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Table 1 Characteristics of TEXT intention-to-treat population, overall and according to availability of blood for DNA analysis

From: Impact of CYP19A1 and ESR1 variants on early-onset side effects during combined endocrine therapy in the TEXT trial

 

Blood for DNA analysis

TEXT population

(n = 2660)

 

No (n = 693)

Yes (n = 1967)

 

Characteristics at randomization

 White/Caucasian,%

73

92

87

 Age (years), median (IQR)

43 (39, 46)

44 (40, 47)

43 (40, 46)

 Normal menstruation, %

87

88

87

 BMI (kg/m2), median (IQR)

24 (22, 29)

24 (21, 28)

24 (21, 28)

 Presence of any grade (1–3) hot flashes, %

5

8

7

 Presence of any grade (1–2) sweating, %

4

7

6

 Presence of any grade (1–4) musculoskeletal symptoms, %

13

15

15

Concomitant adjuvant therapy

 Adjuvant chemotherapy, %

64

58

59

 HER2-directed therapy, %

3

7

6

Protocol adjuvant therapy

 Treatment assignment

   

  Exemestane + OFS, %

50

50

50

  Tamoxifen + OFS, %

50

50

50

 Oral endocrine therapy (exemestane or tamoxifen) treatment <12 months, %

19

6

10

 OFS <12 months, %

16

4

7

Analysis endpointsa

 Early-onset grade ≥2 hot flashes/sweating, %

41

43

43

 Early-onset grade ≥2 musculoskeletal symptoms, %

28

26

27

  1. aAdverse events according to common terminology criteria for adverse events (CTCAE) v3.0 of hot flashes and/or sweating reported at 3 or 6 months after randomization; musculoskeletal symptoms, i.e., myalgia, arthralgia (joint pain), or stiffness, reported at 3, 6, 9 or 12 months after randomization. TEXT Tamoxifen and Exemestane Trial, BMI body mass index, IQR interquartile range, HER2 human epidermal growth factor receptor 2, OFS ovarian function suppression