Initial US Approval
19981
Indications
For the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma (GEJ).1
Recommended Dose/Route
The recommended dosage of trastuzumab in metastatic HER2-overexpressing gastric cancer is an initial dose of 8 mg/kg over 90 minutes IV infusion, followed by 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks.1
Pivotal Study
ToGA (NCT01041404)2
Key Inclusion Criteria: Patients with previously untreated metastatic gastric or GEJ adenocarcinoma with overexpression of HER2 protein by IHC or gene amplification by FISH.1,2
Treatment
Patients were randomly assigned 1:1 to trastuzumab in combination with cisplatin and a fluoropyrimidine (FC+ H arm) or chemotherapy alone (FC arm).1
Safety
The most common any grade adverse events (AEs) reported in ≥20% of patients treated with trastuzumab plus chemotherapy were neutropenia (78%), diarrhea (37%), fatigue (35%), hypokalemia (28%), anemia (28%), stomatitis (24%), and decreased weight (23%).1
References
- TUKYSA (tucatinib). Prescribing information.Seagen, Inc; 2023. Accessed June 12, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213411s004lbl.pdf
- Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010;376(9742):687-697. doi:10.1016/S0140-6736(10)61121-X