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

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.

Trial registration: ClinicalTrials.gov NCT00380770.

Conflict of interest statement

Fahmida Shaik

No relationship to disclose

Thomas S. Uldrick

Research Funding: Celgene (Inst), Merck (Inst), Bayer (Inst), Genentech (Inst)

Patents, Royalties, Other Intellectual Property: As an employee of the US Government, I have provisional patent application regarding methods for the treatment of Kaposi sarcoma and Kaposi sarcoma herpesvirus–induced lymphoma using immunomodulatory compounds, and uses of biomarkers (Inst)

Tonya Esterhuizen

No relationship to disclose

Anisa Mosam

No relationship to disclose

Figures

Fig 1

Participant flow diagram and available quality-of-life data (QOL) at each visit.

Fig 2

Changes in European Organization for Research and Treatment of Cancer quality-of-life questionnaire (EORTC-QLQ-C30) scores in the KAART (Kaposi Sarcoma AIDS Anti-Retroviral Therapy) study from baseline to month 12. Box and whisker plot of EORTC-QLQ-C30 scores; for each measurement, the first box and whisker (blue dot) represents baseline scores, and the second box and whisker (red dot) represents month 12. Range of scores (0 to 100); 100 score best for functional scales and 0 score best for symptom scales. Boxes represent interquartile range, central lines represent medians, and whiskers represent adjacent values.P values for test of change between baseline and month 12, P < .01 considered statistically significant.