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

Abstract

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. Methods: 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%. Results: 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 m2 (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/mm3, systemic illness or KPS <70%. GEM dosing was: 1 g (n=19), 1 g/m2 (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. Conclusions: 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. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Eli Lilly