Comparison of hematological toxicity and lenalidomide exposure between patients with and without the del(5q) abnormality
| . | del(5q) abnormality . | P . | |
|---|---|---|---|
| No (n = 17) . | Yes (n = 7) . | ||
| Myelosuppression | |||
| Grade 3 or 4 neutropenia | 47.1% | 100% | .022* |
| Grade 3 or 4 thrombocytopenia | 23.5% | 57.1% | .167 |
| Grade 3 or 4 neutropenia and/or thrombocytopenia | 58.8% | 100% | .065 |
| Grade 3 or 4 neutropenia and thrombocytopenia | 11.8% | 57.1% | .038* |
| Decrease in neutrophil counts at nadir | 53.4% ± 16.6% | 71.2% ± 16.3% | .028* |
| Decrease in platelet counts at nadir | 44.7% ± 20.1% | 70.9% ± 19.2% | .008* |
| Lenalidomide exposure | |||
| Lenalidomide Cmax at steady state, ng/mL | 193 ± 84 | 211 ± 51 | .393 |
| Lenalidomide AUC5 at steady state, ng/h/mL | 568 ± 201 | 647 ± 179 | .291 |
| Lenalidomide AUCcum to neutrophil nadir, μg/h/mL | 13.5 ± 4.3 | 15.5 ± 4.9 | .431 |
| Lenalidomide AUCcum to platelet nadir, μg/h/mL | 12.3 ± 6.3 | 15.6 ± 6.4 | .235 |
| . | del(5q) abnormality . | P . | |
|---|---|---|---|
| No (n = 17) . | Yes (n = 7) . | ||
| Myelosuppression | |||
| Grade 3 or 4 neutropenia | 47.1% | 100% | .022* |
| Grade 3 or 4 thrombocytopenia | 23.5% | 57.1% | .167 |
| Grade 3 or 4 neutropenia and/or thrombocytopenia | 58.8% | 100% | .065 |
| Grade 3 or 4 neutropenia and thrombocytopenia | 11.8% | 57.1% | .038* |
| Decrease in neutrophil counts at nadir | 53.4% ± 16.6% | 71.2% ± 16.3% | .028* |
| Decrease in platelet counts at nadir | 44.7% ± 20.1% | 70.9% ± 19.2% | .008* |
| Lenalidomide exposure | |||
| Lenalidomide Cmax at steady state, ng/mL | 193 ± 84 | 211 ± 51 | .393 |
| Lenalidomide AUC5 at steady state, ng/h/mL | 568 ± 201 | 647 ± 179 | .291 |
| Lenalidomide AUCcum to neutrophil nadir, μg/h/mL | 13.5 ± 4.3 | 15.5 ± 4.9 | .431 |
| Lenalidomide AUCcum to platelet nadir, μg/h/mL | 12.3 ± 6.3 | 15.6 ± 6.4 | .235 |
Data were obtained from 24 patients who received lenalidomide 10 mg daily for up to 28 days during the first cycle. Lenalidomide AUC5 and Cmax were determined on day 14 of the first cycle (at steady state). Cumulated lenalidomide AUC5 = AUC5 × days to reach nadir. A 2-sided Fisher exact test was used to compare percentage of patients with grade 3 or 4 neutropenia/thrombocytopenia between groups, and 2-sided t test was used to compare all other parameters between groups.
Significantly different between “no” and “yes” groups.