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Role of topotecan, vinorelbine, thiotepa, and gemcitabine (TVTG) chemotheapy in relapsed/refractory adult acute leukemia: A single-institution retrospective analysis.

6603 Background: Patients with multiply relapsed or refractory acute leukemia (R/R-AL) have very limited treatment options and dismal prognosis. Limited data is available about the role of TVTG in adult patients with acute leukemia (AML or ALL). Our report is the largest retrospective analysis of TVTG in this population.


METHODS
From 2004 to 2010 we identified 18 patients (pts) with R/R-AL received TVTG regimen (Table). Primary end points were complete response (CR) rate and the rate of pts reaching allogeneic transplant (allo-SCT). Secondary end points included partial response (PR) and grade 3-4 adverse events (AE) rates. CR was defined as <5% blasts in the bone marrow (BM) and PR as 5-25%, each with recovery of peripheral counts. PRa was defined as BM aplasia/hypoplasia with <5% blasts, but without hematopoietic recovery.


RESULTS
Of the 18 pts (12 male) who received TVTG, 15 had AML (11 relapsed) and 3 had ALL (pre-B-cell type, 2 relapsed). Median age at initial diagnosis was 45.5 years (19-63), and median age at treatment with TVTG was 46.5 years. All received gemcitabine on day 7 except 1 pt (Table). Overall response rate (CR, PR, PRa) was 33% (6 pts). Four pts (22%) achieved CR. In AML pts, 2 out of 15 had CR (13%), 1 had PR (7%) and 1 had PRa (7%). In ALL pts, 2 out of 3 achieved CR (67%). A total of 4 pts (22%) proceeded to allo-SCT; 3 while in CR after TVTG. The median time from CR to transplant was 4 weeks. 7 out of 18 pts died within 6 weeks of therapy of which 4 (28%) died within 30 days; deaths were attributed to severe infections and/or refractory disease. Hematologic and infectious AE were almost universal. Other common grade 3-4 AE included hyperbilirubinemia in 8 pts (44%) and diarrhea in 6 pts (33%).


CONCLUSIONS
In heavily pretreated adult R/R-AL pts, TVTG is a reasonable option for ALL as salvage therapy prior to allo-SCT. The benefit in AML pts is less defined, with high AE and therapy-related mortality rates. New therapies are warranted for R/R-AL. [Table: see text].