背景:我们旨在研究加压腹膜内雾化化疗(PIPAC)在卵巢癌和腹膜癌铂耐药复发中的疗效和安全性,而我们的次要终点是确定通过EORTCQLQ-30和QLQ-OV28问卷估计的生活质量的任何变化.
方法:在这个单中心,单臂,第二阶段试验,前瞻性招募女性患者,每28~42天接受一次PIPAC疗程,即通过序贯腹腔镜检查给予阿霉素2.1mg/m2,然后给予顺铂10.5mg/m2.
结果:总体而言,从2016年1月至2020年1月,对43名妇女进行了98次PIPAC手术;由于广泛的腹腔内粘连,3次手术流产。82%的女性达到了临床获益率(CBR)。18名妇女(45%)完成了三个PIPAC周期,13例(32.5%)和9例(22.5%)患者接受了一个和两个周期,分别。在两个PIPAC程序中,患者出现术中肠穿孔。没有治疗相关的死亡。根据腹膜回归评分(PRGS),19例患者无应答,8例患者根据PRGS显示轻微应答。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)。而中位总生存期为27个月(95%CI20.337-33.663).EORTCQLQ-28和EORTCQLQ-30评分在治疗期间没有恶化。
结论:PIPAC似乎是治疗这一部分患者的可行方法,对他们的生活质量没有任何影响。由于本研究样本量小,单中心设计,未来的研究是强制性的,如它的应用除了全身化疗。
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/m2 followed by cisplatin 10.5 mg/m2 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.