Table 2.
Clinical data of everolimus in patients with trastuzumab-refractory, HER2-positive breast cancer
| Author/phase | Population (N) | Treatment | Efficacy | Most common toxic effects |
|---|---|---|---|---|
| Andre/phase Ib [71] | TRAS-refractory, mBC (33) | EVE + PAC + TRAS | ORR: 44%; CBR: 74%; mPFS: 34 weeks | Any grade: neutropenia (64%) and stomatitis (82%); grade 3/4: neutropenia (52%) |
| Dalenc/phase II [73] | TRAS- and taxane-refractory mBC (55) | EVE + PAC + TRAS | ORR: 19%; CBR: 40%; mPFS: 26 weeks | Grade 3/4: neutropenia (27%) |
| Jerusalem/phase I [75] | TRAS-refractory mBC (50) | EVE + VIN + TRAS | ORR: 19%; CBR: 54%; mPFS: 30.7 weeks | Any grade: neutropenia (92%) and stomatitis (70%); grade 3/4: neutropenia (86%) |
| Campone/phase I and II pooled analysis [74] | TRAS-refractory mBC with (57) or without (77) previous LAP exposure | EVE + TRAS + PAC: n = 84; EVE + TRAS + VIN: n = 50 | ORR, LAP-exposed: 21%; ORR, LAP-nonexposed: 29%; mPFS, LAP-exposed: 29 weeks; mPFS, LAP-nonexposed: 36.1 weeks | Grade 3/4: similar in LAP-exposed and nonexposed patients |
| Jerusalem/phase Ib and II extension [72] | TRAS-refractory mBC (31) | EVE + TRAS | ORR: 15%; CBR: 34%; mPFS: 41 weeks | Grade 3/4: neutropenia, leukopenia, and lymphopenia (n = 2 for each) and stomatitis (n = 1) |
| Morrow/phase I and II pooled analysis [76] | TRAS-refractory mBC (47) | EVE + TRAS | ORR: 15%; CBR: 34%; mPFS: 4.1 months | Grade ≥2: mucositis (34%), fatigue (32%), and lymphopenia (26%); grade 3/4: lymphopenia (13%) and hyperglycemia (11%) |
AE, adverse event; CBR, clinical benefit rate (CR + PR + SD); CR, complete response; EVE, everolimus; LAP, lapatinib; mBC, metastatic breast cancer; mPFS, median progression-free survival; ORR, overall response rate (CR + PR); PAC, paclitaxel; PR, partial response; SD, stable disease; TRAS, trastuzumab; VIN, vinorelbine.