The effect of Pressurised Intraperitoneal Aerosol Chemotherapy on the quality of life of patients with primary diagnosed ovarian cancer with peritoneal carcinomatosis during combined treatment

A. Dzasokhov, A. Kostin, V. Astashov, A. Turiev, A. Uskov
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Abstract

Purpose of the study. To evaluate the effect of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) on the quality of life of patients during standard combined treatment of newly diagnosed ovarian cancer.Patients and methods. A combination of surgical cytoreduction with a simultaneous session of intra‑abdominal aerosol chemotherapy under pressure and subsequent systemic chemotherapy within the framework of a single hospitalization was used. The study included 164 patients (79 in the main group, 85 in the control group). All patients were operated on at the first stage, all underwent systemic cytostatic therapy according to the TS scheme (6 courses with an interval of 21 days). In the main group, 3 PIPEC sessions were added to standard treatment: the first one simultaneously with cytoreductive surgery, followed by 2 more PIPAC sessions with an interval of 42 days. To assess the quality of life, the EORTC‑QLQ – C30 questionnaire was used, which the patients filled out 4 times: before the cytoreductive stage, and then after completing the first, third and fifth courses of systemic polychemotherapy (PCT).Results. Before the start of treatment in the control group, the average general condition was 1.6 ± 1.1 points, then 1.32 ± 1.0 points, then 0.96 ± 0.97 and 0.78 ± 0.87 points at the end of the 6th course of systemic PCT. A similar situation has developed in the main group. The average baseline value before treatment was 1.7 ± 1.1 points, with the second questionnaire – 1.3 ± 1.1 points, with the third questionnaire – 0.66 ± 0.83, and 0.43 ± 0.75 points with the fourth questionnaire. In the control group, the average assessment of the quality of life before treatment was 55.0 ± 11.0 points, and then sequentially with the following three surveys 50,8 ± 7,5, 47 ± 8, 45,6 ± 8,1 points, which indicates an improvement in the quality of life against the background of ongoing treatment. In the main group, the basic level of assessment of the quality of life was 53.8 ± 11.3 points. Subsequently, an improvement in the indicators was also revealed: 49.6 ± 7.5 points, 44.2 ± 5.3 points and 42.1 ± 5.4 points, respectively. The homogeneity of the distribution in the groups was established by means of an accurate two–way Wilcoxon–Mann‑Whitney rank sum criterion, the actual significance level was p = 0.498. A two‑factor model of nonparametric analysis of variance (ANOVA) was used to analyze the data obtained. To identify a significant difference between the indicators at different stages of the study, the Page rank criterion for an ordered alternative and an algorithm based on the Friedman rank sum test were used. As a result, it was shown that the revealed positive dynamics of indicators within the groups over the entire study period is statistically significant (p < 0.0001).Conclusion. The results of the study showed that PIPAC not only does not reduce the quality of life and does not worsen the well‑being of patients, but also improves these indicators by the time of completion of combined treatment (after the 6th course of systemic PCT): in the main group, the overall ECOG condition at this stage was estimated at 0.43 ± 0.75 points, in the control group – 0.78 ± 0.87 points. The survey of patients using EORTC‑QLQ – C30 at this stage showed that in the main group the indicator was 42.1 ± 5.4 points versus 45.6 ± 8.1 points in the control group of the study.
加压腹腔气雾剂化疗对原发性卵巢癌合并腹膜癌患者联合治疗期间生活质量的影响
研究目的:目的探讨加压腹腔气雾化疗(PIPAC)对新诊断卵巢癌标准联合治疗患者生活质量的影响。患者和方法。采用手术细胞减少与同时进行腹部压力下气雾剂化疗和随后在单次住院框架内的全身化疗的组合。该研究包括164例患者(主要组79例,对照组85例)。所有患者一期均行手术治疗,均按TS方案进行全身细胞抑制剂治疗(6个疗程,间隔21天)。主组在标准治疗基础上增加3次PIPEC治疗:第一次与细胞减少手术同时进行,随后再进行2次PIPAC治疗,间隔42天。为了评估患者的生活质量,采用EORTC - QLQ - C30问卷,患者分别在细胞减少期前和完成全身多化疗(PCT)第一、第三和第五疗程后填写4次问卷。对照组患者在治疗前平均总分为1.6±1.1分,到第6个疗程结束时平均总分为1.32±1.0分,分别为0.96±0.97分和0.78±0.87分,主组患者也出现类似情况。治疗前平均基线值为1.7±1.1分,第二次问卷为- 1.3±1.1分,第三次问卷为- 0.66±0.83分,第四次问卷为0.43±0.75分。对照组患者治疗前生活质量平均评分为55.0±11.0分,随后依次进行3次调查,分别为50分、8分±7分、5分、47分±8分、45分、6分±8分、1分,表明在持续治疗的背景下,患者的生活质量有所改善。主组患者生活质量基本评分为53.8±11.3分。随后各项指标也有所改善,分别为49.6±7.5分、44.2±5.3分、42.1±5.4分。通过精确的双向Wilcoxon-Mann - Whitney秩和标准来确定组内分布的均匀性,实际显著性水平为p = 0.498。采用非参数方差分析(ANOVA)的双因素模型对获得的数据进行分析。为了确定研究不同阶段指标之间的显著差异,使用了有序替代的Page秩标准和基于Friedman秩和检验的算法。结果表明,在整个研究期间,组内指标显示的积极动态具有统计学意义(p < 0.0001)。研究结果表明,PIPAC不仅没有降低患者的生活质量,也没有使患者的幸福感恶化,而且在联合治疗完成时(全身PCT第6个疗程后),这些指标都有所改善:主组在该阶段的总体ECOG状况估计为0.43±0.75分,对照组为- 0.78±0.87分。对该阶段使用EORTC - QLQ - C30的患者的调查显示,主组该指标为42.1±5.4分,对照组为45.6±8.1分。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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