Baseline patient demographics and clinical characteristics (intention-to-treat population)
| . | Pola-R-CHP (n = 141) . | R-CHOP (n = 140) . |
|---|---|---|
| Median age (range), y | 63 (19-79) | 64 (23-78) |
| Age, n (%) | ||
| <65 y | 83 (58.9) | 73 (52.1) |
| ≥65 y | 58 (41.1) | 67 (47.9) |
| Sex, n (%) | ||
| Female | 70 (49.6) | 62 (44.3) |
| Male | 71 (50.4) | 78 (55.7) |
| Country, n (%) | ||
| Mainland China | 75 (53.2) | 75 (53.6) |
| Japan | 43 (30.5) | 42 (30.0) |
| Republic of Korea | 15 (10.6) | 16 (11.4) |
| Taiwan | 8 (5.7) | 7 (5.0) |
| Ann Arbor stage, n (%) | ||
| I-II | 19 (13.5) | 21 (15.0) |
| III-IV | 122 (86.5) | 119 (85.0) |
| Extranodal sites, n (%) | ||
| 0-1 | 77 (54.6) | 82 (58.6) |
| ≥2 | 64 (45.4) | 58 (41.4) |
| Bulky disease, n (%)∗ | ||
| <7.5 cm | 97 (68.8) | 93 (66.4) |
| ≥7.5 cm | 44 (31.2) | 47 (33.6) |
| ECOG PS, n (%) | ||
| 0-1 | 116 (82.3) | 121 (86.4) |
| 2 | 25 (17.7) | 19 (13.6) |
| LDH level, n (%) | ||
| Normal | 45 (31.9) | 41 (29.3) |
| Elevated | 96 (68.1) | 99 (70.7) |
| IPI score, n (%)∗ | ||
| 2 | 54 (38.3) | 53 (37.9) |
| 3–5 | 87 (61.7) | 87 (62.1) |
| Median time from initial diagnosis to treatment initiation (IQR), days | 17 (10-29) | 15 (10-26) |
| Cell of origin, n (%)† | n = 100 | n = 100 |
| GCB | 30 (30.0) | 40 (40.0) |
| ABC | 55 (55.0) | 46 (46.0) |
| Unclassified | 15 (15.0) | 14 (14.0) |
| DEL, n (%)† | n = 110 | n = 113 |
| DEL | 35 (31.8) | 41 (36.3) |
| Non-DEL | 75 (68.2) | 72 (63.7) |
| Double-/triple-hit lymphoma, n (%)† | n = 103 | n = 99 |
| Yes | 3 (2.9) | 5 (5.1) |
| No | 100 (97.1) | 94 (94.9) |
| Previous history of hepatitis B infection‡ | 45 (32.1)§ | 59 (42.4)§ |
| . | Pola-R-CHP (n = 141) . | R-CHOP (n = 140) . |
|---|---|---|
| Median age (range), y | 63 (19-79) | 64 (23-78) |
| Age, n (%) | ||
| <65 y | 83 (58.9) | 73 (52.1) |
| ≥65 y | 58 (41.1) | 67 (47.9) |
| Sex, n (%) | ||
| Female | 70 (49.6) | 62 (44.3) |
| Male | 71 (50.4) | 78 (55.7) |
| Country, n (%) | ||
| Mainland China | 75 (53.2) | 75 (53.6) |
| Japan | 43 (30.5) | 42 (30.0) |
| Republic of Korea | 15 (10.6) | 16 (11.4) |
| Taiwan | 8 (5.7) | 7 (5.0) |
| Ann Arbor stage, n (%) | ||
| I-II | 19 (13.5) | 21 (15.0) |
| III-IV | 122 (86.5) | 119 (85.0) |
| Extranodal sites, n (%) | ||
| 0-1 | 77 (54.6) | 82 (58.6) |
| ≥2 | 64 (45.4) | 58 (41.4) |
| Bulky disease, n (%)∗ | ||
| <7.5 cm | 97 (68.8) | 93 (66.4) |
| ≥7.5 cm | 44 (31.2) | 47 (33.6) |
| ECOG PS, n (%) | ||
| 0-1 | 116 (82.3) | 121 (86.4) |
| 2 | 25 (17.7) | 19 (13.6) |
| LDH level, n (%) | ||
| Normal | 45 (31.9) | 41 (29.3) |
| Elevated | 96 (68.1) | 99 (70.7) |
| IPI score, n (%)∗ | ||
| 2 | 54 (38.3) | 53 (37.9) |
| 3–5 | 87 (61.7) | 87 (62.1) |
| Median time from initial diagnosis to treatment initiation (IQR), days | 17 (10-29) | 15 (10-26) |
| Cell of origin, n (%)† | n = 100 | n = 100 |
| GCB | 30 (30.0) | 40 (40.0) |
| ABC | 55 (55.0) | 46 (46.0) |
| Unclassified | 15 (15.0) | 14 (14.0) |
| DEL, n (%)† | n = 110 | n = 113 |
| DEL | 35 (31.8) | 41 (36.3) |
| Non-DEL | 75 (68.2) | 72 (63.7) |
| Double-/triple-hit lymphoma, n (%)† | n = 103 | n = 99 |
| Yes | 3 (2.9) | 5 (5.1) |
| No | 100 (97.1) | 94 (94.9) |
| Previous history of hepatitis B infection‡ | 45 (32.1)§ | 59 (42.4)§ |
DEL, double-expressor lymphoma; ECOG PS, Eastern Cooperative Oncology Group performance status; GCB, germinal center B-cell subtype; IQR, interquartile range; LDH, lactate dehydrogenase.
Based on stratification.
Centrally performed tests: cell-of-origin identification was performed by NanoString Lymph 2Cx; MYC and BCL2 immunohistochemistry were performed for DEL; MYC and BCL2, and/or BCL6 rearrangements were performed for double- and triple-hit lymphoma; percentages are calculated from the evaluable population. The remainder of the results were considered unknown and/or represent test failures.
Based on laboratory data at screening (hepatitis B core antibody detected).
Based on the safety-evaluable population; Pola-R-CHP, n = 140; R-CHOP, n = 139.