Chemotherapy of Childhood Acute Lymphoblastic Leukemia

Bell, Beverly; Whitehead, V. Michael

doi:10.1159/000457088

Cited by 6 publications

(5 citation statements)

References 51 publications

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“…Use of intracranial tumor models in secondary testing (i.e., orthotopic implantation) would be required for any agent demonstrating significant activity against brain tumors in the initial Stage 1 testing. Consistent with clinical data 29–31, cyclophosphamide‐induced CRs or maintained CRs in each of seven ALL models.…”

Section: Discussionsupporting

confidence: 79%

The pediatric preclinical testing program: Description of models and early testing results

Houghton

Morton

Tucker

et al. 2006

Pediatric Blood & Cancer

448

550

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Section: Discussionsupporting

confidence: 79%

The pediatric preclinical testing program: Description of models and early testing results

Houghton

Morton

Tucker

et al. 2006

Pediatric Blood & Cancer

448

550

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“…L-ASP is a tetramer of four identical subunits (321 amino acids each) held together by non-covalent forces. 22) Since L-ASP is derived from bacteria, it has the potential to be immunogenic. Hypersensitivity reactions to L-ASP occur in up 30% of patients, and are frequently associated with the development of neutralizing antibodies.…”

mentioning

confidence: 99%

Reconstitution of L-Asparaginase in Siliconized Syringes with Shaking and Headspace Air Induces Protein Aggregation

Uchino

Miyazaki

Ohkawa

et al. 2015

CHEMICAL & PHARMACEUTICAL BULLETIN

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The aim of this study was to characterize protein aggregation during reconstitution of a highly concentrated solution of lyophilized L-asparaginase (L-ASP). The effect of the preparation method on L-ASP aggregation using siliconized or non-siliconized syringes and the effect of storage after preparation were evaluated by far-UV circular dichroism spectroscopy, Raman microscopy, flow cytometry, and flow particle image analysis. To investigate the effect of syringe type in combination with shaking and headspace air on L-ASP aggregation, four kinds of L-ASP in 5% glucose solutions were prepared (in the presence or absence of silicon oil and headspace air). Slight differences in L-ASP secondary structure were observed between the siliconized and non-siliconized syringe systems before shaking. Large numbers of sub-visible (0.1-100 µm) and submicron (0.1-1 µm) particles were formed by preparation with siliconized syringes and the combination of shaking and headspace air. The number of aggregated particles was not decreased with increased storage time. The Raman microscopy, flow cytometry and flow particle image results suggested that L-ASP interacted with silicone oil, which induced aggregation. Nevertheless, sub-visible and submicron particles were also formed with non-siliconized syringes. However, using non-siliconized syringes, the number of aggregated particles decreased with storage. No changes in particle character were observed before or after shaking with headspace air in non-siliconized syringes, indicating that soluble aggregates formed and dissolved with storage. Silicone oil in syringes, in combination with shaking and headspace air, strongly affected the aggregation of lyophilized L-ASP formulations during preparation.Key words protein aggregation; silicone oil; L-asparaginase (L-ASP); sub-visible particle; flow cytometry; Raman microscopy Various therapeutic proteins have been commercialized owing to recent advances in biotechnology and formulation. These therapeutic proteins are used for the treatment of numerous diseases including cancer, autoimmune diseases, and diabetes mellitus. However, it has been reported that protein aggregates in these products have caused side effects, immunogenicity, and allergic reactions.1-3) Substantial effort has been expended to develop stable formulations to prevent these events. These stable formulations are necessary for safe and effective pharmaceutical therapies.There has been great interest in the external stress affecting protein stability during production, filling, shipment, storage, and final administration. [4][5][6] These external stressors include temperature changes, lyophilization, rehydration, oxidation, and light exposure. [5][6][7] Interactions between proteins and foreign materials, such as rubber, metal particles, and administration devices, can also occur. [8][9][10][11][12] For injectable formulations, syringes (glass or polypropylene) and needles are used for reconstitution and administration. In these devices, silicone oil is used as a lubricant ...

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“…The incidence of toxic complications during the use of chemotherapy is a well-known symptom that oncologists encounter when using cytostatic agents during the course of cancer treatment [ 22 ].…”

Section: Discussionmentioning

confidence: 99%

Assessment of Cytological Changes in the Oral Mucosa in Young Hematological Patients Treated with Systemic Chemotherapy

Fiwek

Irga‐Jaworska

Wojtylak

et al. 2023

JCM

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Background and Objectives: The primary objective of the undertaken study was to determine the morphological changes that occur within the oral epithelium in children undergoing chemotherapy following a diagnosis of hematological malignancies. Materials and Methods: The study group consisted of 18 patients diagnosed with leukemia or lymphoma undergoing treatment with chemotherapy. Swabs (liquid-based cytology) were collected from the oral cavity for microscopic evaluation at baseline, during the chemotherapy cycle with oral mucositis symptoms present, and upon completion of the cycle. Both the neutrophil count and oral mucositis (OM) were registered using the WHO (World Health Organization) scale. The control group included 41 children who were generally healthy. All samples underwent microscopical analyses at the Department of Pathology, Medical University of Gdansk, Poland. Results: A total of 190 cytological preparations were evaluated. The baseline preparations revealed similar cytological images, and the superficial cells of the epithelial layers were seen. A significant (p < 0.01) increase in the number of cells in the intermediate layer of the oral epithelium, as well as a decrease (p < 0.01) in the volume of cells in the superficial layers, was observed in further stages of cytostatic treatment. Conclusions: A decrease in the percentage of superficial epithelial cells with a corresponding increase in the number of intermediate epithelial cells is considered to be a result of toxic damage to the oral mucosa during chemotherapy.

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Chemotherapy of Childhood Acute Lymphoblastic Leukemia

Cited by 6 publications

References 51 publications

The pediatric preclinical testing program: Description of models and early testing results

The pediatric preclinical testing program: Description of models and early testing results

Reconstitution of L-Asparaginase in Siliconized Syringes with Shaking and Headspace Air Induces Protein Aggregation

Assessment of Cytological Changes in the Oral Mucosa in Young Hematological Patients Treated with Systemic Chemotherapy

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