Demographics and baseline disease characteristics
| Characteristic . | R/R MZL (N = 20) . | R/R FL (N = 33) . |
|---|---|---|
| Age, y | ||
| Median (range) | 69.5 (52-85) | 63 (38-79) |
| Age category, n (%) | ||
| ≥65 y | 16 (80.0) | 13 (39.4) |
| ≥75 y | 4 (20.0) | 1 (3.0) |
| Sex, n (%) | ||
| Male | 10 (50.0) | 20 (60.6) |
| Female | 10 (50.0) | 13 (39.4) |
| Baseline ECOG performance status score, n (%) | ||
| 0 | 7 (35.0) | 18 (54.5) |
| 1 | 11 (55.0) | 13 (39.4) |
| 2 | 2 (10.0) | 2 (6.1) |
| Bulky disease*, n (%) | 5 (25.0) | 8 (24.2) |
| Bone marrow involvement, n (%) | 14 (70.0)† | 13 (39.4) |
| Extranodal disease, n (%) | 20 (100.0)‡ | 18 (54.5) |
| Refractory disease§ | 4 (20.0) | 11 (33.3) |
| Baseline cytopeniaǁ | 6 (30.0) | 8 (24.2) |
| MZL subtypes | ||
| Extranodal | 9 (45.0) | – |
| Nodal | 5 (25.0) | – |
| Splenic | 6 (30.0) | – |
| FLIPI scores | ||
| High | – | 14 (42.4) |
| Intermediate | – | 6 (18.2) |
| Low | – | 11 (33.3) |
| Not derived | – | 2 (6.1)¶ |
| Number of previous therapies | ||
| Median (range) | 2 (1-5) | 3 (1-8) |
| Previous therapy, n (%) | ||
| Rituximab-based chemoimmunotherapy | 19 (95.0) | 32 (97.0) |
| Rituximab monotherapy | 4 (20.0) | 19 (57.6) |
| RCVP | 13 (65.0) | 9 (27.3) |
| BR | 4 (20.0) | 7 (21.2) |
| RCHOP | 5 (25.0) | 19 (57.6) |
| Rituximab/lenalidomide | 0 | 0 |
| Radiation therapy | 1 (5.0) | 9 (27.3) |
| Splenectomy | 1 (5.0) | 0 |
| Autologous hematopoietic stem cell transplant | 0 | 6 (18.2) |
| Characteristic . | R/R MZL (N = 20) . | R/R FL (N = 33) . |
|---|---|---|
| Age, y | ||
| Median (range) | 69.5 (52-85) | 63 (38-79) |
| Age category, n (%) | ||
| ≥65 y | 16 (80.0) | 13 (39.4) |
| ≥75 y | 4 (20.0) | 1 (3.0) |
| Sex, n (%) | ||
| Male | 10 (50.0) | 20 (60.6) |
| Female | 10 (50.0) | 13 (39.4) |
| Baseline ECOG performance status score, n (%) | ||
| 0 | 7 (35.0) | 18 (54.5) |
| 1 | 11 (55.0) | 13 (39.4) |
| 2 | 2 (10.0) | 2 (6.1) |
| Bulky disease*, n (%) | 5 (25.0) | 8 (24.2) |
| Bone marrow involvement, n (%) | 14 (70.0)† | 13 (39.4) |
| Extranodal disease, n (%) | 20 (100.0)‡ | 18 (54.5) |
| Refractory disease§ | 4 (20.0) | 11 (33.3) |
| Baseline cytopeniaǁ | 6 (30.0) | 8 (24.2) |
| MZL subtypes | ||
| Extranodal | 9 (45.0) | – |
| Nodal | 5 (25.0) | – |
| Splenic | 6 (30.0) | – |
| FLIPI scores | ||
| High | – | 14 (42.4) |
| Intermediate | – | 6 (18.2) |
| Low | – | 11 (33.3) |
| Not derived | – | 2 (6.1)¶ |
| Number of previous therapies | ||
| Median (range) | 2 (1-5) | 3 (1-8) |
| Previous therapy, n (%) | ||
| Rituximab-based chemoimmunotherapy | 19 (95.0) | 32 (97.0) |
| Rituximab monotherapy | 4 (20.0) | 19 (57.6) |
| RCVP | 13 (65.0) | 9 (27.3) |
| BR | 4 (20.0) | 7 (21.2) |
| RCHOP | 5 (25.0) | 19 (57.6) |
| Rituximab/lenalidomide | 0 | 0 |
| Radiation therapy | 1 (5.0) | 9 (27.3) |
| Splenectomy | 1 (5.0) | 0 |
| Autologous hematopoietic stem cell transplant | 0 | 6 (18.2) |
BR, bendamustine/rituximab; ECOG, Eastern Cooperative Oncology Group; FDG, 18F fluorodeoxyglucose; RCHOP, rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone; RCVP, rituximab/cyclophosphamide/vincristine sulfate/prednisone.
Bulky disease is defined as longest transverse diameter (LDi) >5 cm for MZL and ≥6 cm for FL.
Derived from baseline tumor biopsy/aspiration per investigator assessment.
Extranodal disease is defined as patients with extranodal baseline target or nontarget lesions or bone marrow involvement by biopsy as per investigator assessment.
Refractory disease is defined as best overall response of stable disease or progressive disease from last prior anticancer treatment regimen.
Cytopenia is defined as baseline neutrophils ≤ 1.5 × 109/L or baseline platelet ≤ 100 × 109/L or baseline hemoglobin ≤ 110 g/L.
FLIPI score not derived because of no nodal site involved at baseline.