Patient and disease characteristics in comparison with the ZUMA-1 phase 2 trial cohort
| Baseline characteristics . | Stanford . | ZUMA-1 . | P . |
|---|---|---|---|
| Patients, N | 41 | 101 | |
| Age, median (range), y | 56 (21-76) | 58 (23-76) | |
| Males | 24 (58.5) | 68 (67) | |
| ECOG PS score* | |||
| 0 | 12 (29.3) | 42 (42) | .04 |
| 1 | 26 (63.4) | 59 (58) | |
| 2 | 3 (7.3) | ||
| Disease classification | |||
| DLBCL | 26 (63.4) | 77 (76) | |
| TFL | 12 (29.3) | 16 (16) | |
| PMBCL | 3 (7.3) | 8 (8) | |
| Double-expressor status† | 20 (55.6) | 27 (62.8) | |
| Double- or triple-hit status‡ | 9 (24.3) | 6 (14) | |
| Non-GCB cell-of-origin status§ | 19 (48.7) | 18 (24.3) | .01 |
| Disease stage | |||
| 1-2 | 9 (22) | 15 (15) | |
| 3-4 | 32 (78) | 86 (85) | |
| IPI score | |||
| 0-2 | 24 (58.5) | 53 (52) | |
| 3-4 | 17 (41.5) | 48 (48) | |
| Prior therapies | |||
| Number of lines, median (IQR) | 3 (2-4) | 3 (2-4) | |
| ≥3 lines | 25 (61) | 70 (69) | |
| Chemorefractory disease at apheresis¶ | 38 (92.7) | 101 (100) | .02 |
| History of primary refractory disease | 19 (46.3) | 26 (26) | .03 |
| Relapse after autologous SCT | 8 (19.5) | 21 (21) | |
| ZUMA-1 ineligible at apheresis|| | 16 (39) |
| Baseline characteristics . | Stanford . | ZUMA-1 . | P . |
|---|---|---|---|
| Patients, N | 41 | 101 | |
| Age, median (range), y | 56 (21-76) | 58 (23-76) | |
| Males | 24 (58.5) | 68 (67) | |
| ECOG PS score* | |||
| 0 | 12 (29.3) | 42 (42) | .04 |
| 1 | 26 (63.4) | 59 (58) | |
| 2 | 3 (7.3) | ||
| Disease classification | |||
| DLBCL | 26 (63.4) | 77 (76) | |
| TFL | 12 (29.3) | 16 (16) | |
| PMBCL | 3 (7.3) | 8 (8) | |
| Double-expressor status† | 20 (55.6) | 27 (62.8) | |
| Double- or triple-hit status‡ | 9 (24.3) | 6 (14) | |
| Non-GCB cell-of-origin status§ | 19 (48.7) | 18 (24.3) | .01 |
| Disease stage | |||
| 1-2 | 9 (22) | 15 (15) | |
| 3-4 | 32 (78) | 86 (85) | |
| IPI score | |||
| 0-2 | 24 (58.5) | 53 (52) | |
| 3-4 | 17 (41.5) | 48 (48) | |
| Prior therapies | |||
| Number of lines, median (IQR) | 3 (2-4) | 3 (2-4) | |
| ≥3 lines | 25 (61) | 70 (69) | |
| Chemorefractory disease at apheresis¶ | 38 (92.7) | 101 (100) | .02 |
| History of primary refractory disease | 19 (46.3) | 26 (26) | .03 |
| Relapse after autologous SCT | 8 (19.5) | 21 (21) | |
| ZUMA-1 ineligible at apheresis|| | 16 (39) |
Unless otherwise stated, data are n (%).
DLBCL, diffuse LBCL; ECOG, PS Eastern Cooperative Oncology Group Performance Status; GCB, germinal center B-cell like; IPI, International Prognostic Index; IQR, interquartile range; PMBCL, primary mediastinal B-cell lymphoma; SCT, hematopoietic stem cell transplant; TFL, transformed follicular lymphoma.
Patients were required to have an ECOG PS score = 0 or 1 to be enrolled in the ZUMA-1 study.1,4
Measured by immunohistochemistry; n = 36, no. of patients with available data within the Stanford cohort. n = 43, no. of patients with available data within the ZUMA-1 cohort. In the Stanford cohort, 8 patients were not evaluable.
Measured by fluorescent in situ hybridization. No. of patients with FISH data available in order to determine double- or triple-hit status within each cohort (n = 43, ZUMA-1 cohort; n = 43, Stanford cohort). In the Stanford cohort, all evaluable patients harbored MYC and BCL2 rearrangements; 6 patients were not evaluable.
Determined by immunohistochemistry using Hans algorithm.16 No. of patients with IHC data available in order to determine cell-of-origin status within each cohort (n = 39, Stanford cohort; n = 74, ZUMA-1 cohort). Two patients were not evaluable in the Stanford cohort.
Defined as stable disease or progressive disease to last line of therapy or relapse ≤12 mo following autologous SCT.
Patients would not have been eligible for ZUMA-1 for the following reasons: deep venous thrombosis within 6 mo (n = 4), ECOG PS score = 2 at enrollment (n = 3), autoimmune disease within 2 y (n = 2), history of other malignancy within 3 y (n = 2), clinically significant cardiac disease within 12 mo (n = 2), transaminitis/hyperbilirubinemia (n = 2), grade 2 renal insufficiency (n = 1), grade 3 thrombocytopenia (n = 1), grade 3 neutropenia (n = 1), left ventricular ejection fraction < 50% (n = 1), and clinically significant pleural effusion at enrollment (n = 1).