HAART and response to therapy improve quality of life (QOL) of African patients with advanced HIV-associated Kaposi’s sarcoma (HIV-KS): a prospective analysis of QOL in the KAART trial

Abstract

Background Quality of Life (QOL) assessment is important in oncology studies. Effect of therapy on QOL is important in HIV-KS, as decreasing morbidity is a goal of therapy. This is the first prospective study to evaluate the effect of HAART, +/- chemotherapy, on QOL in African patients with HIV-KS. Within the KAART study, we assessed the impact of HAART over 12 months in all patients, differences in QOL between arms, as well as associations between QOL and several clinical parameters. Methods KAART is a randomized, controlled, open label trial of HAART vs. HAART plus chemotherapy (CXT) in treatment-naive South African patients with HIV-KS. QOL outcomes were assessed prospectively in English or isiZulu using EORTC-QOL30. We evaluated intra-group changes between baseline and month 12 QOL scores (Wilcoxon rank sign test), changes between baseline and month 12 QOL scores between the two groups (Mann-Whitney test), and the relationship between clinical responses and global QOL (Kruskal-Wallis test). Given multiple comparisons, p-values <0.01 are considered statistically significant; 0.01< p <0.05 represent important trends. Results 111 participants had QOL information. Median global health score (perfect score = 100) was 50 at baseline, improving to 67 at month 12 (p<0.001). Significant improvements in median scores from baseline to month 12 were seen in emotional, cognitive, and social scales, but not physical function and role function. Most symptom scales (fatigue, pain, dyspnea, insomnia, appetite, diarrhea, and constipation) showed significant improvement over time. Improvement in nausea was borderline (p=0.03). There were no statistically significant changes over time between arms; however role function (p=0.011) trended toward greater improvement in the CXT arm. Complete or partial response was associated with increased global health scores (p<0.001), while number or severity of adverse events, adherence, HIV viral load, or CD4 count were not. Conclusion African HIV-KS patients benefit significantly in their overall global health status, functioning and symptoms from HAART. Partial and complete responses to therapy are significant predictors of global health, and the role of early chemotherapy in advanced HIV-KS merits further investigation. Improving QOL is an important goal in the treatment of advanced KS in resource-limited settings. QOL results from this study inform treatment paradigms for management of African patients with HIV-KS.