Table 2.
Efficacy results; summary of survival and response rates in each treatment arm (ITT population)
| Lapatinib 1,250 mg QD plus vinorelbine 20 mg/m2 (N = 75) | Lapatinib 1,250 mg QD plus capecitabine 2,000 mg/m2 (N = 37) | |
|---|---|---|
| Overall response rate, n (%) | ||
| CR | 1 (1) | 2 (5) |
| PR | 14 (19) | 11 (30) |
| CR + PR (95 %CI) | 15 (20) (11.6, 30.8) | 13 (35) (20.2, 52.5) |
| SD | 35 (47) | 15 (41) |
| PD | 15 (20) | 7 (19) |
| Unknowna | 10 (13) | 2 (5) |
| Duration of response, months | ||
| Median duration of response (95 % CI) | 6.7 (4.6, 8.3) | 10.8 (4.3, NE) |
| Clinical benefit response rate, n (%) | ||
| CR | 1 (1) | 2 (5) |
| PR | 14 (19) | 11 (30) |
| SD < 24 weeks | 21 (28) | 10 (27) |
| SD ≥ 24 weeks | 14 (19) | 5 (14) |
| PD | 15 (20) | 7 (19) |
| Unknown | 10 (13) | 2 (5) |
| Total CBR (95 % CI) | 29 (39) (27.6, 50.6) | 18 (49) (31.9, 65.6) |
| Time to response | ||
| Response events, n (%) | 15 (20) | 13 (35) |
| Median time to response, weeks (95 % CI) | 9.4 (9.0, 10.1) | 9.3 (9.1, 10.0) |
aPatients did not have their responses assessed at the 9-week timepoint for the following reasons: lapatinib plus vinorelbine arm: AE (5 patients), patient’s choice (1 patient), disease progression (2 patients), investigator discretion (1 patient), and protocol deviation (1 patient); lapatinib plus capecitabine arm: patient’s choice (1 patient), and disease progression (1 patient). AE adverse event; CI confidence interval; CBR clinical benefit rate; CR complete response; ITT intent-to-treat; NE not evaluable; PD progressive disease; PR partial response; QD once daily; SD stable disease