研究动态
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基于紫杉醇的腹腔热灌注化疗对晚期高级别浆液性卵巢癌患者的影响 - 随机对照试验(C-HOC 试验)的安全性和即时疗效的中期分析。

The impact of Paclitaxel-based hyperthermic intraperitoneal chemotherapy in advanced high-grade serous ovarian cancer patients - interim analysis of safety and immediate efficacy of a randomized control trial (C-HOC trial).

发表日期:2024 Jul 12
作者: Qun Wang, Hua Liu, Yuhong Shen, Lifei Shen, Jian Li, Weiwei Feng
来源: Journal of Ovarian Research

摘要:

本研究评估了中国妇产科联合会 (FIGO) IIIC、IVA 和 IVB 期高级别浆液性卵巢患者中紫杉醇腹腔热灌注化疗 (HIPEC) 联合序贯静脉新辅助化疗相对于单独静脉新辅助化疗的潜在优越性/输卵管癌(HGSOC)。该中期分析重点关注两种方案的安全性和即时疗效,以确定计划试验(C-HOC 试验)的可行性。在一项单中心、开放标签、随机对照试验中,FIGO IIIC、IVA 和 IVB 期不适合初次减瘤手术(PDS)中最佳细胞减灭术的 HGSOC 患者(腹腔镜探查期间 FAGOTTI 评分 ≥ 8)在腹腔镜探查期间按 2:1 随机分配。实验组(HIPEC组)接受1周期腹腔新辅助腹腔镜腹腔热腹腔化疗(紫杉醇),随后3周期静脉化疗(紫杉醇+卡铂),而对照组仅接受3周期静脉化疗。两组随后均接受了间歇减瘤手术(IDS)。比较IDS后化疗不良反应、术后并发症及病理化疗反应评分(CRS)。 65例入组患者中,HIPEC组39例,对照组21例接受IDS。 3-4级化疗相关不良反应主要是血液学不良反应,两组之间无显着差异。 HIPEC 组表现出较高比例的 CRS 3(20.5% vs. 4.8%;P = 0.000)。 IDS 中的 R0 切除率为 69.2%(HIPEC 组)和 66.7%(对照组)。 R2 切除发生率为 2.6%(HIPEC 组)和 14.3%(对照组)病例。无再次手术或术后死亡的报道,并发症得到保守处理。HIPEC联合IV NACT治疗卵巢癌显示出安全性和可行性,没有增加化疗相关的不良反应或术后并发症。 HIPEC 改善了肿瘤对新辅助化疗的反应,有可能提高无进展生存期 (PFS)。然而,最终的总生存期结果尚待确定,以确定 HIPEC 联合 IV NACT 是否优于单独 IV NACT。© 2024。作者。
This study evaluates the potential superiority of combining paclitaxel-based hyperthermic intraperitoneal chemotherapy (HIPEC) with sequential intravenous neoadjuvant chemotherapy over intravenous neoadjuvant chemotherapy alone in Chinese patients with Federation of Gynecology and Obstetrics (FIGO) stage IIIC, IVA and IVB high-grade serous ovarian/fallopian tube carcinoma (HGSOC). This interim analysis focuses on the safety and immediate efficacy of both regimens to determine the feasibility of the planned trial (C-HOC Trial).In a single-center, open-label, randomized control trial, FIGO stage IIIC, IVA, and IVB HGSOC patients (FAGOTTI score ≥ 8 during laparoscopic exploration) unsuitable for optimal cytoreduction in primary debulking surgery (PDS) were randomized 2:1 during laparoscopic exploration. The Experiment Group (HIPEC Group) received one cycle of intraperitoneal neoadjuvant laparoscopic hyperthermic intraperitoneal chemotherapy (paclitaxel) followed by three cycles of intravenous chemotherapy (paclitaxel plus carboplatin), while the Control Group received only three cycles of intravenous chemotherapy. Both groups subsequently underwent interval debulking surgery (IDS). The adverse effects of chemotherapy, postoperative complications, and pathological chemotherapy response scores (CRS) after IDS were compared.Among 65 enrolled patients, 39 HIPEC Group and 21 Control Group patients underwent IDS. Grade 3-4 chemotherapy-related adverse effects were primarily hematological with no significant differences between the two groups. The HIPEC Group exhibited a higher proportion of CRS 3 (20.5% vs. 4.8%; P = 0.000). R0 resection rates in IDS were 69.2% (HIPEC Group) and 66.7% (Control Group). R2 resection occurred in 2.6% (HIPEC Group) and 14.3% (Control Group) cases. No reoperations or postoperative deaths were reported, and complications were managed conservatively.Combining HIPEC with IV NACT in treating ovarian cancer demonstrated safety and feasibility, with no increased chemotherapy-related adverse effects or postoperative complications. HIPEC improved tumor response to neoadjuvant chemotherapy, potentially enhancing progression-free survival (PFS). However, the final overall survival results are pending, determining if HIPEC combined with IV NACT is superior to IV NACT alone.© 2024. The Author(s).