Gemcitabine for previously treated AIDS-related Kaposi's sarcoma: The Western Kenya experience.

10566 Background: The Academic Model for the Prevention and Treatment of HIV (AMPATH) Oncology Program in collaboration with Moi Teaching and Referral Hospital provides treatment for patients (pts) with AIDS-related Kaposi's sarcoma (AR-KS) and other AIDS- related malignancies in Western Kenya. The objectives of this study are to evaluate the activity of gemcitabine (GEM) in previously treated pts with AR-KS and assess the feasibility of chemotherapy administration in a developing country.,A retrospective chart review was conducted for 23 consecutive pts receiving GEM from Aug 2006 to Oct 2007. All pts were on HAART and failed prior doxorubicin, bleomycin, and vincristine-based therapy. Responses were evaluated 4 wks after the last dose of GEM and at the last follow-up visit. Pts free of all lesions were considered to have a complete response (CR). A partial response (PR) was defined as a >50% reduction in lesions. Clinical benefit response (CBR) was defined as ≥50% reduction in pain intensity, ≥ 50% reduction in analgesic consumption, ≥20 point increase in KPS, and/or a weight gain of ≥7%.,The population consisted of 19 males (82.6%) and 4 females (17.4%); the mean age was 38 yrs (range: 20-57). Average BSA was 1.73 m (range: 1.5-2.1). Pts were on HAART for an average of 13.4 mos (range: 4 - 41) before starting GEM. According to the AIDS Clinical Trials Group Oncology Committee classification of AR- KS, all pts were poor-risk based on tumor extent, CD4 cell count < 200 cells/mm, systemic illness or KPS <70%. GEM dosing was: 1 g (n=19), 1 g/m (n=3), or both (n=1). Pts received a mean of 7.4 doses (range: 3-15). Average time between doses was 18.6 days. Objective response was seen in 11 pts (CR-3, PR-8; CR+PR= 48%); 11 were classified with stable disease (SD) and 1 with progressive disease (PD). CBR occurred in 15 pts (65%). Mean progression-free survival was 3.8 mos. With a median follow-up of 5.1 mos, 2 pts were still receiving chemotherapy, 3 were lost to follow-up, and 18 completed chemotherapy; 5 pts progressed and one died from hepatoma.,Despite modest dosages, GEM may have activity in previously treated AR-KS. While barriers to treatment exist in Kenya, it is feasible to successfully administer GEM on a modified schedule. Further studies are warranted to confirm activity. [Table: see text].