Table 1.
Demographics and baseline characteristics for the matched analysis sets for systemic therapies pooled, BR, and R-GemOx with the absolute standardized difference for covariates used for 1:1 NN matching.
| MAS for systemic therapies pooled | MAS for BR | MAS for R-GemOx | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Tafasitamab + lenalidomide | Systemic therapies pooled | Absolute standardized difference | Tafasitamab + lenalidomide | BR | Absolute standardized difference | Tafasitamab + lenalidomide | R-GemOx | Absolute standardized difference | ||
| (n = 76) | (n = 76) | (n = 75) | (n = 75) | (n = 74) | (n = 74) | |||||
| Cohort balancing characteristics | ||||||||||
| Age, n (%) | Age < 70 years | 33 (43.4) | 31 (40.8) | 0.05 | 33 (44.0) | 33 (44.0) | 0.00 | 31 (41.9) | 26 (35.1) | 0.14 |
| Age ≥ 70 years | 43 (56.6) | 45 (59.2) | 42 (56.0) | 42 (56.0) | 43 (58.1) | 48 (64.9) | ||||
| Ann Arbor stage, n (%) | I+II | 19 (25.0) | 19 (25.0) | 0.00 | 18 (24.0) | 19 (25.3) | 0.03 | 18 (24.3) | 15 (20.3) | 0.10 |
| III+IV | 57 (75.0) | 57 (75.0) | 57 (76.0) | 56 (74.7) | 56 (75.7) | 59 (79.7) | ||||
| Refractoriness to last prior therapy, n (%) | Yes | 34 (44.7) | 35 (46.1) | 0.03 | 33 (44.0) | 32 (42.7) | 0.03 | 33 (44.6) | 29 (39.2) | 0.11 |
| No | 42 (55.3) | 41 (53.9) | 42 (56.0) | 43 (57.3) | 41 (55.4) | 45 (60.8) | ||||
| Number of prior systemic treatment lines, n (%) | 1 | 39 (51.3) | 39 (51.3) | 0.00 | 39 (52.0) | 39 (52.0) | 0.00 | 39 (52.7) | 41 (55.4) | 0.05 |
| 2/3 | 37 (48.7) | 37 (48.7) | 36 (48.0) | 36 (48.0) | 35 (47.3) | 33 (44.6) | ||||
| History of primary refractoriness, n (%) | Yes | 14 (18.4) | 12 (15.8) | 0.07 | 14 (18.7) | 19 (25.3) | 0.16 | 14 (18.9) | 14 (18.9) | 0.00 |
| No | 62 (81.6) | 64 (84.2) | 61 (81.3) | 56 (74.7) | 60 (81.1) | 60 (81.1) | ||||
| Prior ASCT, n (%) | Yes | 9 (11.8) | 10 (13.2) | 0.04 | 9 (12.0) | 14 (18.7) | 0.19 | 8 (10.8) | 8 (10.8) | 0.00 |
| No | 67 (88.2) | 66 (86.8) | 66 (88.0) | 61 (81.3) | 66 (89.2) | 66 (89.2) | ||||
| Elevated LDH (> ULN), n (%) | LDH > ULN | 41 (53.9) | 44 (57.9) | 0.08 | 41 (54.7) | 37 (49.3) | 0.11 | 41 (55.4) | 48 (64.9) | 0.19 |
| LDH < ULN | 35 (46.1) | 32 (42.1) | 34 (45.3) | 38 (50.7) | 33 (44.6) | 26 (35.1) | ||||
| Neutropenia (cutoff < 1.5×109/L), n (%) | ANC < 1.5×109/L | 2 (2.6) | 2 (2.6) | 0.00 | 2 (2.7) | 4 (5.3) | 0.14 | 2 (2.7) | 5 (6.8) | 0.19 |
| ANC ≥ 1.5×109/L | 74 (97.4) | 74 (97.4) | 73 (97.3) | 71 (94.7) | 72 (97.3) | 69 (93.2) | ||||
| Anemia (cutoff hemoglobin < 10 g/dL), n (%) | Hb < 10 g/dL | 6 (7.9) | 5 (6.6) | 0.05 | 6 (8.0) | 5 (6.7) | 0.05 | 6 (8.1) | 5 (6.8) | 0.05 |
| Hb > 10 g/dL | 70 (92.1) | 71 (93.4) | 69 (92.0) | 70 (93.3) | 68 (91.9) | 69 (93.2) | ||||
| Other characteristics | ||||||||||
| Sex, n (%) | Female | 36 (47.4) | 32 (42.1) | 36 (48.0) | 30 (40.0) | 35 (47.3) | 38 (51.4) | |||
| Male | 40 (52.6) | 44 (57.9) | 39 (52.0) | 45 (60.0) | 39 (52.7) | 36 (48.6) | ||||
| Age at index date, years | Mean (SD) | 69.1 (9.71) | 68.7 (11.88) | 69.0 (9.75) | 69.3 (9.23) | 69.5 (9.59) | 71.0 (9.64) | |||
| Median (Q1–Q3) | 71.5 (62.0–76.0) | 72.0 (60.0–77.0) | 71.0 (62.0–76.0) | 71.0 (62.0–76.0) | 72.0 (62.0–76.0) | 73.5 (66.0–77.0) | ||||
| Range (min–max) | 41–86 | 37–87 | 41–86 | 48–86 | 41–86 | 40–87 | ||||
| ECOG PS, n (%) | 0 | 29 (38.2) | 17 (22.4) | 29 (38.7) | 11 (14.7) | 28 (37.8) | 15 (20.3) | |||
| 1 | 41 (53.9) | 27 (35.5) | 40 (53.3) | 29 (38.7) | 40 (54.1) | 22 (29.7) | ||||
| 2 | 6 (7.9) | 18 (23.7) | 6 (8.0) | 20 (26.7) | 6 (8.1) | 22 (29.7) | ||||
| 3 | 0 | 3 (3.9) | 0 | 3 (4.0) | 0 | 5 (6.8) | ||||
| 4 | 0 | 0 | 0 | 0.00 | 0 | 1 (1.4) | ||||
| Race, n (%) | Black or African American | 0 | 6 (7.9) | 0 | 12 (16.0) | 0 | 10 (13.5) | |||
| American Indian | 0 | 1 (1.3) | 0 | 0.00 | 0 | 1 (1.4) | ||||
| Asian | 0 | 9 (11.8) | 0 | 13 (17.3) | 0 | 2 (2.7) | ||||
| Native Hawaiian or other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 1 (1.4) | ||||
| White | 70 (92.1) | 49 (64.5) | 69 (92.0) | 36 (48.0) | 68 (91.9) | 49 (66.2) | ||||
| Unknown | 0.00 | 4 (5.3) | 0.00 | 11 (14.7) | 0.00 | 3 (4.1) | ||||
| Other | 1 (1.3) | 7 (9.2) | 1 (1.3) | 3 (4.0) | 1 (1.4) | 8 (10.8) | ||||
| Missing | 5 (6.6) | 0 | 5 (6.7) | 0 | 5 (6.8) | 0.00 | ||||
| Primary progressive disease, n (%) | Yes | 2 (2.6) | 5 (6.6) | 2 (2.7) | 8 (10.7) | 2 (2.7) | 6 (8.1) | |||
| No | 74 (97.4) | 71 (93.4) | 73 (97.3) | 67 (89.3) | 72 (97.3) | 68 (91.9) | ||||
| Early relapse, n (%) | Yes | 12 (15.8) | 7 (9.2) | 12 (16.0) | 11 (14.7) | 12 (16.2) | 8 (10.8) | |||
| No | 64 (84.2) | 69 (90.8) | 63 (84.0) | 64 (85.3) | 62 (83.8) | 66 (89.2) | ||||
| Imaging modalities used for best tumor response assessment | Patients with best tumor response assessment performeda | 70 (92.1) | 71 (93.4) | 69 (92.0) | 68 (90.7) | 68 (91.9) | 72 (97.3) | |||
| No radiologic assessment doneb | 0 | 1 (1.4) | 0 | 0 | 0 | 0 | ||||
| PET/CT b | 14 (20.0) | 36 (50.7) | 14 (20.3) | 45 (66.2) | 14 (20.6) | 39 (54.2) | ||||
| PET/MRIb | 0 | 1 (1.4) | 0 | 0 | 0 | 0 | ||||
| PET onlyb | 0 | 1 (1.4) | 0 | 0 | 0 | 1 (1.4) | ||||
| MRIb | 2 (2.9) | 2 (2.8) | 2 (2.9) | 0 | 2 (2.9) | 1 (1.4) | ||||
| CTb | 54 (77.1) | 24 (33.8) | 53 (76.8) | 15 (22.1) | 52 (76.5) | 28 (38.9) | ||||
| Unknownb | 0 | 1 (1.4) | 0 | 1 (1.5) | 0 | 0 | ||||
| Otherb | 0 | 5 (7.0) | 0 | 7 (10.3) | 0 | 3 (4.2) | ||||
Abbreviations: ANC, absolute neutrophil count; ASCT, autologous stem-cell transplant; BR, bendamustine + rituximab; CT, computed tomography; ECOG PS, Eastern Cooperative Oncology Group performance status; Hb, hemoglobin; LDH, lactate dehydrogenase; MAS, matched analysis set; N, total number of patients in that cohort; MRI, magnetic resonance imaging; n, number of patients with nonmissing values for that variable; PET, positron emission tomography; Q1, lower quartile; Q3, upper quartile; R-GemOx, rituximab + gemcitabine + oxaliplatin; SD, standard deviation; ULN, upper limit of normal.
aPercentages were calculated based on the number of patients in each cohort with best response.
bPercentages were calculated based on the number of patients with assessments in each cohort with best response.