PURPOSE: To evaluate the efficacy and safety of docetaxel/cisplatin chemotherapy followed by pelvic radiation therapy after staging surgery in patients with high-risk endometrial cancer. METHODS AND MATERIALS: In this open-label, single-arm, phase 2 trial conducted at 2 South Korean centers, we enrolled patients with histologically confirmed endometrial cancer who had undergone staging surgery. Inclusion criteria were based on International Federation of Gynecology and Obstetrics (FIGO) Staging 2009: stage I patients with ≥2 risk factors (grade 3, positive lymphovascular invasion, more than half of myometrium invasion)
stage IB and II patients with clear cell or serous adenocarcinoma
stage II patients post-type 1 hysterectomy
and patients at stage III. Patients underwent 3 cycles of chemotherapy with docetaxel (70 mg/m RESULTS: A total of 62 patients were included in this study and were followed for a median duration of 65 months (IQR, 48-86 months). The progression-free survival rates at 1, 3, and 5 years were 98.4%, 86.9%, and 79.1%, respectively. The overall survival rates at 1, 3, and 5 years were 98.4%, 96.4%, and 96.4%, respectively. After chemotherapy, 62.9% of patients experienced severe neutropenia, with 3.2% having grade 3 or 4 anemia. Common mild side effects included nausea (58.1%) and alopecia (38.7%). Postradiation, 16.7% experienced grade 3 neutropenia, and a few had grade 1 or 2 anemia (3.3%), with most other side effects being mild and no critical toxicities reported. CONCLUSIONS: Patients with endometrial cancer with high-risk factors could benefit from adjuvant chemotherapy using docetaxel/cisplatin, followed by radiation therapy, with manageable toxicities.