Oncotype DX® and Adjuvant! Breast TANG: B-14/20 Adjuvant! Rev4Rev 11-29-10
Breast Cancer Res Treat 25-Oct-18 05:02:44
SUPPLEMENTAL MATERIALS
Supplemental Table S1A:Comparison of the Distribution of Demographic, Clinical, and Treatment Characteristics of NSABP B-14 Patients Who Did and Did Not Have RSAssessment
Characteristic
/ Recurrence Score Population in B-14(N = 668) / Remaining B-14 Population (N = 1947) / All NSABP B-14 Population
(N = 2615)
Treatment enrollment
TAM-randomized Pts
/ 290 (43%) / 1114 (57%) / 1404 (54%)TAM-registered pts
/ 378 (57%) / 833 (43%) / 1211 (46%)Age at enrollment
< 50 yr of age / 194 (29%) / 617 (32%) / 811 (31%)50 ≤ age < 60 / 173 (26%) / 583 (30%) / 756 (29%)
≥ 60 yr of age / 301 (45%) / 747 (38%) / 1048 (40%)
Race
White / 615 (92%) / 1761 (91%) / 2376 (91%)Black / 31 (5%) / 87 (4%) / 118 (5%)
Others / 22 (3%) / 99 (5%) / 121 (5%)
Tumor size
0 – 1.0 cm / 112 (17%) / 358 (18%) / 470 (18%)
1.1 – 2.0 cm / 303 (45%) / 898 (46%) / 1201 (46%)
2.1 – 4.0 cm / 218 (33%) / 592 (30%) / 810 (31%)
4.1+ cm / 35 (5%) / 99 (5%) / 134 (5%)
Supplemental Table S1B:Comparison of the Distribution of Demographic, Clinical, and Treatment Characteristics of NSABP B-20 Patients Who Did and Did Not Have RSAssessments
Characteristic
/ Recurrence Score Population in B-20(N = 651) / Remaining B-20 Population
(N = 1648) / NSABP B-20 Population
(N = 2299)
Treatment enrollment
TAM-only
/ 227 (35%) / 543 (33%) / 770 (33%)TAM + chemo
/ 290 (65%) / 1239 (67%) / 1529 (67%)Age at enrollment
< 50 yr of age / 289 (44%) / 752 (46%) / 1041 (45%)50 ≤ age < 60 / 166 (26%) / 478 (29%) / 643 (28%)
≥ 60 yr of age / 196 (30%) / 418 (25%) / 615 (27%)
Race
White / 593 (91%) / 1431 (87%) / 2024 (88%)Black / 33 (5%) / 103 (6%) / 136 (6%)
Others / 25 (4%) / 114 (7%) / 139 (6%)
Tumor size
0 – 1.0 cm / 83 (13%) / 261 (16%) / 344 (15%)
1.1 – 2.0 cm / 313 (48%) / 843 (51%) / 1156 (50%)
2.1 – 4.0 cm / 226 (35%) / 486 (29%) / 712 (31%)
4.1+ cm / 29 (4%) / 58 (4%) / 87 (4%)
Supplemental Table S2:
Models / Variables / HR / P1 / RI intermediate vs low / 2.51 (1.55, 4.21) / 0.001
RI high vs low / 2.01 (1.25, 3.23)
RS intermediate vs low / 2.21 (1.28, 3.81) / <0.001
RS high vs low / 3.8 (2.36, 6.1)
2 / Age (>50 vs <=50) / 0.76 (0.52, 1.13) / 0.173
Tumor size / 1.2(1.07, 1.36) / 0.003
Grade (moderate vs well) / 1.51 (0.75, 3.05) / 0.003
Grade (poor vs well) / 3.18 (1.42, 7.15)
RI intermediate vs low / 1.51 (0.82, 2.78) / 0.176
RI high vs low / 0.95 (0.52, 1.76)
RS intermediate vs low / 2.07 (1.18, 3.61) / <0.001
RS high vs low / 2.88 (1.74, 4.76)
Results of Multivariate Cox Models Assessing the Relative Associations of RS and RI Risk Groups among 668 B-14 Tamoxifen-treated Patients using DRFI as the Endpoint
Supplemental Table S3: Results from Multivariate Cox Models Assessing the Relative Associations of RI-PCT/50 and RS-PCT/50 among 668 B-14 Tamoxifen-treated Patients Using Breast Cancer-specific Mortality as the Endpoint
Models / Variables / Hazard ratio (95% CI) / P / -2log(L)a1 / Age (>50 vs <=50) / 0.81 (0.55, 1.21) / 0.3 / 1270.6
Tumor size (cm) / 1.21 (1.1, 1.35) / <0.001
Grade (moderate vs well) / 2.71 (1.46, 5.06) / <0.001
Grade (poor vs well) / 6.45 (3.48, 11.94)
2 / RI-PCT/50 / 3.28 (2.2, 4.89) / <0.001 / 1295.7
3 / RS-PCT/50 / 3.32 (2.29, 4.81) / <0.001 / 1288.9
4 / RI-PCT/50 / 2.31 (1.51, 3.53) / <0.001 / 1273.1
RS-PCT/50 / 2.45 (1.66, 3.61) / <0.001
5 / Age (>50 vs <=50) / 0.87 (0.58, 1.29) / 0.49 / 1257.8
Tumor size (cm) / 1.22 (1.05, 1.41) / 0.008
Grade (moderate vs well) / 2.24 (1.07, 4.72) / 0.001
Grade (poor vs well) / 4.35 (1.86, 10.15)
RI-PCT/50 / 0.93 (0.49, 1.78) / 0.83
RS-PCT/50 / 2.02 (1.35, 3) / <0.001
6 / Age (>50 vs <=50) / 0.87 (0.59, 1.29) / 0.49 / 1257.8
Tumor size (cm) / 1.2 (1.08, 1.34) / <0.001
Grade (moderate vs well) / 2.15 (1.14, 4.07) / <0.001
Grade (poor vs well) / 4.11 (2.11, 8.01)
RS-PCT/50 / 2.01 (1.35, 2.98) / <0.001
7 / Age (>50 vs <=50) / 0.81 (0.55, 1.21) / 0.31 / 1270.5
Tumor size (cm) / 1.2 (1.05, 1.38) / 0.01
Grade (moderate vs well) / 2.59 (1.24, 5.4) / <0.001
Grade (poor vs well) / 6.04 (2.67, 13.71)
RI-PCT/50 / 1.08 (0.57, 2.03) / 0.82
aL represents the likelihood function for a model.
Supplemental Table S4:Results from Multivariate Cox Models Assessing the Relative Associations of RI-PCT/50 and RS-PCT/50 among 668 B-14 Tamoxifen-treated
Models / Variables / Hazard ratio (95% CI) / P / -2log(L)a1 / Age (>50 vs <=50) / 1.48 (1.06, 2.05) / 0.021 / 2324.1
Tumor size (cm) / 1.1 (1, 1.21) / 0.047
Grade (moderate vs well) / 1.66 (1.15, 2.39) / <0.001
Grade (poor vs well) / 2.68 (1.8, 3.99)
2 / RI-PCT/50 / 1.63 (1.24, 2.14) / <0.001 / 2342.9
3 / RS-PCT/50 / 1.95 (1.51, 2.52) / <0.001 / 2328.9
4 / RI-PCT/50 / 1.31 (0.98, 1.75) / 0.074 / 2325.6
RS-PCT/50 / 1.77 (1.35, 2.33) / <0.001
5 / Age (>50 vs <=50) / 1.55 (1.11, 2.16) / 0.01 / 2310.7
Tumor size (cm) / 1.14 (1, 1.29) / 0.057
Grade (moderate vs well) / 1.63 (1.01, 2.61) / 0.013
Grade (poor vs well) / 2.4 (1.33, 4.33)
RI-PCT/50 / 0.77 (0.47, 1.26) / 0.3
RS-PCT/50 / 1.67 (1.26, 2.22) / <0.001
6 / Age (>50 vs <=50) / 1.56 (1.12, 2.17) / 0.01 / 2311.8
Tumor size (cm) / 1.08 (0.98, 1.19) / 0.13
Grade (moderate vs well) / 1.4 (0.96, 2.05) / 0.011
Grade (poor vs well) / 1.95 (1.26, 3.02)
RS-PCT/50 / 1.65 (1.24, 2.19) / <0.001
7 / Age (>50 vs <=50) / 1.47 (1.06, 2.05) / 0.022 / 2323.6
Tumor size (cm) / 1.14 (1, 1.29) / 0.045
Grade (moderate vs well) / 1.85 (1.16, 2.94) / <0.001
Grade (poor vs well) / 3.12 (1.77, 5.5)
RI-PCT/50 / 0.83 (0.51, 1.35) / 0.462
Patients Using Overall Survival as the Endpoint
aL represents the likelihood function for a model.
Supplemental Table S5:Results from Multivariate Cox Models Assessing the Relative Associations of RI-PCT/50 and RS-PCT/50 among 668 B-14 Tamoxifen-treated
Models / Variables / Hazard ratio (95% CI) / P / -2log(L)a1 / Age (>50 vs <=50) / 1.15 (0.89,1.5) / 0.287 / 3453.4
Tumor size (cm) / 1.06 (0.98, 1.15) / 0.13
Grade (moderate vs well) / 1.19 (0.9, 1.58) / 0.002
Grade (poor vs well) / 1.77 (1.29, 2.43)
2 / RI-PCT/50 / 1.3 (1.04, 1.61) / 0.021 / 3463.8
3 / RS-PCT/50 / 1.77(1.44, 2.18) / <0.001 / 3439.5
4 / RI-PCT/50 / 1.05(0.83,1.33) / 0.69 / 3439.3
RS-PCT/50 / 1.75(1.4, 2.18) / <0.001
5 / Age (>50 vs <=50) / 1.2(0.99,1.24) / 0.175 / 3432.6
Tumor size (cm) / 1.11(0.99,1.24) / 0.07
Grade (moderate vs well) / 1.17 (0.8, 1.7) / 0.12
Grade (poor vs well) / 1.58 (0.97,2.56)
RI-PCT/50 / 0.76 (0.5, 1.15) / 0.188
RS-PCT/50 / 1.69 (1.34, 2.14) / <0.001
6 / Age (>50 vs <=50) / 1.21(0.93,1.57) / 0.161 / 3434.3
Tumor size (cm) / 1.05 (0.96,1.14) / 0.27
Grade (moderate vs well) / 1 (0.75,1.34) / 0.268
Grade (poor vs well) / 1.27 (0.89,1.81)
RS-PCT/50 / 1.67(1.32,2.11) / <0.001
7 / Age (>50 vs <=50) / 1.15(0.88,1.49) / 0.3 / 3452.6
Tumor size (cm) / 1.1 (0.99,1.23) / 0.07
Grade (moderate vs well) / 1.33 (0.92,1.93) / 0.004
Grade (poor vs well) / 2.07 (1.31,3.29)
RI-PCT/50 / 0.83 (0.55, 1.24) / 0.357
Patients Using DFS as the Endpoint
aL represents the likelihood function for a model.
Supplemental Table S6:Association between RS or RI Risk Groups and Benefit from Chemotherapy among 651 B-20 Patients usingBreast Cancer-specific Mortality as the Endpoint
Cohort / HR for benefit from MF/CMF (95% CI) / Pa / Pb (interaction)Overall / 0.62 (0.36, 1.06) / 0.081
RS low / 1.86 (0.38, 9.19) / 0.449 / 0.025
RS intermediate / 0.94 (0.32, 2.82) / 0.918
RS high / 0.27 (0.13, 0.55) / <0.001
Adjuvant! low / 1.03 (0.35, 3.01) / 0.96 / 0.463
Adjuvant! intermediate / 0.62 (0.23, 1.71) / 0.358
Adjuvant! high / 0.44 (0.19, 1.02) / 0.054
aFrom Wald tests.
b From likelihood ratio tests.
SUPPLEMENTAL FIGURES
SUPPLEMENTAL FIGURES LEGENDS
Fig. S1 Kaplan-Meier curves for distant recurrence across RS risk groups in B-14 tamoxifen-treated patients.
Fig. S2 Kaplan-Meier curves for distant recurrence across RI risk groups in B-14 tamoxifen-treated patients.
Fig.S3 Point estimates and 95% confidence intervals for the percentage of
B-14 patients with distant recurrence at 10 years by RS then RI risk groups.
Fig. S1 Kaplan-Meier curves for distant recurrence across RS risk groups in B-14 tamoxifen-treated patients.
Fig. S2 Kaplan-Meier curves for distant recurrence across RI risk groups in B-14 tamoxifen-treated patients.
Fig.S3 Point estimates and 95% confidence intervals for the percentage of
B-14 patients with distant recurrence at 10 years by RS then RI risk groups.
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