| Disease | A PHASE-TWO TRIAL OF 16 HOMOSEXUAL MALES WITH HISTOPATHOLOGICALLY CONFIRMED AIDS-KS WERE ACCRUED FOR THIS PHASE II CLINICAL TRIAL. PPS WAS ADMINISTERED AT THE DOSE OF 25 MG/M2 Q6 HRS AT DAY 1, FOLLOWED BY 25 MG/M2 Q12 HRS DAILY BY A SUBCUTANEOUS
INJECTION. THE NUMBER OF PATIENTS TO BE INCLUDED IN THE TRIAL WAS CALCULATED ACCORDING TO THE TWO-STAGE GEHAN METHOD. TOXICITY WAS GRADED ACCORDING TO THE NCI COMMON TOXICITY CRITERIA, WHILE RESPONSES WERE EVALUATED ACCORDING TO THE WHO CRITERIA
ADAPTED FOR KS LESIONS. PATIENTS WERE ALL HOMOSEXUAL MALES, MEDIAN AGE 35(27-43) YEARS, PERFORMANCE STATUS (WHO) 1 (0-2), NYU STAGE II-IV AND PRIOR THERAPY INCLUDED VINCRISTINE AND ETOPOSIDE (3 CASES), LOCAL IRRADIATION (4 CASES) AND MEGESTROL
ACETATE (2 CASES). CONCOMITANT AZT (ZIDOVUDINE) WAS GIVEN TO 3 PATIENTS, WHILE DDI (DIDEOXYINOSINE) WAS ADMINISTERED IN ONE CASE. RESULTS: A MEDIAN OF 5 (3-11) WEEKS OF THERAPY WAS ADMINISTERED TO THE PATIENTS. PAIN AT THE INJECTION SITE AND LOW
GRADE FEVER WERE THE ONLY TOXICITIES OBSERVED. DRUG-RELATED EFFECTS ON COAGULATION PARAMETERS OR THROMBOCYTOPENIA WERE NOT OBSERVED IN THE TRIAL. ONE OBJECTIVE RESPONSE (6%) WAS DOCUMENTED, WHICH LASTED FOR 9 WEEKS, WHILE STABLE DISEASE WAS
OBSERVED IN THREE PATIENTS, LASTING FOR 11, 9 AND 5 WEEKS, RESPECTIVELY. CONCLUSION: THIS IS THE FIRST OBSERVATION OF OBJECTIVE ANTITUMOR ACTIVITY WITH A B-FGF INHIBITOR IN PATIENTS WITH AIDS-KS. CONSIDERING ITS NOVELTY AND THE LACK OF
SIGNIFICANT TOXICITY, THE AUTHORS SUGGEST THAT THIS EXPERIMENTAL APPROACH DESERVES FURTHER EVALUATION. |