Table 2.
Clinical Outcomes 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 = 73) | Yes (n = 114) | |||||||
| Best clinical response, n (%) | ||||||||||
| CR | 73 | 39.0 | 37 | 45.1 | 36 | 34.3 | 31 | 42.5 | 42 | 36.8 |
| PR | 59 | 31.6 | 24 | 29.3 | 35 | 33.3 | 26 | 35.6 | 33 | 29.0 |
| ORR [CR + PR], n (%) | 132 | 70.6 | 61 | 74.4 | 71 | 67.6 | 57 | 78.1 | 75 | 65.8 |
| PD | 23 | 12.3 | 5 | 6.1 | 18 | 17.1 | 5 | 6.9 | 18 | 15.8 |
| SD | 17 | 9.1 | 8 | 9.8 | 9 | 8.6 | 5 | 6.9 | 12 | 10.5 |
| Unknown | 15 | 8.0 | 8 | 9.8 | 7 | 6.7 | 6 | 8.2 | 9 | 7.9 |
| TNT-D | ||||||||||
| n, % censored | 37 | 19.8 | 16 | 19.5 | 21 | 20.0 | 18 | 24.7 | 19 | 16.7 |
| Median, mo (95% CI) | 14.6 (11.8–18.6) | 20.9 (14.4–26.2) | 11.8 (9.0–15.2) | 20.9 (14.4–26.8) | 11.9 (9.8–15.2) | |||||
| EFS | ||||||||||
| n, % censored | 36 | 19.3 | 16 | 19.5 | 20 | 19.0 | 18 | 24.7 | 18 | 15.8 |
| Median, mo (95% CI) | 14.4 (11.0–18.0) | 20.1 (14.4–25.4) | 10.7 (7.7–14.5) | 19.5 (12.0–26.2) | 11.8 (8.5–14.6) | |||||
| 18-mo EFS rate, % | 44.2 | 54.9 | 35.8 | 54.7 | 37.4 | |||||
| OS | ||||||||||
| n, % censored | 114 | 61.0 | 58 | 70.7 | 56 | 53.3 | 50 | 68.5 | 64 | 56.1 |
| Median, mo (95% CI) | 128.0 (78.1–NR) | NR (128.0–NR) | 78.1 (45.8–146.7) | 128.0 (70.6–NR) | 101.9 (59.5–NR) | |||||
| 2-y OS rate, % | 92.4 | 90.0 | 75.9 | 88.8 | 77.9 | |||||
| Histological transformation after start of index therapy, n (%) | ||||||||||
| Yes | 32 | 17.1 | 8 | 9.8 | 24 | 22.9 | 32 | 17.1 | 8 | 9.8 |
| No | 151 | 80.8 | 72 | 87.8 | 79 | 75.2 | 151 | 80.8 | 72 | 87.8 |
| Unknown | 4 | 2.1 | 2 | 2.4 | 2 | 1.9 | 4 | 2.1 | 2 | 2.4 |
| Type of histological transformation, among patients with transformation, n (%) | (n = 32) | (n = 8) | (n = 24) | (n = 32) | (n = 8) | |||||
| DLBCL | 25 | 78.13 | 6 | 75.00 | 19 | 79.17 | 8 | 80.00 | 17 | 77.27 |
| BCLU | 1 | 3.13 | 1 | 12.50 | – | – | 1 | 10.00 | – | – |
| Other | 2 | 6.25 | – | – | 2 | 8.33 | – | – | 2 | 9.09 |
| Unknown | 4 | 12.50 | 1 | 12.50 | 3 | 12.50 | 1 | 10.00 | 3 | 13.64 |
| Median (range) time to transformation, months, among patients with transformation | 16.4 (0–103.4) | 27.3 (1.2–72.5) | 12.4 (0–103.4) | 14.2 (0–103.4) | 16.7 (1.2–84.9) | |||||
BCLU = Unclassifiable B-cell lymphoma; CI = confidence intervals; CR = complete response; DLBCL = Diffuse large B-cell lymphoma; EFS = event-free survival; FL = follicular lymphoma; NR = not reached; ORR = overall response rate; OS = overall survival; PD = progression of disease; POD4 = progression of disease within 24 months following the start of front-line immunochemotherapy; PR = partial response; SD = stable disease; TNT-D = time to next treatment or death.