研究动态
Articles below are published ahead of final publication in an issue. Please cite articles in the following format: authors, (year), title, journal, DOI.

三线复发内铂耐药卵巢癌患者二次细胞减灭术的评估:一项多中心、随机对照研究。

Evaluation of Secondary Cytoreduction Surgery in Platinum-Resistant Ovarian Cancer Patients Within Three-Line Recurrent: A Multicenter, Randomized Controlled Study.

发表日期:2023 Oct 30
作者: Tingting Chen, Junfen Xu, Bairong Xia, Hui Wang, Yuanming Shen
来源: Journal of Gynecologic Oncology

摘要:

上皮性卵巢癌是妇科恶性肿瘤中死亡的主要原因。铂类耐药仍然是治疗的困境和瓶颈,挽救性化疗的效果有限。最近,二次细胞减灭术(SCS)在铂耐药复发性卵巢癌(ROC)患者中的作用引起了人们的关注,尤其是寡转移患者。然而,迄今为止,尚无高质量的循证证据,也没有标准化的标准来为铂类耐药ROC患者选择SCS。这项多中心、随机、对照临床试验旨在评估SCS的价值,并阐明使用SCS的可靠标准。 ROC女性SCS研究,由浙江大学医学院附属妇女医院妇科肿瘤学组牵头。招募已于 2023 年 1 月 1 日开始,计划于 2026 年 12 月结束。 140 名符合“RSCS 标准”的铂耐药 ROC 参与者将按 1:1 的比例随机分配到实验组或实验组。手臂或标准手臂。实验组的患者将接受 SCS,然后接受非铂单药化疗(紫杉醇、吉西他滨或脂质体阿霉素)至少 4 个周期,而标准组的患者将仅接受非铂单药化疗。主要结局是无进展生存期。次要结局是总体生存率、不良事件和与健康相关的癌症特定生活质量。ClinicalTrials.gov 标识符:NCT05633199。© 2023。亚洲妇科肿瘤学会、韩国妇科肿瘤学会和日本妇科肿瘤学会。
Epithelial ovarian cancer is the leading cause of death among gynecological malignancies. Platinum resistance remains a dilemma and bottleneck in treatment, and salvage chemotherapy has limited effectiveness. Recently, the role of secondary cytoreductive surgery (SCS) in patients with platinum-resistant recurrent ovarian cancer (ROC) has caused attention especially in patients with oligometastases. However, there is neither high-quality evidence-based evidence nor standardized criteria for selecting SCS for patients with platinum-resistant ROC until now.This multicenter, randomized, controlled clinical trial is to evaluate the value of SCS and to clarify reliable criteria of utilizing SCS in women with ROC, which is led by Gynecologic Oncology Group, Women's Hospital, Zhejiang University School of Medicine. Recruitment has started on January 1st, 2023, and is scheduled to end in December 2026. One hundred and forty participants with platinum-resistant ROC who meet the "RSCS criteria" will be randomized assigned at a ratio of 1:1 to either the experimental arm or the standard arm. Patients in the experimental arm will receive SCS followed by non-platinum single agent chemotherapy (paclitaxel, gemcitabine or liposomal adriamycin) for at least 4 cycles while patients in the standard arm will be provided with only non-platinum single agent chemotherapy. The primary outcome is progression-free survival. The secondary outcomes are overall survival, adverse events and health-related cancer-specific quality of life.ClinicalTrials.gov Identifier: NCT05633199.© 2023. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.