Health-Related Quality of Life and Psychological Distress in Japanese Postmenopausal Women with Breast Cancer Treated with Tamoxifen, Exemestane or Anastrozole for Adjuvant Endocrine Therapy: A Final Analysis of National Surgical Adjuvant Study of Breast Cancer (N-SAS BC) 04.

Abstract

Abstract Background: National Surgical Adjuvant Study of Breast Cancer (N-SAS BC) 04, a sub-study of Tamoxifen (TAM) and Exemestane (EXE) Adjuvant Multinational (TEAM) trial, analyzed lipid metabolism (LM), bone mineral density (BMD), health-related quality of life (HRQOL), psychological distress, and blood coagulation between patients (pts) randomly assigned to take TAM, EXE or anastrozole (ANA). We report here a final analysis for HRQOL and psychological distress in N-SAS BC 04.Patients and Methods: Eligible pts were postmenopausal women with surgically treated stage I to IIIA hormone responsive breast cancer (BC), and with at least one of following criteria; pathologically ≥3 cm, pathologically positive nodes, nuclear grade 3, invasive lobular carcinoma or metaplastic carcinoma. They were randomly assigned to take EXE or TAM (TEAM International groups) when they were receiving treatment of hyperlipidemia or osteoporosis, when they had a high level of total cholesterol (≥260 mg/dl) or triglyceride (≥300 mg/dl) and a low BMD (<70% YAM), or when their LM and BMD were unknown. Other eligible pts were randomly assigned to take TAM, EXE or ANA (TEAM Japan groups). All participants were required to answer questionnaires of Functional Assessment of Cancer Therapy (FACT)-G, -B and -ES, and Center for Epidemiologic Studies Depression (CES-D), at baseline, 3 and 12 months. The data were analyzed on an intent-to-treat basis. Statistical significance was determined using the repeated-measures ANOVA with a baseline value as a covariant.Results: Of a total of 242 pts included in N-SAS BC 04, 56, 55 and 55 were assigned to take TAM, EXE and ANA, respectively (TEAM Japan groups). In addition, 37 and 39 pts were assigned to take TAM and EXE, respectively; finally 93 and 94 pts were included in the TAM and EXE groups, respectively (TEAM International groups). Clinical and pathological characteristics at baseline were well balanced between the groups. Response rates for the questionnaires were consistently high (> 84%) in each group. Scores of FACT-G, -B and -ES increased at 3 and 12 months from baseline in pts on TAM; however, these did not in pts on EXE or ANA. In result the scores of FACT-B were statistically significantly better in the TAM group than the EXE or ANA groups (P<0.05). In regard to the items of the breast cancer and endocrine symptom subscales, a change in weight was better; however, vaginal discharge was worse in pts on TAM than in pts on EXE or ANA. Scores of CES-D showed no between-group difference. These results were consistent between the TEAM Japan and TEAM International groups.Discussion: In this study HRQOL was better by adjuvant TAM compared to adjuvant EXE or ANA in Japanese postmenopausal pts. This result is consistent with those of N-SAS BC 03 which were reported at the 31st SABCS and showed that HRQOL was better in the TAM group than the ANA group. An ethnic difference was reported in menopausal symptoms and adverse events of pts taking letrozole. There may be an ethnic difference in HRQOL of pts taking endocrine agents, which needs to be further investigated. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 5041.