多西他赛/顺铂化疗后盆腔放疗用于分期手术后的高危子宫内膜癌患者:II 期研究。

IF 6.4 1区 医学 Q1 ONCOLOGY
Ok-Ju Kang, Yoon-Jung Cho, Myong Cheol Lim, Yeon Jee Lee, Sang Soo Seo, Sokbom Kang, Sang-Yoon Park, Young Seok Kim, Joo-Hyun Nam, Jeong-Yeol Park
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引用次数: 0

摘要

目的评估高危子宫内膜癌患者在分期手术后接受多西他赛/顺铂化疗和盆腔放疗的疗效和安全性:在这项开放标签、单臂、2 期试验中,我们在韩国的两个中心招募了接受过分期手术的组织学确诊子宫内膜癌患者。纳入标准以2009年FIGO分期为基础:≥2个危险因素(3级、淋巴管侵犯阳性、子宫肌层半数以上受侵)的I期患者;IB期和II期透明细胞腺癌或浆液性腺癌患者;1型子宫切除术后的II期患者;以及III期患者。患者接受三个周期的多西他赛(70 毫克/平方米)和顺铂(60 毫克/平方米)化疗,然后接受 45 至 50.4 Gy 的盆腔放疗。在整个研究过程中,分别使用 RECIST 1.1 和 CTCAE 4.0 对疾病状态和不良反应进行评估,并定期进行影像学检查和评估:本研究共纳入 62 例患者,中位随访时间为 65 个月(IQR:48-86)。1年、3年和5年的无进展生存率分别为98.4%、86.9%和79.1%。1年、3年和5年的总生存率分别为98.4%、96.4%和96.4%。化疗后,62.9%的患者出现严重的中性粒细胞减少症,其中3.2%出现3级或4级贫血。常见的轻微副作用包括恶心(58.1%)和脱发(38.7%)。放疗后,16.7%的患者出现3级中性粒细胞减少症,少数患者出现1级或2级贫血(3.3%),其他副作用大多较轻,无严重毒性反应:结论:具有高危因素的子宫内膜癌患者可从多西他赛/顺铂辅助化疗中获益,随后接受放疗,且毒性反应可控。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Docetaxel/Cisplatin Chemotherapy Followed by Pelvic Radiation Therapy in Patients With High-risk Endometrial Cancer After Staging Surgery: A Phase 2 Study.

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.

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来源期刊
CiteScore
11.00
自引率
7.10%
发文量
2538
审稿时长
6.6 weeks
期刊介绍: International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field. This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.
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