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. 2025 Jul 8;9(13):3336-3339.
doi: 10.1182/bloodadvances.2024014570.

Gastrointestinal toxicity of gemtuzumab ozogamicin: real-life data from the AMLCG, SAL, and CELL study groups

Ricarda Knabe  1 , Philippe Muller  2   3 , Christoph Schliemann  4 , Maher Hanoun  2 , Julia Marie Unglaub  5 , Barbora Weinbergerová  6 , Jiří Mayer  6 , Carolin Krekeler  4 , Stefan W Krause  7 , Martin Kaufmann  8 , Sabrina Kraus  9 , Björn Steffen  10 , Franziska Modemann  11 , Marion Subklewe  1   12   13   14 , Veit Bücklein  1 , Wolfgang G Kunz  15 , Martina Rudelius  16 , Michael von Bergwelt-Baildon  1   12   14 , Katja Gutmair  17 , Eva Hoster  17 , Tobias Herold  1 , Christoph Röllig  18 , Karsten Spiekermann  1   12
Affiliations

Gastrointestinal toxicity of gemtuzumab ozogamicin: real-life data from the AMLCG, SAL, and CELL study groups

Ricarda Knabe et al. Blood Adv. .
No abstract available

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Conflict of interest statement

Conflict-of-interest disclosure: C.S. reports honoraria/advisory board fees from AbbVie, Astellas, AstraZeneca, Bristol Myers Squibb (BMS), Laboratoires Delbert, Jazz Pharmaceuticals, Novartis, Otsuka, Pfizer, and Roche; research support (institutional) from Jazz Pharmaceuticals; and travel grants from AbbVie, BMS, Jazz Pharmaceuticals, and Pfizer. J.M.U. reports travel support from AbbVie and Jazz Pharmaceuticals. J.M. reports research support from Novartis, BMS, Pfizer, and AbbVie. F.M. reports support for medical writing from Servier and Springer Verlag; research grants from Apis Technologies and Daiichi Sankyo; speaker honoraria from Servier, Jazz Pharmaceuticals, and AbbVie; advisory board fees from Otsuka Pharma and Servier. M.S. reports consulting, honoraria, and other financial relationships with Pfizer. V.B. reports consulting fees, honoraria, and other financial relationships with Pfizer. T.H. reports research funding from Roche; and advisory board fees from Servier and Jazz pharmaceuticals. C.R. reports honoraria/advisory board fees from AbbVie, Astellas, BMS, Daiichi Sankyo, Janssen, Jazz, Novartis, Otsuka, Pfizer, and Servier; and institutional research funding from AbbVie, Astellas, Novartis, and Pfizer. K.S. reports consulting fees, honoraria, and financing investigation support from Pfizer. The remaining authors declare no competing financial interests.

Figures

Figure 1.
Figure 1.
Nonhematological toxicity. (A) Bar plot of relative frequencies of nonhematological toxicity grade 3 to 4; enteritis/colitis (using Common Terminology Criteria for Adverse Events [CTCAE] V 3.0 criteria; P = .09 [2-sided Fisher exact test, α level, .05]); and relative frequencies of nonhematological grade 3 to 4 toxicity; other categories (using CTCAE V 5.0 criteria) of patients being treated with (red column) or without (blue column) an induction regimen including GO in the single-center analysis. (B) Bar plot of relative frequencies of grade 4 enteritis/colitis (using CTCAE V 5.0; P = .12 [2-sided Fisher exact test, α level, .05]); and relative frequencies of neutropenic enterocolitis (P = .13 [2-sided Fisher exact test, α level, .05]) of patients treated with GO (red column) or without GO (blue column) as part of the induction therapy in the single-center analysis. (C) Bar plot of relative frequencies of GI toxicity grade ≥3 (including diarrhea, nausea/vomiting, enteritis/colitis, and stomach pain using CTCAE V5; P = .03 [χ2 test]) and relative frequencies of GI toxicity grade 4 (P = .1 [Fisher exact test]) of patients treated with GO (red column) or without GO (blue column) as part of the induction therapy in the multicenter analysis. ALT, alanine aminotransferase; AST, aspartate aminotransferase; GI Tox., gastro intestinal toxicity; NEC, neutropenic enterocolitis.
Figure 2.
Figure 2.
CT imaging and histological examination of bowels affected by neutropenic enterocolitis. (A-B) Abdominal computed tomography (CT) imaging of patients (G2, left; G1, right) being treated with a GO-containing therapy regimen with grade 4 enteritis/colitis. Clinical and CT-based findings confirmed them to be cases of neutropenic enterocolits; red arrow indicates colonic wall thickening; yellow star, ascites and peritoneal contrast enhancement as a sign of peritoneal irritation. Immunohistochemistry was performed on 6-μm sections of formalin-fixed, paraffin-embedded tissue. After antigen retrieval, slides were incubated with antibodies against CD33 (PWS44; Leica) or cleaved caspase-3 (5A1E; 1:200; Cell Signaling Technology). The signal was visualized using the ImmPress anti-rabbit immunoglobulin G polymer kit (Vector Laboratories) according to the manufacturer's instructions. The total number of positive cells was quantified in 10 HPFs. H&E(hematoxylin and eosin) staining of colon (normal [C] and colitis [F]). CD33 stains stromal cells in normal (D) and inflamed colon (G), whereas no staining is observed in epithelial cells. Immunohistochemistry for cleaved caspase 3 (normal [E] and colitis [H]) highlights apoptotic epithelial cells (indicated by red arrow). Panels F-H are specimens of the ileocecal resection of a patient being treated with 3+7 + GO (G2).
See this image and copyright information in PMC

References

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