Retrospective, real-life study of venetoclax plus azacitidine or low-dose cytarabine in French patients with acute myeloid leukemia ineligible for intensive chemotherapy.

BACKGROUND: Recently, the combination of venetoclax plus a hypomethylating agent (HMA; azacitidine ordecitabine) or low-dose cytarabine (LDAC) showed promise in Phase III trials in previously untreated AML. In France at the time of this study, venetoclax was not yet approved for AML and there were therefore no formal usage recommendations. Here we report the first study in a French cohort that assessed venetoclax in combination with existing treatments for AML under real-life conditions. METHOD: This retrospective, real-life study collected data on venetoclax use and management in a French cohort with acute myeloid leukemia (AML) ineligible for intensive chemotherapy. RESULT: Of 118 patients, 81 were in second line/beyond (71.6% also hypomethylating agent [HMA]; 23.5% lowdose cytarabine [LDAC]) and 37 in first line. For venetoclax initiation, 57.3% underwent ramp up and 74.6% were hospitalized. Median venetoclax duration was 2.5 months (range 0.03-16.2). With all treatment lines and regimens, most common grade 3/4 adverse events were hematologic (overall 96.4% of patients) and infections (57.1%). Dosage adjustments for drug interactions and safety varied between centers. In second-line/beyond, median progression-free survival was 4.0 months (95% confidence interval [CI] 2.7-12.8) with venetoclax-HMA and 3.4 months (1.3-8.9) with venetoclax-LDAC; overall response rate was 51.9% and 41.2%, respectively. Thus, we showed that venetoclax-based treatment yields promising findings in patients with AML, but to address treatment complexity, practice harmonization is needed.

Gabapentinoid use in French most precarious populations: Insight from Lyon Permanent Access to Healthcare (PASS) units, 2016-1Q2021.

BACKGROUND: Gabapentinoids (i.e., gabapentin and pregabalin) are medications approved for epilepsy, chronic pain, or generalized anxiety disorder. Recently, there have been regular reports of misuse of pregabalin, and to a lesser extent, gabapentin, in particular among opioid and polydrug users. OBJECTIVES: To longitudinally explore the amounts of gabapentinoids dispensed in Lyon's Permanent Access to Healthcare (PASS) units, which offer permanent and free healthcare to precarious populations with no healthcare insurance coverage. METHODS: We collected the amounts of pregabalin and gabapentin dispensed in the three PASS units of Lyon and calculated the average doses dispensed monthly between 2016 and the first quarter of 2021 (1Q2021), with and without adjustment for the number of dispensing visits. RESULTS: The total doses of gabapentinoid dispensed every month in Lyon's PASS units displayed a 1233% increase for pregabalin, and a 1185% increase for gabapentin, between 2016 and 1Q2021. When adjusted for the number of visits, this increase reached a factor of 8.5 for pregabalin and 8.3 for gabapentin, respectively. However, while the increase in pregabalin dispensing was constant throughout the study period, gabapentin total dispensed doses were more fluctuating over time, and the rise of dispensations was thus less straightforward. CONCLUSION: Our study reveals a local but substantial increase in gabapentinoid use in populations with no social insurance. These findings should be confirmed more widely and plead for the systematic collection of anonymous patient data in free healthcare centers in France.