Background: Infusion of peripheral blood stem cell (PBSC) in patients undergoing autologous transplantation (ASCT) has been conventionally performed using central venous catheters (CVC) inserted through the subclavian or internal jugular vein. Peripheral inserted central catheters (PICC) are routinely used for infusion of blood products and medication, but its use for PBSC infusion has not been well established. Our study aimed to evaluate the feasibility and safety of using PICC to deliver PBSC for ASCT through an in-vitro lab-based validation process, followed by a clinical review. Methods: Lab based validation In vitro infusion of 6 cryopreserved PBSCs was performed, 3 infused PICC whist 3 via CVC. Each product was thawed for the same amount of time and drained by gravity. Pre-infusion and post-infusion total nucleated cell counts (TNC), CD34 counts and CD34 viability of the PBSCs were analysed by flow-cytometry and compared using paired T test. In vitro infusion rates were also compared between PICC and CVC groups. Clinical Outcome Analysis The clinical study included 31 patients (Lymphoma N=21, myeloma N=5, Others, N=4) who underwent ASCT at National University Cancer Institute, Singapore (NCIS) from September 2019 to July 2021. All patients had a 19G BARDS dual lumen PICC inserted in either the brachial or basilic veins and used for PBSC infusion. The PBSC infusion rate, infusion associated complications, time to absolute neutrophil count (ANC) >1, and platelet count engraftment >100K were analysed. Clinical outcomes in the lymphoma cohort, who received BEAM conditioning (N=17) were also compared with a control group, matched for conditioning, cell dose and age, who had PBSC infused via CVC. Results: In vitro findings: Overall flow rates for infusion through PICC was slower (mean 0.1mls/s vs 0.3mls/s, p < 0.05). However, there were no significant % differences in TNC counts (5% vs 9%, p=0.4), CD34 counts (17% vs 15%, p=0.9) and viability (4% vs 7%, p=0.2) between pre and post infusion samples for PICC and CVC.. Clinical findings: 30 patients (Lymphoma N=21, myeloma N=5, N=4) were included. 15 (50% of patients) had a for ASCT while 15 (50%) had an existing PICC. For patients with an existing PICC, the median duration of catheter in situ was 86 days. New lines were inserted 2-7 days prior to the PBSC infusion. The median age of the patients was 54 (20-71) with 19 males (63%). . There were 5 infusion related complications, 2 in an existing PICC and 3 in new PICCs. 4 were related to slow flow rate and 1 was related to sediments seen in the line. None led to a need for alternative line for infusion. The median time to ANC recovery was 10 (range 9-14), 10 (range 9-11) and 11 days (range 10-12), while the median time to platelet engraftment was 18 (range 10-195), 20 (range 15-55) and 22 (16-85 days) for the lymphoma BEAM conditioning (N=17), lymphoma Carmustine/ Thiotepa conditioning (N=4), and the myeloma (N=5) cohorts respectively. Clinical outcomes in the lymphoma cohort, who also compared with a control group matched for conditioning, cell dose and conditioning. The in-vivo infusion rate was slower in the PICC group, compared to the CVC group (3.1 mls/min vs 4.5mls/min, p<0.05).There was however no differences in engraftment with median time to ANC recovery 10 days (range 9-14) vs 11 days (range 9-13) (p>0.05) and median time to platelet engraftment 18 (range 14-195) vs 19 days (range 14 -57) (p>0.05) in the PICC vs CVC groups respectively. Conclusion: Our in-vitro and clinical findings confirmed that the use of PICC for PBSC infusion is safe and efficacious and reduces the need for CVC insertion. Our findings have led to change in clinical practice with utilization of PICCs for PBSC infusions for ASCT. Disclosures No relevant conflicts of interest to declare.
Introduction: In acute lymphoblastic leukemia (ALL) adolescents and young adults (AYA), there are benefits when using pediatric over adult treatment regimes. There is improved overall survival (OS), progression free survival (PFS) and reduced need for hematopoietic stem cell transplantation; all while having an acceptable toxicity profile. Yet, studies supporting this were largely performed in a western population (e.g., United Kingdom and United States) and thus may have had limited representation of the Asian population. Whether these results are generalizable and applicable to an Asian population is in question. MASPORE, a locally designed pediatric regiment based on BFM regimen, which has been used successfully in Singapore and Malaysia's AYA cohort since 2007. MASPORE protocol utilized PCR-based minimal residual disease (MRD) marker to risk stratify patients according to disease severity and used a 3- or 4-drug induction regimen depending on intermediate or high-risk stratification (L-asparaginase, Vincristine, Dexamethasone +/- daunorubicin). In contrast HyperCVAD does not use MRD to stratify or guide management. In this retrospective study performed in Singapore, we aim to demonstrate that MASPORE is an effective treatment option for AYA ALL in Asian population. Methods: Patient registries (IRB approved) spanning from January 2005 to June 2021 from three tertiary hospitals in Singapore were reviewed. ALL patients who were AYA, defined as less than 40 years of age, treated during this time were included and analyzed. Patients were treated with either the pediatric protocol MASPORE or with the adult protocol HyperCVAD. Patients who are Philadelphia positive were excluded from the MASPORE arm up to 2020. Patients' demographics, functional status, risk profile, adverse events, as well as the hematological response and transplant status were collected and analyzed with Pearson chi-square test. Kaplan Meier curve analysis were performed for OS and PFS with SPSS software. Results: In this retrospective study, 116 patients were analyzed. Among these patients 29 (25%) received MASPORE and 87 (75%) received HyperCVAD. The median age was 23 (range 18-40) for MASPORE arm vs 28 years (range 15-40) for the HCVAD arm. median follow-up time was 4.5 vs 10.8 years. Both groups were similar in gender, race, ECOG status, and ALL risk status at diagnosis. Likewise, both arms did not have differences in starting hematological parameters: hemoglobin, total white blood cell count, platelet count, absolute neutrophil count, and bone marrow blast percentages. Median time from diagnosis to treatment was 3 and 4 days for MASPORE and HyperCVAD arms respectively. There were increased adverse rates for patients in the MASPORE arm. They had more (13.8 vs 0.0%, p < 0.001) of which 75% of the pancreatitis were CTCAE grade 3/4, avascular necrosis (13.8 vs 2.2%, p = 0.016), cerebral venous thrombosis (13.8 vs 1.1%, p = 0.004) and other thrombosis (27.6 vs 5.7%, p = 0.004). For the MASPORE and HyperCVAD arms there was one induction death, one from sepsis and the other from pneumonia . Both arms managed to achieve complete response (CR) with equivalent rates (82.5 vs 80.5%, p = 0.752). However, there was less relapsed or refractory disease in those treated with MASPORE (10.3 vs 44.8%, p < 0.001). The 5- OS was better in the MASPORE versus the HyperCVAD arm (4.4 vs 3.7 years; p = 0.049). Likewise, the 5-year PFS was superior in the MASPORE arm (4.2 vs 3.2 years, p = 0.034). Furthermore, a smaller proportion of patients required consolidative stem cell transplant (13.8 vs 49.4%, p < 0.001). Conclusion: The pediatric-inspired protocol MASPORE achieved similar CR rates with OS and PFS benefit, reduced relapse rates, and less need for consolidative stem cell transplant. MASPORE serves as a viable treatment option when treating AYA patients with ALL. Larger prospective studies are needed to further explore its use. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.