Outcomes after FCR by patient pretreatment characteristics
| Pretreatment characteristics . | No. of patients . | NCI-WG response, % . | Median . | |||
|---|---|---|---|---|---|---|
| CR . | nPR . | OR . | PFS, mo . | OS, mo . | ||
| All patients | 284 | 30 | 14 | 74 | 21 | 46.5 |
| Age, y* | ||||||
| 0-60 | 154 | 39 | 12 | 74 | 28 | 60 |
| 61-70 | 90 | 23‡ | 19 | 78 | 22 | 48 |
| > 70 | 40 | 13‡ | 13 | 68 | 13‡ | 22§ |
| Rai stage* | ||||||
| 0-II | 154 | 40 | 18 | 84 | 29 | 67 |
| III | 34 | 26§ | 12 | 76 | 21‡ | 48§ |
| IV | 96 | 16§ | 10 | 57§ | 7§ | 31§ |
| Bulky disease† | ||||||
| No | 260 | 32 | 15 | 76 | 23 | 48 |
| Yes | 20 | 10‡ | 6 | 55 | 8 | 20 |
| β2-microglobulin, mg/L* | ||||||
| < 4 | 111 | 45 | 18 | 86 | 33 | 67 |
| 4-5.9 | 92 | 30‡ | 13 | 75 | 20 | 50‡ |
| ≥ 6 | 74 | 7§ | 12 | 57§ | 7‡ | 22§ |
| Karyotype (nd = 102)* | ||||||
| Diploid or 13q deletion | 97 | 34‡ | 18 | 82§ | 27§ | 54§ |
| Trisomy 12 | 16 | 38 | 13 | 69 | 20 | 78 |
| 11q deletion | 13 | 15 | 15 | 69 | 12‡ | 33 |
| Complex | 22 | 9 | 27 | 64 | 9‡ | 26‡ |
| Abnormal chromosome 17 | 20 | 0§ | 5 | 35§ | 5§ | 10.5§ |
| Others | 14 | 29 | 7 | 71 | 27 | 48 |
| No. of prior treatment regimens* | ||||||
| 1 | 116 | 44 | 14 | 82 | 30 | 58 |
| 2 | 80 | 33 | 15 | 75 | 28 | 54 |
| 3 | 46 | 17‡ | 26 | 70 | 20 | 38‡ |
| ≥ 4 | 42 | 2§ | 2 | 57‡ | 9§ | 25§ |
| Fludarabine refractory | ||||||
| No | 230 | 36 | 16 | 79 | 28 | 52 |
| Yes | 54 | 7§ | 9 | 56§ | 8§ | 38‡ |
| Alkylating agent refractory | ||||||
| No | 217 | 36 | 15 | 77 | 27 | 53 |
| Yes | 67 | 10§ | 12 | 66 | 9§ | 39‡ |
| Prior rituximab | ||||||
| No | 186 | 30 | 16 | 76 | 21 | 44 |
| Yes | 98 | 32 | 11 | 71 | 20 | 48 |
| CD38 expression, BM (nd = 35) | ||||||
| < 30% | 175 | 34 | 17 | 77 | 26 | 48 |
| ≥ 30% | 74 | 27 | 11 | 68 | 16‡ | 45 |
| ZAP70 expression, flow (nd = 215) | ||||||
| < 20% | 26 | 31 | 8 | 69 | 24 | 51 |
| ≥ 20% | 43 | 23 | 21 | 72 | 24 | 41 |
| IGHV mutation status (nd = 198) | ||||||
| Mutated | 27 | 33 | 11 | 78 | 44 | NR |
| Unmutated | 59 | 37 | 12 | 86 | 28‡ | 50‡ |
| Pretreatment characteristics . | No. of patients . | NCI-WG response, % . | Median . | |||
|---|---|---|---|---|---|---|
| CR . | nPR . | OR . | PFS, mo . | OS, mo . | ||
| All patients | 284 | 30 | 14 | 74 | 21 | 46.5 |
| Age, y* | ||||||
| 0-60 | 154 | 39 | 12 | 74 | 28 | 60 |
| 61-70 | 90 | 23‡ | 19 | 78 | 22 | 48 |
| > 70 | 40 | 13‡ | 13 | 68 | 13‡ | 22§ |
| Rai stage* | ||||||
| 0-II | 154 | 40 | 18 | 84 | 29 | 67 |
| III | 34 | 26§ | 12 | 76 | 21‡ | 48§ |
| IV | 96 | 16§ | 10 | 57§ | 7§ | 31§ |
| Bulky disease† | ||||||
| No | 260 | 32 | 15 | 76 | 23 | 48 |
| Yes | 20 | 10‡ | 6 | 55 | 8 | 20 |
| β2-microglobulin, mg/L* | ||||||
| < 4 | 111 | 45 | 18 | 86 | 33 | 67 |
| 4-5.9 | 92 | 30‡ | 13 | 75 | 20 | 50‡ |
| ≥ 6 | 74 | 7§ | 12 | 57§ | 7‡ | 22§ |
| Karyotype (nd = 102)* | ||||||
| Diploid or 13q deletion | 97 | 34‡ | 18 | 82§ | 27§ | 54§ |
| Trisomy 12 | 16 | 38 | 13 | 69 | 20 | 78 |
| 11q deletion | 13 | 15 | 15 | 69 | 12‡ | 33 |
| Complex | 22 | 9 | 27 | 64 | 9‡ | 26‡ |
| Abnormal chromosome 17 | 20 | 0§ | 5 | 35§ | 5§ | 10.5§ |
| Others | 14 | 29 | 7 | 71 | 27 | 48 |
| No. of prior treatment regimens* | ||||||
| 1 | 116 | 44 | 14 | 82 | 30 | 58 |
| 2 | 80 | 33 | 15 | 75 | 28 | 54 |
| 3 | 46 | 17‡ | 26 | 70 | 20 | 38‡ |
| ≥ 4 | 42 | 2§ | 2 | 57‡ | 9§ | 25§ |
| Fludarabine refractory | ||||||
| No | 230 | 36 | 16 | 79 | 28 | 52 |
| Yes | 54 | 7§ | 9 | 56§ | 8§ | 38‡ |
| Alkylating agent refractory | ||||||
| No | 217 | 36 | 15 | 77 | 27 | 53 |
| Yes | 67 | 10§ | 12 | 66 | 9§ | 39‡ |
| Prior rituximab | ||||||
| No | 186 | 30 | 16 | 76 | 21 | 44 |
| Yes | 98 | 32 | 11 | 71 | 20 | 48 |
| CD38 expression, BM (nd = 35) | ||||||
| < 30% | 175 | 34 | 17 | 77 | 26 | 48 |
| ≥ 30% | 74 | 27 | 11 | 68 | 16‡ | 45 |
| ZAP70 expression, flow (nd = 215) | ||||||
| < 20% | 26 | 31 | 8 | 69 | 24 | 51 |
| ≥ 20% | 43 | 23 | 21 | 72 | 24 | 41 |
| IGHV mutation status (nd = 198) | ||||||
| Mutated | 27 | 33 | 11 | 78 | 44 | NR |
| Unmutated | 59 | 37 | 12 | 86 | 28‡ | 50‡ |
NCI-WG indicates National Cancer Institute-Working Group; CR, complete remission; nPR, nodular partial remission; OR, overall response; PFS, progression-free survival; OS, overall survival; BM, bone marrow; IGHV, immunoglobulin heavy chain variable gene; LN, lymph node; and nd, not done.
Age, Rai stage, karyotype, β-2 microglobulin and number of prior treatment analysis performed in a hierarchical manner with each group compared to lower-ranked risk groups only (eg, Rai stage III compared to Rai stage 0 to II only). In karyotype analysis, diploid/deletion 13q also compared to all other cytogenetic abnormalities.
Bulky disease, by physical examination lymph nodes greater than 5 cm in maximum diameter.
P < .05,
P < .001 (2-tailed Fisher exact test).