Table 2.
Pathological response by (a) central assessment, (b) central assessment in patients who discontinued or received a reduced dose
| FEC (n = 27) | TX (n = 239) | T (n = 238) | Difference | p value | |
|---|---|---|---|---|---|
| % (95% CI) | % (95% CI) | % (95% CI) | (TX-T) (95 %CI) | ||
| (a) | |||||
| pCR | 7.4 | 23 (17.8–28.9) | 24.4 (19.1–30.3) | −1.4 (−9.0 to 6.3) | 0.7476 |
| pINV | 48.1 (28.7–68.1) | 72.4 (66.3–78.0) | 71.4 (65.2–77.1) | 1 | |
| Missing* | 44.4 (25.5–64.7) | 4.6 (2.3–8.1) | 4.2 (2.0–6.7) | 0.4 | |
| (b) | |||||
| pCR | 7.4 | 23 (17.8–28.9) | 24.4 (19.1–30.3) | −1.4 (−9.0 to 6.3) | 0.7476 |
| With discontinuation | (n = 12/53) | (n = 1/13) | |||
| pCR | – | 22.6 (12.3–36.2) | 7.7 (0.2–36.0) | 14.9 (−3.4 to 33.3) | |
| With dose reduction | (n = 19/79) | (n = 2/14) | |||
| pCR | – | 24.1 (15.1–35.0) | 14.3 (1.8–42.8) | 9.8 (−10.8 to 30.4) |
pCR pathological complete response, pINV pathological presence of invasive tumor, * patients missing post-baseline mainly due to discontinuation as a result of toxicity, CI confidence interval, FEC 5-fluorouracil–epirubicin–cyclophosphamide, TX docetaxel plus capecitabine, T docetaxel alone