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. 2015 Oct 30;108(1):djv304. doi: 10.1093/jnci/djv304

Table 3.

Summary of the findings for the trials in which proportionality of the hazards was not satisfied*

Trial Outcome Median follow-up time, y Treatment group HR (95% CI)† P Change point, y, τ First interval, ≤ τ Second interval, > τ
HR (95% CI) P HR (95% CI) P
B-05 DFS 21.0 Placebo Ref
P 0.83 .004 1.14 0.45 .001 1.02 .88
(0.66 to 1.05) (0.27 to 0.73) (0.78 to 1.35)
Recurrence P 0.78 .002 1.14 0.39 <.001 1.03 .84
(0.60 to 1.02) (0.23 to 0.66) (0.75 to 1.43)
B-11 DFS 12.7 PF Ref
PAF 0.81 .002 4.47 0.68 <.001 1.44 .08
(0.67 to 0.97) (0.55 to 0.85) (0.96 to 2.18)
Recurrence PAF 0.75 .01 3.79 0.65 <.001 1.23 .37
(0.61 to 0.92) (0.52 to 0.83) (0.78 to 1.92)
LR Recurrence PAF 0.59 .006 3.81 0.48 <.001 1.62 .24
(0.43 to 0.81) (0.33 to 0.68) (0.73 to 3.61)
B-12 OS 20.3 PF+TAM Ref
PAF+TAM 1.02 .002 2.79 0.54 .005 1.13 .15
(0.88 to 1.19) (0.35 to 0.83) (0.96 to 1.33)
B-14 DFS 20.4 Placebo Ref
TAM 0.74 <.001 3.42 0.53 <.001 0.84 .002
(0.67 to 0.82) (0.44 to 0.65) (0.75 to 0.94)
Recurrence TAM 0.59 .006 3.47 0.46 <.001 0.70 <.001
(0.51 to 0.68) (0.37 to 0.58) (0.58 to 0.84)
LR recurrence TAM 0.47 .001 9.08 0.35 <.001 0.79 .23
(0.37 to 0.60) (0.26 to 0.48) (0.54 to 1.16)
B-16 OS 16.1 TAM Ref
AC+TAM 0.89 .002 3.47 0.51 .001 1.03 .74
(0.74 to 1.07) (0.34 to 0.76) (0.84 to 1.27)
DFS AC+TAM 0.84 .003 3.85 0.63 <.001 1.05 .69
(0.71 to 0.99) (0.49 to 0.81) (0.84 to 1.31)
B-20 LR recurrence 14.6 TAM Ref
M→F+TAM 0.76 .02 3.8 0.59 .07 0.91 .68
(0.53 to 1.08) (0.34 to 1.03) (0.57 to 1.45)
CMF+TAM 0.35 0.09 <.001 0.58 .04
(0.22 to 0.55) (0.03 to 0.29) (0.34 to 0.99)
B-23 DFS 11.0 CMF±TAM Ref
AC±TAM 1.13 .001 1.5 0.66 .03 1.31 .005
(0.96 to 1.34) (0.46 to 0.96) (1.08 to 1.59)
Recurrence AC±TAM 1.06 .006 1.5 0.65 .04 1.30 .05
(0.85 to 1.32) (0.43 to 0.98) (1.00 to 1.70)
LR recurrence AC±TAM 1.14 <.001 1.93 0.50 .02 2.03 .004
(0.81 to 1.62) (0.28 to 0.89) (1.26 to 3.28)
B-31 Distant recurrence 9.0 AC→T1 Ref
AC→T1+H 0.51 .02 1.32 0.81 .35 0.45 <.001
(0.42 to 0.64) (0.53 to 1.25) (0.35 to 0.57)

* All statistical tests were two-sided. A = adriamycin; C = cyclophosphamide; CI = confidence interval; DFS = disease-free survival; F = 5-fluorouracil; H = herceptin; HR = hazard ratio; LR = local-regional; M = methotrexate; OS = overall survival; P = L-Phenylalanine mustard; TAM = tamoxifen; T1 = taxol; y = years.

† Assuming proportionality of hazards.

‡ For statistical significance of time-dependent treatment effect (P value for β2 in [1] with Z(t), as defined in [2]).