Skip to main content

Advertisement

Springer Nature is making SARS-CoV-2 and COVID-19 research free. View research | View latest news | Sign up for updates

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