Table 1.
Factor definitions | No. of patients in each group | No. of events/no. of patients | Relapse-free survival |
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Univariate analysis |
Multivariable analysis |
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HR (95% CI) | P | HR (95% CI) | P | |||
Pathological tumor size† | ||||||
T1/2 vs T3/4 | 138/33 | 47/171 | 2.7 (1.4 to 5.0) | .002 | 3.0 (1.54 to 5.91) | .001 |
T1 vs T2–4 | 53/118 | 47/171 | 2.01 (1.0 to 4.1) | .05 | — | |
Node status (positive vs negative) | 90/69 | 44/159 | 3.9 (1.8 to 8.4) | <.001 | 2.8 (1.31 to 6.19) | .009 |
Ki67 level, per 2.7-fold increase‡ | NA | 48/174 | 1.4 (1.2 to 1.6) | <.001 | 1.3 (1.05 to 1.50) | .01 |
ER, Allred score (0 or 2 vs 3–8)§ | 16/157 | 48/173 | 2.4 (1.0 to 5.3) | .04 | 2.6 (1.1 to 6.0) | .03 |
Clinical response (yes vs no) | 70/104 | 49/174 | 2.8 (1.6 to 4.9) | <.001 | 1.72 (0.96 to 3.09) | .07 |
Grade (I vs II/III) | 33/126 | 46/159 | 3.8 (1.4 to 10.8) | .011 | 2.72 (0.95 to 7.8) | .06 |
The total number in each univariate analysis varied depending on the number of cases in which information on the individual factor was available. Cox proportional hazards models were used to calculate hazard ratios (HRs) and their 95% confidence intervals (CIs) of relapse, comparing tumors with the adverse factor relative to tumors without the adverse factor. Two-sided P values are provided throughout.
Tumor size was examined with two cutoff points, pT1/2 vs pT3/4 and pT1 vs pT2–4. A cutoff point of pT1/2 provided the smallest univariate P value and was used in the multivariable analysis (which excluded factors with a univariate P value of >.05).
Ki67 was analyzed as the natural logarithm values, or per 2.7-fold increase according to the original scale of percentage values.
The estrogen receptor (ER) analysis refers to the posttreatment values; before treatment all tumors in this dataset were ER+.
NA (not applicable) because K167 divided into five risk groups (see Table 4).