Table 1.
Patient demographics and baseline characteristics in the second-line subgroup of patients negative for brain metastases.
| SG (n = 33) | TPC (n = 32) | |
|---|---|---|
| Female—no. (%) | 33 (100) | 32 (100) |
| Median age—y (range) | 49 (30–80) | 51 (30–80) |
| ECOG PS—no. (%) | ||
| 0 | 17 (52) | 10 (31) |
| 1 | 16 (48) | 22 (69) |
| Race or ethnic group—no. (%) | ||
| White | 26 (79) | 27 (84) |
| Black | 3 (9) | 3 (9) |
| Asian | 3 (9) | 1 (3) |
| Other | 1 (3) | 1 (3) |
| Median baseline creatinine clearance—mL/min (range) | 115 (62–249) | 115 (61–213) |
| Serum bilirubin at baseline—no. (%) | ||
| Normal (≤ULN) | 31 (94) | 32 (100) |
| >1 to ≤1.5× ULN | 2 (6) | 0 |
| >1.5× ULN | 0 | 0 |
| Initial diagnosis of TNBCa—no. (%) | ||
| Yes | 26 (79) | 27 (84) |
| No | 7 (21) | 5 (16) |
| Median time to metastatic diseaseb—mo (range) | 13.3 (0.2–41.7) | 13.2 (6.9–121.7) |
| Median number of metastatic sites—no. (range) | 2 (1–7) | 3 (1–8) |
| Number of metastatic sites—no. (%) | ||
| <3 | 17 (51.5) | 12 (37.5) |
| ≥3 | 16 (48.5) | 20 (62.5) |
| Sites of metastatic diseasec | ||
| Lung | 19 (58) | 17 (53) |
| Liver | 14 (42) | 16 (50) |
| Bone | 6 (18) | 4 (13) |
| Germline BRCA1/2 mutational status—no. (%) | ||
| Negative | 19 (58) | 19 (59) |
| Positive | 3 (9) | 0 |
| Unknown | 11 (33) | 13 (41) |
| Setting of prior systemic therapies—no. (%) | ||
| Adjuvant | 20 (61) | 13 (41) |
| Neoadjuvant | 27 (82) | 29 (91) |
| Metastatic | 33 (100) | 32 (100) |
| Locally advanced disease | 0 | 1 (3) |
| Previous use of PARP inhibitorsd,e—no. (%) | 2 (6) | 0 |
| Previous use of checkpoint inhibitors—no. (%) | 3 (9) | 4 (13) |
| Most common prior systemic therapies—no. (%) | ||
| Cyclophosphamide | 30 (91) | 31 (97) |
| Paclitaxel | 28 (85) | 29 (91) |
| Carboplatin | 19 (58) | 27 (84) |
| Capecitabine | 18 (55) | 18 (56) |
| Doxorubicinf | 16 (48) | 16 (50) |
| Epirubicing | 13 (39) | 14 (44) |
Second-line patients were defined as those who received 1 line of therapy in the metastatic setting and recurred ≤12 months after (neo)adjuvant chemotherapy, prior to study enrollment.
BRCA breast cancer susceptibility gene, ECOG PS Eastern Cooperative Oncology Group performance score, NA not available, PARP poly adenosine diphosphate-ribose polymerase, TNBC triple-negative breast cancer, ULN upper limit of normal, SG sacituzumab govitecan, TPC treatment of physician’s choice.
aPatients in study either had TNBC at initial diagnosis or had hormone receptor-positive disease that converted to hormone-negative at time of study entry.
bOnly patients with complete date of diagnosis available for time from diagnosis of early stage disease (stage I, II, and III) to metastatic disease (stage IV) were included in this analysis (26 and 29 patients in the SG and TPC arm, respectively).
cBased on an independent central review of target and non-target lesions. The sites listed are not all-inclusive.
dPrior PARP inhibitor use in the post-neoadjuvant setting only.
ePARP inhibitor received was olaparib in both patients (1 in the adjuvant setting; 1 in the metastatic setting).
fIncludes doxorubicin and (liposomal) doxorubicin hydrochloride.
gIncludes epirubicin and epirubicin hydrochloride.