Table I:
Baseline Demographic and Disease Characteristics at Diagnosis of Entire Cohort of 640 FL Patients Receiving Frontline BR Followed by either MR or no maintenance.
| Characteristic | Entire Cohort (N = 640) | MR (N = 357) | No maintenance (N = 283) | P |
|---|---|---|---|---|
| Age, years; median (range) | 60 (21–88) | 59 (26–85) | 60 (21–88) | 0.07 |
| Gender | 1.0 | |||
| Male (n, %) | 335(52) | 187 (52) | 148 (52) | |
| Female (n, %) | 305(48) | 170 (48) | 1135 (48) | |
| Race (%) (n=397) | ||||
| Caucasian | 344 (87) | 218 (87) | 126 (86) | 0.65 |
| African-American | 17 (4) | 13 (5) | 4 (3) | |
| Asian/Pacific Island | 5 (1) | 3 (1) | 2 (1) | |
| Non-white Hispanic | 19 (5) | 11 (5) | 8 (6) | |
| Other/not Specified | 12 (3) | 6 (2) | 6 (4) | |
| ECOG performance status at diagnosis (n=404) | ||||
| 0 | 265 (66) | 177 (70) | 88 (58) | 0.01 |
| 1 | 118 (29) | 69 (27) | 49 (33) | |
| 2 | 17 (4) | 6 (2) | 11 (7) | |
| 3 | 4 (1) | 1 (1) | 3 (2) | |
| LDH > ULN (n=557) | 106 (19) | 53(17) | 53(22) | 0.16 |
| Bone marrow Involvement (n=319) | 164 (51) | 109(53) | 55(49) | 0.56 |
| Ann Arbor stage at diagnosis (n=567) | ||||
| I/II | 61 (11) | 32 (10) | 29 (12) | 0.41 |
| III/IV | 506 (89) | 296 (90) | 210 (88) | |
| B Symptoms(n=422) | 88 (21) | 47 (18) | 41 (26) | 0.05 |
| Serum β2-microglobulin > ULN (n=243) | 119 (49) | 72 (46) | 47 (55) | 0.18 |
| >4 Nodal Sites (n=584) | 322 (55) | 195 (58) | 127 (51) | 0.11 |
| Largest node ≥ 7 cm (n=408) | 95 (23) | 65 (25) | 30 (20) | 0.33 |
| Haemoglobin < 120 g/l (n=578) | 110 (19) | 57 (18) | 53 (21) | 0.29 |
| FLIPI (n=491) | ||||
| Low (0–2) | 283 (58) | 171 (60) | 112 (54) | 0.40 |
| Intermediate (3) | 141 (29) | 79 (28) | 62 (30) | |
| High (4–5) | 67 (14) | 35 (12) | 32 (16) | |
| Grade (n=632) | ||||
| I/II | 576 (91) | 328 (93) | 248 (89) | 0.09 |
| IIIA | 56 (9) | 25 (7) | 31 (11) | |
| Time from diagnosis to treatment, months; median (range) | 1 (0–139) | 1.1 (0–135) | 1 (0–139) | 0.62 |
BR; bendamustine and rituximab; ECOG: Eastern Cooperative Oncology Group; FL: follicular lymphoma; FLIPI: Follicular lymphoma International Prognostic Index; LDH: lactate dehydrogenase; MR: maintenance rituximab; ULN: upper limit of normal.