The following is a summary of “Trastuzumab Deruxtecan for Human Epidermal Growth Factor Receptor 2–Expressing Advanced or Recurrent Uterine Carcinosarcoma (NCCH1615): The STATICE Trial,” published in the May 2023 issue of Oncology by Nishikawa, et al.
For a study, researchers sought to investigate the effectiveness and safety of trastuzumab deruxtecan, an antibody-drug conjugate that targets human epidermal growth factor receptor 2 (HER2), in patients with uterine carcinosarcoma (UCS) who express HER2.
The study included patients with recurrent UCS who had previously received chemotherapy and had HER2 immunohistochemistry scores ≥1+. The patients were categorized into the HER2-high group (immunohistochemistry score ≥2+; n = 22) and the HER2-low group (immunohistochemistry score of 1+; n = 10) for primary and exploratory analyses, respectively. Trastuzumab deruxtecan was administered intravenously every 3 weeks at doses of 6.4 or 5.4 mg/kg until unacceptable toxicity or disease progression. Dose modifications were made based on the recommended phase II dose for breast cancer (5.4 mg/kg). The primary endpoint was the objective response rate in the HER2-high group as assessed by central review. Secondary endpoints included overall response rate, progression-free survival, overall survival, and safety.
The objective response rate in the HER2-high group as assessed by the central review was 54.5% (95% CI, 32.2 to 75.6), and in the HER2-low group, it was 70.0% (95% CI, 34.8 to 93.3). The objective response rates as assessed by the investigator assessment were 68.2% and 60.0% in the HER2-high and HER2-low groups, respectively. The median progression-free survival was 6.2 months in the HER2-high group and 13.3 months in the HER2-low group. The median overall survival was 6.7 months in the HER2-high group and not reached in the HER2-low group. Grade ≥3 adverse events were observed in 61% of patients. Pneumonitis/interstitial lung disease of grades 1-2 occurred in 24% of patients, while grade 3 events occurred in 3% of patients.
Trastuzumab deruxtecan demonstrated efficacy in patients with UCS, regardless of their HER2 status. The safety profile was consistent with previous reports, and toxicities were manageable with appropriate monitoring and treatment.