Table 1.
Baseline characteristics of the study population: distribution by switch status (n = 605).
| Variable | N (% miss.) | Overall (n = 605) | Vincristine group (n = 406) | Vinorelbine group (n = 199) | p value* |
|---|---|---|---|---|---|
| Demographic variables | |||||
| Age (years) | 605 (0%) | 65 [54–74] | 64 [52–74] | 65 [56–73] | 0.835 |
| Female gender | 605 (0%) | 299 (49%) | 197 (49%) | 102 (51%) | 0.527 |
| ECOG (points) | 604 (0%) | 1 [0–1] | 1 [0–1] | 1 [0-1] | 0.106 |
| Tumor characteristics | |||||
| Cell of origin: Non-GCB | 575 (5%) | 300 (52%) | 212 (53%) | 88 (50%) | 0.488 |
| Clinical stage: III–IV | 605 (0%) | 322 (53%) | 209 (51%) | 113 (57%) | 0.219 |
| Extranodal manifestation | 605 (0%) | 320 (53%) | 216 (53%) | 104 (52%) | 0.828 |
| Double expressor biology** | 405 (33%) | / | / | / | 0.253 |
| 0 points | / | 79 (20%) | 59 (20%) | 20 (19%) | / |
| 1 point | / | 231 (57%) | 176 (59%) | 55 (52%) | / |
| 2 points | / | 95 (23%) | 64 (21%) | 31 (29%) | / |
| Risk stratification | |||||
| R-IPI (points) | 605 (0%) | 2 [2–3] | 2 [2–3] | 3 [2–3] | 0.491 |
| NCCN-IPI (points) | 605 (0%) | 3 [2–5] | 3 [2–4] | 3 [2–5] | 0.269 |
| CNS-IPI (points) | 605 (0%) | 1 [1–2] | 1 [1–2] | 2 [1–2] | 0.239 |
| Treatment characteristics | |||||
| Cycles of primary treatment | 605 (0%) | 6 [6–8] | 6 [6–8] | 6 [6–8] | 0.005 |
| Cycles before switch to vinorelbine | 199 (0%) | / | / | 2 [2–4] | / |
| ASCT | 605 (0%) | 45 (7%) | 29 (7%) | 16 (8%) | 0.693 |
| Outcomes | |||||
| Best response to first-line therapy | 605 (0%) | / | / | / | 0.009 |
| CR | / | 498 (82%) | 322 (79%) | 176 (88%) | / |
| PR | / | 46 (8%) | 33 (8%) | 13 (7%) | / |
| PD | / | 61 (10%) | 51 (13%) | 10 (5%) | / |
| Long-term outcomes | 605 (0%) | / | / | / | 0.004 |
| No relapse | / | 422 (70%) | 269 (66%) | 153 (77%) | / |
| Relapse | / | 87 (14%) | 59 (15%) | 28 (14%) | / |
| Primary progression | / | 96 (16%) | 78 (19%) | 18 (9%) | / |
| Death from DLBCL | 605 (0%) | 144 (24%) | 105 (26%) | 39 (20%) | 0.089 |
| Death from other causes | 605 (0%) | 107 (18%) | 65 (16%) | 42 (21%) | 0.123 |
N (% miss.) denotes the number of patients with fully observed variable (% missing denotes the percentage of patients with lack of data). *p values are from rank-sum tests, χ2 tests, and Fisher’s exact tests, as appropriate. **Double expressor biology as assessed by immunohistochemistry for BCL2 and MYC with scoring according to the published algorithm of Hans et al. [33]
Abbreviations: ECOG Eastern Cooperative Oncology Group performance status, GCB germinal center B cell, R-IPI Revised International Prognostic Index, NCCN-IPI National Comprehensive Cancer Network International Prognostic Index, CNS-IPI Central Nervous System International Prognostic Index, ASCT autologous stem cell transplantation, CR complete remission, PR partial remission, PD progressive disease, DLBCL diffuse large B cell lymphoma