MEDITERRANEAN KAPOSIS-SARCOMA IN THE ELDERLY - A RANDOMIZED STUDY OF ORAL ETOPOSIDE VERSUS VINBLASTINE

Background. This Phase III trial was performed to compare the roles of oral etoposide and intravenous (i.v.) vinblastine in the treatment of Mediterranean Kaposi's Sarcoma (MEKS) in elderly patients with severe disease (Stages II, Ac/B, III, and IV). Patients and Methods. Sixty-f ive patients were randomized to receive either oral etoposide (60 mg/m (2) on Days 1-3 during the first course; 60 mg/m(2) on Days 1-4 during the second course, and 60 mg/m(2) on Days 1-5 during the third course ; the courses were recycled every 3 weeks) or an i.v. bolus of vinblas tine (3 mg/m(2) weekly for 3 weeks, and then 6 mg/m(2) every 3 weeks). Results. No significant difference between the two drugs was observed in terms of response rates (etoposide, 73.5% vs. vinblastine, 58%; P = 0.3), duration of response, or survival (median not yet reached at a median followup of 38 months). Side effects of both treatments were l imited, although myelotoxicity was more evident in the vinblastine arm . Conclusions. Although it is feasible and well tolerated, the oral ad ministration of etoposide at these doses and in this regimen does not appear superior to vinblastine in the treatment of MEKS. Further evalu ation of a more intensive schedule in large cooperative clinical trial s is needed to establish the role of this drug in comparison with refe rence treatments.