Corrigendum to "Breaking barriers in triple negative breast cancer (TNBC) - Unleashing the power of antibody-drug conjugates (ADCs)" [Cancer Treatment Reviews 123 (2024) 102672]

The authors regret that the indications concerning the management of sacituzumab govitecan (SG) adverse events (AEs) outlined in the text (paragraph “Safety and adverse events management”) and in the original Fig. 1 are referred to the Food and Drug Administration (FDA) data sheet [https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761115s035lbl.pdf, while the reference related to the European Medicines Agency (EMA) data sheet was cited by mistake]. However, the recommendations for SG AEs management are slightly different between FDA and EMA data sheets. A more precise report is given below, along with two updated figures showing the respective correct indications According to FDA, 25% dose reduction is indicated after the first occurrence of severe neutropenic toxicity, which is defined as: grade 4 (G4) neutropenia lasting ≥ 7 days, grade 3 (G3) or G4 febrile neutropenia, and G3 or G4 neutropenia requiring a dose delay by 2 or 3 weeks for recovery to ≤ grade 1 (G1). The administration of granulocyte-colony stimulating factors (G-CSF) is advisable in these situations.1 Similarly, a 25% dose reduction is also indicated after the first occurrence of severe non-neutropenic AEs which are defined as: G4 non-hematologic toxicity regardless of duration; G3 or G4 nausea, emesis or diarrhea that are not resolved by using symptomatic agents; G3 or G4 non-hematologic toxicity persisting > 48 h notwithstanding an appropriated medical management; G3 or G4 non-neutropenic hematologic and non-hematologic AEs at the time of planned treatment which delay subsequent administration by 2 or 3 weeks for recovery to ≤ G1. In case of second occurrence of the above-mentioned severe AEs (both neutropenic and non-neutropenic) despite 25% dose reduction, then 50 % dose reduction is recommended. Treatment discontinuation is deemed necessary if the above listed severe AEs present for a third time despite dose modifications, and at first occurrence of G3 or G4 (both hematologic and non-hematologic) AEs at time of planned treatment requiring more than 3 weeks for recovery to ≤ G1.1 [Fig. 1a] Instead, the European Medicines Agency (EMA) data sheet defines the following recommendations [https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdf]. A dose reduction is not deemed necessary at first occurrence of severe neutropenic toxicities as previously defined, and the administration of G-CSF is advisable as per clinical practice. At time of second and third occurrence of severe neutropenic AEs, respectively 25% and 50% dose reductions are indicated. Treatment discontinuation is recommended at fourth occurrence of severe neutropenic AEs and at the first occurrence of G3 or G4 neutropenia at time of planned treatment requiring dose delay more than 3 weeks for recovery to ≤ G1.2 Concerning severe non-neutropenic AEs as previously defined, 25% dose reduction is indicated at first occurrence and 50% dose reduction is required at time of second occurrence, despite the previous dose modification. Treatment discontinuation is recommended in case of third occurrence of the above listed severe non-neutropenic AEs and in case of first occurrence of the following situations: G3 or G4 non-neutropenic hematologic or non-hematologic toxicity, G3 nausea, and G3 or G4 vomiting all requiring more than 3 weeks for recovery to ≤ G1.2 [Fig. 1b][Formula presented] Fig. 1a. Sacituzumab govitecan clinical practice notes: indications, prescribing information and adverse events management (according to Food and Drug Administration data sheet). AEs: adverse events; FDA: Food and Drug Administration; G1: grade 1; G3: grade 3; G4: grade 4; G-CSF: granulocyte colony stimulating factor; IV: intravenous; TNBC: triple negative breast cancer; UGT1A1: uridine diphosphate-glucuronosyl transferase 1A1.[Formula presented] Fig. 1b. Sacituzumab govitecan clinical practice notes: indications, prescribing information and adverse events management (according to European Medicines Agency data sheet). AEs: adverse events; EMA: European Medicines Agency; G1: grade 1; G3: grade 3; G4: grade 4; G-CSF: granulocyte colony stimulating factor; IV: intravenous; TNBC: triple negative breast cancer; UGT1A1: uridine diphosphate-glucuronosyl transferase 1A1. References 1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761115s035lbl.pdf2. https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdfThe authors would like to apologise for any inconvenience caused.