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AIDS-Related Kaposi’s Sarcoma: Evaluation of Potential New Prognostic Factors and Assessment of the AIDS Clinical Trial Group Staging System in the Haart Era—the Italian Cooperative Group on AIDS and Tumors and the Italian Cohort of Patients Naïve From Antiretrovirals

From the Division of Medical Oncology A, National Cancer Institute, Aviano; Epidemiology Unit, National Cancer Institute, Aviano; Division of Infectious Diseases, IRCCS Spallanzani, Rome; II Division of Infectious Diseases, Sacco Hospital, Milan; Infectious Diseases Clinic, University of Bologna, Bologna; Division of Infectious Diseases, Santa Croce Hospital, Ravenna; Division of Infectious Diseases, S. Salvatore Hospital, Pesaro; Infectious Diseases Department, University of Torino, Torino; Division of Infectious Diseases, Cuggiono Hospital, Cuggiono; Infectious Diseases Clinic, Sacco Hospital, Milan, Italy.

Address reprint requests to Umberto Tirelli, MD, National Cancer Institute, Via Pedemontana Occidentale 12, 33081 Aviano (PN), Italy; email: oma{at}cro.it.

Purpose: To assess potential new prognostic factors and to validate the AIDS Clinical Trials Group (ACTG) for AIDS-related Kaposi’s sarcoma (AIDS-KS) staging system in the highly active antiretroviral therapy (HAART) era.

Patients and Methods: We collected epidemiologic, clinical, staging, and survival data from 211 patients with AIDS-KS enrolled in two prospective Italian human immunodeficiency virus (HIV) cohort studies. We included in the analysis all patients with the diagnosis of KS made from January 1996, the time at which HAART became available in Italy.

Results: In the univariate analysis, survival was not influenced by sex, age, level of HIV viremia at KS diagnosis, HAART at KS diagnosis (HAART-naïve v HAART-experienced), or type of HAART combination. Regarding ACTG classification, the 3-year survival rate was 85% for T0 patients and 69% for T1 patients (P = .007), 83% for S0 patients and 63% for S1 patients (P = .003), and 83% for I0 patients and 71% for I1 patients (P = .06). In the multivariate analysis, only the combination of poor tumor stage (T1) and poor systemic disease (S1) risk identified patients with unfavorable prognosis. The 3-year survival rate of patients with T1S1 was 53%, which was significantly lower compared with the 3-year survival rates of patients with T0S0, T1S0, and T0S1, which were 88%, 80%, and 81%, respectively (P = .0001).

Conclusion: In the era of HAART, a refinement of the original ACTG staging system is needed. CD4 level does not seem to provide prognostic information. Two different risk categories are identified: a good risk (T0S0, T1S0, T0S1) and a poor risk (T1S1).

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