Table 2 –
Treatment toxicity during pembrolizumab and lenvatinib therapy for the whole study population and by lenvatinib dose subgroups.
| Lenvatinib starting dose | |||||||
|---|---|---|---|---|---|---|---|
| Recommended dose (n = 16) | Reduced dose (n = 54) | ||||||
| Overall (n = 70) | |||||||
| Toxicity endpoint | N | % | N | % | N | % | p |
| Any hospitalization | 0.695 | ||||||
| No | 32 | 45.7% | 8 | 50.0% | 24 | 44.4% | |
| Yes | 38 | 54.3% | 8 | 50.0% | 30 | 55.6% | |
| Hospitalization related to toxicity | 0.553 | ||||||
| No | 47 | 67.1% | 12 | 75.0% | 35 | 64.8% | |
| Yes | 23 | 32.9% | 4 | 25.0% | 19 | 35.2% | |
| Treatment discontinuation due to toxicity | 0.285 | ||||||
| No | 43 | 61.4% | 8 | 50.0% | 35 | 64.8% | |
| Yes | 27 | 38.6% | 8 | 50.0% | 19 | 35.2% | |
| Lenvatinib dose interruption | 0.272 | ||||||
| No | 12 | 17.1% | 1 | 6.2% | 11 | 20.4% | |
| Yes | 58 | 82.9% | 15 | 93.8% | 43 | 79.6% | |
| Number of lenvatinib dose reductions | 0.016 | ||||||
| 0 | 40 | 57.1% | 6 | 37.5% | 34 | 63.0% | |
| 1 | 22 | 31.4% | 5 | 31.3% | 17 | 31.4% | |
| 2 | 6 | 8.6% | 3 | 18.8% | 3 | 5.6% | |
| 3 | 2 | 2.9% | 2 | 12.5% | 0 | 0.0% | |
| Cause of lenvatinib dose reduction* | |||||||
| Fatigue | 14 | 20.0% | 6 | 37.5% | 8 | 14.8% | 0.046 |
| Anorexia | 7 | 10.0% | 4 | 25.0% | 3 | 5.6% | 0.043 |
| Gastrointestinal | 13 | 18.6% | 7 | 43.8% | 6 | 11.1% | 0.003 |
| Hematologic | 4 | 5.7% | 3 | 18.8% | 1 | 1.9% | 0.035 |
| Hypertension | 4 | 5.7% | 1 | 6.3% | 3 | 5.6% | NP |
| Cardiac | 1 | 1.4% | 0 | 0.0% | 1 | 1.9% | NP |
| Renal | 1 | 1.4% | 0 | 0.0% | 1 | 1.9% | NP |
| Musculoskeletal | 2 | 2.9% | 0 | 0.0% | 2 | 3.7% | NP |
| Dermatologic | 2 | 2.9% | 0 | 0.0% | 2 | 3.7% | NP |
*
Causes of dose reductions may be multifactorial, and the reported percentages are out of each cohort. NP = not performed due to small numbers.