Table 2. Treatment summary.
| |
Part 1 |
Part 2 |
|
||
|---|---|---|---|---|---|
| Parameter, n (%) | Neratinib 160 mg+paclitaxel (n=3) | Neratinib 240 mg+paclitaxel (n=5) | Group Aa (n=71) | Group Bb (n=31) | Total (N=110) |
| Median neratinib treatment duration (range), weeks | 12.3 (8.1–24.3) | 15.0 (4.3–63.4) | 48.1 (0.1–144.4) | 52.3 (7.7–147.3) | 47.9 (0.1–147.3) |
| Median paclitaxel treatment duration (range), weeks | 11.1 (7.1–23.1) | 15.0 (3.0–46.9) | 31.0 (1.0–81.0) | 30.0 (3.0–97.1) | 29.6 (1.0–97.1) |
| Median neratinib dose intensity (range), mg per day | 160.0 (150.7–160.0) | 239.5 (166.7–240.0) | 239.6 (152.9–241.1) | 240.0 (100.5–240.0) | 239.6 (100.5–241.1.) |
| Median paclitaxel dose intensity (range), mg m−2 per cycle |
225.8 (207.4–244.1) |
211.9 (158.1–237.5) |
212.4 (78.7–245.1) |
226.2 (131.1–244.9) |
213.5 (78.7–245.1) |
|
Neratinib dose modification | |||||
| Dose delay | 1 (33) | 3 (60) | 42 (59) | 12 (39) | 58 (53) |
| Dose reduction | 0 | 1 (20) | 13 (18) | 7 (23) | 21 (19) |
| Due to adverse event | 0 | 1 (20) | 10 (14) | 5 (16) | 16 (15) |
| Other/not stated |
0 |
0 |
7 (10) |
2 (6) |
9 (8) |
|
Paclitaxel dose modification | |||||
| Dose delay | 1 (33) | 5 (100) | 46 (65) | 19 (61) | 71 (65) |
| Dose reduction | 1 (33) | 2 (40) | 25 (35) | 13 (42) | 41 (37) |
| Due to adverse event | 1 (33) | 2 (40) | 25 (35) | 12 (39) | 40 (36) |
| Other/not stated | 0 | 0 | 0 | 1 (3) | 1 (1) |
a
Group A allowed ⩽1 prior cytotoxic chemotherapy regimen for metastatic disease.
b
Group B allowed ⩽3 prior cytotoxic chemotherapy regimens for metastatic disease, with prior lapatinib permitted.