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.

Sustained Tumor Control With MAPK Inhibition in BRAF V600-Mutant Adult Glial and Glioneuronal Tumors.

OBJECTIVE: To assess whether RAF and MEK inhibitors (RAFi/MEKi) can provide long-term clinical benefit in adult patients with BRAF V600-mutant glial and glioneuronal tumors (GGNTs), we analyzed tumor response and long-term outcome in a retrospective cohort. METHODS: We performed a retrospective search in the institutional databases of 6 neuro-oncology departments for adult patients with recurrent or disseminated BRAF V600-mutant GGNTs treated with RAFi/MEKi. RESULTS: Twenty-eight adults with recurrent or disseminated BRAF V600-mutant gangliogliomas (n = 9), pleomorphic xanthoastrocytomas (n = 9), and diffuse gliomas (n = 10) were included in the study. At the time that treatment with RAFi/MEKi was started, all tumors displayed radiologic features of high-grade neoplasms. Thirteen patients received RAFi as single agents (vemurafenib [n = 11], dabrafenib [n = 2]), and 15 received combinations of RAFi/MEKi (vemurafenib + cobimetinib [n = 5], dabrafenib + trametinib [n = 10]). Eleven patients achieved a partial or complete response (11 of 28, 39%), with a median reduction of -78% in their tumor burden. Responders experienced a median increase of 10 points in their Karnofsky Performance Status (KPS) score and a median progression-free survival of 18 months, which was longer than achieved with first-line treatment (i.e., 7 months, p = 0.047). Responders had better KPS score (p = 0.018) and tended to be younger (p = 0.061) and to be treated earlier (p = 0.099) compared to nonresponders. Five patients were rechallenged with RAFi/MEKi at progression, with novel tumor responses in 2. On univariate and multivariate analyses, response to RAFi/MEKi was an independent predictor of overall survival. CONCLUSIONS: Our study highlights the long-term clinical benefits of RAFi/MEKi in adult patients with BRAF V600-mutant GGNTs and encourages rechallenge in responders. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that, for adult patients with BRAF V600-mutant GGNT, RAFi/MEKi can reduce tumor burden and provide clinical benefit.

[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.