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

Table 4.

Summary of the findings for the NSABP B-09 protocol*

Trial Outcome Median follow-up time, y Treatment group HR
(95% CI) †
P Change point, y, τ First interval,
≤ 1.57
Second interval,
> 1.57, ≤ 3.32
Third interval,
> 3.32
HR (95% CI) P HR (95% CI) P HR (95% CI) P
B-09 DFS 23.7 PF Ref .003 1.57
PF+TAM 0.99 1.01 .91 0.62 <.001 1.24 .01
(0.88 to 1.10) <.001 3.32 (0.81 to 1.27) (0.50 to 0.78) (1.05 to 1.45)

* All statistical tests were two-sided. CI = confidence interval; DFS = disease-free survival; F = 5-fluorouracil; HR = hazard ratio; NSABP = National Surgical Adjuvant Breast and Bowel Project; P = L-Phenylalanine mustard; TAM = tamoxifen.

† Assuming proportionality of hazards.

‡ For statistical significance of time-dependent treatment effects.