Demographics and baseline characteristics per investigator assessment
| . | R/R MCL (N = 32) . |
|---|---|
| Age, median (range), y | 70.5 (42-86) |
| Age category | |
| <65 y | 8 (25.0) |
| ≥65 to <75 y | 12 (37.5) |
| ≥75 y | 12 (37.5) |
| Sex | |
| Male | 22 (68.8) |
| Female | 10 (31.3) |
| Race | |
| White | 30 (81.1) |
| Asian | 3 (8.1) |
| Black or African American | 1 (2.7) |
| Other | 3 (8.1) |
| Baseline ECOG performance score | |
| 0 | 15 (46.9) |
| 1 | 14 (43.8) |
| 2 | 3 (9.4) |
| Stage at study entry | |
| Stage I | 2 (6.3) |
| Stage II | 1 (3.1) |
| Stage III | 1 (3.1) |
| Stage IV | 28 (87.5) |
| MIPI* | |
| Low risk | 9 (28.1) |
| Intermediate risk | 13 (40.6) |
| High risk | 10 (31.3) |
| Blastoid variant | |
| Yes | 2 (6.3) |
| No | 28 (87.5) |
| Missing | 2 (6.3) |
| Bulky disease, cm† | |
| >5 | 7 (21.9) |
| >10 | 3 (9.4) |
| Bone marrow involvement‡ | |
| Yes | 18 (56.3) |
| No | 14 (43.8) |
| Extranodal disease§ | |
| Yes | 25 (78.1) |
| No | 7 (21.9) |
| Refractory disease¶ | 8 (25.0) |
| No. of previous therapies, median (range) | 1 (1-4) |
| Previous therapy | |
| Any chemotherapy | 31 (96.9) |
| Rituximab or rituximab-containing regimen | 30 (93.8) |
| R-CHOP/R-CHOPE/R-CHOPE–like | 19 (59.4) |
| Bendamustine/purine analog | 11 (34.4) |
| Various chemotherapies | 7 (21.9) |
| Hyper-CVAD/hyper-CVAD–like regimen | 7 (21.9) |
| Autologous stem cell transplantation | 5 (15.6) |
| Bortezomib | 2 (6.3) |
| . | R/R MCL (N = 32) . |
|---|---|
| Age, median (range), y | 70.5 (42-86) |
| Age category | |
| <65 y | 8 (25.0) |
| ≥65 to <75 y | 12 (37.5) |
| ≥75 y | 12 (37.5) |
| Sex | |
| Male | 22 (68.8) |
| Female | 10 (31.3) |
| Race | |
| White | 30 (81.1) |
| Asian | 3 (8.1) |
| Black or African American | 1 (2.7) |
| Other | 3 (8.1) |
| Baseline ECOG performance score | |
| 0 | 15 (46.9) |
| 1 | 14 (43.8) |
| 2 | 3 (9.4) |
| Stage at study entry | |
| Stage I | 2 (6.3) |
| Stage II | 1 (3.1) |
| Stage III | 1 (3.1) |
| Stage IV | 28 (87.5) |
| MIPI* | |
| Low risk | 9 (28.1) |
| Intermediate risk | 13 (40.6) |
| High risk | 10 (31.3) |
| Blastoid variant | |
| Yes | 2 (6.3) |
| No | 28 (87.5) |
| Missing | 2 (6.3) |
| Bulky disease, cm† | |
| >5 | 7 (21.9) |
| >10 | 3 (9.4) |
| Bone marrow involvement‡ | |
| Yes | 18 (56.3) |
| No | 14 (43.8) |
| Extranodal disease§ | |
| Yes | 25 (78.1) |
| No | 7 (21.9) |
| Refractory disease¶ | 8 (25.0) |
| No. of previous therapies, median (range) | 1 (1-4) |
| Previous therapy | |
| Any chemotherapy | 31 (96.9) |
| Rituximab or rituximab-containing regimen | 30 (93.8) |
| R-CHOP/R-CHOPE/R-CHOPE–like | 19 (59.4) |
| Bendamustine/purine analog | 11 (34.4) |
| Various chemotherapies | 7 (21.9) |
| Hyper-CVAD/hyper-CVAD–like regimen | 7 (21.9) |
| Autologous stem cell transplantation | 5 (15.6) |
| Bortezomib | 2 (6.3) |
Unless otherwise noted, data are n (%).
ECOG, Eastern Cooperative Oncology Group; hyper-CVAD, cyclophosphamide, vincristine, doxorubicin, cytarabine, methotrexate, and leucovorin; MIPI, MCL International Prognostic Index; R-CHOEP, rituximab cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone; R-CHOP, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.
Calculated with cutoffs of low (<5.7), intermediate (5.7 to <6.2), and high (≥6.2).
Included 2 R/R patients without baseline target lesion.
Derived from baseline tumor biopsy/aspiration per investigator assessment.
Extranodal disease defined as patients with extranodal baseline target or nontarget lesions or bone marrow involvement by biopsy per investigator assessment.
Refractory disease defined as best overall response of stable disease or PD from last prior anticancer regimen.