TABLE 2.
Most Common (≥30%) Treatment-Related Adverse Events in the Inavo + Palbo + Letro and Inavo + Palbo + Fulv Arms (safety-evaluable population)
| Patient | Inavo + Palbo + Letro Arm (n = 33), No. (%) | Inavo + Palbo + Fulv Arm (n = 20), No. (%) | ||
|---|---|---|---|---|
| All Grade | Grade ≥3 | All Grade | Grade ≥3 | |
| Stomatitis (grouped terms)a | 22 (66.7) | 1 (3) | 18 (90) | 2 (10) |
| Neutropenia | 27 (81.8) | 22 (66.7) | 17 (85.0) | 14 (70.0) |
| Hyperglycemia | 21 (63.6) | 7 (21.2) | 14 (70.0) | 3 (15.0) |
| Diarrhea | 16 (48.5) | 0 | 11 (55.0) | 1 (5.0) |
| Thrombocytopenia | 16 (48.5) | 2 (6.1) | 10 (50.0) | 4 (20.0) |
| Anemia | 19 (57.6) | 2 (6.1) | 9 (45.0) | 1 (5.0) |
| Nausea | 15 (45.5) | 0 | 6 (30.0) | 0 |
| Asthenia | 6 (18.2) | 0 | 6 (30.0) | 0 |
| Decreased appetite | 12 (36.4) | 0 | 6 (30.0) | 0 |
| Leukopenia | 9 (27.3) | 4 (12.1) | 6 (30.0) | 3 (15.0) |
| Alopecia | 15 (45.5) | 0 | 5 (25.0) | 0 |
| Rash (grouped terms)b | 12 (36.4) | 0 | 3 (15) | 0 |
Abbreviations: Fulv, fulvestrant; Inavo, inavolisib; Letro, letrozole; Palbo, palbociclib.
a
Stomatitis grouped terms: stomatitis, mucosal inflammation, mouth ulceration, and tongue ulceration.
b
Rash grouped terms: rash, rash maculopapular, dermatitis acneiform, and hand dermatitis.