Table 3. Treatment efficacy—pathological response by treatment regimen.
| EC-DT | EC-DL | |
|---|---|---|
| Pathological responsea n (%) | n =48 | n =51 |
| Grade 1 |
2 (4.2) |
2 (3.9) |
| Grade 2 |
6 (12.5) |
6 (11.8) |
| Grade 3 |
9 (18.7) |
13 (25.5) |
| Grade 4 |
6 (12.5) |
11 (21.5) |
| Grade 5b |
25 (52.1) |
13 (25.5) |
| Unknown |
0 (0) |
6c (11.8) |
| pCR breast |
25 (52.1) |
13 (25.5) |
| (95% CI) |
(38.0–66.2) |
(13.5–37.5) |
| |
P-value=0.0065 | |
| pCR breast and axilla (Grade 5-A & 5-D)d |
23 (47.9) |
12 (23.5) |
| (95% CI) |
(33.8–62.0) |
(11.9–35.1) |
| P-value=0.0112 | ||
Abbreviations: EC-DL=epirubicin plus cyclophosphamide x 4 cycles followed by docetaxel plus lapatinib; EC-DT=epirubicin plus cyclophosphamide x 4 cycles followed by docetaxel plus trastuzumab; pCR=pathological complete response.
Grade 1-Grade 5: Miller and Payne classification of pathological response.
Absence of any residual invasive tumour in the breast, residual DCIS permitted.
All six patients were withdrawn from the study and treated with a different therapy. Four cases were related to lapatinib as follows: 1 grade 3 supraventricular arrhythmia; 1 grade 4 mucositis-estomatitis plus grade 4 skin rash; 1 grade 3 diarrhea; and 1 grade 3 diarrhea plus grade 3 skin rash.
The absence of any residual invasive tumour in the breast and axilla at diagnosis in node-negative patients (grade 5-A) or in node-positive patients (grade 5-D).