Table 2.
Study Outcomes.
| Nivestim (N = 65) | Neupogen (N = 66) | p-value | |
|---|---|---|---|
| Primary Outcome | |||
| • Mobilization success, n (%) | 63 (96.9) | 64 (97) | 0.988 |
| Secondary Outcomes | |||
| Safety | |||
| • Incidence of adverse events, n (%) | 12 (18.5) | 5 (7.6) | 0.583 |
| Back pain | 6* | 4 | |
| Bone pain | 3* | 1 | |
| Body aches | 2 | 0 | |
| Headaches | 1 | 0 | |
| Hip pain | 1 | 0 | |
| Atypical chest pain | 1 | 0 | |
| • Missing data, n (%) | 25 (38.5) | 51 (77.3) | |
| Mobilization and Apheresis | |||
| • Median number of cells mobilized (x 106) | 7.56 | 6.81 | 0.318 |
| Range | 0–45.9 | 0.2–40.63 | |
| • Median duration of G-CSF received per mobilization (days) | 9 | 10 | 0.126 |
| Range | 3–18 | 5–24 | |
| • Median number of Injections received per mobilization | 20 | 22 | 0.49 |
| Range | 8–48 | 10–48 | |
| • Median number of apheresis sessions (days) | 2 | 2 | 0.874 |
| Range | 0–4 | 1–7 | |
| • Medium length of hospitalization (days) | 15 | 17 | 0.035 |
| Range | 2–152 | 5–61 | |
| Drug Acquisition Cost† | |||
| • Median drug acquisition cost for G-CSF per patient ($) | 533.4 | 1261.9 | <0.0001 |
| Range | 213.4–1280.2 | 574–2755.2 | |
| Engraftment Kinetics | |||
| • Median time to neutrophil engraftment (days) | 11 | 11 | 0.719 |
| Range | 9–16 | 9–17 | |
| • Median time to platelet engraftment (days) | 13 | 11.5 | 0.100 |
| Range | 9–26 | 8–22 | |
*2 patients in the Nivestim arm had both back pain and bone pain.
†Drug acquisition cost was calculated based on the drug cost at the time of the study.