Mediterranean Kaposi's 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-five patients were randomized to receive either oral etoposide (60 mg/m2 on Days 1-3 during the first course; 60 mg/m2 on Days 1-4 during the second course, and 60 mg/m2 on Days 1-4 during the second course, and 60 mg/m2 on Days 1-5 during the third course; the courses were recycled every 3 weeks) or an i.v. bolus of vinblastine (3 mg/m2 weekly for 3 weeks, and then 6 mg/m2 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 follow-up of 38 months). Side effects of both treatments were limited, although myelotoxicity was more evident in the vinblastine arm.

CONCLUSIONS

Although it is feasible and well tolerated, the oral administration of etoposide at these doses and in this regimen does not appear superior to vinblastine in the treatment of MEKS. Further evaluation of a more intensive schedule in large cooperative clinical trials is needed to establish the role of this drug in comparison with reference treatments.