Clinical Benefit of Pembrolizumab in Advanced Urothelial Cancer Patients in Real-Life Setting: An Efficacy and Safety Monocentric Study.

BACKGROUND: Pembrolizumab is approved for patients with metastatic urothelial carcinoma (UC) who progressed under platinum therapy. The aim of this study was to assess the efficacy and safety of pembrolizumab in a cohort of real-life UC patients. METHODS: This retrospective, observational study included advanced UC patients treated with pembrolizumab in a single institution in France. The co-primary endpoints were overall survival (OS) and progression-free survival (PFS) at 6 months. Secondary endpoints were objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety. RESULTS: 78 patients were included in the study. The median OS was 7.3 months (3.8-12.2). The estimated OS rate at 6 months was 61.5% (50.5-72.6). The median PFS was 3.1 months (1.4-7.2). The estimated PFS rate at 6 months was 42.3% (31.1-53.5). The best ORR was 35.9%. The mean DOR was 95.5 days. The DCR was 30.8%. The most common treatment-related adverse events (AEs) of any grade were fatigue (46.2%), diarrhea (11.5%), pruritus (10.3%) and nausea (9.0%). There were no grade 3 AEs that occurred with an incidence of 5% or more. CONCLUSION: Our results confirmed those of randomized clinical trials concerning the treatment with pembrolizumab in patients with advanced UC that progressed after platinum-based chemotherapy.

De-simplifying single-tablet antiretroviral treatments for cost savings in France: From the patient perspectives to a 6-month follow-up on generics.

In developed countries, most people living with HIV/AIDS are treated with costly brand single-tablet regimens. Given the economic impact, French guidelines recommend using generic antiretroviral therapy when possible to decrease antiretroviral therapy costs. We aimed to study HIV-infected patients' acceptability to switch from a brand single-tablet regimens [abacavir/lamivudine/dolutegravir (Triumeq®) or emtricitabine/tenofovir disoproxil fumarate/rilpivirine (Eviplera®)] to a treatment comprising of two pills: one is a fixed-dose generic combination of 2 Nucleoside Analogs and the second tablet is the third antiretroviral. This study was a prospective observational study in a French hospital. During their follow-up, patients on stable single-tablet regimens were made aware of the possible cost-saving. They were questioned about their willingness and barriers accepting the substitution. Participants chose between the two regimens, either to remain on single-tablet regimens or switch to the de-simplified regimen. Six months later, a second survey was given to the patient who chose to de-simplify and HIV viral load was controlled. The study included 98 patients: 60 receiving emtricitabine/tenofovir disoproxil fumarate/rilpivirine (Eviplera®) and 38 on abacavir/lamivudine/dolutegravir (Triumeq®). Forty-five patients accepted the de-simplified treatment, 37 refused and 16 were undecided and followed the decision offered by their physician. The main reason for unwillingness to switch is the number of pills (77.3%). In multivariate model analysis, male patients (p = 0.001) who have taken antiretroviral therapy for over 20 years (p = 0.04) and who retrieve their treatment in their community hospital (p = 0.03) are more likely to accept the switch. Fifty-one patients accepted to replace their single-tablet regimens and six months later, the majority was satisfied; only four returned to single-tablet regimens because of suspected side effects. Half of the people living with HIV/AIDS in our cohort accepted to switch from brand single-tablet regimens to a two-tablet regimen containing generic drugs within a process that emphasizes health expenditure savings.

[Implementation of a remote oncology-monitoring program for cancer patients in outpatient care unit: A major challenge for the different actors]. / Mise en place d'un programme de suivi à distance des patients atteints de cancer et traités par chimiothérapie en hôpital de jour : un enjeu de taille pour les différents acteurs.

INTRODUCTION: The development of outpatient departments requires health professionals to reorganize practices for a better patient monitoring and a better patient care pathway. OBJECTIVE: To evaluate, using indicators, the impact of an oncology-monitoring program on activity and organizational fluidity in a Cytotoxic Preparation Unit and clinical departments. Method the clinical and biological data are collected between two injections by calling the patient two days prior chemotherapy is performed by a specialist nurse of an outsourced medical call center. After medical and pharmaceutical validation, early preparations (D-1) for expensive and non-expensive molecules are performed. RESULTS: The program is started in February 2016. After 3 months, 382 patients were included into the program. Twenty-three patients on average are called per day related to 1162 completed clinical questionnaires (87%). Among the files, 47% are complete at D-2 (biological and clinical data). The early preparation rate of expensive drugs, zero before the program for financial reasons, has reached 40% at 3 months. The destroyed preparation rate because of non-administration decreased from 5 to 2%. DISCUSSION: Preliminary results show a significant patient compliance, feasibility of early preparation of expensive and non-expensive chemotherapy. These are preliminary results of a one-year study. They will be completed by an evaluation of patients' and health professionals' satisfaction, evaluation of length of stay, optimization of operations for clinical departments and CPU. The D-2 biological data collection must be improved. A strong doctor/pharmacist collaboration is essential for better patient care pathway.

How well Informed are Cancer Patients Prior to a Life Cycle of Injectable Chemotherapy Drug Treatment?

Cancer patient dissatisfaction, due to a long waiting time for chemotherapy treatment, is a common complaint. To improve patient satisfaction, our pharmaceutical team was prompted to design a series of information tools for injectable chemotherapy drug treatment (ICDT) patients. This study was based on French Health Authorities recommendations. All three stages were monitored: the preparation stage using a 204 patient survey, the design stage, and the assessment stage with a 12 point questionnaire patient evaluation. An information brochure and a 10-min film were designed which chronologically described key stages in the life cycle of ICDT. Both tools were assessed by 29 and 84 patients respectively. The questionnaire confirmed that this approach met the needs of more than 90 % of patients. The brochure and the film also accurately met the objectives and improved the understanding of the chemotherapy long waiting time which resulted in higher patient satisfaction. The designed tools will continue to evolve with changes in oncology practices based on various indicators defined in the study. Our study proposes an original method to assist health professionals to better inform cancer patients regarding the preparation of ICDT. It is also a part of a continuous quality program to assure quality outpatient healthcare.

Surgery versus medical follow-up in patients with asymptomatic primary hyperparathyroidism: a decision analysis.

OBJECTIVES: To examine the cost-effectiveness of strategies for management of primary asymptomatic hyperparathyroidism: surgical strategies and medical follow-up versus surgery. DESIGN: We used a Markov state-transition decision-analytic model for an hypothetical cohort of 55-year-old women to compare with a lifetime horizon costs and effectiveness of bilateral neck exploration (BNE), unilateral neck exploration (UNE), video-assisted parathyroidectomy (VAP) and lifelong medical follow-up shifting for either BNE or UNE in case of disease progression. METHODS: Data on localization tests, complications and treatment efficacies were derived from a systematic review of the literature. Outcomes were expressed as quality-adjusted life years (QALY). Costs (2002 Euro) discounted at 3% yearly were estimated from the health care system perspective. RESULTS: In the base-case analysis, VAP strategy (VAPS) was the most effective and BNE strategy (BNES) was the least costly. UNE strategy (UNES) had an incremental cost-effectiveness ratio of 2688 Euro/QALY versus BNES and VAPS of 17,250 Euro/QALY in comparison with UNES. Surgical management was more effective than medical follow-up with acceptable incremental cost-effectiveness ratios. VAPS became less effective than UNES over 71 years. Differences between UNES and VAPS were sensitive to success and complication rates, quality-of-life weights and procedural costs. Medical follow-up strategies became the most effective if quality-of-life weight for this condition was higher than 0.99. CONCLUSIONS: Surgery is more effective than medical follow-up at a reasonable cost and can be preferred except in patients choosing medical follow-up. Minimally invasive surgery is cost-effective compared to the traditional surgical approach.