Table 1.
Baseline characteristics and treatment details for the training and test datasets
|
NCRI-XI: training set |
MRC-IX: test set |
||||
|---|---|---|---|---|---|
| Included (n=1852) | Included (n=520) | Excluded (n=329) | Total (n=849) | ||
| Median age | 74·0 (71·0–78·0) | 73·0 (70·0–77·0) | 74·0 (70·0–77·0) | 73·0 (70·0–77·0) | |
| Age group (years) | |||||
| <70 | 313 (17%) | 129 (25%) | 81 (25%) | 210 (25%) | |
| 70–74 | 620 (34%) | 189 (36%) | 108 (33%) | 297 (35%) | |
| 75–79 | 597 (32%) | 131 (25%) | 103 (31%) | 234 (28%) | |
| ≥80 | 322 (17%) | 71 (14%) | 37 (11%) | 108 (13%) | |
| Sex | |||||
| Men | 1047 (57%) | 285 (55%) | 188 (57%) | 473 (56%) | |
| Women | 805 (43%) | 235 (45%) | 141 (43%) | 376 (44%) | |
| WHO performance status | |||||
| 0 | 478 (26%) | 93 (18%) | 63 (19%) | 156 (18%) | |
| 1 | 810 (44%) | 238 (46%) | 171 (52%) | 409 (48%) | |
| 2 | 342 (18%) | 111 (21%) | 62 (19%) | 173 (20%) | |
| 3 | 110 (6%) | 68 (13%) | 28 (9%) | 96 (11%) | |
| 4 | 11 (1%) | 10 (2%) | 1 (0%) | 11 (1%) | |
| Data missing | 101 (6%) | 0 (0%) | 4 (1%) | 4 (1%) | |
| ISS stage | |||||
| I | 318 (17%) | 68 (13%) | 42 (13%) | 110 (13%) | |
| II | 731 (39%) | 215 (41%) | 97 (29%) | 312 (37%) | |
| III | 659 (36%) | 237 (46%) | 96 (29%) | 333 (39%) | |
| Data missing | 144 (8%) | 0 (0%) | 94 (29%) | 94 (11%) | |
| CRP (mg/L) | 5·0 (3·0–16·0) | 8·0 (4·0–20·0) | 7·0 (5·0–19·0) | 8·0 (4·0–20·0) | |
| Data missing | 262 | 0 | 276 | 276 | |
| LDH (IU/L) | 278·0 (190·0–396·5) | 328·0 (244·0–423·0) | 324·0 (230·0–433·0) | 328·0 (242·5–424·0) | |
| Data missing | 416 | 159 | 218 | 377 | |
| L:W | 0·3 (0·2–0·4) | 0·3 (0·2–0·3) | 0·3 (0·2–0·4) | 0·3 (0·2–0·4) | |
| Data missing | 7 | 2 | 2 | 4 | |
| Cytogenetic risk groups | |||||
| Standard | 399 (22%) | 169 (33%) | 84 (26%) | 253 (30%) | |
| High risk | 265 (14%) | 77 (15%) | 52 (16%) | 129 (15%) | |
| Ultra-high risk | 67 (4%) | 43 (8%) | 14 (4%) | 57 (7%) | |
| NA | 1121 (61%) | 231 (44%) | 179 (54%) | 410 (48%) | |
| Induction regimen | |||||
| CTDa | 924 (50%) | 248 (48%) | 178 (54%) | 426 (50%) | |
| CRDa | 928 (50%) | NA | NA | NA | |
| MP | NA | 272 (52%) | 151 (46%) | 423 (50%) | |
| Allocated bisphosphonate | |||||
| Sodium clodronate | NA | 267 (51%) | 156 (47%) | 423 (50%) | |
| Zoledronic acid | NA | 253 (49%) | 173 (53%) | 426 (50%) | |
| CVD received | |||||
| Yes | 157 (8%) | NA | NA | NA | |
| No | 1695 (92%) | NA | NA | NA | |
| Maintenance regimen | |||||
| Observation | 318 (17%) | 93 (18%) | 70 (21%) | 163 (19%) | |
| Thalidomide | NA | 97 (19%) | 66 (20%) | 163 (19%) | |
| Lenalidomide | 407 (22%) | NA | NA | NA | |
| Lenalidomide and vorinostat | 111 (6%) | NA | NA | NA | |
| No maintenance regimen | 1016 (55%) | 330 (63%) | 193 (59%) | 523 (62%) | |
Data are n (%) or median (IQR). NCRI-XI=NCRI Myeloma XI. MRC-IX=MRC Myeloma IX. ISS=International Staging System. CRP=C-reactive protein. LDH=lactate dehydrogenase. L:W=lymphocyte to total white blood cell ratio. NA=not applicable. CTDa=attenuated cyclophosphamide, thalidomide, and dexamethasone. CRDa=attenuated cyclophosphamide, lenalidomide, and dexamethasone. MP=melphalan and prednisolone. CVD=cyclophosphamide, bortezomib, and dexamethasone. Standard risk was defined as the absence of any of the risk lesions: t(4;14), t(14;16), t(14;20), del(17p) and gain(1q). High risk was defined as one lesion present. Ultra-high risk was defined as more than one lesion present (UK definition). High risk and ultra-high risk categories were combined and defined as high risk for the analysis.