Patients’ characteristics at baseline
| Characteristics . | ITT, n = 670 . | Efficacy set, n = 617 . | Per protocol set, n = 594 . | |||
|---|---|---|---|---|---|---|
| Obinutuzumab, n = 336 . | Rituximab, n = 334 . | Obinutuzumab, n = 311 . | Rituximab, n = 306 . | Obinutuzumab, n = 296 . | Rituximab, n = 298 . | |
| Median age (range), y | 49 (19-60) | 48 (18-61) | 49 (19-60) | 47 (18-60) | 49 (19-60) | 47 (18-60) |
| Sex, male, n (%) | 203 (60.4) | 170 (50.9) | 189 (60.8) | 153 (50.0) | 180 (60.8) | 152 (51.0) |
| ECOG | ||||||
| 0-1 | 286 (85.1) | 289 (86.8) | 266 (85.5) | 264 (86.3) | 252 (85.1) | 255 (85.6) |
| >1 | 50 (14.9) | 44 (13.2) | 45 (14.5) | 41 (13.4) | 44 (14.9) | 42 (14.1) |
| Missing | 0 | 1 | 1 | 1 | 0 | 1 |
| Ann Arbor stage, n (%) | ||||||
| I-II | 55 (16.4) | 63 (18.9) | 52 (16.7) | 62 (20.3) | 51 (17.2) | 60 (20.1) |
| III-IV | 281 (83.6) | 271 (81.1) | 259 (83.3) | 244 (79.7) | 245 (82.8) | 238 (79.9) |
| LDH elevated, yes, n (%) | 239 (71.1) | 248 (74.3) | 218 (70.1) | 230 (75.2) | 212 (71.6) | 225 (75.5) |
| aaIPI, n (%) | ||||||
| 0 | 1 (0.3) | 1 (0.3) | 1 (0.3) | 1 (0.3) | 0 (0) | 0 (0) |
| 1 | 142 (42.5) | 138 (41.7) | 135 (43.4) | 126 (41.2) | 128 (43.2) | 123 (41.3) |
| 2 | 149 (44.6) | 156 (47.1) | 136 (43.7) | 143 (46.7) | 129 (43.6) | 138 (46.3) |
| 3 | 42 (12.6) | 36 (10.9) | 37 (11.9) | 33 (10.8) | 37 (12.5) | 34 (11.4) |
| Extranodal involvement, yes, n (%) | 273 (81.3) | 271 (81.1) | 255 (82.0) | 238 (77.8) | 243 (82.1) | 233 (78.2) |
| Bulky disease, >10 cm, n (%) | 104 (31.0) | 109 (32.6) | 95 (30.5) | 101 (33.0) | 87 (29.4) | 99 (33.2) |
| Pathology review, n = 646, n (%) | ||||||
| DLBCL* | 288 (85.7) | 292 (87.4) | 269 (86.5) | 269 (87.9) | 269 (90.9) | 269 (90.3) |
| Misdiagnosis† | 21 (6.3) | 19 (5.7) | 19 (6.1) | 15 (4.9) | 5 (1.7) | 7 (2.3) |
| No or insufficient material | 27 (8.0) | 23 (6.9) | 23 (7.4) | 22 (7.2) | 22 (7.4) | 22 (7.4) |
| COO according to | ||||||
| Hans, n = 411 | ||||||
| GC, n (%) | 114 (55.6) | 125 (60.7) | 107 (55.2) | 119 (64.3) | 107 (55.2) | 118 (63.8) |
| Non-GCB, n (%) | 91 (44.4) | 81 (39.3) | 87 (44.8) | 66 (35.7) | 87 (44.8) | 67 (36.2) |
| No or insufficient material | 47 | 33 | 37 | 31 | 37 | 31 |
| Nanostring, n = 375 | ||||||
| GCB, n (%) | 126 (66.3) | 122 (65.9) | 116 (65.9) | 115 (68.0) | 116 (65.9) | 114 (67.5) |
| ABC, n (%) | 43 (22.6) | 40 (21.6) | 41 (23.3) | 34 (20.1) | 41 (23.3) | 35 (20.7) |
| Unclassified, n (%) | 21 (11.1) | 23 (12.4) | 19 (10.8) | 20 (11.8) | 19 (10.8) | 20 (11.8) |
| No or insufficient material | 62 | 54 | 55 | 47 | 55 | 47 |
| BCL2 expression, n = 544 | ||||||
| ≥70%, n (%) | 186 (69.4) | 208 (75.4) | 174 (68.8) | 188 (74.3) | 167 (68.4) | 186 (74.7) |
| <70%, n (%) | 82 (30.6) | 68 (24.6) | 79 (31.2) | 65 (25.7) | 77 (31.6) | 63 (25.3) |
| No or insufficient material | 70 | 62 | 60 | 55 | 54 | 51 |
| MYC expression, n = 466 | ||||||
| ≥40%, n (%) | 120 (51.7) | 123 (52.6) | 115 (51.6) | 109 (51.2) | 114 (52.8) | 106 (51.0) |
| <40%, n (%) | 112 (48.3) | 111 (47.4) | 108 (48.4) | 104 (48.8) | 102 (47.2) | 102 (49.0) |
| No or insufficient material | 106 | 104 | 90 | 95 | 82 | 92 |
| DE MYC/BCL2, n = 454 | ||||||
| Yes, n (%) | 93 (40.6) | 92 (40.9) | 88 (40.0) | 80 (39.0) | 87 (40.8) | 80 (39.8) |
| No, n (%) | 136 (59.4) | 133 (59.1) | 132 (60.0) | 125 (61.0) | 126 (59.2) | 121 (60.2) |
| No or insufficient material | 109 | 113 | 93 | 103 | 85 | 99 |
| Chemotherapy | ||||||
| CHOP, n (%) | 169 (50.9) | 170 (51.4) | 159 (51.1) | 160 (52.3) | 150 (50.7) | 157 (52.7) |
| ACVBP, n (%) | 163 (49.1) | 161 (48.6) | 152 (48.9) | 146 (47.7) | 146 (49.3) | 141 (47.3) |
| Not treated | 4 | 3 | 0 | 0 | 0 | 0 |
| Characteristics . | ITT, n = 670 . | Efficacy set, n = 617 . | Per protocol set, n = 594 . | |||
|---|---|---|---|---|---|---|
| Obinutuzumab, n = 336 . | Rituximab, n = 334 . | Obinutuzumab, n = 311 . | Rituximab, n = 306 . | Obinutuzumab, n = 296 . | Rituximab, n = 298 . | |
| Median age (range), y | 49 (19-60) | 48 (18-61) | 49 (19-60) | 47 (18-60) | 49 (19-60) | 47 (18-60) |
| Sex, male, n (%) | 203 (60.4) | 170 (50.9) | 189 (60.8) | 153 (50.0) | 180 (60.8) | 152 (51.0) |
| ECOG | ||||||
| 0-1 | 286 (85.1) | 289 (86.8) | 266 (85.5) | 264 (86.3) | 252 (85.1) | 255 (85.6) |
| >1 | 50 (14.9) | 44 (13.2) | 45 (14.5) | 41 (13.4) | 44 (14.9) | 42 (14.1) |
| Missing | 0 | 1 | 1 | 1 | 0 | 1 |
| Ann Arbor stage, n (%) | ||||||
| I-II | 55 (16.4) | 63 (18.9) | 52 (16.7) | 62 (20.3) | 51 (17.2) | 60 (20.1) |
| III-IV | 281 (83.6) | 271 (81.1) | 259 (83.3) | 244 (79.7) | 245 (82.8) | 238 (79.9) |
| LDH elevated, yes, n (%) | 239 (71.1) | 248 (74.3) | 218 (70.1) | 230 (75.2) | 212 (71.6) | 225 (75.5) |
| aaIPI, n (%) | ||||||
| 0 | 1 (0.3) | 1 (0.3) | 1 (0.3) | 1 (0.3) | 0 (0) | 0 (0) |
| 1 | 142 (42.5) | 138 (41.7) | 135 (43.4) | 126 (41.2) | 128 (43.2) | 123 (41.3) |
| 2 | 149 (44.6) | 156 (47.1) | 136 (43.7) | 143 (46.7) | 129 (43.6) | 138 (46.3) |
| 3 | 42 (12.6) | 36 (10.9) | 37 (11.9) | 33 (10.8) | 37 (12.5) | 34 (11.4) |
| Extranodal involvement, yes, n (%) | 273 (81.3) | 271 (81.1) | 255 (82.0) | 238 (77.8) | 243 (82.1) | 233 (78.2) |
| Bulky disease, >10 cm, n (%) | 104 (31.0) | 109 (32.6) | 95 (30.5) | 101 (33.0) | 87 (29.4) | 99 (33.2) |
| Pathology review, n = 646, n (%) | ||||||
| DLBCL* | 288 (85.7) | 292 (87.4) | 269 (86.5) | 269 (87.9) | 269 (90.9) | 269 (90.3) |
| Misdiagnosis† | 21 (6.3) | 19 (5.7) | 19 (6.1) | 15 (4.9) | 5 (1.7) | 7 (2.3) |
| No or insufficient material | 27 (8.0) | 23 (6.9) | 23 (7.4) | 22 (7.2) | 22 (7.4) | 22 (7.4) |
| COO according to | ||||||
| Hans, n = 411 | ||||||
| GC, n (%) | 114 (55.6) | 125 (60.7) | 107 (55.2) | 119 (64.3) | 107 (55.2) | 118 (63.8) |
| Non-GCB, n (%) | 91 (44.4) | 81 (39.3) | 87 (44.8) | 66 (35.7) | 87 (44.8) | 67 (36.2) |
| No or insufficient material | 47 | 33 | 37 | 31 | 37 | 31 |
| Nanostring, n = 375 | ||||||
| GCB, n (%) | 126 (66.3) | 122 (65.9) | 116 (65.9) | 115 (68.0) | 116 (65.9) | 114 (67.5) |
| ABC, n (%) | 43 (22.6) | 40 (21.6) | 41 (23.3) | 34 (20.1) | 41 (23.3) | 35 (20.7) |
| Unclassified, n (%) | 21 (11.1) | 23 (12.4) | 19 (10.8) | 20 (11.8) | 19 (10.8) | 20 (11.8) |
| No or insufficient material | 62 | 54 | 55 | 47 | 55 | 47 |
| BCL2 expression, n = 544 | ||||||
| ≥70%, n (%) | 186 (69.4) | 208 (75.4) | 174 (68.8) | 188 (74.3) | 167 (68.4) | 186 (74.7) |
| <70%, n (%) | 82 (30.6) | 68 (24.6) | 79 (31.2) | 65 (25.7) | 77 (31.6) | 63 (25.3) |
| No or insufficient material | 70 | 62 | 60 | 55 | 54 | 51 |
| MYC expression, n = 466 | ||||||
| ≥40%, n (%) | 120 (51.7) | 123 (52.6) | 115 (51.6) | 109 (51.2) | 114 (52.8) | 106 (51.0) |
| <40%, n (%) | 112 (48.3) | 111 (47.4) | 108 (48.4) | 104 (48.8) | 102 (47.2) | 102 (49.0) |
| No or insufficient material | 106 | 104 | 90 | 95 | 82 | 92 |
| DE MYC/BCL2, n = 454 | ||||||
| Yes, n (%) | 93 (40.6) | 92 (40.9) | 88 (40.0) | 80 (39.0) | 87 (40.8) | 80 (39.8) |
| No, n (%) | 136 (59.4) | 133 (59.1) | 132 (60.0) | 125 (61.0) | 126 (59.2) | 121 (60.2) |
| No or insufficient material | 109 | 113 | 93 | 103 | 85 | 99 |
| Chemotherapy | ||||||
| CHOP, n (%) | 169 (50.9) | 170 (51.4) | 159 (51.1) | 160 (52.3) | 150 (50.7) | 157 (52.7) |
| ACVBP, n (%) | 163 (49.1) | 161 (48.6) | 152 (48.9) | 146 (47.7) | 146 (49.3) | 141 (47.3) |
| Not treated | 4 | 3 | 0 | 0 | 0 | 0 |
ABC, activated B cell; ACVBP, doxorubicin (75 mg/m2 at day 1), prednisone (60 mg/m2 day 1 to day 5), cyclophosphamide (1200 mg/m2 at day 1), vindesine (2 mg/m2 at day 1 and day 5), and bleomycin (10 mg at day 1 and day 5); aIPI, age-adjusted International Prognostic Index; CHOP, cyclophosphamide (750 mg/m2 at day 1), doxorubicin (50 mg/m2 at day 1), vincristine (1.4 mg/m2, maximum 2 mg, at day 1), and prednisone (40 mg/m2 day 1 to day 5); COO, cell of origin; DE, double expressor; ECOG, Eastern Cooperative Oncology Group scale; GCB, germinal center B cell; ITT, intention to treat; LDH, lactate dehydrogenase.
DLBCL includes DLBCL NOS, PMBL, EBV DLBCL, high-grade B-cell lymphoma, double-hit or high-grade B-cell lymphoma NOS, T-cell–rich B-cell lymphoma.
Follicular lymphoma (FL) grade 3B (n = 7), FL grade 3A (n = 6), FL grade 1-2 (n = 7), follicular lymphoma of undetermined grade (n = 2), nodular lymphocyte predominant Hodgkin lymphoma (n = 4), mantle cell lymphoma–pleomorphic variant (n = 2), B-NHL unclassifiable for technical reason (n = 7), angioimmunoblastic T-cell lymphoma (n = 1), atypical Burkitt lymphoma (n = 1), Burkitt lymphoma/ leukemia (n = 1), precursor B lymphoblastic leukemia/lymphoma (n = 1), anaplastic large cell lymphoma (ALK) + (n = 1).