Docetaxel/Cisplatin Chemotherapy Followed by Pelvic Radiation Therapy in Patients With High-risk Endometrial Cancer After Staging Surgery: A Phase 2 Study.

Abstract

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/m²) and cisplatin (60 mg/m²) followed by pelvic radiation therapy ranging from 45 to 50.4 Gy. Disease status and adverse events were evaluated using RECIST 1.1 and Common Terminology Criteria for Adverse Events 4.0, respectively, with scheduled imaging and assessments throughout the study.

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.