Table 1.
Baseline Patient Characteristics by Double Refractoriness and POD24 Status
| All Patients (N = 187) | Double Refractory Before the Index Treatment Line | POD24 to Frontline Anti-CD20 mAb Treatment | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No (n = 82) | Yes (n = 105) | No (n = 82) | Yes (n = 105) | |||||||
| Age category at index, n (%) | ||||||||||
| ≤60 y | 103 | 55.1 | 46 | 56.10 | 57 | 54.29 | 35 | 47.95 | 68 | 59.65 |
| >60 y | 84 | 44.9 | 36 | 43.90 | 48 | 45.71 | 38 | 52.05 | 46 | 40.35 |
| Age, median (range) | 58 (25–86) | 57.5 (25–82) | 59 (30–86) | 62 (25–82) | 58 (30–86) | |||||
| Time from FL diagnosis to index date, months | ||||||||||
| Mean (SD) | 57.1 (39.9) | 71.3 (38.5) | 46.0 (37.5) | 81.5 (40.1) | 41.5 (31.0) | |||||
| Median (range) | 46.0 (2.8–241.7) | 62.8 (19.3–241.7) | 32.8 (2.8–168.5) | 80.2 (28.0–241.7) | 32.0 (2.8–138.0) | |||||
| Gender, n (%) | ||||||||||
| Male | 106 | 56.7 | 48 | 58.54 | 58 | 55.24 | 47 | 64.38 | 59 | 51.75 |
| Female | 81 | 43.3 | 34 | 41.46 | 47 | 44.76 | 26 | 35.62 | 55 | 48.25 |
| FLIPI score at index, n (%) | ||||||||||
| Low | 25 | 13.4 | 13 | 15.85 | 12 | 11.43 | 10 | 13.70 | 15 | 13.16 |
| Intermediate | 28 | 15.0 | 8 | 9.76 | 20 | 19.05 | 9 | 12.33 | 19 | 16.67 |
| High | 71 | 38.0 | 30 | 36.59 | 41 | 39.05 | 31 | 42.47 | 40 | 35.09 |
| Unknown | 63 | 33.7 | 31 | 37.80 | 32 | 30.48 | 23 | 31.51 | 40 | 35.09 |
| ECOG PS at index, n (%) | ||||||||||
| 0 | 87 | 46.52 | 44 | 53.66 | 43 | 40.95 | 37 | 50.68 | 50 | 43.86 |
| 1 | 100 | 53.48 | 38 | 46.34 | 62 | 59.05 | 36 | 49.32 | 64 | 56.14 |
| Line of index treatment, n (%) | ||||||||||
| 3L | 150 | 80.2 | 67 | 81.71 | 83 | 79.05 | 59 | 80.82 | 91 | 79.82 |
| 4L | 31 | 16.6 | 13 | 15.85 | 18 | 17.14 | 13 | 17.81 | 18 | 15.79 |
| 5L | 4 | 2.1 | 2 | 2.44 | 2 | 1.90 | – | – | 4 | 3.51 |
| 6L | 2 | 1.1 | – | – | 2 | 1.90 | 1 | 1.37 | 1 | 0.88 |
| Index treatment regimen, n (%)a | ||||||||||
| Idelalisib | 10 | 5.4 | 6 | 7.32 | 4 | 3.81 | 4 | 5.48 | 6 | 5.26 |
| Anti-CD20 mAb + alkylator | 97 | 51.9 | 34 | 41.46 | 63 | 60.00 | 37 | 50.68 | 60 | 52.63 |
| Anti-CD20 mAb monotherapy | 15 | 8.0 | 13 | 15.85 | 2 | 1.90 | 8 | 10.96 | 7 | 6.14 |
| Anti-CD20 mAb + nonalkylator | 23 | 12.3 | 13 | 15.85 | 10 | 9.52 | 12 | 16.44 | 11 | 9.65 |
| Alkylator not in combo w/anti-CD20 mAb | 21 | 11.2 | 8 | 9.76 | 13 | 12.38 | 7 | 9.59 | 14 | 12.28 |
| Neither anti-CD20 mAb nor alkylator | 21 | 11.2 | 8 | 9.76 | 13 | 12.38 | 5 | 6.85 | 16 | 14.04 |
| Had prior auto-HSCT, n (%) | ||||||||||
| No | 146 | 78.1 | 55 | 67.07 | 91 | 86.67 | 51 | 69.86 | 95 | 83.33 |
| Yes | 41 | 21.9 | 27 | 32.93 | 14 | 13.33 | 22 | 30.14 | 19 | 16.67 |
| Years from index date until last available follow-up, median (range) | 9.3 (1.0–21.3) | 11.5 (3.8–21.3) | 7.6 (1.0–19.7) | 11.3 (3.8–21.3) | 7.8 (1.0–20.7) | |||||
| Total number of treatment lines received after initial FL diagnosis, median (range) | 5 (3–11) | 5 (3–11) | 4 (3–11) | 5 (3–11) | 5 (3–11) | |||||
aAlkylating agents were defined as bendamustine, carmustine, cyclophosphamide, ifosfamide, busulfan, chlorambucil, melphalan, nitrosoureas, cisplatin, trofosfamide, as well as any alkylator-containing regimen—BR (bendamustine and rituximab), R-CHOP (rituximab, cyclophosphamide, doxorubicin [doxorubicin hydrochloride {hydroxydaunorubicin hydrochloride}], vincristine, and prednisone), R-DHAP (rituximab, dexamethasone, cytarabine, and cisplatin), DHAP (dexamethasone, cytarabine, and cisplatin), R-CVP (rituximab, cyclophosphamide, vincristine, prednisone), R-EPOCH (rituximab, etoposide, prednisone, vincristine [Oncovin], cyclophosphamide, and doxorubicin hydrochloride [hydroxydaunorubicin hydrochloride]), EPOCH (etoposide, prednisone, vincristine [Oncovin], cyclophosphamide, and doxorubicin hydrochloride [hydroxydaunorubicin hydrochloride]), and RICE (rituximab, ifosfamide, carboplatin, and etoposide).
– = no patients in this category; 3L = third line; 4L = fourth line; 5L = fifth line; 6L = six line; auto-HSCT = autologous hematopoietic stem cell transplantation; ECOG = Eastern Cooperative Oncology Group; FL = follicular lymphoma; mAb = monoclonal antibody; POD4 = progression of disease within 24 months following the start of front-line immunochemotherapy.