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. 2021 Feb 20;57:5–17. doi: 10.1016/j.breast.2021.02.009

Table 4.

Disease-free survival in RCTs.

First Author (year) or NCT record number [trial name] Intergroup Difference
Intervention
Comparator
Effect Estimate 95% CI p-value Treatment Proportion Treatment Proportion (95% CI)
96-week (2 year) DFS

Kurebayashi 2017;
NCT01546649
Difference: 1.2% −5.2 - 7.8 NR TAP-144-SR
(6 month depot)
97.3% (95% CI: 93.6–100.0) TAP-144-SR (3 month depot) 97.5% (95% CI: 94.1–100.0)
5-year DFS
Ruiz-Borrego (2019);
NCT00543127 [GEICAM/2006–10]
NR NR NR Anastrozole + fulvestrant 91.0% (95% CI: 88.2–93.9) Anastrozole 90.8% (95% CI: 88.0–93.6)
Smith (2017) [FACE] HR: 0.96 0.82–1.13 NR Letrozole 84.7% (95% CI: 82.9–86.3) Anastrozole 83.4% (95% CI: 81.6–85.1)
Tjan-Heijnen (2017)a [DATA] HR: 0.79 0.61–1.03 NR Anastrozole
(6 years)
83.2% (95% CI: 79.7–86.7) Anastrozole (3 years) 79.7% (95% CI: 76.2–83.3)
Colleoni (2018) [SOLE] HR: 1.12 0.94–1.33 NR Intermittent letrozole 85.0% Continuous letrozole 86.6%
Francis (2015) [SOFT] HR: 0.88 0.69–1.13 NR Tamoxifen + OFS 86.3%b (95% CI: NR) Tamoxifen 85.3%b (95% CI: NR)
7-year DFS
Ruiz-Borrego (2019);
NCT00543127 [GEICAM/2006–10]
HR: 0.84 0.58–1.22 0.352 Anastrozole + fulvestrant 86.9% (95% CI: 83.3–90.6) Anastrozole 83.3 (95% CI: 79.2–87.5)
8-year DFS
Filho (2015) [BIG 1–98] HR for ILC: 0.48 0.31–0.74 NR Letrozole 82% (95% CI: NR) Tamoxifen 66% (95% CI: NR)
HR for IDC: 0.80 0.68–0.94 82% (95% CI: NR) 75% (95% CI: NR)
10-year DFS
Derks (2017) [TEAM] NR NR NR Tamoxifen → exemestane 67% (95% CI: 66–69) Exemestane 68% (95% CI: 66–70)

Abbreviations: CI = confidence interval; DFS = disease-free survival; HR = hazard ratio; IDC = invasive ductal carcinoma; ILC = invasive lobular carcinoma; NR = not reported; OFS = ovarian function suppression; RCT = randomized controlled trial.

a

Study included patients who were disease-free after 3 years, as such the DFS outcome was termed 5-year “adapted” DFS.

b

Reported in-text as proportion experiencing DFS events; subtracted from 100%.