Table 2.
Response Rates According to Baseline Characteristics for Patients With Refractory CLL Treated With Ofatumumab
| Baseline Characteristic | FA-ref |
BF-ref |
||||
|---|---|---|---|---|---|---|
| No. of Patients | ORR (%) | P* | No. of Patients | ORR (%) | P* | |
| Age, years | ||||||
| < 65 | 32 | 63 | .4400 | 46 | 48 | 1.00 |
| ≥ 65 | 27 | 52 | 33 | 45 | ||
| < 70 | 49 | 57 | 1.00 | 60 | 48 | .7929 |
| ≥ 70 | 10 | 60 | 19 | 42 | ||
| Prior rituximab | ||||||
| Yes | 35 | 54 | .5984 | 43 | 44 | .6553 |
| No | 24 | 63 | 36 | 50 | ||
| Prior FCR | ||||||
| Refractory to FCR† | 16 | 50 | .5585 | 16 | 44 | 1.00 |
| Other† | 43 | 60 | 63 | 48 | ||
| Prior FC | ||||||
| Refractory to FC‡ | 33 | 64 | .4264 | 46 | 50 | .6480 |
| Other‡ | 26 | 50 | 33 | 42 | ||
| Palpable lymph node size, cm | ||||||
| ≤ 5 | 43 | 56 | 1.00 | 39 | 54 | .1647 |
| > 5 | 11 | 55 | 36 | 36 | ||
| Disease stage | ||||||
| Rai stage I or II | 26 | 58 | 1.00 | 24 | 54 | .4654 |
| Rai stage III or IV | 32 | 56 | 55 | 44 | ||
| ECOG PS | ||||||
| 0-1 | 46 | 59 | 1.00 | 66 | 50 | .2384 |
| 2 | 12 | 58 | 13 | 31 | ||
| FISH cytogenetic abnormalities§ | ||||||
| 17p del | 17 | 41 | .1429 | 14 | 14 | .0073 |
| No 17p del | 40 | 65 | 62 | 55 | ||
| 11q del | 24 | 63 | .5963 | 22 | 64 | .0838 |
| No 11q del | 33 | 55 | 56 | 41 | ||
| 12q trisomy | 3 | 33 | .5669 | 8 | 38 | .7147 |
| No 12q trisomy | 54 | 59 | 70 | 49 | ||
Abbreviations: CLL, chronic lymphocytic leukemia; FA-ref, fludarabine and alemtuzumab refractory; BF-ref, bulky fludarabine refractory; ORR, overall response rate; FCR, fludarabine plus cyclophosphamide and rituximab; FC, fludarabine plus cyclophosphamide; ECOG, Eastern Cooperative Oncology Group; PS, performance status; FISH, fluorescent in situ hybridization.
Two-sided Fisher's exact test.
Patients considered refractory to FCR, with or without other drugs; other represents patients refractory to a fludarabine-based regimen other than that containing FCR.
Patients considered refractory to FC, with or without other drugs; other represents patients refractory to a fludarabine-based regimen other than that containing FC.
Categories adapted from Döhner hierarchical classification of FISH cytogenetic abnormalities.27