Table 2. Investigator-Reported Best Overall Responseto Alvocidib in the ITT Population.
Hybrid Criteriaa | NCI-96 Criteriab | |||
---|---|---|---|---|
Number | Percent | Number | Percent | |
Overall Response Rate | 41 | 25 | 50 | 30 |
Complete Response | 3 | 2 | 6 | 4 |
Nodular Partial Response (nPR) | 2 | 1 | 2 | 1 |
Partial Response | 36 | 22 | 42 | 26 |
Stable Disease | 53 | 32 | 66 | 40 |
Disease Progression | 21 | 13 | 26 | 16 |
Not assessed | 50a | 30 | 23b | 14 |
del(17p) (n = 49) | 7 | 14 | 13 | 27 |
del(11q) (n = 43)c | 11 | 26 | 12 | 28 |
Bulky lymphadenopathy (n = 115) | 29 | 25 | 33 | 29 |
“Double refractory”d (n = 48) | 5 | 10 | 7 | 15 |
TLS (n = 39) | 12 | 31 | 15 | 38 |
Of the 50 patients not assessed for best response, 6 were never treated with alvocidib and 28 receivedonly one treatment cycle. The remaining 16 patients received between 2 and 6 cycles of treatment, but the investigator failed to report a best response by hybrid criteria. No missing data imputation was performed.
Of the 23 patients who were not assessed for best response, 6 were never treated with alvocidib and 14 had only one treatment cycle. The remaining 3 patients received 2 or 3 cycles of treatment, but the investigator failed to report a best response by NCI 96 criteria. No missing data imputation was performed.
Classified according to Döhner, et al31.
Refractory to both fludarabine and alemtuzumab