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. 2014 May 27;32(21):2255–2269. doi: 10.1200/JCO.2013.54.2258

Table 2.

Efficacy Outcomes

Study, Author, Year Intervention/Comparison No. of Patients Evaluated Overall Survival
 Mortality
 Recurrence
 Contralateral Breast Cancer
Overall
 Breast Cancer Specific
 Disease-Free Survival
 Risk of Recurrence
 Risk of Recurrence by Years
No. % No. % No. % No. % No. % %
ECOG, Tormey, 1996 Continue 100 (57 premenopausal, 43 postmenopausal) 86 86 (5-yr) 14 14* 8 8* 85 85* 15 (7 pre, 8 post) 15 NR NR
Stop (observation) 93 (49 premenopausal, 43 postmenopausal) 83 89 (5-yr) 10 10.7* 8 8.6* 70 73* 23 (9 pre, 14 post) 25 NR NR
    P 0.10
ER+ .81
OS
.18 pre, .72 post		 0.52 .10 .10 ( ER+ .014); .38 pre, .16 post
NSABP B-14, Fisher, 2001a Continue 583 NR 91 57 9.8 NR NR 446 event-free 76.5 47 8.1
(rate, 12.5)		 36.3 average annual rate events per 1,000 NR
     Stop (placebo) 569 94 39 6.9 463 event-free 81.4 34 6.0 (rate, 8.9) 27.7 average annual rate events per 1,000
    RR 1.5 1.4 (first events)
LRR
1.6 (distant)
    95% CI 0.8 to 2.9 0.9 to 2.2
0.6 to 2.6 (first events)
LRR
0.8 to 3.1 (distant)		 1.0 to 1.7 0.4 to 1.7
    P .07
> 5 years, .61		 .03 DFS
.13 RFS		 .13 RR .03
(.03, time-by-treatment interaction)
Scottish Cancer Trials Breast Group, Stewart, 2001 Continue 173 103 (including relapse) total alive (all-cause) 59.5* 70 40* 40 deaths with relapse 23* 94 54* 9 Relapse 5.2 9/295c
Both arms
Stop 169b 115 (including relapse) total alive (all-cause) 68* 54 32* 26 deaths with relapse 15* 103 61* 12 relapse 7.1 NR
    Hazard ratio 1.32 1.44d
    95% CI 0.93 to 1.88 0.87 to 2.38
    P .12 .15 (two-tailed)e
ATLAS, Davies, 2012 Continue (≤ 10 yrs) 3,428f NR NR 639 18.6* 331h 9.66* 308 8.98* 617 18 21.4 419g
Premenopausal 326 64 20
Postmenopausal 3,102 553 18
Stop 3,418f NR NR 722 21.1* 397h 11.6* 325h 9.51* 711 20.74 25.1 (years 5-14)
Premenopausal 304 73 24
Postmenopausal 3,114 638 20
    Summary statistic 0.87 ERR, log-rank (variance) O-E = −47.7 (340.2) 0.83g ERR, log rank (variance) O-E = −32.9 (182.0) 0.91 ERR, log rank (variance) = −14.8 (158.1) 0.845 annual event RR 0.81 pre,
0.85 post
annual event RR		 ≥ 10 years, log-rank by years = 0.75 0.88 ERRg
    95% CI 0.78 to 0.97 0.72 to 0.96g 0.78 to 1.06 0.76 to 0.94, SE = 0.051 SE = 0.15 pre, .05 post ≥ 10 years
0.62 to 0.9, log-rank by years		 0.77 to 1.00g
    P .01 .01g .24 .002g, log-rank (variance) = −55.9 (331.9) .002i,j, ≥ 10 yrs, .003 RR log-rank by years .05g
aTTom, Gray, 2013 Continue 3,468 849 24.5 885 34 404 24 481 34 580 28 4.8% (5-6 yrs)
6.3% (7-9 yrs)
7.1% (10-14 yrs)
3.9% (≥15 yrs)		 NR
     Stop 3,485 910 26.1 939 (AC)l,m 35 452 21 487 37 672 32 4.4% (5-6 yrs)
7.9% (7-9 yrs)
9.0% (10-14 yrs)
5.8% (15+ yrs)
    RR −30.6 90.94 (AC) 0.88l, 0.88g,k,h,n, 1.08f,k,n,k (5-9 yrs)
0.74f,k,n (≥ 10 yrs)		 0.95 0.85 1.10 (5-6 yrs)
0.79 (7-9 yrs)
0.78 (10-14 yrs)
0.66 (≥ 15 yrs)
    95% CI 0.85 to 1.02 OR
439.7
O-E Variance		 0.86 to 1.03 (AC)
(non–breast cancer)
0.82 to 1.07		 0.77 to 1.01i,l
0.74 to 1.03f,k,i,n
0.85 to 1.38 (5-9 yrs)f,k,n
0.59 to 0.92 (10+ yrs)f,g,n 		0.84 to 1.08 0.76 to 0.95 0.88 to 1.38 (5-6 yrs)
0.65 to 0.96 (7-9 yrs)
0.63 to 0.95 (10-14 yrs)
0.43 to 1.02 (≥ 15 yrs)		 0.85 to 1.02 OR
439.7
O-E variance
    P Effect 2p = .1, NS 2p = .2 (AC) .06 (two-tailed), .05 (one-tailed)
0.1f,k,i
NR RR (5-9 yrs)
0.007 RR (10+ yrs)f 		.4 .003 Effect 2p = .1, NS

Abbreviations: AC, all-cause; ATLAS, Adjuvant Tamoxifen Longer Against Shorter; aTTom, Adjuvant Tamoxifen—to Offer More?; ER, estrogen receptor; ERR, event rate ratio; LRR, locoregional rate; NR, not reported; NS, nonsignificant; O-E, observed-expected; OR, odds ratio; RFS, recurrence-free survival; RR, rate ratio; RRR, recurrence rate ratio; SE, standard error.

*

Percentages calculated when not reported in original study.

a

After 7 years of follow-up.

b

See note in Data Supplement, second randomization after 5 years of adjuvant tamoxifen.

c

Main trial (duration > 66 months).

d

Breast cancer deaths only.

e

Survival free of systemic disease.

f

ER positive.

g

Analysis of all patients, regardless of ER status.

h

Overall mortality intention-to-treat analysis (ER positive).

i

All years.

j

Death without recurrence.

k

Breast cancer death (denominator 6.934).

l

OR by years 5-6, 7-9, 10-14, ≥ 15 in presentation.

m

Analysis of RRs of overall mortality by treatment and year of follow-up: 849 versus 910, RR 1.05 (95% CI, 0.90 to 1.22) during years 5-9, RR 0.86 (95% CI, 0.75 to 0.97) later; P .01.

n

Source: Correction, personal communication from Richard Gray, MD.