Efficacy and Safety Profile of Biosimilar Polyethylene Glycol (PEG)-Asparaginase (Asviia) in Patients With Acute Leukemia: A Retrospective Study From Kashmir.
| Autor: | R Guru F; Department of Medical Oncology, Sher-i-Kashmir Institute of Medical Sciences, Soura, IND., Akhter R; Department of Pathology, Sher-i-Kashmir Institute of Medical Sciences, Soura, IND., Bashir S; Department of Chest Medicine, Government Medical College (GMC) Baramulla, Baramulla, IND., Nisar SA; Department of Medical Oncology, Sher-i-Kashmir Institute of Medical Sciences, Soura, IND., Mir MH; Department Of Medical Oncology, Sher-i-Kashmir Institute of Medical Sciences, Soura, IND., Zahir Z; Department of Pathology, Sher-i-Kashmir Institute of Medical Sciences, Soura, IND., Ara Wani U; Department of Medical Oncology, Sher-i-Kashmir Institute of Medical Sciences, Soura, IND., Bharat S; Medical Affairs, Zydus Lifesciences LTD, Ahmedabad, IND., Tripathi R; Medical Affairs, Zydus Lifesciences LTD, Ahmedabad, IND. |
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| Jazyk: | angličtina |
| Zdroj: | Cureus [Cureus] 2024 Nov 15; Vol. 16 (11), pp. e73727. Date of Electronic Publication: 2024 Nov 15 (Print Publication: 2024). |
| DOI: | 10.7759/cureus.73727 |
| Abstrakt: | Background: Biosimilar pegylated L-asparaginase offers a promising alternative to the innovator molecule for treating acute lymphoblastic leukemia (ALL) in Indian children. It addresses challenges associated with drug availability and cost while providing similar therapeutic advantages. This biosimilar ensures wider access to essential treatment in resource-limited settings such as India. Materials and Methods: A retrospective study was conducted at the Pediatric Oncology unit of the Department of Medical Oncology, Sher-I-Kashmir Institute of Medical Sciences (SKIMS) Srinagar. The study evaluated the efficacy and safety of biosimilar polyethylene glycol-asparaginase (PEG-ASP) (Asviia) in newly diagnosed pediatric ALL patients treated between January 2021 and December 2023. Each patient received two induction doses of PEG-ASP. Results: The study included 45 patients (29 boys, 16 girls) with a median age of 7.5 years (range: 1-16 years), with most patients diagnosed with Pre-B ALL. The median PEG-ASP dose administered intravenously was 1175 IU (range: 1125-3750 IU). Significant improvements in hemoglobin and platelet counts were observed following the first dose of PEG-ASP. The biosimilar PEG-ASP was well tolerated, with no life-threatening events reported. At the end of the induction phase, 40 patients (88.89%) achieved complete remission with minimal residual disease (MRD) negativity, while five patients had MRD positivity. Conclusion: The study provides valuable insights into the efficacy and safety of biosimilar PEG-ASP for pediatric ALL in resource-limited settings, with strong data on remission rates and minimal adverse events. Competing Interests: Human subjects: Consent for treatment and open access publication was obtained or waived by all participants in this study. Institutional Ethics Committee - Sher-i-Kashmir Institute of Medical Sciences, Srinagar issued approval 227/2024. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work. (Copyright © 2024, R Guru et al.) |
| Databáze: | MEDLINE |
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