Nivolumab combined with brentuximab vedotin with or without mediastinal radiotherapy for relapsed/refractory primary mediastinal large B-cell lymphoma.

Not available.

Covid-19: The impact of lockdown on the dispensing of hospital drugs to outpatients / COVID-19 : répercussions du confinement sur l'activité de délivrance des médicaments en rétrocession

Introduction: In response to the COVID-19 pandemic, France was under lockdown for the first time from March 17 to May 10, 2020. Purpose of the Research: The aim of this work is to study the impact of lockdown on outpatients' visits to the hospital pharmacy to collect chronic medication, in order to highlight the pharmaceutical classes concerned and to assess whether a decrease in medication adherence could be observed. Method: Retrospectively, using hospital dispensing traceability software, the dispensing of drugs during the eight weeks of lockdown was compared with that during the two eight-week periods before and after lockdown. Evolutions in the number of medicine lines dispensed and outpatient visits were analyzed over the three time periods, according to pharmaceutical classes. A specific analysis was performed between drugs only available at the hospital pharmacy and drugs available at both the community and hospital pharmacy. Results: During lockdown, 67% of patients still came regularly, but a significant decrease in the average number of lines dispensed was observed. 15% of regular patients limited their visits during this period. Patients taking drugs available at both the community and hospital pharmacy were significantly more impacted than those taking drugs that could only be dispensed at the hospital pharmacy. On the other hand, age is not a factor associated with the restriction of visits. Conclusions: Lockdown affected the visits to the hospital pharmacy of at least one in ten regular outpatients. Sending hospital drugs to community pharmacies and the help of home health care providers limited therapeutic disruptions.

Introduction: Du fait de la pandémie de COVID-19, la France a été confinée pour la première fois du 17 mars au 10 mai 2020. But de l'étude: L'objectif de ce travail est d'étudier les répercussions du confinement sur la venue des patients en rétrocession, sur les classes pharmaceutiques dispensées et sur l'observance thérapeutique. Méthodes: Les délivrances durant les huit semaines de confinement ont été comparées aux huit semaines précédentes et suivantes à partir du logiciel de traçabilité des rétrocessions. Les évolutions du nombre de lignes dispensées et de venues des patients ont été analysées sur ces trois périodes, en regard des classes pharmaceutiques. Une analyse spécifique sur les médicaments disponibles uniquement à l'hôpital et ceux disponibles également en pharmacie d'officine a été réalisée. Résultats: Durant le confinement, 67 % des patients ont continué à venir régulièrement, mais une baisse significative du nombre moyen de lignes dispensées est observée. Durant cette période, 15 % des patients réguliers ont été affectés par le confinement, n'ayant pas pu se rendre à la pharmacie. Les patients accueillis pour un médicament en double circuit ont été significativement plus affectés par le confinement que ceux accueillis pour un médicament seulement rétrocédable. L'âge n'est en revanche pas un facteur associé à la restriction des venues. Conclusions: Le confinement a influé sur les venues à la pharmacie hospitalière de près d'un patient régulier sur dix. L'envoi des médicaments rétrocédables en officine, ou l'aide des prestataires de santé à domicile, a permis de limiter les ruptures thérapeutiques.

Mechanical Thrombectomy with Intravenous Thrombolysis versus Thrombolysis Alone for the Treatment of Stroke: A Systematic Review of Economic Evaluations.

Mechanical thrombectomy has revolutionized the management of stroke by improving the recanalization rates and reducing deleterious consequences. It is now the standard of care despite the high financial cost. A considerable number of studies have evaluated its cost effectiveness. Therefore, this study aimed to identify economic evaluations of mechanical thrombectomy with thrombolysis compared with thrombolysis alone to provide an update of existing evidence, focusing on the period after proof of effectiveness of mechanical thrombectomy. Twenty-one studies were included in the review: 18 were model-based economic evaluations to simulate long-term outcomes and costs, and 19 were conducted in high-income countries. Incremental cost-effectiveness ratios ranged from -$5,670 to $74,216 per quality-adjusted life year. Mechanical thrombectomy is cost-effective in high-income countries and in the populations selected for clinical trials. However, most of the studies used the same data. There is a lack of real-world and long-term data to analyze the cost effectiveness of mechanical thrombectomy in treating the global burden of stroke.

Evaluation of supportive care needs, sexuality and quality of life in phase 1 trials: a prospective monocentric study.

PURPOSE: Patients enrolled in oncology phase 1 trials (ph1) usually have advanced heavily pre-treated cancers with few therapeutic options. Quality of life (QoL) is one of the key cancer-treatment outcome measures, especially in ph1, and sexuality is an important part of Qol but rarely explored. This prospective study aims to assess supportive care needs, QoL and sexuality in ph1. METHODS: Between September 2020 and June 2021, we prospectively recruited patients enrolled in ph1 at Gustave Roussy in France. Supportive care needs, QoL (EORTC QLQ-C30) and sexuality (female sexual function index for women, male sexual health questionnaire [MSHQ] for men) were assessed at baseline, one, three and 5 months. We performed multivariate analyses to identify associations between clinical characteristics, QoL and quality of sexual life over time. RESULTS: At baseline, we analyzed 187 patients (45% women (n = 84) and 55% men (n = 103)). Patients expressed the need for consultations in pain management, nutrition, psychology and sexology in 28%, 26%, 19% and 9%, respectively. Lower global QoL was independently associated with Royal Marsden Hospital score (p = 0.012), urogenital location tumor (p = 0.021), elevated CRP levels (p = 0.014) and pain intensity (p = 0.005). Ninety-two percent of women had sexual dysfunction. In men, a lower MSHQ score was independently associated with urogenital location tumor (p = 0.021), ECOG Performance Status (p = 0.006), comorbidity at risk (p = 0.024) and pain intensity (p = 0.004). CONCLUSIONS: There are significant needs for supportive care in ph1, especially in some subgroups of patients. New models of care should be developed to improve early phase pathways.

The cost of molecular-guided therapy in oncology: a prospective cost study alongside the MOSCATO trial.

AIM: There is increasing use of molecular technologies to guide cancer treatments, but few cost data are available. Our objective was to assess the costs of molecular-guided therapy for patients with advanced solid tumors alongside the Molecular Screening for Cancer Treatment and Optimization (MOSCATO) trial. MATERIALS AND METHODS: The study population consisted of 529 patients. The molecular diagnosis included seven steps from tumor biopsy to the multidisciplinary molecular tumor board. The cost of a complete molecular diagnosis was assessed by micro-costing. Direct costs incurred from enrollment until progression were assessed from the French National Health Insurance perspective. RESULTS: The patients' mean age was 54 years (range: 3-82) and the mean follow-up period was 145 days (range: 1-707 days). A complete molecular diagnosis cost [euro ]2,396. There were 220 patients with an actionable target (42%), among whom 105 (20%) actually received a targeted therapy. The cost of molecular-guided therapy per patient was [euro ]31,269. The main cost drivers were anticancer drugs (54%) and hospitalizations (35%). CONCLUSION: This prospective cost analysis showed that molecular diagnosis accounts for only 6% of the cost of molecular-guided therapy per patient. The costs of drugs and hospitalizations are the main cost drivers.Genet Med advance online publication 01 December 2016.

Cost Effectiveness of Candida Polymerase Chain Reaction Detection and Empirical Antifungal Treatment among Patients with Suspected Fungal Peritonitis in the Intensive Care Unit.

BACKGROUND: Mortality from intra-abdominal candidiasis in intensive care units (ICUs) is high. It takes many days for peritoneal-fluid fungal culture to become positive, and the recommended empirical antifungal therapy involves excessive costs. Polymerase chain reaction (PCR) should produce results more rapidly than fungal culture. OBJECTIVES: To perform a cost-effectiveness analysis of the combination of several diagnostic and therapeutic strategies to manage Candida peritonitis in non-neutropenic adult patients in ICUs. METHODS: We constructed a decision tree model to evaluate the cost effectiveness. Cost and effectiveness were taken into account in a 1-year time horizon and from the French National Health Insurance perspective. Six strategies were compared: fluconazole or echinocandin as an empirical therapy, plus diagnosis by fungal culture or detection by PCR of all Candida species, or use of PCR to detect most fluconazole-resistant Candida species (i.e., Candida krusei and Candida glabrata). RESULTS: The use of fluconazole empirical treatment and PCR to detect all Candida species is more cost effective than using fluconazole empirical treatment without PCR (incremental cost-effectiveness ratio of €40,055/quality-adjusted life-year). Empirical treatment with echinocandin plus PCR to detect C. krusei and C. glabrata is the most effective strategy, but has an incremental cost-effectiveness ratio of €93,776/quality-adjusted life-year. If the cost of echinocandin decreases, then strategies involving PCR plus empirical echinocandin become more cost-effective. CONCLUSIONS: Detection by PCR of all Candida species and of most fluconazole-resistant Candida species could improve the cost-effectiveness of fluconazole and echinocandin given to non-neutropenic patients with suspected peritoneal candidiasis in ICUs.

Impact of Clonal Hematopoiesis-Associated Mutations in Phase I Patients Treated for Solid Tumors: An Analysis of the STING Trial.

PURPOSE: With liquid biopsy's widespread adoption in oncology, an increased number of clonal hematopoiesis-associated mutations (CHm) have been identified in patients with solid tumors. However, its impact on patient outcomes remains unclear. This study aimed to analyze and describe CHm in a cohort of phase I patients. METHODS: Retrospective data collection from medical records and molecular profiles (Foundation One Liquid CDx Assay) was performed before first study drug administration at the Drug Development Department of Gustave Roussy (France) within the STING trial (ClinicalTrials.gov identifier: NCT04932525). CHm prevalence was assessed using any and ≥1% variant allele frequency (VAF) in epigenetic modifier genes (DNMT3A, TET2, and ASXL1). RESULTS: From January 2021 to December 2022, 255 patients were enrolled in a phase I clinical trial. A total of 55% were male, with a median age of 62 years (24-86). Principal tumor locations were GI (27%) and genitourinary (21%). Overall, 104 patients (41%) had at least one CHm in liquid biopsy, with 55 patients (22%) having a VAF of ≥ 1%. The most frequent mutation was DNMT3A 73% at any VAF (n = 76) and 22% at 1% VAF (n = 23). Median progression-free survival (PFS) and overall survival were 3.8 months (m) for the CHm group versus 3.2 m for nonclonal hematopoiesis (CH; P = .08) and 18.26 m CHm versus 15.8 m non-CH (P = .9), respectively. PFS increased in the CHm population treated with targeted therapy (hazard ratio, 0.6 [95% CI, 0.42 to 0.84]; P = .004). CONCLUSION: CHm was commonly found in patients with solid tumors treated in phase I trials, with a prevalence of 41% in our cohort. The most frequently mutated gene was DNMT3A. The presence of CHm had no impact on the population of patients treated in the phase I trials.

Activity of Lutetium-177 Prostate-specific Membrane Antigen and Determinants of Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer Previously Treated with Cabazitaxel: The PACAP Study.

BACKGROUND: Both cabazitaxel and lutetium-177 prostate-specific membrane antigen (Lu-PSMA) improve survival in metastatic castration-resistant prostate cancer (mCRPC) after an androgen receptor pathway inhibitor and docetaxel, but there are limited data regarding Lu-PSMA activity after cabazitaxel. OBJECTIVE: To assess the activity of Lu-PSMA and determinants of outcomes after cabazitaxel in mCRPC. DESIGN, SETTING, AND PARTICIPANTS: A retrospective analysis was conducted of consecutive mCRPC patients from eight European centers treated with Lu-PSMA after cabazitaxel. INTERVENTION: Lu-PSMA every 6-8 wk at a dose of 6-7.6 GBq. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was radiographic progression-free survival (rPFS). The secondary endpoints included time to prostate-specific antigen (PSA) progression (TTPSA), overall survival (OS), PSA decline, objective response rate (ORR), clinical benefit, and safety. RESULTS AND LIMITATIONS: Of 126 patients, 68% had International Society of Urological Pathology (ISUP) grade 4-5 disease, 21% had visceral metastases, and 7% had lymph node disease only. DNA damage repair (DDR) alterations were detected in 11/50 (22%) patients with available testing. Patients received a median number of 3 Lu-PSMA cycles (interquartile range 2-4). With a median follow-up of 12.0 mo, the median rPFS was 4.4 mo (95% confidence interval [CI] 3.2-5.4), TTPSA 3.5 mo (95% CI 3.0-4.6), and OS 8.9 mo (95% CI 6.5-12.7). The ORR was 35%, and 55 patients (44%) experienced a PSA decline of ≥50%. The time to castration resistance of <12 mo was associated with shorter rPFS (p = 0.01). A similar trend was observed for ISUP grade 4-5 (p = 0.08), and baseline positron-emission tomography parameters including PSMA mean standardized uptake value (SUV) and maximum SUV (respectively, p = 0.06 and 0.05). The duration of previous cabazitaxel or DDR status did not impact outcomes. Patients experiencing a PSA decline of ≥ 50% on therapy demonstrated longer rPFS, TTPSA, and OS (all p < 0.0001). Limitations include retrospective data collection and investigator-based rPFS assessment. CONCLUSIONS: Lu-PSMA demonstrated a substantial PSA decline but limited rPFS after cabazitaxel in a real-life setting. Adverse baseline characteristics, baseline positron-emission tomography parameters, and quality of PSA response may help identify patients less likely to benefit from Lu-PSMA. PATIENT SUMMARY: Lutetium-177 prostate-specific membrane antigen (Lu-PSMA) improved outcomes in patients with castration-resistant prostate cancer, but there are limited data about its activity after cabazitaxel, a chemotherapy that is also the standard of care in this setting. We conducted a study across eight European centers and showed substantial responses on Lu-PSMA after cabazitaxel, although activity was short lived in a heavily pretreated population. Our findings prompt for real-life evaluation of Lu-PSMA in earlier settings to define the best therapeutic sequence.

Opioid Reduced Anesthesia in Major Oncologic Cervicofacial Surgery: A Retrospective Study.

Opioid sparing is one of the new challenges in anesthesia and perioperative medicine. Opioid reduced anesthesia (ORA) is part of this approach, and it consists of a multimodal analgesia-associating non-opioid analgesic regional anesthesia to reduce intraoperative opioid requirements. Major cervicofacial oncologic surgery could specifically benefit from ORA, since it is known to generate intense and prolonged postoperative pain, with a high risk of pulmonary complications. METHODS: This is a retrospective case-controlled study of 172 patients with major cervicofacial oncologic surgery. Group ORA (dexmedetomidine and lidocaine), n = 86, was compared to patients treated with standard opioid based anesthesia, Group control, n = 86. The main endpoint was to study perioperative opioid consumption and postoperative pain scores, and the secondary endpoint was to observe opioid related side effects. RESULTS: The ORA group received 6.2 ± 3.1 mg morphine titration at the end of surgery, while the control group received 10.1 ± 3.7 mg p < 0.0001; there was no significant difference in post-operative analgesia requirements and pain scores between the groups. Intraoperatively, the ORA protocol yielded bradycardia in 4 persons, while in the control group, only 2 persons had bradycardia necessitating intervention, p < 0.05. Postoperatively, episodes of hypoxemia (50%) and the need for additional pressure-assisted ventilation (6%), was significantly different in the ORA group than in the control group (70% and 19%), p < 0.05. There was no difference between the two groups for the incidence of nausea and vomiting, ileus, or postoperative delirium. DISCUSSION: ORA was not associated with a decrease in postoperative pain and opioid requirement, but possibly reduced the incidence of hypoxemia and the use of additional pressure-assisted ventilation, although we cannot rule out confounding factors. The possible benefits of ORA remain to be demonstrated by prospective studies.

COVID-19 impact on an oncologic emergency department visits: observational study.

OBJECTIVE: This study aimed at evaluating the impact of COVID-19 on emergency department (ED) visits in a tertiary cancer centre and providing information on the features of the unplanned events during the first wave of COVID-19 pandemic. METHODS: This retrospective observational study based on data from ED reports was divided into three periods of 2 months each around the first lockdown announcement of 17 March 2020: pre-lockdown, lockdown and post-lockdown. RESULTS: A total of 903 ED visits were included in the analyses. The mean (±SD) daily number of ED visits did not change during the lockdown period (14.6±5.5) when compared with the periods before (13.6±4.5) and after lockdown (13.7±4.4) (p=0.78). The proportion of ED visits for fever and respiratory disorders increased significantly to 29.5% and 28.5%, respectively (p<0.01) during lockdown. Pain, the third most frequent motive, remained stable with 18.2% (p=0.83) throughout the three periods. Symptom severity also showed no significant differences in the three periods (p=0.31). CONCLUSION: Our study shows that ED visits during the first wave of the COVID-19 pandemic remained stable for our patients regardless of the symptom's severity. The fear of an in-hospital viral contamination appears weaker than the need for pain management or for the treatment of cancer-related complications. This study highlights the positive impact of cancer ED in the first-line treatment and supportive care of patients with cancer.

Implementing a PROACTive Care Pathway to Empower and Support Survivors of Breast Cancer.

PURPOSE: Optimal comprehensive survivorship care is insufficiently delivered. To increase patient empowerment and maximize the uptake of multidisciplinary supportive care strategies to serve all survivorship needs, we implemented a proactive survivorship care pathway for patients with early breast cancer at the end of primary treatment phase. METHODS: Pathway components included (1) a personalized survivorship care plan (SCP), (2) face-to-face survivorship education seminars and personalized consultation for supportive care referrals (Transition Day), (3) a mobile app delivering personalized education and self-management advice, and (4) decision aids for physicians focused on supportive care needs. A mixed-methods process evaluation was performed according to the Reach, Effectiveness, Adoption, Implementation and Maintenance framework including administrative data review, pathway experience survey (patient, physician, and organization), and focus group. The primary objective was patient-perceived satisfaction with the pathway (predefined progression criteria for pathway continuation ≥70%). RESULTS: Over 6 months, 321 patients were eligible for the pathway and received a SCP and 98 (30%) attended the Transition Day. Among 126 patients surveyed, 77 (66.1%) responded. 70.1% received the SCP, 51.9% attended the Transition Day, and 59.7% accessed the mobile app. 96.1% of patients were very or completely satisfied with the overall pathway, whereas perceived usefulness was 64.8% for the SCP, 90% for the Transition Day, and 65.2% for the mobile app. Pathway implementation seemed to be positively experienced by physicians and the organization. CONCLUSION: Patients were satisfied with a proactive survivorship care pathway, and the majority reported that its components were useful in supporting their needs. This study can inform the implementation of survivorship care pathways in other centers.

Pain after Interventional Radiology in Oncology: A Case-Control Study from a 5-Year Cohort.

Background: Interventional radiology plays a major role in oncology both for curative and palliative treatment, but few reports address post-procedural pain. The purpose of this study was to quantify postoperative pain after interventional radiology procedures in oncology and to identify major pain-associated pre and intraoperative factors. Methods: From 2015 to 2019, all patients treated with interventional radiology were included retrospectively in a cohort study. Anesthetic protocols were standardized by the type of radiological procedure. Demographic data, preoperative treatments, analgesic agents, pain score levels, and morphine consumption from the post-anesthesia care unit (PACU) to hospital discharge were collected from databases. In an additional case-control study, patients reporting strong or intolerable pain in PACU were compared to those with no pain. Matching to control cases was based on the type of intervention, sex, and age. Results: From 4411 procedures, severe pain in PACU was more frequent in women (p < 0.04) and the youngest patients (p < 0.0001), after general anesthesia (p < 0.0001). Higher pain levels were associated with certain procedures, such as arterial embolization, limb cementoplasty, osteosynthesis, and abdominal tumor ablation, and when the intervention duration exceeded 160 min (p = 0.038). In the cohort study, high-dose remifentanil (≥0.055 µg/kg/min) was a risk factor for post-procedural high pain levels (p < 0.001). Intraoperative ketoprofen was associated with a decrease in high pain level incidence (p < 0.0001). Severe pain in PACU was a risk factor for severe pain in wards from day 0 until discharge. Conclusion: Severe pain depends on the type and duration of interventional radiology, type of anesthesia, and preoperative use of opiates. Limiting doses of remifentanil and injecting intraoperative analgesics, especially ketoprofen, may reduce the incidence of post-intervention severe pain.

Healthcare Costs Associated with Potentially Inappropriate Medication Prescribing Detected by Computer Algorithm Among Older Patients.

INTRODUCTION: Potentially inappropriate medication prescribing (PIP) among older patients is associated with an increased risk of adverse events and hospitalization, and sometimes increased healthcare costs. OBJECTIVE: The aim of this study was to explore the association between healthcare costs and PIP exposure among older patients. METHODS: Analyses were conducted using data from the Multidomain Alzheimer Preventive Trial (MAPT). A computer algorithm was constructed to detect PIP based on various different explicit criteria-based tools, and the results were expressed in number of medication-related potential non-compliances (MRNCs). A prescription was considered potentially inappropriate if there were one or more MRNCs. We performed a cost analysis from the French National Health Insurance perspective, and also performed a multivariate analysis to identify the association between healthcare costs and PIP (number of MRNCs). RESULTS: The computer algorithm analyzed medication prescribing from included patients (N = 1525 aged 75.3 ± 4.4 years; 64% women [n = 978]). PIP was associated with increased total healthcare costs and non-medication healthcare costs after adjusting for potential confounders. We also noted that healthcare costs tended to increase with the number of MRNCs. The mean additional healthcare costs were €517, €921, and €1669 per patient and year for patients with one or two MRNCs, three or four MRNCs, and five or more MRNCs, respectively, in comparison with patients with appropriate medication prescriptions. CONCLUSION: These observations led us to conclude that interventions focused on reducing PIP could result in savings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00672685.

Screening for deficits on intrinsic capacity domains and associated healthcare costs.

BACKGROUND/OBJECTIVE: Intrinsic capacity (IC) defined by the World Health Organization is divided into six domains (locomotion, psychological, vitality/nutrition, cognition, vision and hearing). The main objective of this study therefore is to explore the association between healthcare costs and IC domains deficits among older patients. PARTICIPANTS AND SETTING: This longitudinal secondary analysis was performed on data from the Multidomain Alzheimer Preventive Trial (MAPT), a 3-year randomized controlled trial with non-demented community-dwelling participants aged 70 years or over. METHODS: We used an adapted version of the ICOPE (Integrated Care for Older People) Step 1 to screen for the six operational IC domains deficits at three time-points: baseline, one year and two years. We performed bivariate and multivariate analyzes using generalized linear models and generalized estimating equation models to identify associations between healthcare cost and deficits on IC domains. RESULTS: We analyzed 693 patients (aged 75.2 ± 4.22 years; 64% women (N = 442)). At baseline, among the included patients, 89% had at least one impairment in IC domains (N = 619). A deficit on visual capacity was associated with increased immediate healthcare costs (CR: 1.48; 95CI: [1.16-1.89]). Regarding persistent impairment of IC, locomotor (CR: 1.27; 95CI: [1.01-1.60], additional annual healthcare cost: €1092 per patient) and psychological (CR: 1.28; 95CI: [1.03-1.59], additional annual healthcare cost: €817 per patient) capacities were associated with increased healthcare costs. CONCLUSION: In conclusion, this study showed that some deficits on IC domains, as measured by simple screening tests and questions, can be associated with higher healthcare costs. CLINICALTRIALS: gov identifier: NCT00672685.

Therapy-related Myeloid Neoplasms Following PARP Inhibitors: Real-life Experience.

PURPOSE: To provide insights into the diagnosis and management of therapy-related myeloid neoplasms (t-MN) following PARP inhibitors (PARPi). EXPERIMENTAL DESIGN: In a French cancer center, we identified and described the profiles of 13 t-MN diagnosed among 37 patients with ovarian cancer referred to hematology consultation for cytopenia under PARPi. Next, we described these 13 t-MN post-PARPi among 37 t-MN post ovarian cancer according to PARPi exposure. Finally, we described 69 t-MN post-PARPi in a national cohort. RESULTS: From 2016 to 2021, cumulative incidence of t-MN was 3.5% (13/373) among patients with ovarian cancer treated with PARPi. At time of hematologic consultation, patients with t-MN had a longer PARPi exposure (9 vs. 3 months, P = 0.01), lower platelet count (74 vs. 173 G/L, P = 0.0005), and more cytopenias (2 vs. 1, P = 0.0005). Compared with t-MN not exposed to PARPi, patients with t-MN-PARPi had more BRCA1/2 germline mutation (61.5% vs. 0%, P = 0.03) but similar overall survival (OS). In the national cohort, most t-MN post-PARPi had a complex karyotype (61%) associated with a high rate of TP53 mutation (71%). Median OS was 9.6 months (interquartile range, 4-14.6). In multivariate analysis, a longer time between end of PARPi and t-MN (HR, 1.046; P = 0.02), olaparib compared with other PARPi (HR, 5.82; P = 0.003) and acute myeloid leukemia (HR, 2.485; P = 0.01) were associated with shorter OS. CONCLUSIONS: In a large series, we described a high incidence of t-MN post-PARPi associated with unfavorable cytogenetic and molecular abnormalities leading to poor OS. Early detection is crucial, particularly in cases of delayed cytopenia.

Diabetes and Frail Older Patients: Glycemic Control and Prescription Profile in Real Life.

(1) Background: The latest recommendations for diabetes management adapt the objectives of glycemic control to the frailty profile in older patients. The purpose of this study was to evaluate the proportion of older patients with diabetes whose treatment deviates from the recommendations. (2) Methods: This cross-sectional observational study was conducted in older adults with known diabetes who underwent an outpatient frailty assessment in 2016. Glycated hemoglobin (HbA1c) target is between 6% and 7% for nonfrail patients and between 7% and 8% for frail patients. Frailty was evaluated using the Fried criteria. Prescriptions of glucose-lowering drugs were analyzed based on explicit and implicit criteria. (3) Results: Of 110 people with diabetes with an average age of 81.7 years, 67.3% were frail. They had a mean HbA1c of 7.11%. Of these patients, 60.9% had at least one drug therapy problem in their diabetes management and 40.9% were potentially overtreated. The HbA1c distribution in relation to the targets varied depending on frailty status (p < 0.002), with overly strict control in frail patients (p < 0.001). (4) Conclusions: Glycemic control does not seem to be routinely adjusted to the health of frail patients. Several factors can lead to overtreatment of these patients.

Potentially Inappropriate Medication Prescribing Detected by Computer Algorithm among Older Patients: Results from the MAPT Study.

(1) Background: Some medications may be dangerous for older patients. Potentially inappropriate medication prescribing (PIP) among older patients represents a significant cause of morbidity. The aim of this study was to create an algorithm to detect PIP in a geriatric database (Multidomain Alzheimer Preventive Trial (MAPT) study), and then to assess the algorithm construct validity by comparing the prevalence of PIP and associated factors with literature data. (2) Methods: An algorithm was constructed to detect PIP and was based on different explicit criteria among which the European list of potentially inappropriate medications (EU(7)-PIM), the STOPP and START version 2 tools. For construct validity assessment, logistic mixed-effects model repeated measures analyses were used to identify factors associated with PIP. (3) Results: Prevalence of PIP was 59.0% with the EU(7)-PIM list criteria, 43.2% with the STOPP criteria and 51.3% with the START criteria. Age, polypharmacy, and higher Charlson comorbidity index were associated with PIP. (4) Conclusions: Prevalence of PIP and associated factors are consistent with literature data, supporting the construct validity of our algorithm. This algorithm opens up interesting perspectives both in terms of analysis of very large databases and integration into e-prescribing or pharmaceutical validation software.

Factors Associated With the Choice of Oral Anticoagulant Class in the Older Patients: An Observational Study.

AIM: Oral anticoagulants are the first-line drugs for treating thrombotic disorders related to nonvalvular atrial fibrillation and for treating deep vein thrombosis, diseases that increase in prevalence with age. Older patients have a greater risk of thrombotic and hemorrhagic events and are more prone to drug interactions. Given this backdrop, we wanted to determine the factors associated with the prescription of direct oral anticoagulants and vitamin K antagonists in older patients. METHODS: We performed a cross-sectional observational study using a hospital prescription database. The study population consists of 405 older patients who were given oral anticoagulants. The 2 variables of interest were the prescription of 1 of the 2 classes of oral anticoagulants (direct oral anticoagulants vs vitamin K antagonists) and appropriateness of oral anticoagulant prescribing according to Summary of Product Characteristics (potentially inappropriate vs appropriate). RESULTS: The factors associated with direct oral anticoagulant prescribing were the female gender (odds ratio [OR]: 1.87, 95% confidence interval [CI]: 1.22-2.88) and initiation during hospital stay (OR: 2.56, 95% CI: [1.52-4.32]). Stage 4 and 5 chronic kidney diseases (OR: 0.39, 95% CI: [0.19-0.79] and OR: 0.07, 95% CI: [0.01-0.53]) were factors favoring vitamin K antagonist prescription. Being 90 years of age or more (OR: 2.05, 95% CI: [1.06-3.98]) was a factor for potentially inappropriate anticoagulant prescribing. The gastroenterology department (OR: 2.91, 95% CI: [1.05-8.11]) was associated with potentially inappropriate anticoagulant prescribing. CONCLUSIONS: Direct oral anticoagulants are the drugs of choice for anticoagulant treatment, including in older adults. The female gender and the initiation during hospital stay increased the chances of being prescribed a direct oral anticoagulant in older adults. Stage 4 and 5 chronic kidney disease increased the likelihood of having a vitamin K antagonist prescribed. Our study also revealed a persistence of potentially inappropriate oral anticoagulant prescriptions in older patients.

Potentially Inappropriate Drug Prescribing in French Nursing Home Residents: An Observational Study.

Purpose: To identify the prevalence of potentially inappropriate drug prescription in a sample of nursing home residents in France, combining explicit criteria and implicit approach and to involve pharmacists in the multi-professional process of therapeutic optimization. Methods: A cross-sectional, observational, multicenter study was conducted during a five-month period in a sample of French nursing homes. Information on drug prescription, diseases, and socio-demographic characteristics of nursing home residents was collected. For each prescription, identification of potentially inappropriate drug prescription was done, based on explicit and implicit criteria. Results: Nursing home residents were administered an average of 8.1 (SD 3.2, range 0-20) drugs per day. Nearly 87% (n = 237) of the residents had polypharmacy with five or more drugs prescribed per day. Among the 274 nursing home residents recruited from five nursing homes, 212 (77.4%) had at least one potentially inappropriate drug prescription. According to the Laroche list, 84 residents (30.7%) had at least one drug with an unfavorable benefit-harm balance. An overdosing was found for 20.1% (n = 55) of the residents. Nearly 30% (n = 82) of the residents had a drug prescribed without valid medical indication. Conclusions: This study shows that potentially inappropriate drug prescriptions are highly prevalent among nursing home residents, nevertheless pharmacists can take part in drug utilization review in collaboration with the nursing home staff.