Patient characteristics and toxicities in patients with elevated bilirubin and normal bilirubin levels prior to therapy
| Patient characteristics . | Elevated bilirubin . | Normal bilirubin . | P . | ||
|---|---|---|---|---|---|
| N = 10 . | N = 59 . | ||||
| Median age, y | 39 (18-56) | 52 (20-75) | .24 | ||
| Male sex (%) | 5/10 (50) | 30/59 (51) | 1.00 | ||
| Lymphoma type (%) | |||||
| B cell | 5/10 (50) | 52/59 (88) | .011 | ||
| T cell | 5/10 (50) | 7/59 (12) | |||
| Stage III/IV (%) | 10/10 (100) | 44/59 (75) | .10 | ||
| Elevated lactate dehydrogenase (%) | 7/10 (70) | 27/59 (46) | .19 | ||
| Involvement > 1 extranodal site (%) | 6/10 (60) | 30/59 (51) | .74 | ||
| Performance status ≥ 2 (%) | 7/10 (70) | 12/59 (20) | .0032 | ||
| IPI (intermediate high/high risk) (%) | 7/10 (70) | 21/59 (36) | .078 | ||
| Bilirubin, total (median) | 2.7 mg/dL | 0.5 mg/dL | n/a | ||
| Bilirubin, total (range) | 1.2-22.5 mg/dL | 0.2-1 mg/dL | |||
| Toxicity (390 cycles assessed) | |||||
| Cycle 1 | All cycles | Cycle 1 | All cycles | P (C1) | |
| ANC < 500/mm3 (% cycles) | 9/10 (90) | 29/44 (66) | 30/59 (51) | 195/337 (58) | .035 |
| Platelet < 25 × 103/mm3 (% cycles) | 4/10 (40) | 12/44 (27) | 4/59 (7) | 21/337 (6) | .013 |
| Febrile neutropenia (% cycles) | 2/10 (20) | 4/44 (9) | 5/59 (8) | 36/337 (11) | .27 |
| G3/4 GI toxicity and neurotoxicity (% cycles) | 3/10 (30) | 5/44 (11) | 8/59 (14) | 36/337 (11) | .19 |
| Response (%) | |||||
| Complete response | 7/10 (70) | 49/59 (83) | .38 | ||
| Partial response | 0/10 (0) | 3/59 (5) | 1.00 | ||
| Stable disease | 1/10 (10) | 1/59 (2) | .27 | ||
| Progressive disease | 2/10 (20) | 5/59 (8) | .27 | ||
| Patient characteristics . | Elevated bilirubin . | Normal bilirubin . | P . | ||
|---|---|---|---|---|---|
| N = 10 . | N = 59 . | ||||
| Median age, y | 39 (18-56) | 52 (20-75) | .24 | ||
| Male sex (%) | 5/10 (50) | 30/59 (51) | 1.00 | ||
| Lymphoma type (%) | |||||
| B cell | 5/10 (50) | 52/59 (88) | .011 | ||
| T cell | 5/10 (50) | 7/59 (12) | |||
| Stage III/IV (%) | 10/10 (100) | 44/59 (75) | .10 | ||
| Elevated lactate dehydrogenase (%) | 7/10 (70) | 27/59 (46) | .19 | ||
| Involvement > 1 extranodal site (%) | 6/10 (60) | 30/59 (51) | .74 | ||
| Performance status ≥ 2 (%) | 7/10 (70) | 12/59 (20) | .0032 | ||
| IPI (intermediate high/high risk) (%) | 7/10 (70) | 21/59 (36) | .078 | ||
| Bilirubin, total (median) | 2.7 mg/dL | 0.5 mg/dL | n/a | ||
| Bilirubin, total (range) | 1.2-22.5 mg/dL | 0.2-1 mg/dL | |||
| Toxicity (390 cycles assessed) | |||||
| Cycle 1 | All cycles | Cycle 1 | All cycles | P (C1) | |
| ANC < 500/mm3 (% cycles) | 9/10 (90) | 29/44 (66) | 30/59 (51) | 195/337 (58) | .035 |
| Platelet < 25 × 103/mm3 (% cycles) | 4/10 (40) | 12/44 (27) | 4/59 (7) | 21/337 (6) | .013 |
| Febrile neutropenia (% cycles) | 2/10 (20) | 4/44 (9) | 5/59 (8) | 36/337 (11) | .27 |
| G3/4 GI toxicity and neurotoxicity (% cycles) | 3/10 (30) | 5/44 (11) | 8/59 (14) | 36/337 (11) | .19 |
| Response (%) | |||||
| Complete response | 7/10 (70) | 49/59 (83) | .38 | ||
| Partial response | 0/10 (0) | 3/59 (5) | 1.00 | ||
| Stable disease | 1/10 (10) | 1/59 (2) | .27 | ||
| Progressive disease | 2/10 (20) | 5/59 (8) | .27 | ||
IPI, international prognostic index; n/a, there is no legitimate p-value since the categories are formed based on the bilirubin being within the normal or elevated range.