Table 3.
Treatment patterns.
| Variable | All (N = 91) | Treatment naïve |
Relapsed or ≥second line |
||
|---|---|---|---|---|---|
| Bendamustine monotherapy (n = 10) | Bendamustine + rituximab combination therapy (n = 6) | Bendamustine monotherapy (n = 20) | Bendamustine + rituximab combination therapy (n = 55) | ||
| Median dose (range), mg/m2 | 89.6 (21.8–119.4) | 97.9 (72.6–101.9) | 76.1 (60.4–100.2) | 98.1 (40.2–117.7) | 82.0 (21.8–119.4) |
| Median number of cycles administered (range) | 3 (1–11) | 2 (2–6) | 3 (1–7) | 3 (1–11) | 3 (1–8) |
| Median number of cycles planned (range) | 6 (2–14) | 6 (2–6) | 6 (6–8) | 6 (2–14) | 6 (2–10) |
| Median number of previous treatments (range) | 2 (0–5) | 0 (0–0) | 0 (0–0) | 2 (1–5) | 2 (0–5) |
| Relative dose intensity (%) | |||||
| Mean (SD) | 44.0 (12.2) | 47.4 (8.6) | 38.6 (12.2) | 40.6 (13.9) | 45.1 (12.0) |
| Median (range) | 45.0 (5.4–100.0) | 45.6 (38.5–68.4) | 43.1 (15–48.3) | 44.4 (5.4–61.2) | 46.0 (18.1–100.0) |
| 25th–75th percentile | 38.1–50.3 | 41.4–50.5 | 36.5–45.5 | 32.8–49.8 | 37.8–50.5 |
| Relative dose intensity cut points, n (%) | |||||
| ≤30% | 8 (8.8) | 0 | 1 (16.7) | 3 (15.0) | 4 (7.3) |
| 31–50% | 59 (64.8) | 6 (60.0) | 5 (83.3) | 13 (65.0) | 35 (63.6) |
| ≥51% | 24 (26.4) | 4 (40.0) | 0 | 4 (20.0) | 16 (29.1) |
| Reasons for discontinuation, n (%) | |||||
| No response to treatment | 3 (3.3) | 0 | 0 | 1 (5.0) | 2 (3.6) |
| Patient refused due to toxicity | 1 (1.1) | 0 | 1 (16.7) | 0 | 0 |
| Toxicity, medically required | 10 (11.0) | 2 (20.0) | 0 | 2 (10.0) | 6 (11.0) |
| Patient-specific reason | 4 (4.4) | 0 | 1 (16.7) | 1 (5.0) | 2 (3.6) |
| Progression/relapse | 2 (2.2) | 0 | 0 | 0 | 2 (3.6) |
| Treatment completed as scheduled | 19 (20.9) | 1 (10.0) | 1 (16.7) | 4 (20.0) | 13 (23.6) |
| Other | 7 (7.7) | 0 | 0 | 2 (10.0) | 5 (9.1) |
| Unknown | 42 (46.1) | 7 (70.0) | 3 (50.0) | 10 (50.0) | 22 (40.0) |
| Patients who did not discontinue* | 3 (3.3) | 0 | 0 | 0 | 3 (5.5) |
| Maximum cycle delay, n patients (%) | |||||
| None | 36 (39.5) | 6 (60.0) | 3 (50.0) | 6 (30.0) | 21 (38.2) |
| 1–5 days | 5 (5.5) | 0 | 1 (16.7) | 1 (5.0) | 3 (5.5) |
| 5–10 days | 16 (17.6) | 2 (20.0) | 0 | 4 (20.0) | 10 (18.1) |
| 10–15 days | 16 (17.6) | 1 (10.0) | 0 | 6 (30.0) | 9 (16.4) |
| >15 days | 18 (19.8) | 1 (10.0) | 2 (33.3) | 3 (15.0) | 12 (21.8) |
| Maximum cycle delay, n doses (%) | |||||
| 1–5 days | 7 (8.9) | 0 | 1 (14.3) | 1 (5.0) | 5 (10.6) |
| 5–10 days | 23 (29.1) | 1 (20.0) | 0 | 8 (40.0) | 14 (29.8) |
| 10–15 days | 24 (30.4) | 3 (60.0) | 1 (14.3) | 8 (40.0) | 12 (25.5) |
| >15 days | 25 (31.6) | 1 (20.0) | 5 (71.4) | 3 (15.0) | 16 (34.1) |
| Total | 79 | 5 | 7 | 20 | 47 |
| Doses with no delay | 545 | 62 | 47 | 111 | 325 |
| Number of cycles with dose reduction, n patients (%) | |||||
| 1 | 26 (47.3) | 6 (85.7) | 0 | 6 (66.7) | 14 (40.0) |
| 2 | 14 (25.5) | 1 (14.3) | 2 (50.0) | 1 (11.1) | 10 (28.6) |
| 3 | 6 (10.9) | 0 | 0 | 1 (11.1) | 5 (14.3) |
| 4 | 6 (10.9) | 0 | 2 (50.0) | 0 | 4 (11.4) |
| 5 | 3 (5.4) | 0 | 0 | 1 (11.1) | 2 (5.7) |
| Total | 55 (60.4) | 7 (70.0) | 4 (100) | 9 (45.0) | 35 (63.6) |
| Dosing | |||||
| 1 per cycle | 42 | 3 | 3 | 7 | 29 |
| 2 per cycle | 291 | 32 | 25 | 62 | 172 |
| 3 per cycle | 0 | 0 | 0 | 0 | 0 |
| Patients receiving a granulocyte colony-stimulating factor, n (%) | 61 (67.0) | 2 (20.0) | 4 (66.7) | 12 (60.0) | 43 (78.2) |
| Patients receiving an IV/PO antiemetic, n (%) | 91 (100) | 10 (100) | 6 (100) | 20 (100) | 55 (100) |
| Patients receiving an IV/PO antibiotic during treatment$, n (%) | 9 (9.9) | 1 (10.0) | 1 (16.7) | 2 (10.0) | 5 (9.1) |
| Patients receiving an IV/PO anti-infective for prophylaxis prior to bendamustine administration, n (%) | |||||
| Yes | 13 (14.3) | 0 | 0 | 3 (15.0) | 10 (18.2) |
| No | 64 (70.3) | 5 (50.0) | 6 (100) | 17 (85.0) | 36 (65.5) |
| Missing | 14 (15.4) | 5 (50.0) | 0 | 0 | 9 (16.4) |
IV, intravenous; PO, oral; SD, standard deviation.
*
These patients did not have stop dates for their first bendamustine regimen, and had approximately 3 months of follow up.
$
Patients receiving intravenous antibiotics in a hospital (out of US Oncology Network) were not captured.