Table 3.
Efficacy results (ITT population)
| Characteristic | Lapatinib + nab-paclitaxel (n = 60) |
|---|---|
| Overall response rate (ORR) | |
| Response rate (CR + PR), n (%) (95 % CI) | 32 (53) (40.7–66.0) |
| Best response, n (%) | |
| CR | 4 (7) |
| PR | 28 (47) |
| SD | 10 (17) |
| PD | 8 (13) |
| Unknown | 10 (17)a |
| PFS | |
| Patients, n (%) | 60 (100) |
| Progressed or died due to any cause | 30 (50) |
| Censored, follow-up ended | 19 (32) |
| Censored, follow-up ongoing | 11 (18)b |
| Kaplan–Meier estimate for PFS (weeks) | |
| Median (95 % CI) | 39.7 (34.1–63.9) |
| TTR | |
| Patients, n (%) | 32 (53) |
| Kaplan–Meier estimate for TTR (weeks) | |
| Median (95 % CI) | 7.8 (7.4–8.1) |
| DoR | |
| Patients, n (%) | 32 (53) |
| Progressed or died due to any cause | 17 (53) |
| Censored, follow-up ended | 4 (13) |
| Censored, follow-up ongoing | 11 (34)b |
| Kaplan–Meier estimate for DoR (weeks) | |
| Median (95 % CI) | 48.7 (31.7–57.1) |
| TTP | |
| Patients, n (%) | 60 (100) |
| Progressed or died due to breast cancer | 28 (47) |
| Censored, died due to other cause | 2 (3) |
| Censored, follow-up ended | 19 (32) |
| Censored, follow-up ongoing | 11 (18)b |
| Kaplan–Meier estimate for TTP (weeks) | |
| Median (95 % CI) | 41.0 (39.1–64.6) |
CI confidence interval, CR complete response, DoR duration of response, ITT intent-to-treat, PD progressive disease, PFS progression-free survival, PR partial response, SD stable disease, TTR time to response, TTP time to progression
aPatients who withdrew before the first response assessment. Patients with unknown responses were treated as non-responders
bAt the time of this reporting, there were 11 patients still ongoing on lapatinib monotherapy treatment