Highly Active Antiretroviral Therapy in AIDS-Associated Kaposi's Sarcoma (KS): Implications for the Design of Therapeutic Trials in Patients With Advanced Symptomatic KS

Abstract

TO THE EDITOR: The article by Dr Krown provides very appropriate and timely considerations with regard to the management of patients with advanced, symptomatic, AIDS-related Kaposi’s sarcoma (AIDS-KS) in the era of highly active antiretroviral therapy (HAART) and suggests, on the basis of a comprehensive review of the literature, that in T1 (according to the AIDS Clinical Trials Group [ACTG] staging classification) symptomatic KS patients, concomitant chemotherapy should be added to HAART without awaiting a response to HAART. Moreover, the author, referencing our study, states that “T1 and T0 groupings have been associated with distinct survival distribution.” In response, we would like to clarify our data as reported by Dr Krown. We believe that our data may help to better define which group of patients within the T1 category need a timely institution of chemotherapy concomitantly to HAART, and for which group it is too risky to await a possible response to HAART. In our study, we collected clinical and survival data from 211 patients with AIDS-KS enrolled in two prospective cohort studies beginning in 1996, the time when HAART became available in Italy, with the aim of validating the ACTG staging system for AIDS-KS in the HAART era. All patients received HAART. Our analysis identified two different risk categories: a good-risk group (T0S0, T1S0, and T0S1) and a poor-risk group (T1S1). The 3-year survival rate of patients with T1S1 was 53%, significantly lower than the 3-year survival rates of patients with T0S0, T1S0, and T0S1, which were 88%, 80%, and 81%, respectively (P .0001). Therefore, the T category alone does not provide an appropriate survival discrimination, as occurred in the pre-HAART period. When we considered only patients with pulmonary involvement (namely,Tp1) as compared with T1 patients without pulmonary disease (namely,Tp0), the 3-year survival rate was 46% for Tp1 and 77% for Tp0 patients (P .0002), indicating that patients with pulmonary involvement identify the group of patients with the poorest prognosis, independent of the other ACTG variables. Therefore, we believe that we were able to identify, within the T1 category, a specific subgroup of KS patients (ie, T1S1, Tp1) with an unfavorable survival rate in whom HAART and concomitant chemotherapy should be used.