In the Phase 3 ASCENT trial of patients with metastatic triple-negative breast cancer:
Adverse events of special interest in the ASCENT trial1,2
This is not an exhaustive list. For full details of adverse events, please refer to the Trodelvy Summary of Product Characteristics.
Adapted from Bardia, et al. 2021.1
*Patients may report more than 1 event per preferred term. Adverse events were classified according to the MedDRA systems of preferred terms and system organ class and according to severity by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.2
†Combined preferred terms of “neutropenia” and “decreased neutrophil count”. Due to overlapping reporting of events for these combined terms, all grades reported are not shown for the Trodelvy® arm: Grade 1: 19%; Grade 2: 37%; Grade ≥3: 51%.2
‡Combined preferred terms of “anaemia”, “decreased haemoglobin” and “decreased red-cell count”.2
§Combined preferred terms of “leukopenia” and “decreased white blood cell count”.2
Adverse events leading to discontinuation were infrequent in the ASCENT study
Of the 529 patients enrolled in ASCENT, 482 patients (Trodelvy®, n=258; single-agent chemotherapy, n=224) were included in the safety population (all patients who received ≥1 dose of study treatment).1
*Combined preferred terms of “neutropenia” and “decreased neutrophil count”.1
Most common adverse events reported in TNBC patients treated with Trodelvy3
Diarrhoea (64.5%), nausea (64.2%), neutropenia (64.2%), fatigue (52.5%), alopecia (44.3%), anaemia (43.4%), vomiting (38.5%), constipation (36.3%), decreased appetite (28.1%), cough 22.7% and abdominal pain (20.5%).
Most common serious adverse events in patients treated with Trodelvy3
Neutropenia (2.5%), febrile neutropenia (5.5%), diarrhoea (3.6%), pneumonia (2.7%).
The batch number of the administered Trodelvy doses should be recorded
Trodelvy® can cause severe or life-threatening neutropenia
Trodelvy® should not be administered if the absolute neutrophil count is below 1,500/mm3 on Day 1 of any cycle or below 1,000/mm3 on Day 8 of any cycle
Trodelvy® can cause severe and life-threatening hypersensitivity including anaphylaxis. It is contraindicated in patients with a known hypersensitivity to active drug, excipients or irinotecan
Pre-medication is recommended to prevent infusion reactions. Patients should be closely observed for such reactions during, and for at least 30 minutes after completion of each infusion. Slow down or interrupt infusions if reactions occur. Permanently discontinue Trodelvy in case of life-threatening infusion reactions.
Fatal adverse drug reactions have been reported in 0.5% of patients treated with Trodelvy
Trodelvy® can cause severe diarrhoea and can lead to dehydration and subsequent acute kidney damage. It should not be administered in case of Grade 3-4 diarrhoea at the time of scheduled treatment and treatment should be only continued when resolved to ≤Grade 1
At the onset of diarrhoea, and if no infectious cause can be identified, treatment with loperamide should be initiated with additional supportive measures as clinically indicated
Trodelvy® is emetogenic. Premedication is recommended
Trodelvy® should not be administered in case of Grade 3 nausea or Grade 3-4 vomiting at the time of scheduled treatment and should be only continued with additional supportive measures when resolved to ≤Grade 1
Individuals who are homozygous for UGT1A1*28 allele are potentially at increased risk of adverse reactions following initiation of Trodelvy® treatment
UGT1A1 inhibitors/inducers may increase/reduce systemic exposure to the active SN-38 metabolite after Trodelvy with potential increased toxicity/reduced exposure to SN-38
Breast-feeding should be discontinued during and for 1 month after the last dose of Trodelvy
Based on findings in animals, Trodelvy® may impair fertility in females of reproductive potential
Trodelvy® administration is not recommended during pregnancy. Based on its mechanism of action, Trodelvy® can cause teratogenicity and/or embryo-foetal lethality.
Inform female patients of the risk to the foetus and loss of the pregnancy and to immediately contact their doctor if they are pregnant or become pregnant.
Women of childbearing potential have to use effective contraception during treatment and for 6 months after the last dose.
Male patients with female partners of childbearing potential should have to use effective contraception during treatment with Trodelvy® and for 3 months after the last doseTrodelvy has not been studied in patients with moderate or severe hepatic or renal impairment. See SPC for prescribing restrictions
Always consult the Trodelvy SmPC before prescribing
Adverse events in patients receiving Trodelvy® can usually be managed with dose modifications and routine management strategies.
*Please refer to the Summary of Product Characteristics for a full summary of the safety profile for Trodelvy®, premedication, recommended dose modifications, and management strategies.
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March 2024 UK-TRO-0918
Adverse events should be reported
For the UK, reporting forms and information can be found at www.mhra.gov.uk/yellowcard or via the Yellow Card app (download from the Apple App Store or Google Play Store). Adverse events should also be reported to Gilead to [email protected] or +44 (0) 1223 897500.
