Table 2.
PFS | OS | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n | n1 | n2 | coef | HR | 95%-CI | p | p* | coef | HR | 95%-CI | p | p* | ||||
(A) Learning set † | ||||||||||||||||
Predicted responders | R vs. NR | 36 | 15 | 21 | -1.755 | 0.17 | 0.06-0.51 | 0.001 | 0.002 | -1.354 | 0.26 | 0.08-0.80 | 0.019 | 0.003 | ||
DFS | M1 vs. <24 mo | 36 | 8 | 11 | -1.000 | 0.37 | 0.09-1.43 | 0.150 | -0.044 | 0.96 | 0.21-4.45 | 0.960 | ||||
>24 mo vs. <24 mo | 17 | 11 | -0.107 | 0.90 | 0.35-2.32 | 0.830 | 0.560 | 1.75 | 0.63-4.87 | 0.280 | ||||||
Adjuvant chemotherapy | yes vs. no | 36 | 18 | 18 | -0.664 | 0.51 | 0.17-1.57 | 0.240 | 0.250 | 1.28 | 0.45-3.63 | 0.640 | ||||
Histology | lobular+other vs. ductal | 36 | 8 | 28 | -0.559 | 0.57 | 0.14-2.28 | 0.430 | -0.975 | 0.38 | 0.09-1.50 | 0.170 | ||||
Tumor grade | 3 vs. 1|2|unknown | 36 | 16 | 20 | -0.396 | 0.67 | 0.27-1.70 | 0.400 | -0.282 | 0.75 | 0.32-1.77 | 0.520 | ||||
Receptor status | HR+/HER2- vs. HR-/HER2- | 36 | 26 | 10 | 0.030 | 1.03 | 0.33-3.26 | 0.960 | -0.749 | 0.47 | 0.16-1.42 | 0.180 | ||||
Type of metastases | visceral vs. non-visceral | 36 | 25 | 11 | 1.039 | 2.83 | 0.88-9.11 | 0.082 | 1.393 | 4.03 | 1.11-14.63 | 0.034 | ||||
Origin of specimen | metastasis vs. primary tumor | 36 | 7 | 29 | -0.810 | 0.45 | 0.13-1.58 | 0.210 | -0.913 | 0.40 | 0.12-1.37 | 0.140 | ||||
(B) Optimization set | ||||||||||||||||
Predicted responders | R vs. NR | 48 | 34 | 14 | -1.914 | 0.15 | 0.05-0.41 | <0.001 | 0.006 | -1.573 | 0.21 | 0.08-0.51 | 0.001 | 0.009 | ||
DFS | M1 vs. <24 mo | 48 | 9 | 12 | 0.524 | 1.69 | 0.39-7.27 | 0.480 | 0.069 | 1.07 | 0.26-4.49 | 0.930 | ||||
>24 mo vs. <24 mo | 27 | 12 | -0.056 | 0.95 | 0.33-2.73 | 0.920 | -0.710 | 0.49 | 0.17-1.45 | 0.200 | ||||||
Adjuvant chemotherapy | yes vs. no | 48 | 31 | 17 | 0.084 | 1.09 | 0.45-2.65 | 0.850 | -0.304 | 0.74 | 0.30-1.83 | 0.510 | ||||
ECOG PS | ≥2 vs. 0|1 | 48 | 4 | 44 | 1.026 | 2.79 | 0.75-10.42 | 0.130 | 1.761 | 5.82 | 1.50-22.56 | 0.011 | ||||
Histology | lobular vs. ductal | 48 | 6 | 37 | 1.196 | 3.31 | 1.05-10.41 | 0.041 | 1.236 | 3.44 | 1.07-11.11 | 0.039 | ||||
other vs. ductal | 5 | 37 | 1.669 | 5.31 | 1.73-16.30 | 0.004 | 1.160 | 3.19 | 1.05-9.70 | 0.041 | ||||||
Tumor grade | 3 vs. 1|2|unknown | 48 | 17 | 31 | 1.518 | 4.56 | 1.60-13.01 | 0.005 | 1.091 | 2.98 | 1.14-7.77 | 0.026 | ||||
Receptor status | HR+/HER2- vs. HR-/HER2- | 48 | 30 | 18 | 0.778 | 2.18 | 0.74-6.43 | 0.160 | 0.655 | 1.92 | 0.68-5.44 | 0.220 | ||||
Type of metastases | visceral vs. non-visceral | 48 | 31 | 17 | 0.741 | 2.10 | 0.86-5.10 | 0.100 | 0.508 | 1.66 | 0.67-4.11 | 0.270 | ||||
Line of therapy | ≥2nd vs. 1st | 48 | 33 | 15 | -0.356 | 0.70 | 0.31-1.57 | 0.390 | 0.135 | 1.14 | 0.53-2.47 | 0.730 | ||||
Origin of specimen | metastasis vs. primary tumor | 48 | 11 | 37 | 0.138 | 1.15 | 0.42-3.16 | 0.790 | -0.150 | 0.86 | 0.36-2.08 | 0.740 |
* overall p-value using Wald test
† “ECOC PS” and “line of therapy” were not included in multivariate analysis in the learning set because all patients had ECOG PS 0 or 1 and all were treated 1st-line.
DFS: disease-free survival; ECOG PS: Eastern Cooperative Oncology Group Performance Status; ER: estrogen receptor; PR: progesterone receptor; CI: confidence interval; PFS: progression-free survival; OS: overall survival; coef is the coefficient in the Cox regression model for the respective variable; HR: hazard ratio (=exp(coef)); R: responder; NR: non-responder