Table 1.
Selected baseline characteristics
| Characteristics | Total population N = 168 | TNBC subgroup (n = 58) |
|---|---|---|
| Median age, years (range) | 55 (31–81) | 52.5 (31–80) |
| Age category, n (%) (years) | ||
| < 65 | 140 (83.3) | 54 (93.1) |
| ≥ 65 | 28 (16.7) | 4 (6.9) |
| Sex, n (%) | ||
| Male | 1 (0.6) | 0 |
| Female | 167 (99.4) | 58 (100) |
| Race or ethnic group, n (%) | ||
| White | 143 (85.1) | 45 (7.8) |
| Black or African American | 16 (9.5) | 9 (15.5) |
| Asian | 3 (1.8) | 1 (1.7) |
| Other | 6 (3.6) | 3 (5.2) |
| Geographic region, n (%) | ||
| United States | 112 (66.7) | 48 (82.8) |
| Europe | 56 (33.3) | 10 (17.2) |
| ECOG PS, n (%) | ||
| 0 | 83 (49.4) | 33 (56.9) |
| 1 | 85 (50.6) | 25 (43.1) |
| Smoking history, n (%) | ||
| Never smoker | 107 (63.7) | 36 (62.1) |
| Current or former smoker | 50 (29.8) | 17 (29.3) |
| Unknown | 11 (6.5) | 5 (8.6) |
| Histological subtype of tumor, n (%) | ||
| Ductal | 94 (56.0) | 36 (62.1) |
| Lobular | 6 (3.6) | 0 |
| Carcinoma, not otherwise specified | 14 (8.3) | 6 (10.3) |
| Othera | 54 (32.1) | 16 (27.6) |
| Molecular subtype, n (%) | ||
| TNBC | 58 (34.5) | 58 (100) |
| HER2−/ER+ or PR+ | 72 (42.9) | – |
| HER2+ | 26 (15.5) | – |
| Unknownb | 12 (7.1) | – |
| Median time since first diagnosis, months (range) | 53.5 (7.3–407.5) | 40.3 (7.3–241.0) |
| Median time since diagnosis of metastatic disease, months (range)c | 21.6 (0.7–176.8) | 13.2 (0.7–176.8) |
| Prior anticancer lines of therapy for metastatic or locally advanced disease, n (%)d | ||
| ≤ 1 | 45 (26.8) | 29 (50.0) |
| 2 | 35 (20.8) | 16 (27.6) |
| ≥ 3 | 88 (52.4) | 13 (22.4) |
| Median (range) | 3 (0–10) | 2 (1–6) |
| PD-L1 expression status, n/N (%)e | PD-L1+ | PD-L1− | PD-L1+ | PD-L1− |
|---|---|---|---|---|
| ≥ 1% tumor cells | 85/136 (62.5) | 51/136 (37.5) | 33/48 (68.8) | 15/48 (31.2) |
| ≥ 5% tumor cells | 23/136 (16.9) | 113/136 (83.1) | 13/48 (27.1) | 35/48 (72.9) |
| ≥ 25% tumor cells | 3/136 (2.2) | 133/136 (97.8) | 2/48 (4.2) | 46/48 (95.8) |
| ≥ 10% tumor-associated immune cells | 12/136 (8.8) | 124/136 (91.2) | 9/48 (18.8) | 39/48 (81.2) |
ECOG PS Eastern Cooperative Oncology Group performance status, ER estrogen receptor, HER2 human epidermal growth factor receptor 2, PD-L1 programmed death-ligand 1, PR progesterone receptor, TNBC triple-negative breast cancer
aPatients who were uncoded (overall, 41; TNBC, 11), other histology (overall, 10; TNBC, 5), or missing (overall, 3)
bUnknown molecular subtype was due to incomplete information in the medical records database (ER/PR status known, but HER2 status unknown in four patients) or to information collected retrospectively (molecular subtype status was from post-baseline samples in eight patients and therefore was not used for baseline characterization)
cTime since diagnosis of metastatic disease was missing for eight patients in the overall study population and six patients in the TNBC subgroup
dRegimen for metastatic disease may have included hormonal therapy, either alone or in combination with chemotherapy. Systemic therapies that were not necessarily cytotoxic are included in the number of prior regimens reported here, but the number of prior cytotoxic therapies permitted was ≤ 3
eNon-evaluable specimens included those that were missing, of poor quality or quantity (insufficient tissue on slide or insufficient tumor sample), or otherwise not available to provide results; all biopsy or surgical specimens were required to be collected within 90 days of first administration of avelumab