BackgroundRequirements of blood transfusions rise rapidly in China. Improving the efficiency of blood donation could help maintaining sufficient blood supplement. We conducted a pilot research to investigate the reliability and safety of collecting more units of red blood cell by apheresis.MethodsThirty‐two healthy male volunteers were randomized into two groups: red blood cell apheresis (RA) (n = 16) and whole blood (WB) donation (n = 16). RA group donated individualized RBC volumes by apheresis according to the volunteers' basal total blood volumes and haematocrit levels, WB group donated 400 mL whole blood. All volunteers were scheduled seven visit times in 8 weeks' study period. The cardiovascular functions were assessed by laboratory examinations, echocardiography and cardiopulmonary functional tests. All results were compared between groups at the same visit time and compared between visit 1(before donation) and other visit times within the same group.ResultsThe average donated RBC volume in RA group and in WB group was 627.25 ± 109.74 mL and 175.28 ± 8.85 mL, respectively(p < 0.05); the RBC, haemoglobin and haematocrit levels changed significantly between times and between groups (p < 0.05). Cardiac biomarker levels such as NT‐proBNP, hs‐TnT and CK‐MB did not change significantly between times or between groups (p > 0.05). The echocardiographic and cardiopulmonary results did not change significantly between times or between groups during the whole study period(p > 0.05).ConclusionsWe provided an efficient and secure method for RBC apheresis. By harvesting more RBC volumes at one single‐time, the cardiovascular functions did not change significantly compared with traditional whole blood donation.
Then, WBRT was implemented based on the patient's condition (NCT04083066).Results: Thirty patients were included. After two cycles, the objective response rate (ORR) was 96.4% (27/28, 26 PR, 1 CR, 0 SD, 0 PD, and 2 censored) and the disease control rate (DCR) was 96.4% (27/28). After four cycles, the ORR was 71.4% (15/21, 5 PR, 10 CR, 1 SD, 5 PD, 7 NR, and 2 censored) and the DCR was 76.2% (16/21). After WBRT, the ORR was 72.8% (8/11, 3 PR, 5 CR, 1 SD, and 2 PD) and the DCR was 81.8% (9/11). The median progression-free survival (PFS) was 20.3 months (95% CI: 5.2-35.4). The median overall survival (OS) was 22.0 months (95% CI: 16.1-27.9). The grade III-IV toxicities were mainly leukopenia (20.0%), thrombocytopenia (23.3%) and anaemia (10.0%).
Conclusion:Fotemustine-based therapy in combination with rituximab chemotherapy followed by WBRT can improve outcomes with PFS and OS benefits and has better tolerability for newly diagnosed PCNSL patients.
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