Table 2.
Efficacy
| Variables | n | Response, n | ORR, % [95% CI] | CR rate, % [95% CI] | P-valuea | ||||
|---|---|---|---|---|---|---|---|---|---|
| CR | PR | SD | PD | NE | |||||
| Overall | 38 | 18 | 11 | 5 | 2 | 2 | 76.3 [59.8–88.6] | 47.4 [31.0–64.2] | |
| Sex | |||||||||
| Male | 13 | 3 | 5 | 3 | 1 | 1 | 61.5 [31.6–86.1] | 23.1 [5.0–53.8] | P = 0.226 |
| Female | 25 | 15 | 6 | 2 | 1 | 1 | 84.0 [63.9–95.5] | 60.0 [38.7–78.9] | |
| Age, years | P = 1.000 | ||||||||
| > 75 | 11 | 4 | 4 | 2 | 1 | 0 | 72.7 | 36.4 | |
| [39.0–94.0] | [10.9–69.2] | ||||||||
| 65–75 | 20 | 9 | 6 | 2 | 1 | 2 | 75.0 | 45.0 | |
| [50.9–91.3] | [23.1–68.5] | ||||||||
| < 65 | 7 | 5 | 1 | 1 | 0 | 0 | 85.7 | 71.4 | |
| [42.1–99.6] | [29.0–96.3] | ||||||||
| Number of prior chemotherapy regimens | |||||||||
| 1 | 23 | 11 | 7 | 4 | 1 | 0 | 78.3 | 47.8 | P = 1.000 |
| [56.3–92.5] | [26.8–69.4] | ||||||||
| 2 | 15 | 7 | 4 | 1 | 1 | 2 | 73.3 | 46.7 | |
| [44.9–92.2] | [21.3–73.4] | ||||||||
| ECOG performance status | |||||||||
| 0 | 14 | 9 | 4 | 1 | 0 | 0 | 92.9 | 64.3 | P = 0.115 |
| [66.1–99.8] | [35.1–87.2] | ||||||||
| 1 | 24 | 9 | 7 | 1 | 2 | 2 | 66.7 | 37.5 | |
| [44.7–84.4] | [18.8–59.4] | ||||||||
| Ann Arbor stage | |||||||||
| I–III | 19 | 9 | 6 | 3 | 1 | 0 | 78.9 | 47.4 | P = 1.000 |
| [54.4–93.9] | [24.4–71.1] | ||||||||
| IV | 19 | 9 | 5 | 2 | 1 | 2 | 73.7 | 47.4 | |
| [48.8–90.9] | [24.4–71.1] | ||||||||
| Relapsed after HDC/ASCT | |||||||||
| 6 | 3 | 2 | 1 | 0 | 0 | 83.3 [35.9–99.6] | 50.0 [11.8–88.2] | ||
| Time-to-enrollment after the initiation of first-line therapyb | |||||||||
| < 12 months | 7 | 1 | 2 | 3 | 1 | 0 | 42.9 | 14.3 | P = 0.017 |
| [9.9–81.6] | [0.4–57.9] | ||||||||
| ≥ 12 months | 16 | 10 | 5 | 1 | 0 | 0 | 93.8 | 62.5 | |
| [69.8–99.8] | [35.4–84.8] | ||||||||
| Tumor size | |||||||||
| < 5 cm | 28 | 14 | 9 | 2 | 2 | 1 | 82.1 | 50.0 | P = 0.205 |
| [63.1–93.9] | [30.6–69.4] | ||||||||
| ≥ 5 cm | 10 | 4 | 2 | 3 | 0 | 1 | 60.0 | 40.0 | |
| [26.2–87.8] | [12.2–73.8] | ||||||||
| Cell of origin—gene expression profiling | |||||||||
| GCB | 6 | 5 | 1 | 0 | 0 | 0 | 100 | 83.3 | P=0.082 |
| [54.1-100.0] | [35.9-99.6] | ||||||||
| ABC | 9 | 3 | 2 | 2 | 0 | 2 | 55.6 | 33.3 | |
| [21.2-86.3] | [7.5-70.0] | ||||||||
| Unclassified | 5 | 2 | 3 | 0 | 0 | 0 | 100 | 40.0 | |
| [47.8-100.0] | [5.3-85.3] | ||||||||
| Cell of origin—Hans algorithm | |||||||||
| GCB | 12 | 8 | 2 | 0 | 1 | 1 | 83.3 | 66.7 | P = 1.000 |
| [51.6–97.9] | [34.9–90.1] | ||||||||
| Non-GCB | 23 | 9 | 9 | 4 | 0 | 1 | 78.3 | 39.1 | |
| [56.3–92.5] | [19.7–61.5] | ||||||||
| Serum LDH, IU/L | |||||||||
| < 240 | 25 | 15 | 7 | 2 | 0 | 1 | 88.0 | 60.0 | P = 0.040 |
| [68.8–97.5] | [38.7–78.9] | ||||||||
| ≥ 240 | 13 | 3 | 4 | 3 | 2 | 1 | 53.8 | 23.1 | |
| [25.1–80.8] | [5.0–53.8] | ||||||||
| All patients | 38 | 18 | 11 | 5 | 2 | 2 | 76.3 [59.8–88.6] | 47.4 [31.0–64.2] | |
| Extranodal involvement | |||||||||
| < 2 lesions | 34 | 16 | 9 | 5 | 2 | 2 | 73.5 | 47.1 | P = 0.554 |
| [55.6–87.1] | [29.8–64.9] | ||||||||
| ≥ 2 lesions | 4 | 2 | 2 | 0 | 0 | 0 | 100.0 | 50.0 | |
| [39.8–100.0] | [6.8–93.2] | ||||||||
| IPI risk category—low, low-intermediate: score < 3; high-intermediate, high: score ≥ 3) | |||||||||
| < 3 | 29 | 17 | 8 | 3 | 0 | 1 | 86.2 | 58.6 | P = 0.020 |
| [68.3–96.1] | [38.9–76.5] | ||||||||
| ≥ 3 | 9 | 1 | 3 | 2 | 2 | 1 | 44.4 | 11.1 | |
| [13.7–78.8] | [0.3–48.2] | ||||||||
aCalculated for the overall response rate according to Fisher’s exact test
bIncludes eligible patients who received 1 regimen; other patients who received 2 regimens or ASCT were not included
n number of patients, CR complete response, PR partial response, SD stable disease, PD progressive disease, NE not evaluable, ECOG Eastern Cooperative Oncology Group, ORR overall response rate, CI confidence interval, HDC/ASCT high-dose chemotherapy/autologous stem cell transplantation, GCB germinal center B-cell-like, ABC activated B-cell-like, LDH lactate dehydrogenase, IPI international prognostic index