{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,4]],"date-time":"2025-11-04T11:02:24Z","timestamp":1762254144315,"version":"3.41.2"},"reference-count":21,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2022,5,13]],"date-time":"2022-05-13T00:00:00Z","timestamp":1652400000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Blood &amp; Cancer"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p><jats:sc>l<\/jats:sc>\u2010Asparaginase (ASP) plays a crucial role in the treatment of childhood acute lymphoblastic leukemia (ALL). Currently, different ASP products are available in the market, including both native and pegylated drugs. Several biogeneric <jats:italic>Escherichia coli<\/jats:italic> ASP (GEN\u2010ASP) products have been developed in response to shortages and expensiveness of the native <jats:italic>E. coli<\/jats:italic> ASP innovator compounds, but some concerns have been raised about their quality. Recently, a number of generic pegylated ASP products (GEN\u2010PEG\u2010ASP) have been marketed to substitute for the innovator product (PEG\u2010ASP).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Clinical courses and serum asparaginase activity (SAA) levels were monitored in 12 children with ALL, who were treated in our institution with two doses of a GEN\u2010PEG\u2010ASP product, given IV at 2500\u00a0IU\/m<jats:sup>2<\/jats:sup> during the remission induction phase. Results were compared with those obtained in a reference cohort of 35 patients treated in our institution, who received the innovator PEG\u2010ASP product at same dosage and within the same chemotherapy background.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Compared to the reference cohort treated with PEG\u2010ASP, SAA levels were significantly lower in the 12 patients receiving GEN\u2010PEG\u2010ASP (<jats:italic>p<\/jats:italic>\u00a0&lt;\u00a0.0001); a higher proportion of ASP\u2010associated hypersensitivity reactions (2\/12 vs. 0\/35; <jats:italic>p<\/jats:italic>\u00a0=\u00a0.061) and silent inactivation (3\/12 vs. 0\/35; <jats:italic>p<\/jats:italic>\u00a0=\u00a0.014) were observed in comparison with the reference cohort.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our results highlighted different pharmacological profiles and different rates of hypersensitivity reactions and silent inactivation in the GEN\u2010PEG\u2010ASP cohort compared to those treated with the innovator product. Our findings suggest that a rigorous clinical attention and a thorough pharmacological monitoring are advisable in patients treated with GEN\u2010PEG\u2010ASP products.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pbc.29753","type":"journal-article","created":{"date-parts":[[2022,5,13]],"date-time":"2022-05-13T11:25:17Z","timestamp":1652441117000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Pharmacological and clinical monitoring in children with acute lymphoblastic leukemia treated with a biogeneric PEG\u2010<scp>l<\/scp>\u2010asparaginase product"],"prefix":"10.1002","volume":"69","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8910-1104","authenticated-orcid":false,"given":"Cristina","family":"Matteo","sequence":"first","affiliation":[{"name":"Laboratory of Cancer Pharmacology, Oncology Department Istituto di Ricerche Farmacologiche Mario Negri IRCCS  Milan 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Ematologia Pediatrica Fondazione MBBM, Universit\u00e0 di Milano\u2010Bicocca  Monza Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fabiola","family":"Dell'Acqua","sequence":"additional","affiliation":[{"name":"Unit\u00e0 di Ematologia Pediatrica Fondazione MBBM, Universit\u00e0 di Milano\u2010Bicocca  Monza Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5024-7894","authenticated-orcid":false,"given":"Giacomo","family":"Gotti","sequence":"additional","affiliation":[{"name":"Unit\u00e0 di Ematologia Pediatrica Fondazione MBBM, Universit\u00e0 di Milano\u2010Bicocca  Monza Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudia","family":"Nastasi","sequence":"additional","affiliation":[{"name":"Laboratory of Cancer Pharmacology, Oncology Department Istituto di Ricerche Farmacologiche Mario Negri IRCCS  Milan 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