Early Access Program Results From Turkey and a Literature Review on Daratumumab Monotherapy Among Heavily Pretreated Patients With Relapsed/Refractory Myeloma.

BACKGROUND: In countries where frontline drug approval is limited to first-generation proteasome inhibitors or immunomodulatory drugs, relapses have been both more frequent and less durable. We investigated real world data on the efficacy and safety of daratumumab monotherapy among patients with relapsed refractory multiple myeloma (RRMM) from Turkey using a prospective early access program. PATIENTS AND METHODS: A total of 42 patients with RRMM after a minimum of 3 previous lines of proteasome inhibitor/immunomodulatory drug-based treatments were included from 25 centers across Turkey. Daratumumab monotherapy was administered intravenously at a dose of 16 mg/kg weekly (cycles 1-2), on alternate weeks (cycles 3-6), and monthly thereafter. RESULTS: The median daratumumab monotherapy duration was 5.5 months (range, 0.2-28.7 months). The overall response rate was 45.2%, including 14 (33.3%) partial responses, 4 (9.5%) very good partial responses, and 1 (2.4%) complete response. The median duration of response was 4.9 months. The median progression-free survival (PFS) was 5.5 (95% confidence interval, 2.6-8.4 months) with 12- and 18-month PFS rates of 35.7% and 31.0%, respectively. The median overall survival was not reached; the 12- and 18-month overall survival rates were 64.3% and 59.5%, respectively. The depth of response had a significant effect on PFS (log-rank test, P = .026). Overall, of the 76 adverse events reported, 33 (43.4%) were grade ≥ 3; only 4 (9.52%) were grade 3 infusion-related reactions. No infusion-related reactions or adverse events led to treatment discontinuation. CONCLUSION: The present findings from our daratumumab early access program have confirmed the efficacy and safety profile of daratumumab monotherapy in heavily pretreated Turkish patients with RRMM.

Effects of one year simvastatin and atorvastatin treatments on acute phase reactants in uncontrolled type 2 diabetic patients.

Type 2 diabetes mellitus is the leading cause of macrovascular diseases and related death. Additionally, diabetes mellitus is frequently complicated by other cardiovascular risk factors, such as hypercholesterolemia, hypertension, obesity, hypercoagulability, and inflammation. We wanted to evaluate and compare the effects of treating with a one-year course of atorvastatin or simvastatin on inflammatory markers such as high sensitive C-reactive protein (hsCRP), fibrinogen, and ferritin in uncontrolled type 2 diabetic patients. Also, we planned to investigate the correlation between inflammatory markers and metabolic parameters. Fifty type 2 diabetic patients (30 women, 20 men; mean age: 49.9 +/- 8.5 years) were enrolled into the study. Twenty healthy subjects, matched on body mass index and age, were also included in the study as a control group. Diabetic patients were divided into two groups and received simvastatin or atorvastatin (Group S and A, respectively). After 1 year of statin treatment (Group A), there were significant decreases in total cholesterol (217.3 +/- 46.5-173.8 +/- 37.2 mg/dl; P < 0.0001), LDL-cholesterol (146.7 +/- 50.3-102.3 +/- 31.1 mg/dl, P < 0.0001), hsCRP (0.88 +/- 0.62-0.35 +/- 0.18 mg/dl, P < 0.0001), fibrinogen (258.2 +/- 16.9-215.5 +/- 10.6 mg/l; P < 0.0001), and ferritin (118.2 +/- 73.9-81.2 +/- 72.5 ng/ml, P < 0.0001) levels compared to basal values. In the S group, there were significant decreases in total cholesterol (224.4 +/- 61.2-175.0 +/- 47.8 mg/dl; P < 0.0001), LDL-cholesterol (140.9 +/- 56.7-110.9 +/- 42.2 mg/dl, P < 0.0001), hsCRP (0.98 +/- 1.3-0.46 +/- 0.25 mg/dl, P < 0.0001), fibrinogen (265.7 +/- 26.8-222.1 +/- 20.6 mg/l; P < 0.0001), and ferritin (136.7 +/- 101.1-85.6 +/- 32.1 ng/ml, P < 0.0001) levels compared to basal values. At the end of the study, hsCRP, fibrinogen, and ferritin levels were correlated with LDL (r = 0.42; P = 0.005, with hsCRP), (r = 0.40; P = 0.008, with fibrinogen), (r = 0.46; P = 0.002, with ferritin) and HDL (r = -0.50; P < 0.0001, with hsCRP), (r = -0.32; p = 0.042, with fibrinogen), (r = -0.48; P < 0.0001, with ferritin) cholesterol levels. Atorvastatin and simvastatin treatments were found to be effective for the control of hypercholesterolemia and resulted in a significant decrease in acute phase reactants in uncontrolled type 2 diabetic patients.

Polycythemia Vera Presenting with Fulminant Hepatic Failure Due to Acute Budd-Chiari Syndrome: Case Report.

We describe a 38 year-old woman with polycythemia vera who presented with fulminant hepatic failure due to acute Budd-Chiari syndrome. She had a history of abdominal pain and distention for 4 days. Laboratory and clinical findings showed fulminant hepatic failure due to acute Budd-Chiari syndrome. Diagnosis was confirmed with abdominal ultrasonography and doppler ultrasonography showing ascites, hepatomegaly, portal hypertension and total occlusion of hepatic veins. Complete blood count and other clinical findings were compatible with polycythemia vera. The patient was successfully treated with urgent administration of continuous heparin infusion, repeated phlebotomies and hydroxyurea. We emphasize that early diagnosis and effective treatment in such fulminant cases can be life saving.