Table 4 Multivariable linear regression model for mean difference in 18-month post-enrollment FACT-B total score.

From: Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT)

Covariate

Estimate

95% CI

SE

p-value

Intercept

36.37

19.38, 53.37

8.64

<0.001

Age ≤50 (vs. >50)

−3.87

−10.52, 2.77

3.38

0.252

Arm – T-DM1 vs. TH

−1.51

−6.31, 3.29

2.44

0.536

Age (≤50) * Arm (T-DM1)

7.99

0.47, 15.51

3.82

0.037

 ≤50 vs. >50, arm = T-DM1

4.12

0.32, 7.92

1.93

0.034

 ≤50 vs. >50, arm = TH

−3.87

−10.52, 2.77

3.38

0.252

 T-DM1 vs. TH, age ≤50

6.48

0.51, 12.46

3.04

0.034

 T-DM1 vs. TH, age >50

−1.51

−6.31, 3.29

2.44

0.536

Baseline FACT-B total score

0.73

0.63, 0.83

0.05

<0.001

Early discontinuation of TH/T-DM1 (vs. no)

−0.82

−5.17, 3.53

2.21

0.711

Race (vs. white)

 Asian

1.60

−5.46, 8.66

3.59

0.656

 Black

−5.89

−12.59, 0.82

3.41

0.085

 Other

0.19

−6.55, 6.94

3.43

0.955

Mastectomy (vs. lumpectomy)

−0.29

−11.74, 11.16

5.82

0.960

Receipt of radiotherapy (vs. no)

−2.29

−13.86, 9.28

5.88

0.697

Taking endocrine therapy 18 months (vs. no)

0.37

−2.79, 3.53

1.61

0.819

  1. Variables tested include age group, treatment arm, and their interaction term (arm*age group), race, early discontinuation, surgery type, receipt of radiotherapy, and endocrine therapy use at 18 months and the respective PRO score at baseline. A positive estimate indicates a higher (superior) FACT-B total score in the first comparator group vs. the second. P-value is derived from the linear regression model.
  2. FACT-B Functional Assessment of Cancer Therapy-Breast Cancer, CI confidence interval, SE standard error, T-DM1 trastuzumab emtansine, TH paclitaxel plus trastuzumab.
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