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原发性晚期卵巢癌的细胞减灭术加腹腔内热灌注化疗:来自沙特阿拉伯的首次报道的初步经验。

A Cytoreductive Surgery plus Hyperthermic Intraperitoneal Chemotherapy in Primary Advanced Ovarian Cancer: The First Reported Pilot Experience from Saudi Arabia.

机构信息

College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.

Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.

出版信息

Gulf J Oncolog. 2020 Sep;1(34):19-25.

PMID:33431358
Abstract

BACKGROUND

Around two thirds of patients with ovarian cancer present to clinical attention with advanced-stage disease in the form of peritoneal carcinomatosis (PC) or distant metastasis, which is correlated with a poor fiveyear overall survival (OS) of less than 20%. The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to cytoreductive surgery (CRS) has been depicted to offer survival benefits in patients with PC arising from primary advanced ovarian cancer. However, no similar study was conducted from Saudi Arabia, specifically, or the Gulf region, generally. The primary aim of this study is to describe our pilot single-institutional experience (feasibility, safety and survival outcomes) with CRS plus HIPEC in managing PC arising from primary advanced ovarian cancer..

MATERIAL AND METHOD

A retrospective cross-sectional study was conducted at Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia. From January 2016 to July 2019, the medical records of 16 eligible patients were reviewed for clinical, perioperative and survival data. Survival analyses of DFS were calculated according to the Kaplan-Meier estimates method and compared by using two-tailed log-rank test. Statistical significance was regarded as a p value < 0.05.

RESULTS

Cytoreduction completeness CC-0 (optimal) and CC-1 (suboptimal) were achieved in 10 (63%) and six (37%) patients, respectively. The median peritoneal cancer index (PCI) score was 11 (range: 6-18). Nine patients (56%) received combination cisplatin (50 mg/m2) plus doxorubicin (15 mg/m2) as HIPEC regimen whereas the remaining seven patients (44%) received intense single-agent cisplatin (100 mg/m2). No intraoperative morbidity or mortality occurred. Four patients (25%) developed grade III-IV postoperative adverse events based on the Clavien-Dindo surgical complications; no patient developed HIPEC-related renal or hematological toxicities. The median hospital stay was 13 days (range: 11-40). The median follow-up time was 16 months (range: 7-43). The mean OS and DFS were 38.7 months (95% confidence interval [CI]: 31.7-45.6) and 28.4 months (95% CI: 20.7-36.0), respectively. Eleven patients were alive and disease-free (69%). Disease recurrence occurred in five patients (31%). One patient died 30 months after CRS plus HIPEC due to distant brain metastasis. Univariate analysis of parameters related to DFS showed that advanced stage IV disease (p = 0.01), suboptimal CC-1 cytoreduction completeness (p = 0.01) and >11 high PCI score (p = 0.03) were independent factors associated with statistically significant poor DFS.

CONCLUSION

CRS plus HIPEC is technically feasible, largely morbid-free and correlates with enhanced survival outcomes in patients with primary advanced ovarian cancer.

摘要

背景

大约三分之二的卵巢癌患者以腹膜癌(PC)或远处转移的形式出现晚期疾病,这与五年总生存率(OS)不到 20%的不良预后相关。细胞减灭术(CRS)联合腹腔内热化疗(HIPEC)已被证明可使原发性晚期卵巢癌患者的 PC 患者获益。然而,来自沙特阿拉伯或海湾地区的类似研究尚未开展。本研究的主要目的是描述我们在管理原发性晚期卵巢癌引起的 PC 时采用 CRS 联合 HIPEC 的单中心初步经验(可行性、安全性和生存结果)。

材料和方法

这是一项在沙特阿拉伯利雅得法赫德国王专科医院妇产科进行的回顾性横断面研究。2016 年 1 月至 2019 年 7 月,回顾了 16 名符合条件的患者的临床、围手术期和生存数据。采用 Kaplan-Meier 估计法计算无病生存率(DFS)的生存分析,并通过双侧对数秩检验进行比较。有统计学意义的 P 值 < 0.05。

结果

10 名(63%)和 6 名(37%)患者的细胞减灭术完全性分别达到 CC-0(最佳)和 CC-1(次优)。中位腹膜癌指数(PCI)评分 11 分(范围:6-18)。9 名患者(56%)接受顺铂(50mg/m2)联合多柔比星(15mg/m2)作为 HIPEC 方案,而其余 7 名患者(44%)接受单药高强度顺铂(100mg/m2)。无术中并发症或死亡。根据 Clavien-Dindo 手术并发症,4 名患者(25%)发生 3 级-4 级术后不良事件;无 HIPEC 相关肾或血液学毒性。中位住院时间为 13 天(范围:11-40)。中位随访时间为 16 个月(范围:7-43)。平均 OS 和 DFS 分别为 38.7 个月(95%CI:31.7-45.6)和 28.4 个月(95%CI:20.7-36.0)。11 名患者无病存活(69%)。5 名患者(31%)出现疾病复发。1 名患者在接受 CRS 加 HIPEC 治疗 30 个月后因远处脑转移而死亡。DFS 相关参数的单因素分析显示,晚期 IV 期疾病(p=0.01)、次优 CC-1 细胞减灭术完全性(p=0.01)和 PCI 评分>11 分(p=0.03)是与显著不良 DFS 相关的独立因素。

结论

CRS 联合 HIPEC 在技术上是可行的,且主要无病生存,与原发性晚期卵巢癌患者的生存结果改善相关。

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