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细胞减灭术(CRS)联合腹腔热灌注化疗(HIPEC)治疗 HRR 突变的铂敏感复发性上皮性卵巢癌:一项 III 期随机临床试验。

Cytoreductive Surgery (CRS) Combined With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Platinum-Sensitive Recurrence Epithelial Ovarian Cancer With HRR Mutation: A Phase III Randomized Clinical Trial.

机构信息

89674Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.

Hubei Key Laboratory of Tumor Biological Behaviors, Wuhan, China.

出版信息

Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221104565. doi: 10.1177/15330338221104565.

DOI:10.1177/15330338221104565
PMID:35929135
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9358559/
Abstract

: Epithelial ovarian cancer (EOC) remains the leading cause of gynecologic cancer death worldwide due to the high recurrence rate. Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) is an alternative modality for platinum-sensitive recurrent EOC. The latest studies demonstrate homologous recombination-related (HRR) mutation status increases the sensitivity to platinum-based chemotherapy drugs in EOC. However, the molecular analysis of recurrent EOC patient benefits from HIPEC is unknown. Thus, we aimed to evaluate the efficacy and safety of CRS combined with HIPEC for platinum-sensitive in recurrent EOC with HRR mutation. This is a phase III randomized controlled clinical trial in patients with platinum-sensitive recurrent EOC. Participants were divided into 2 groups based on the HRR mutation status and randomized to receive CRS + HIPEC. The patients then received periodic chemotherapy and follow-up. The primary objective of this study was to evaluate the effect of CRS + HIPEC compared to CRS alone in patients with a platinum-sensitive recurrent EOC stratified for HRD status. We hypothesize that the addition of HIPEC to CRS improves the progression-free survival (PFS) of platinum-sensitive recurrent EOC patients with HRR mutation compared with patients without HRR mutation. Recurrent EOC has a poor prognosis due to implantation and metastasis in the abdominal cavity. Intraperitoneal chemotherapy reduced seeding by removing free tumor cells. HIPEC utilizes physical and biological properties to significantly increase the clearance rate of tumors. Van Driel WJ et al proposed that HIPEC using platinum-based chemotherapy improves the survival of patients with ovarian cancer. HRR mutation, as a common pathogenic mutation in ovarian cancer, has a predictive effect on the platinum sensitivity of ovarian cancer patients. Whether lobaplatin-based HIPEC will play a greater role in ovarian cancer patients with HRR mutations is currently unknown.

摘要

上皮性卵巢癌 (EOC) 仍然是全球妇科癌症死亡的主要原因,这是由于其高复发率所致。细胞减灭术 (CRS) 联合腹腔热灌注化疗 (HIPEC) 是铂敏感复发性 EOC 的另一种治疗方式。最新研究表明同源重组相关 (HRR) 突变状态增加了 EOC 对铂类化疗药物的敏感性。然而,尚不清楚 HIPEC 对复发性 EOC 患者的分子分析有何获益。因此,我们旨在评估 HRR 突变铂敏感复发性 EOC 患者接受 CRS 联合 HIPEC 的疗效和安全性。这是一项 HRR 突变铂敏感复发性 EOC 患者的 III 期随机对照临床试验。参与者根据 HRR 突变状态分为 2 组,并随机接受 CRS+HIPEC。然后,患者接受周期性化疗和随访。本研究的主要目的是评估 CRS+HIPEC 与单独 CRS 在 HRD 状态分层的铂敏感复发性 EOC 患者中的疗效。我们假设与没有 HRR 突变的患者相比,HIPEC 联合 CRS 可改善 HRR 突变铂敏感复发性 EOC 患者的无进展生存期 (PFS)。复发性 EOC 由于在腹腔内种植和转移而预后不良。腹腔内化疗通过清除游离肿瘤细胞减少播种。HIPEC 利用物理和生物学特性显著提高肿瘤的清除率。Van Driel WJ 等人提出,使用铂类化疗的 HIPEC 可改善卵巢癌患者的生存。HRR 突变作为卵巢癌的常见致病突变,对卵巢癌患者对铂类药物的敏感性具有预测作用。目前尚不清楚基于洛铂的 HIPEC 在 HRR 突变的卵巢癌患者中是否会发挥更大的作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c78e/9358559/934be0533345/10.1177_15330338221104565-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c78e/9358559/3b91f4642ba4/10.1177_15330338221104565-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c78e/9358559/a37f028fd0aa/10.1177_15330338221104565-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c78e/9358559/934be0533345/10.1177_15330338221104565-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c78e/9358559/3b91f4642ba4/10.1177_15330338221104565-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c78e/9358559/a37f028fd0aa/10.1177_15330338221104565-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c78e/9358559/934be0533345/10.1177_15330338221104565-fig3.jpg

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