Topical treatment of cutaneous lesions of acquired immunodeficiency syndrome-related Kaposi sarcoma using alitretinoin gel - Results of phase 1 and 2trials
M. Duvic et al., Topical treatment of cutaneous lesions of acquired immunodeficiency syndrome-related Kaposi sarcoma using alitretinoin gel - Results of phase 1 and 2trials, ARCH DERMAT, 136(12), 2000, pp. 1461-1469
Objective: To evaluate the efficacy and safety of topical alitretinoin gel
(9-cis-retinoic acid [LGD 1057], Panretin gel, Ligand Pharmaceuticals, Inc,
San Diego, Calif) in cutaneous Kaposi sarcoma (KS).
Design: Open-label, within-patient, controlled, dose-escalating phase 1 and
2 clinical trials. In all patients, 1 or more cutaneous KS lesions were tr
eated with alitretinoin gel, and at least 2 other lesions served as untreat
ed controls for up to 16 weeks. Alitretinoin (0.05% or 0.1% gel) was applie
d twice daily for the first 2 weeks and up to 4 times daily thereafter, if
tolerated.
Setting: Nine academic clinical centers.
Patients: One hundred fifteen patients with biopsy-proven acquired immunode
ficiency syndrome (AIDS)-related KS.
Main Outcome Measures: AIDS Clinical Trials Group response criteria.
Results: Statistically significant clinical responses were observed in 31 (
27%) of 115 patients for the group of treated index lesions compared with 1
3 (11%) for the group of untreated control lesions (P<.001). Responses occu
rred with low CD4(+) lymphocyte counts (<200 cells/muL) and in some patient
s with refractory response to previous systemic anti-KS therapy. The incide
nce of disease progression was significantly lower for treated index lesion
s compared with untreated control lesions (39/115 [34%] vs 53/115 [46%]; P=
.02). Alitretinoin gel generally was well tolerated, with 90% of treatment-
related adverse events confined to the application site and only mild or mo
derate in severity.
Conclusions: Alitretinoin gel has significant antitumor activity as a topic
al treatment for AIDS-related KS lesions, substantially reduces the inciden
ce of disease progression in treated lesions, and is generally well tolerat
ed.