TABLE 2.
Summary of Tumor Molecular Alterations at Baseline for Enrolled Patients
| Squamous n = 30 | Nonsquamous n = 33 | Total N = 63 | |
|---|---|---|---|
| PIK3CA mutation status, n (%) | |||
| n | 29 | 31 | 60 |
| PIK3CA mutation | 6 (20.7) | 14 (45.2) | 20 (33.3) |
| PIK3CA wild-type | 19 (65.5) | 13 (41.9) | 32 (53.3) |
| Unknown | 4 (13.8) | 4 (12.9) | 8 (13.3) |
| PTEN mutation status, n (%) | |||
| n | 29 | 30 | 59 |
| PTEN mutation | 8 (27.6) | 12 (40.0) | 20 (33.9) |
| PTEN wild-type | 18 (62.1) | 14 (46.7) | 32 (54.2) |
| Unknown | 3 (10.3) | 4 (13.3) | 7 (11.9) |
| PTEN expression, n (%) | |||
| n | 29 | 25 | 54 |
| PTEN negative (<10% IHC) | 18 (62.1) | 6 (24.0) | 24 (44.4) |
| PTEN positive | 11 (37.9) | 16 (64.0) | 27 (50.0) |
| Unknown | 0 | 3 (12.0) | 3 (5.6) |
| PI3K pathway activation status, n (%) | |||
| n | 30 | 33 | 63 |
| PIK3CA mutation only | 4 (13.3) | 8 (24.2) | 12 (19.0) |
| PTEN mutation only | 5 (16.7) | 5 (15.2) | 10 (15.9) |
| PTEN negative only | 12 (40.0) | 2 (6.1) | 14 (22.2) |
| PIK3CA wild-type and PTEN alterationa | 19 (63.3) | 12 (36.4) | 31 (49.2) |
| PIK3CA mutation and PTEN alterationa | 1 (3.3) | 3 (9.1) | 4 (6.3) |
| PIK3CA mutation or PTEN alterationa | 29 (96.7) | 28 (84.8) | 57 (90.5) |
| Patients with known PTEN mutation and expression status, n (%) | |||
| n | 25 | 18 | 43 |
| PTEN mutation and PTEN positive | 6 (24.0) | 6 (33.3) | 12 (27.9) |
| PTEN wild-type and PTEN negative | 13 (52.0) | 3 (16.7) | 16 (37.2) |
| PTEN mutation and PTEN negative | 2 (8.0) | 1 (5.6) | 3 (7.0) |
| PTEN wild-type and PTEN positive | 4 (16.0) | 8 (44.4) | 12 (27.9) |
Percentages were calculated from the number of samples assessed, n. “Unknown” includes patients whose tumors were assessed, but whose results were not evaluable. Concomitant mutations were calculated omitting samples with “unknown” or “missing” status as appropriate.
a
PTEN alteration is defined as either PTEN mutation or PTEN negative.
IHC, immunohistochemistry; PI3K, phosphatidylinositol 3-kinase; PTEN, phosphatase and tensin homolog.