{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T22:44:47Z","timestamp":1777934687332,"version":"3.51.4"},"reference-count":16,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T00:00:00Z","timestamp":1745884800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Oncol Pharm Pract"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:p>Inotuzumab (InO) is an anti-CD22 immunoconjugate for patients with relapsed or refractory CD22 positive B-cell acute lymphoblastic leukemia (B-ALL). Liver toxicity is a recognized side effect of InO, including sinusoidal obstruction syndrome (SOS), but is not fully understood. This study describes a new aspect of InO-induced hepatotoxicity by outlining six patients who developed abnormal liver function tests (LFTs) and thrombocytopenia, with liver biopsies showing sinusoidal congestion without evidence of SOS. Liver biopsies were obtained from all six patients and LFTs were monitored before initiating InO treatment, during treatment, and after discontinuing treatment. All six patients experienced abnormal LFTs at a median of 15 days after the last dose of InO and improvement in LFTs at a median of 17 days after discontinuing InO. Initial baseline AST, ALT, ALP, and total bilirubin values prior to InO therapy ranged from 10\u201345\u2005U\/L, 10\u201345\u2005U\/L, 60\u2013207\u2005U\/L, and 0.2\u20130.9\u2005mg\/dL respectively and increased up to 2 to 4 times the upper limit of normal after completing varying cycles of InO with hepatotoxicity grades ranging from 1\u20132. LFTs returned to 1 to 1.5 times the upper limit of normal after discontinuing InO. The patients\u2019 liver biopsies all demonstrated different levels of hepatic sinusoidal congestion (HSC) without evidence of SOS. This study provides new evidence describing HSC, where we hypothesize that InO induced hepatotoxicity are due to calicheamicin. We propose a new clinical entity called \u201ccalicheamicin syndrome\u201d with its quadriad components: History of using InO or GO, elevated LFTs, thrombocytopenia, and abnormal liver imaging.<\/jats:p>","DOI":"10.1177\/10781552251332278","type":"journal-article","created":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T03:56:02Z","timestamp":1745898962000},"page":"656-669","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Hepatic sinusoidal congestion associated with inotuzumab therapy in patients with B-cell acute lymphoblastic leukemia, a proposal for a new clinical entity: Calicheamicin syndrome"],"prefix":"10.1177","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6461-5560","authenticated-orcid":false,"given":"Derek","family":"Tai","sequence":"first","affiliation":[{"name":"Loma Linda University Medical Center"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Medicine, University California San Francisco Fresno, Fresno, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-3466-426X","authenticated-orcid":false,"given":"Priscilla","family":"Soria","sequence":"additional","affiliation":[{"name":"Loma Linda University Medical Center"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-0331-892X","authenticated-orcid":false,"given":"Pranati","family":"Shah","sequence":"additional","affiliation":[{"name":"Loma Linda University Medical Center"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kendall","family":"Wick","sequence":"additional","affiliation":[{"name":"Department of Hematology\/Oncology, Loma Linda University Cancer Center, Loma Linda, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"So Young","family":"Son","sequence":"additional","affiliation":[{"name":"Loma Linda University"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Won Jin","family":"Jeon","sequence":"additional","affiliation":[{"name":"Department of Hematology\/Oncology, Loma Linda University Cancer Center, Loma Linda, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kum-Ja","family":"Lee","sequence":"additional","affiliation":[{"name":"University of Southern California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mojtaba","family":"Akhtari","sequence":"additional","affiliation":[{"name":"Division of Transplant, Cellular Therapy, and Hematologic Malignancies, Loma Linda University Cancer Center, Loma Linda, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,4,29]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1509277"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3026(17)30103-5"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-016-1190-4"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.5858\/2004-128-901-SDACIL"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.4254\/wjh.v10.i5.417"},{"key":"e_1_3_2_7_2","doi-asserted-by":"crossref","unstructured":"Furlan A Minervini MI Borhani AA et al. Hepatic sinusoidal dilatation: a review of causes with imaging-pathologic correlation. Semin Ultrasound CT MRI. 2016; 37: 525\u2013532. 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