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腹腔内压力化疗(PIPAC)在铂耐药卵巢肿瘤复发中的应用:单中心经验(ID:PARROT 试验)。

Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) Applied to Platinum-Resistant Recurrence of Ovarian Tumor: A Single-Institution Experience (ID: PARROT Trial).

机构信息

Department of Medicine, University of Udine, Udine, Italy.

Clinic of Obstetrics and Gynecology, "Santa Maria della Misericordia" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.

出版信息

Ann Surg Oncol. 2024 Feb;31(2):1207-1216. doi: 10.1245/s10434-023-14648-0. Epub 2023 Dec 15.

Abstract

BACKGROUND

We aimed to investigate the therapeutic efficacy and safety of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in platinum-resistant recurrence of ovarian cancer and peritoneal carcinomatosis, while our secondary endpoint was to establish any changes in quality of life estimated via the EORTC QLQ-30 and QLQ-OV28 questionnaires.

METHODS

In this monocentric, single-arm, phase II trial, women were prospectively recruited and every 28-42 days underwent courses of PIPAC with doxorubicin 2.1 mg/m followed by cisplatin 10.5 mg/m via sequential laparoscopy.

RESULTS

Overall, 98 PIPAC procedures were performed on 43 women from January 2016 to January 2020; three procedures were aborted due to extensive intra-abdominal adhesions. The clinical benefit rate (CBR) was reached in 82% of women. Three cycles of PIPAC were completed in 18 women (45%), and 13 (32.5%) and 9 (22.5%) patients were subjected to one and two cycles, respectively. During two PIPAC procedures, patients experienced an intraoperative intestinal perforation. There were no treatment-related deaths. Nineteen patients showed no response according to the Peritoneal Regression Grading Score (PRGS) and 8 patients showed minor response according to the PRGS. Median time from ovarian cancer relapse to disease progression was 12 months (95% confidence interval [CI] 6.483-17.517), while the median overall survival was 27 months (95% CI 20.337-33.663). The EORTC QLQ-28 and EORTC QLQ-30 scores did not worsen during therapy.

CONCLUSIONS

PIPAC seems a feasible approach for the treatment of this subset of patients, without any impact on their quality of life. Since this study had a small sample size and a single-center design, future research is mandatory, such as its application in addition to systemic chemotherapy.

摘要

背景

我们旨在研究加压腹腔内气溶胶化疗(PIPAC)在铂类耐药复发性卵巢癌和腹膜癌转移中的治疗效果和安全性,同时我们的次要终点是通过 EORTC QLQ-30 和 QLQ-OV28 问卷评估生活质量的任何变化。

方法

在这项单中心、单臂、二期试验中,前瞻性招募了女性患者,每 28-42 天通过腹腔镜进行一次 PIPAC 治疗,顺铂 10.5mg/m 2 ,多柔比星 2.1mg/m 2 。

结果

2016 年 1 月至 2020 年 1 月,共有 43 名女性患者接受了 98 次 PIPAC 治疗,由于广泛的腹腔内粘连,有 3 次手术被中断。82%的女性患者达到了临床获益率(CBR)。18 名女性患者完成了 3 个周期的 PIPAC(45%),13 名(32.5%)和 9 名(22.5%)患者分别接受了 1 个和 2 个周期。在两次 PIPAC 手术中,患者出现术中肠穿孔。没有与治疗相关的死亡。根据腹膜消退分级评分(PRGS),19 名患者无反应,8 名患者有轻微反应。从卵巢癌复发到疾病进展的中位时间为 12 个月(95%置信区间 [CI] 6.483-17.517),中位总生存期为 27 个月(95%CI 20.337-33.663)。在治疗过程中,EORTC QLQ-28 和 EORTC QLQ-30 评分没有恶化。

结论

PIPAC 似乎是治疗这组患者的一种可行方法,不会对他们的生活质量产生影响。由于本研究样本量小且为单中心设计,因此需要进一步研究,例如将其应用于系统化疗之外。

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