer metastatique du sein ou de la prostate pris en charge dans 5 hopitaux de jour de l’IRFC-FC sur une periode de 3 mois. Resultats Deux cent trente-trois questionnaires ont ete analyses. La prevalence de la douleur etait de 48,5 %. Trois-quarts des patients algiques avaient une douleur chronique de fond, d’intensite moderee a severe, associee ou non a des acces douloureux. Eu egard a l’intensite de leur douleur et a leur traitement antalgique, 42,0 % des patients semblaient sous-traites. Quatre-vingt-cinq pour cent des patients traites declaraient etre observants et estimaient que leur douleur etait bien prise en charge malgre un impact negatif sur la qualite de vie. Conclusion La mise en œuvre d’un chemin clinique est essentielle pour garantir une prise en charge standardisee, optimale et efficiente des patients algiques. L’evaluation de la satisfaction des soins et de la qualite de vie doit etre integree a la pratique clinique pour mieux identifier les patients algiques dont le traitement est inadapte.

The management of advanced gastrointestinal stromal tumors (GISTs) has been modified considerably by the availability of costly tyrosine kinase inhibitors (TKIs); however, the best therapeutic sequence in terms of cost and effectiveness remains unknown. The aim of this study was to compare four potential strategies (reflecting the potential daily practice), each including imatinib 400 mg/day, as first-line treatment: S1 (imatinib400/best supportive care [BSC]); S2 (imatinib400/imatinib800/BSC); S3 (imatinib400/sunitinib/BSC); and S4 (imatinib400/imatinib800/sunitinib/BSC). A Markov model was developed with a hypothetical cohort of patients and a lifetime horizon. Transition probabilities were estimated from the results of clinical trials. The analysis was performed from the French payer perspective, and only direct medical costs were included. Clinical and economic parameters were discounted, and the robustness of results was assessed. The least costly and effective strategy was S1, at a cost of €65,744 for 32.9 life months (reference). S3 was the most cost-effective strategy, with an incremental cost-effectiveness ratio (ICER) of €48,277/life-year saved (LYS). S2 was dominated, and S4 yielded an ICER of €363,320/LYS compared with S3. Sensitivity analyses confirmed the robustness of these results; however, when taking into account a price reduction of 80 % for imatinib, S2 and S4 become the most cost-effective strategies. Our approach is innovative to the extent that our analysis takes into account the sequential application of TKIs. The results suggest that the S1 strategy is the best cost-effective strategy, but a price reduction of imatinib impacts on the results. This approach must continue, including new drugs and their impact on the quality of life of patients with advanced GISTs.

Objectives The goal of this study was to determine the benefit in terms of time disease control (TDC) achieved by the succession of chemotherapy beyond the third line in patients treated for recurrent epithelial ovarian cancer. Secondary objectives were to identify patients who benefited from treatments beyond 3 lines and to estimate overall survival and disease-free progression lengths. Materials and Methods The cohort of 122 patients was identified from a pharmacy database of patients treated with chemotherapy between 1992 and 2010. The evaluation of benefit obtained by each line was based on TDC duration, defined as the interval between the beginning of the treatment and the date of progressive disease or death. Results Median TDC durations was 4.15 (0–54.7), 4 (0–21.7), 3.34 (0–29.6), 4.97 (0–29.2), and 3.13 months (0–15) for the fourth to eighth lines, respectively. Time to disease control was longer than 6 months in 34% to 40% of patients treated by lines 4 to 8. The most important factor influencing TDC length beyond the third line was the TDC duration observed in the 2 previous lines of therapy. Median overall survival after the third line was 15.3 months (95% confidence interval, 12–20 months). Factors associated with longer overall survival after 3 lines were performance status lower than 2 (P = 0.0058), no hepatic metastasis (P = 0.0098), no pulmonary metastasis (P = 0.0003), and platinum sensitivity (P = 0.04) Conclusions These results may justify the administration of chemotherapy beyond the third line, in particular when the 2 previous lines are effective and resulted in disease control longer than 6 months.

Objectives: The aim of the present systematic review was to identify the factors that potentially influence health-related quality of life (HRQoL) in women with breast cancer (BC) in the Middle East. Methods: A systematic search of the PubMed, Ovid Medline, Cochrane, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus, and Ebscohost databases was conducted to identify all relevant articles published in peer-reviewed journals up to April 2018. The keywords were “Health related quality of life”, “Breast Cancer”, and “Middle East countries”. The Newcastle−Ottawa (NOS) scale was used to evaluate the methodological quality of the included studies. Due to the methodological heterogeneity of the identified studies, no statistical pooling of the individual effect estimates was carried out; instead, the results were summarized descriptively. Results: A total of 5668 articles were screened and 33 studies were retained. The vast majority of these studies were cross-sectional and only two were longitudinal prospective studies. Concerning the methodological quality, only 39% were of high quality. Our comprehensive literature review identified several modifiable and non-modifiable risk factors associated with HRQoL, including sociodemographic, clinical, and treatment-related factors as well as behavioral and psychosocial factors. Conclusion: This study has many implications for clinical practice and may provide a framework for establishing policy interventions to improve HRQoL among women with BC. Healthcare systems in the Middle East are encouraged to develop interventional programs targeting modifiable factors, particularly socio-demographic, behavioral, and psychosocial factors.

International audience; BACKGROUND:Infections with antibiotic-resistant pathogens in cancer patients are a leading cause of mortality. Cancer patients are treated with compounds that can damage bacterial DNA, potentially triggering the SOS response, which in turn enhances the bacterial mutation rate. Antibiotic resistance readily occurs after mutation of bacterial core genes. Thus, we tested whether cancer chemotherapy drugs enhance the emergence of resistant mutants in commensal bacteria.METHODS:Induction of the SOS response was tested after the incubation of Escherichia coli biosensors with 39 chemotherapeutic drugs at therapeutic concentrations. The mutation frequency was assessed after induction with the SOS-inducing chemotherapeutic drugs. We then tested the ability of the three most highly inducing drugs to drive the emergence of resistant mutants of major bacterial pathogens to first-line antibiotics.RESULTS:Ten chemotherapeutic drugs activated the SOS response. Among them, eight accelerated the evolution of the major commensal E. coli, mostly through activation of the SOS response, with dacarbazine, azacitidine and streptozotocin enhancing the mutation rate 21.3-fold (P

BACKGROUND Long-term survivors of non-Hodgkin lymphoma (NHL) must cope with treatment complications and late toxicities that affect their health-related quality of life. Little is known about the risk-to-benefit ratio of new agents like rituximab. The impact of treatment regimens and health disorders on long-term fatigue levels was investigated in a cross-sectional study. METHODS Two self-administered questionnaires, the 20-item Multidimensional Fatigue Inventory (MFI-20) and a Life Situation Questionnaire, were mailed in 2015 to NHL survivors enrolled onto 12 successive clinical studies (1993-2010) conducted by the Lymphoma Study Association. Private addresses were obtained for 3317 survivors, of whom 1671 (50%) returned the questionnaires. Severe fatigue was defined as MFI-20 scores ≥60 on dimension scales scored from 0 to 100. Linear regression models were used to assess factors that were linked to increased fatigue levels. RESULTS The study population included 906 men and 765 women, and the median age was 64 years (age range, 24-95 years). Overall, 811 survivors had received cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP)-like chemotherapy, 518 had received high-dose CHOP, and 342 had undergone upfront autologous stem cell transplantation; 829 survivors also had received rituximab. In total, 1100 survivors (66%) reported 1 or more late health disorders. Severe fatigue was reported by 602 survivors (37%). Increased fatigue levels were associated (P

Background Brain metastases (BM) from adult soft tissue or bone sarcomas are rare, and sparse data exist on their prognostic factors and management. Subjects, Materials and Methods A retrospective study was conducted in 15 centers of the French Sarcoma Group, plus one Canadian and one Swiss center, to report on clinical, histological, and treatment characteristics and to identify predictive factors of outcome. Results Between 1992 and 2012, 246 patients with a median age of 50 years (range: 16–86) were managed for BM. BM included 221 cerebral and cerebellar metastases and 40 cases of meningeal sarcomatosis. The most frequent histopathological subtype was leiomyosarcoma (18.7%). Histological grade was high in 118 (48%) cases. Surgery of BM was carried out for 38 (15.5%) patients. Radiotherapy and chemotherapy were administered in 168 (68.3%) and 91 (37.0%) patients, respectively. Irrespective of treatment modality, BM were controlled in 113 patients (45.9%), including 31 partial responses (12.6%) and 18 complete responses (7.3%). The median overall survival from diagnosis of brain metastasis was 2.7 months (range: 0–133). In the multivariate analysis, the following parameters influenced overall survival: chemotherapy (hazard ratio [HR] = 0.38; 95% confidence interval [CI]: 0.26–0.48), surgery (HR = 0.40; 95% CI: 0.22–0.72), stereotactic radiotherapy (HR = 0.41; 95% CI: 0.19–0.90), whole-brain radiotherapy (HR = 0.51; 95% CI: 0.35–0.76), and grade (HR = 0.65; 95% CI: 0.43–0.98). Conclusion BM of sarcomas are rare and associated with a dismal outcome. Multidisciplinary management with chemotherapy, radiation therapy, and surgery is associated with a better survival. Implications for Practice The incidence of brain and meningeal metastasis in bone and soft tissue sarcomas is estimated between 1% and 8%. Published data are derived from small retrospective case series, often in the pediatric population. A prognostic index is important to guide both clinical decision-making and outcomes research, but one such is lacking for adult sarcoma patients with brain metastases. The current study describes brain metastasis in a large cohort of sarcoma patients. This study, conducted within the French Sarcoma Group, describes the natural history of sarcoma brain metastasis and enables the proposal of strategic recommendations for subsequent clinical trials and for the management of such patients.

The immunotherapies known as "inhibitors of checkpoint" (ICP) are monoclonal antibodies used since 2010 and have dramatically modified the management of the advanced or metastatic melanomas. By reactivating the anti-tumoral immune response, these antibodies can activate the immune system in all the tissues with a risk to induce immune related adverse events (IrAE). Thus, the adverse effect's profile of ICP is considered as very different from that usually associated with conventional chemotherapies. The objectives of our retrospective monocentric study were the evaluation of the real life's safety and efficiency of the ipilimumab and the pembrolizumab in patients with an advanced melanoma. Seventy-two patients treated by ipilimumab and\or pembrolizumab between August 1st, 2008 and December 31st, 2016 were investigated. The main IrAE occurring involved the gastro- intestinal, skin, and the endocrine systems. The average onset time of IrAE was 39, 104 and 68 days, respectively and their respective duration was of 67, 50 and 111 days. There were 13 events of grade III and IV along with one death. The overall survival was 5 months for the patients treated in monotherapy with ipilimumab, and 14 months for those treated by pembrolizumab. Our real life's study tends to confirm the current safety profile of ICP treatment. Moreover and according to our analyses, the drug sequence seems to have a global survival impact.