Table 2.
Side effects observed in key trials involving everolimus and temsirolimus
| Neoadjuvant letrozole ± everolimus 10 mg daily (Baselga et al 15)
|
TAMRAD tamoxifen ± everolimus 10 mg daily (Bachelot et al 16)
|
BOLERO-2 exemestane ± everolimus 10 mg daily (Yardley et al 19)
|
BOLERO-3 trastuzumab ± vinorelbine ± everolimus 5 mg daily (O’Regan et al 28)
|
HORIZON Letrozole ± temsirolimus 5/14 days (Wolff et al 14)
|
||||||
|---|---|---|---|---|---|---|---|---|---|---|
| EVE | Placebo | EVE | Placebo | EVE | Placebo | EVE | Placebo | EVE | Placebo | |
| Stomatitis/mucositis | ||||||||||
| All grade | 36.5 | 6.1 | 56 | 7 | 59 | 12 | 63 | 28 | 26 | 4 |
| Grade 3–4 | 2.2 | 0 | 11 | 0 | 8 | 0 | 13 | 2 | 1 | <1 |
| Rash | ||||||||||
| All grade | 20.4 | 7.6 | 44 | 7 | 39 | 7 | 25 | 18 | 15 | 4 |
| Grade 3–4 | 0.7 | 0 | 4 | 0 | 1 | 0 | 0 | 1 | 1 | <1 |
| Fatigue/asthenia | ||||||||||
| All grade | 29.9 | 13.3 | 72 | 53 | 37 | 27 | 43 | 42 | 27 | 21 |
| Grade 3–4 | 1.5 | 0.8 | 6 | 11 | 4 | 1 | 12 | 4 | 3 | 2 |
| Diarrhea | ||||||||||
| All grade | NR | 39 | 11 | 34 | 19 | 38 | 31 | 21 | 9 | |
| Grade 3–4 | 2 | 0 | 2 | <1 | 4 | 1 | 2 | 1 | ||
| Nausea | ||||||||||
| All grade | NR | 35 | 35 | 31 | 29 | 35 | 37 | 16 | 16 | |
| Grade 3–4 | 4 | 0 | <1 | 1 | 3 | 1 | 1 | 1 | ||
| Decreased appetite/anorexia | ||||||||||
| All grade | 12.4 | 3.8 | 43 | 18 | 31 | 13 | 33 | 17 | 15 | 7 |
| Grade 3–4 | 0 | 0 | 7 | 4 | 1 | <1 | 1 | 1 | 1 | 1 |
| Pyrexia | ||||||||||
| All grade | NR | NR | 16 | 7 | 39 | 23 | 14 | 7 | ||
| Grade 3–4 | 3 | 1 | 1 | 1 | ||||||
| Weight decreased | ||||||||||
| All grade | NR | NR | 28 | 7 | NR | NR | ||||
| Grade 3–4 | 1 | 0 | ||||||||
| Cough | ||||||||||
| All grade | NR | NR | 26 | 12 | NR | 15 | 10 | |||
| Grade 3–4 | <1 | 0 | <1 | <1 | ||||||
| Dysgeusia | ||||||||||
| All grade | NR | NR | 22 | 6 | NR | NR | ||||
| Grade 3–4 | 0 | 0 | ||||||||
| Dyspnea | ||||||||||
| All grade | 7.3 | 1.5 | NR | 22 | 11 | NR | 13 | 10 | ||
| Grade 3–4 | 0.7 | 0 | 5 | <1 | 3 | 3 | ||||
| Peripheral edema | ||||||||||
| All grade | NR | NR | 21 | 6 | NR | 15 | 6 | |||
| Grade 3–4 | 1 | <1 | 0 | 0 | ||||||
| Epistaxis | ||||||||||
| All grade | NR | NR | 17 | 1 | NR | NR | ||||
| Grade 3–4 | 0 | 0 | ||||||||
| Hyperglycemia | ||||||||||
| All grade | 13.1 | 3 | NR | 14 | 2 | 9 | 5 | 13 | 5 | |
| Grade 3–4 | 5.1 | 0 | 5 | <1 | 6 | 3 | 4 | 1 | ||
| Pneumonitis | ||||||||||
| All grade | 2.9 | 0 | 17 | 4 | 16 | 0 | 6 | 3 | NR | |
| Grade 3–4 | 2.2 | 0 | 2 | 4 | 3 | 0 | <1 | 1 | ||
Abbreviations: EVE, everolimus; NR, not reported.