Table 1.
Demographic and patient characteristics in the safety population
| Characteristics | Group 1 (N = 30) n (%) |
Group 2 (N = 6) n (%) |
|---|---|---|
| Sex | ||
| Male | 12 (40) | 3 (50) |
| Female | 18 (60) | 3 (50) |
| Age—median years (range) | 67 (43–76) | 73 (69–78) |
| <65 | 10 (33) | 0 (0) |
| ≥65 | 20 (67) | 6(100) |
| Diagnosis (WHO classification) | ||
| Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue | 1 (3) | – |
| Nodal marginal zone B-cell lymphoma | 1(3) | – |
| Follicular lymphoma | 27 (90) | – |
| Mantle cell lymphoma | 1(3) | – |
| Diffuse large B-cell lymphoma | – | 6(100) |
| Cell-of-origin | ||
| Germinal center B-cell-like (GCB) | – | 2 (33) |
| Non-GCB | – | 4 (67) |
| Clinical stage (Ann Arbor classification) | ||
| I | 2(7) | 0(0) |
| II | 6(20) | 1(17) |
| III | 6(20) | 4(67) |
| IV | 16(53) | 1(17) |
| Unknown | 0(0) | 0(0) |
| History of primer treatments | ||
| Absent | 30(100) | 0(0) |
| Present | 0(0) | 6(100) |
| Lines of prior treatments median (range) | 2(1–6) | |
| 1 regimen | – | 1(17) |
| 2 regimens | – | 4(67) |
| ≥3 regimens | – | 1(17) |
| Response to prior treatmentsa | ||
| Responder | – | 6(100) |
| Nonresponder | – | 0(0) |
| Unknown | – | 0(0) |
| Autologous hematopoietic stem cell transplantation | ||
| Absent | – | 6(100) |
| Present | – | 0(0) |
| Radiotherapy | ||
| Absent | – | 5 (83) |
| Present | – | 1(17) |
| Performance status (ECOG criteria) | ||
| 0 | 25(83) | 4(67) |
| 1 | 5(17) | 2(33) |
| 2 | 0(0) | 0(0) |
| 3 | 0(0) | 0(0) |
| 4 | 0(0) | 0(0) |
| Systemic symptoms (B symptoms) (Ann Arbor classification)b | ||
| Absent | 17(57) | 4(67) |
| Present | 13(43) | 2(33) |
| Unknown | 0(0) | 0(0) |
| Tumor diameter | ||
| <5 cm | 10(33) | – |
| ≥5 cm | 20(67) | – |
| LDH | ||
| ≤ Upper limit of normal | 22(73) | 5(83) |
| > Upper limit of normal | 8(27) | 1(17) |
| Number of nodal lesionsc | ||
| <5 | 19(63) | 6(100) |
| ≥5 | 11(37) | 0(0) |
| Number of extranodal lesionsd | ||
| <2 | 24(80) | 6(100) |
| ≥2 | 6(20) | 0(0) |
| Bone marrow infiltration | ||
| Present | 11(37) | 0(0) |
| Absent | 19(64) | 6(100) |
| Undetermined | 0(0) | 0(0) |
| Unknown | 0(0) | 0(0) |
| FLIPI risk category for FLe | 27(100) | – |
| Low (score: 0–1) | 7(26) | – |
| Intermediate (score: 2) | 7(26) | – |
| High (poor) (score: 3–5) | 13(48) | – |
| Unknown | 0(0) | – |
| IPI risk categoryf | ||
| Low (score: 0–1) | – | 1(17) |
| Low–intermediate (score: 2) | – | 4(67) |
| High–intermediate (score: 3) | – | 1(17) |
| High (score: 4–5) | – | 0(0) |
| Unknown | – | 0(0) |
–: not applicable
N number of patients, ECOG Eastern Clinical Oncology Group, LDH lactate dehydrogenase, FLIPI follicular lymphoma international prognostic index, FL follicular lymphoma, IPI international prognostic index
aThe patient, whose best response to 1 or more prior treatments was categorized as “CR or PR”, was categorized as “responder”
bSystemic symptoms (B symptoms): 1 or more tumor-related symptoms were found prior to the initiation of administration
cNumber of nodal lesions: the sum of the number of nodal target lesions and nodal non-target lesions
dNumber of extranodal lesions: the sum of the number of extranodal non-target lesions, as well as of the cases of hepatomegaly, renal enlargement, and bone marrow infiltration
eCategorized based on the number of corresponding poor prognostic factors: age, ≥ 61 years; LDH, > upper limit of normal; hemoglobin, < 12 g/dL; number of nodal lesions, ≥ 5; and clinical stage, III or IV
fCategorized based on the number of corresponding poor prognostic factors: age, ≥ 61 years; LDH, > upper limit of normal; performance status, 2–4; clinical stage, III or IV; and the number of extranodal lesions, ≥ 2