Table I:
Baseline characteristics
| Baseline characteristics | At initial MCL diagnosisa (N=226) | At start of first post-BTKi therapyb (N=149) |
|---|---|---|
| Age ― years | ||
| Median (range) | 68.0 (39.0–92.0) | 71.0 (43.0–91.0) |
| Mean (SD) | 67.1 (10.8) | 70.9 (9.45) |
| Male ― n (%) | 169 (74.8) | 108 (72.5) |
| Disease stage ― n (%) | ||
| I | 2 (1.0) | 5 (4.5) |
| II | 10 (5.0) | 8 (7.2) |
| III | 25 (12.5) | 20 (18.0) |
| IV | 163 (81.5) | 78 (70.3) |
| Missing | 26 | 38 |
| ECOG performance statusc ― n (%) | ||
| 0 | 67 (48.9) | 29 (27.6) |
| 1 | 54 (39.4) | 39 (37.1) |
| ≥2 | 16 (11.7) | 37 (35.2) |
| Missing | 89 | 44 |
| s-MIPI ― n (%) | ||
| Low risk (score 0–3) | 14 (13.6) | 3 (4.8) |
| Intermediate risk (score 4–5) | 18 (17.5) | 14 (22.6) |
| High risk (score ≥6) | 71 (68.9) | 45 (72.6) |
| Missing | 123 | 87 |
| Ki-67 proliferation index ― n (%) | ||
| ≥30% | 55 (58.5) | 17 (77.3) |
| ≥50% | 33 (35.1) | 13 (59.1) |
| Missing | 132 | 127 |
| Morphology ― n (%) | ||
| Blastoid | 36 (25.2) | 17 (37.0) |
| Pleomorphic | 7 (4.9) | 2 (4.3) |
| Non-blastoid or non-pleomorphic | 100 (69.9) | 27 (58.7) |
| Missing | 83 | 103 |
| LDH ― units/L | ||
| Assessed | 156 | 103 |
| Median (range) | 334.5 (10.0–2551.0) | 363.00 (3.0–2990.0) |
| Presence of B symptoms ― n/N (%) | 51/179 (28.5) | 27/100 (27.0) |
| Bulky disease, ≥10 cm ― n/N (%) | 15/179 (8.4) | 19/100 (19.0) |
| Splenic involvement ― n/N (%) | 79/179 (44.1) | 41/100 (41.0) |
| Extranodal disease ― n/N (%) | 49/179 (27.4) | 29/100 (29.0) |
| Bone marrow involvement ― n/N (%) | 130/179 (72.6) | 45/100 (45.0) |
| t(11;14) or cyclin D1 overexpression ― n/N (%) | 130/141 (92.2) | --d |
| t(11;14) ― n/N (%) | 30/35 (85.7) | 10/12 (83.3) |
| Cyclin D1 overexpression ― n/N (%) | 117/134 (87.3) | --d |
| WBC ― x109/L | ||
| Assessed | 164 | --d |
| Median (range) | 8.96 (1.00–47570.0) | --d |
| TP53 mutation ― n/N (%) | 20/37 (54.1) | --d |
| Median no. of prior lines of therapy (range) | -- | 3 (1–11) |
| No. of prior lines of therapy ― n (%) | ||
| 1 | -- | 4 (2.7) |
| 2 | -- | 52 (34.9) |
| 3 | -- | 44 (29.5) |
| ≥4 | -- | 49 (32.9) |
| Previous SCT ― n (%) | ||
| Anye | -- | 50 (33.6) |
| Autologous | -- | 48 (32.2) |
| Allogeneic | -- | 3 (2.0) |
| None | -- | 99 (66.4) |
| Prior BTKi therapy ― n (%) | ||
| Ibrutinib | -- | 145 (97.3) |
| Acalabrutinib | -- | 4 (2.7) |
| Duration on prior BTKi therapy ― months | -- | n=148 |
| Median (range) | -- | 7.1 (0.4–53.7) |
| Mean (SD) | -- | 11.7 (12.0) |
| CR or PR as best response to prior BTKi therapy ― n/N (%) | -- | 46/133 (34.6) |
| Reasons for BTKi discontinuation ― n (%) | ||
| Intolerance to BTKi therapy | -- | 22 (14.8) |
| Disease progression while on BTKi therapy | -- | 127 (85.2) |
| Time interval between BTKi discontinuation and start of post-BTKi therapy ― months | n=148 | |
| Median (range) | -- | 0.4 (0, 48.9) |
| Mean (SD) | -- | 2.5 (7.2) |
Abbreviations: BTKi, Bruton tyrosine kinase inhibitor; CR, complete response; ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase; MCL, mantle cell lymphoma; PR, partial response; SCT, stem cell transplantation; SD, standard deviation; s-MIPI, simplified Mantle Cell Lymphoma International Prognostic Index; WBC, white blood cells
Time window: reported within 3 months (before or after) of diagnosis date.
Time window: reported 6 to 12 months prior to start of first post-BTKi therapy and up to 1 month after.
Performance score was based on Karnofsky performance status in two patients at initial MCL diagnosis and in one patient at start of first post-BTKi therapy and converted to ECOG PS (Karnofsky performance status categories 90–100/70–80/50–60/30–40/10–20 corresponded to ECOG PS 0/1/2/3/4).
WBC, cyclin D1 overexpression, and TP53 mutation not available at start of first post-BTKi therapy.
One patient received both autologous SCT and allogeneic SCT.