A multicenter Phase II study of the intravenous administration of liposomal tretinoin in patients with acquired immunodeficiency syndrome-associated Kaposi's sarcoma
✍ Scribed by Zale P. Bernstein; Asher Chanan-Khan; Kena C. Miller; Donald W. Northfelt; Gabriel Lopez-Berestein; Parkash S. Gill
- Publisher
- John Wiley and Sons
- Year
- 2002
- Tongue
- English
- Weight
- 97 KB
- Volume
- 95
- Category
- Article
- ISSN
- 0008-543X
No coin nor oath required. For personal study only.
✦ Synopsis
Background:
A multicenter trial was conducted to determine the efficacy and toxicity of escalating dosages of liposomal tretinoin (all-trans-retinoic acid) administered once or three times weekly in patients with acquired immunodeficiency syndrome (aids)-associated kaposi sarcoma.
Methods:
Seventy-six patients with acquired immunodeficiency syndrome (aids)-associated kaposi sarcoma were randomized to receive the study drug either once (n = 30) or 3 times weekly (n = 46). the starting dosage was 60 mg/m(2), which was escalated to 90 mg/m(2) and then 120 mg/m(2) if the drug was well tolerated (<or= grade 2 toxicities [according to the southwest oncology group toxicity scale]). four weeks of therapy constituted 1 cycle; patients could receive up to 8 cycles and those who completed 8 cycles were given the option of receiving extended therapy. clinical response was defined as complete response (cr), partial response (pr), or stable disease (sd).
Results:
Efficacy was assessed after the completion of 3 treatment cycles; 28.9% of patients (22 of 76 patients) responded (no crs, 1 pr, and 21 sds). among the patients receiving treatment 3 times weekly, 16 of 49 patients (32.7%) achieved a clinical response at the end of the third treatment cycle (no crs, 1 pr, and 15 sds). concomitant or prior use of protease inhibitors did not appear to affect the patient's response to treatment (p = 0.183).
Conclusions:
Liposomal tretinoin is a new therapeutic agent that has been reported to have some clinical activity in patients with aids-associated kaposi sarcoma. a three-times-per-week dosing schedule was noted to be more effective compared with a once-a-week schedule without any significant difference in toxicity reported.