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.