仅接受抗逆转录病毒疗法与接受化疗及抗逆转录病毒疗法治疗HIV相关卡波西肉瘤患者的健康相关生活质量：一项随机对照试验

Health-Related Quality of Life in Patients Treated With Antiretroviral Therapy Only Versus Chemotherapy and Antiretroviral Therapy for HIV-Associated Kaposi Sarcoma: A Randomized Control Trial.

作者信息

Shaik Fahmida, Uldrick Thomas S, Esterhuizen Tonya, Mosam Anisa

机构信息

Fahmida Shaik and Anisa Mosam, University of Kwa-Zulu Natal, Durban; Tonya Esterhuizen, Stellenbosch University, Stellenbosch, South Africa; and Thomas S. Uldrick, Fred Hutchinson Cancer Research Center, Seattle, WA.

出版信息

J Glob Oncol. 2018 Oct;4:1-9. doi: 10.1200/JGO.18.00105.

DOI:10.1200/JGO.18.00105

PMID:30354935

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6818281/

Abstract

PURPOSE

In sub-Saharan Africa, Kaposi sarcoma (KS) is the most common HIV-associated cancer. KS causes substantial morbidity, and treatment goals should emphasize quality of life (QOL). Antiretroviral therapy (ART) is indicated, and early chemotherapy significantly improves tumor regression. The effect of ART alone or with chemotherapy on QOL in treatment-naïve South Africans with HIV-associated KS was assessed.

METHODS

KAART (Kaposi Sarcoma AIDS Anti-Retroviral Therapy) is a randomized, controlled, open-label trial of ART versus ART plus chemotherapy. Crossover between arms was allowed for patients with progressive disease. Eighty-nine percent of patients had advanced tumor burden. Within KAART, QOL measured by European Organization for Research and Treatment of Cancer-QLQ-C30 questionnaire evaluated functional and symptom domains and global QOL. Intragroup changes between baseline and month 12 (Wilcoxon rank sign test), changes between the arms (Mann-Whitney test), and the relationship between responses, determined by AIDS Clinical Trial Group criteria and QOL measures (Kruskal-Wallis test), were evaluated. P values < .01 were considered significant.

RESULTS

QOL information was available for 111 of 112 patients. Significant improvements over 12 months were seen in global health status and functional scales (emotional, cognitive, and social scales; not physical and role function). Most symptom scales (fatigue, pain, dyspnea, insomnia, appetite, diarrhea, and constipation) also showed significant improvement. There were no statistically significant changes between arms in intention-to-treat analysis. Patients showing a response to the tumor (complete or partial) reported significantly increased global QOL ( P < .001), pain relief, and improved role functioning. Adherence, adverse events, HIV viral load, and CD4 count did not correlate with global QOL.

CONCLUSION

African patients with HIV-associated KS derive a significant benefit in QOL from ART and tumor regression.

摘要

目的

在撒哈拉以南非洲地区，卡波西肉瘤（KS）是最常见的与人类免疫缺陷病毒（HIV）相关的癌症。KS会导致严重的发病情况，治疗目标应强调生活质量（QOL）。抗逆转录病毒疗法（ART）是适用的，早期化疗能显著改善肿瘤消退情况。本研究评估了单纯ART或ART联合化疗对未接受过治疗的南非HIV相关KS患者生活质量的影响。

方法

KAART（卡波西肉瘤艾滋病抗逆转录病毒疗法）是一项关于ART与ART加化疗的随机、对照、开放标签试验。允许病情进展的患者在两组之间交叉治疗。89%的患者肿瘤负担较重。在KAART研究中，通过欧洲癌症研究与治疗组织的QLQ-C30问卷测量生活质量，评估功能和症状领域以及总体生活质量。评估了基线与第12个月之间的组内变化（Wilcoxon秩和检验）、两组之间的变化（Mann-Whitney检验）以及由艾滋病临床试验组标准和生活质量测量确定的反应之间的关系（Kruskal-Wallis检验）。P值<0.01被认为具有显著性。

结果

112例患者中有111例可获得生活质量信息。在全球健康状况和功能量表（情绪、认知和社会量表；不包括身体和角色功能量表）方面，12个月内有显著改善。大多数症状量表（疲劳、疼痛、呼吸困难、失眠、食欲、腹泻和便秘）也显示出显著改善。意向性治疗分析中两组之间没有统计学上的显著变化。对肿瘤有反应（完全或部分）的患者报告总体生活质量显著提高（P<0.001）、疼痛缓解和角色功能改善。依从性、不良事件、HIV病毒载量和CD4细胞计数与总体生活质量无关。