Demographics and baseline characteristics of the EORTC QLQ-C30– and EQ-5D-5L–evaluable populations
| Parameter/category . | EORTC QLQ-C30–evaluable population (n = 181)* . | EQ-5D-5L–evaluable population (n = 186)† . |
|---|---|---|
| Age, y | ||
| Mean (SD) | 60.2 (14.0) | 60.1 (13.9) |
| Median | 63.0 | 63.0 |
| Age group, n (%), y | ||
| <65 | 105 (58) | 109 (59) |
| ≥65 | 76 (42) | 77 (41) |
| <75 | 162 (90) | 166 (89) |
| ≥75 | 19 (10) | 20 (11) |
| Sex, n (%) | ||
| Male | 117 (65) | 121 (65) |
| Female | 64 (35) | 65 (35) |
| Race, n (%) | ||
| White | 155 (86) | 158 (85) |
| Other | 17 (9) | 18 (10) |
| Unknown/missing | 9 (5) | 10 (5) |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 20 (11) | 21 (11) |
| Not Hispanic/Latino | 153 (85) | 157 (84) |
| Unknown | 8 (4) | 8 (4) |
| ECOG PS at screening, n (%) | ||
| 0 | 73 (40) | 73 (39) |
| 1 | 107 (59) | 112 (60) |
| 2 | 1 (1) | 1 (1) |
| Pre–liso-cel ECOG PS, n (%)‡ | ||
| 0 | 44 (24) | 44 (24) |
| 1 | 127 (70) | 132 (71) |
| 2 | 8 (4) | 8 (4) |
| 3 | 1 (1) | 1 (1) |
| Type of B-cell non-Hodgkin lymphoma, n (%) | ||
| DLBCL NOS | 98 (54) | 99 (53) |
| HGBCL | 19 (10) | 21 (11) |
| DLBCL transformed from indolent lymphoma | 50 (28) | 51 (27) |
| Follicular lymphoma | 41 (23) | 42 (23) |
| CLL/SLL | 2 (1) | 2 (1) |
| Marginal zone lymphoma | 5 (3) | 5 (3) |
| Other | 2 (1) | 2 (1) |
| PMBCL | 13 (7) | 14 (8) |
| FL3B | 1 (1) | 1 (1) |
| Refractory or relapsed, n (%)§ | ||
| Refractory | 141 (78) | 145 (78) |
| Relapsed | 40 (22) | 41 (22) |
| Chemotherapy refractory or chemotherapy sensitive, n (%)|| | ||
| Chemotherapy refractory | 122 (67) | 125 (67) |
| Chemotherapy sensitive | 59 (33) | 61 (33) |
| Active CNS disease at first liso-cel infusion, n (%) | ||
| Yes | 3 (2) | 3 (2) |
| No | 178 (98) | 183 (98) |
| Number of prior systemic treatment regimens, n (%)¶ | ||
| 1 | 5 (3) | 6 (3) |
| 2 | 92 (51) | 93 (50) |
| 3 | 45 (25) | 47 (25) |
| 4 | 23 (13) | 24 (13) |
| 5-8 | 16 (9) | 16 (9) |
| Best response to any prior therapy, n (%) | ||
| Complete response | 106 (59) | 110 (59) |
| Partial response | 52 (29) | 53 (28) |
| Stable disease | 11 (6) | 11 (6) |
| Progressive disease | 12 (7) | 12 (6) |
| Time from diagnosis to first liso-cel infusion, months, mean (SD) | 32.3 (35.7) | 32.3 (35.4) |
| Received bridging therapy, n (%)# | 99 (55) | 102 (55) |
| Parameter/category . | EORTC QLQ-C30–evaluable population (n = 181)* . | EQ-5D-5L–evaluable population (n = 186)† . |
|---|---|---|
| Age, y | ||
| Mean (SD) | 60.2 (14.0) | 60.1 (13.9) |
| Median | 63.0 | 63.0 |
| Age group, n (%), y | ||
| <65 | 105 (58) | 109 (59) |
| ≥65 | 76 (42) | 77 (41) |
| <75 | 162 (90) | 166 (89) |
| ≥75 | 19 (10) | 20 (11) |
| Sex, n (%) | ||
| Male | 117 (65) | 121 (65) |
| Female | 64 (35) | 65 (35) |
| Race, n (%) | ||
| White | 155 (86) | 158 (85) |
| Other | 17 (9) | 18 (10) |
| Unknown/missing | 9 (5) | 10 (5) |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 20 (11) | 21 (11) |
| Not Hispanic/Latino | 153 (85) | 157 (84) |
| Unknown | 8 (4) | 8 (4) |
| ECOG PS at screening, n (%) | ||
| 0 | 73 (40) | 73 (39) |
| 1 | 107 (59) | 112 (60) |
| 2 | 1 (1) | 1 (1) |
| Pre–liso-cel ECOG PS, n (%)‡ | ||
| 0 | 44 (24) | 44 (24) |
| 1 | 127 (70) | 132 (71) |
| 2 | 8 (4) | 8 (4) |
| 3 | 1 (1) | 1 (1) |
| Type of B-cell non-Hodgkin lymphoma, n (%) | ||
| DLBCL NOS | 98 (54) | 99 (53) |
| HGBCL | 19 (10) | 21 (11) |
| DLBCL transformed from indolent lymphoma | 50 (28) | 51 (27) |
| Follicular lymphoma | 41 (23) | 42 (23) |
| CLL/SLL | 2 (1) | 2 (1) |
| Marginal zone lymphoma | 5 (3) | 5 (3) |
| Other | 2 (1) | 2 (1) |
| PMBCL | 13 (7) | 14 (8) |
| FL3B | 1 (1) | 1 (1) |
| Refractory or relapsed, n (%)§ | ||
| Refractory | 141 (78) | 145 (78) |
| Relapsed | 40 (22) | 41 (22) |
| Chemotherapy refractory or chemotherapy sensitive, n (%)|| | ||
| Chemotherapy refractory | 122 (67) | 125 (67) |
| Chemotherapy sensitive | 59 (33) | 61 (33) |
| Active CNS disease at first liso-cel infusion, n (%) | ||
| Yes | 3 (2) | 3 (2) |
| No | 178 (98) | 183 (98) |
| Number of prior systemic treatment regimens, n (%)¶ | ||
| 1 | 5 (3) | 6 (3) |
| 2 | 92 (51) | 93 (50) |
| 3 | 45 (25) | 47 (25) |
| 4 | 23 (13) | 24 (13) |
| 5-8 | 16 (9) | 16 (9) |
| Best response to any prior therapy, n (%) | ||
| Complete response | 106 (59) | 110 (59) |
| Partial response | 52 (29) | 53 (28) |
| Stable disease | 11 (6) | 11 (6) |
| Progressive disease | 12 (7) | 12 (6) |
| Time from diagnosis to first liso-cel infusion, months, mean (SD) | 32.3 (35.7) | 32.3 (35.4) |
| Received bridging therapy, n (%)# | 99 (55) | 102 (55) |
CLL, chronic lymphocytic leukemia; CNS, central nervous system; ECOG PS, Eastern Cooperative Oncology Group performance status; FL3B, follicular lymphoma grade 3B; HGBCL, high-grade B-cell lymphoma; NOS, not otherwise specified; PMBCL, primary mediastinal B-cell lymphoma; SLL, small lymphocytic lymphoma.
Liso-cel–treated patients for whom all scales were analyzable (ie, answers were provided for ≥50% of the items for each scale) at baseline, and at least 1 scale was amenable to postbaseline analysis.
Liso-cel–treated patients with baseline data for both the EQ-5D-5L index score and the VAS and at least 1 postbaseline assessment for the EQ-5D-5L index score or the VAS.
The most recent ECOG PS after lymphodepleting chemotherapy and before liso-cel infusion.
Relapse was defined as best response to last systemic or transplant treatment with curative intent of complete response; refractory was defined as best response of partial response, stable disease, or progressive disease.
Chemotherapy refractory was defined as stable disease or progressive disease during the last chemotherapy-containing regimen or relapse <12 months after autologous stem cell transplantation. Patients who did not fulfill these criteria were categorized as chemotherapy sensitive.
The original study protocol enrolled patients with at least 2 previous lines of treatment, but there was no requirement for at least 2 previous lines of systemic treatment. As a result, 9 enrolled patients had received only 1 previous line of systemic treatment (plus consolidation with hematopoietic stem cell transplantation or radiation therapy). During enrollment, the protocol was amended to require at least 2 previous lines of systemic treatment.
Systemic treatment and/or radiotherapy provided after consent and before lymphodepleting chemotherapy.