Kang Ok-Ju, Cho Yoon-Jung, Lim Myong Cheol, Lee Yeon Jee, Seo Sang Soo, Kang Sokbom, Park Sang-Yoon, Kim Young Seok, Nam Joo-Hyun, Park Jeong-Yeol
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
Center for Gynecologic Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.
Int J Radiat Oncol Biol Phys. 2025 Apr 1;121(5):1229-1236. doi: 10.1016/j.ijrobp.2024.11.071. Epub 2024 Nov 16.
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.
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) and cisplatin (60 mg/m) 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.
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.
Patients with endometrial cancer with high-risk factors could benefit from adjuvant chemotherapy using docetaxel/cisplatin, followed by radiation therapy, with manageable toxicities.
评估多西他赛/顺铂化疗后行盆腔放疗在高危子宫内膜癌患者分期手术后的疗效和安全性。
在韩国2个中心进行的这项开放标签、单臂、2期试验中，我们纳入了经组织学确诊且已接受分期手术的子宫内膜癌患者。纳入标准基于国际妇产科联盟（FIGO）2009年分期：I期患者有≥2个危险因素（3级、淋巴管浸润阳性、肌层浸润超过一半）；IB期和II期透明细胞或浆液性腺癌患者；II期1型子宫切除术后患者；以及III期患者。患者接受3个周期的多西他赛（70mg/m²）和顺铂（60mg/m²）化疗，随后进行45至50.4Gy的盆腔放疗。在整个研究过程中，分别使用RECIST 1.1和不良事件通用术语标准4.0评估疾病状态和不良事件，并进行定期成像和评估。
本研究共纳入62例患者，中位随访时间为65个月（四分位间距，48 - 86个月）。1年时无进展生存率为98.4%，3年时为86.9%，5年时为79.1%。1年时总生存率为98.4%，3年时为96.4%，5年时为96.4%。化疗后，62.9%的患者出现严重中性粒细胞减少，3.2%的患者出现3级或4级贫血。常见的轻度副作用包括恶心（58.1%）和脱发（38.7%）。放疗后，16.7%的患者出现3级中性粒细胞减少，少数患者出现1级或2级贫血（3.3%），大多数其他副作用较轻，未报告严重毒性反应。
具有高危因素的子宫内膜癌患者可从多西他赛/顺铂辅助化疗后行放疗中获益，且毒性可控。
