Oral tretinoin (ATRA) is active in acute promyelocytic leukemia (APL) and T-cell NHL. Liposomal encapsulated ATRA (Atragen) is considerably more active than free ATRA when tested against lymphoma cell lines. In addition it downregulates bcl-2. We therefore tested the clinical activity of ATRAGEN in patients with relapsed or refractory NHL or CTCL, 16 years, normal liver function, neutrophils 0.5K, platelets 20K, and no HIV infection, or central nervous system disease. ATRAGEN was given at 120 mg/m2 IV every other day in 28-day courses. Responders were treated for up to 6 courses, with dose adjustment for toxicity. Of the 65 registered pts, 59 are already évaluable for response and are the subject of this report. Median age was 64 years (range 20-80), and 33 were male. Median number of prior regimens was 3 (range 1-11). Serum LDH was high in 50%, and β2-microglobulin 3.0 mg/L in 75% pts. There were 16 responses in 56 pts (27%) with 95% confidence intervals (CI) of 17%-42%. Responses according to histology are shown below: Indolent Aggressive Aggressive B-Cell B-Cell T-Cell CTCL Evaluable 6 16 24 13 CR/PR 03 86 % CR/PR 0 19 33 46 95% Cl 0-46 14-46 17-55 19-75 Most striking was the response rate seen in 13 pts with primary refractory disease of whom 6 responded (2/5 with aggressive B-cell and 4/8 with aggressive T-cell histology). Median progression-free survival was 6 months for responders. There was no ATRA syndrome, serious myelosuppression or toxic deaths. The most common toxicity was headache (N=14; grade 3=7), dry skin (N=9), edema (N=8), arthralgia (N=6; grade 3=1), and xerostomia (N=3). We conclude that ATRAGEN shows promising activity in a heavily pretreated highly unfavorable population.
|Original language||English (US)|
|Issue number||11 PART I|
|State||Published - Dec 1 2000|
ASJC Scopus subject areas
- Cell Biology