Clinical Study

Phase II Study of Bortezomib as a Single Agent in Patients with Previously Untreated or Relapsed/Refractory Acute Myeloid Leukemia Ineligible for Intensive Therapy

Table 3

The extent of antileukemic effect induced by bortezomib is reported for peripheral blood and bone marrow of 13 evaluable patients affected with acute myeloid leukemia. Comparison was performed between baseline values and the time when the maximum effect was recorded.

PatientsMaximum variation in PB blast count (×109/L)Maximum variation in BM blast (%)Variation in ANC (×109/L)Therapy duration (days)Antileukemic activity
(% reduction)1

1 0.37→0.02n.v.0.15→0.3211PB (93%)
20.54→0.3453→503.3→1.252PB (37%), BM (6%)
30.04→160→910.16→0.0285progression
41.81→1.140→160.98→0.2532PB (39%), BM (60%)
57.22→3.42n.v.0→0.2432PB (53%)
61.73→1.8070→701.01→1.7828stable disease
72.5→5.560→604.64→2.130progression
80.95→1.845→800.74→1.7830progression
92.31→74.1675→701.87→2.7911BM (7%)
101.2→0.0230→580.51→1.054PB (99%)
110.13→0.0980→800.6→190PB (93%)
120.36→1.2717→500.35→0.3558progression
131.2→0.840→351.8→1.811PB (33%) BM (13%)

Abbreviations: PB: peripheral blood; BM: bone marrow; ANC: absolute neutrophil count; n.v.: not evaluable; PB: decrease in PB blast count; BM: decrease in BM blast count.
1In brackets, PB and/or BM blast reduction is reported as percentage difference compared to the baseline evaluation.