299P - Assessment of quality of life, BMD and safety profiles in postmenopausal breas cancer patients with letrozole as an early adjuvant treatment (KBCSG...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Early Stage
Presenter sehwan Han
Citation Annals of Oncology (2014) 25 (suppl_4): iv85-iv109. 10.1093/annonc/mdu327
Authors S. Han1, S.J. Lee2, W. Noh3, S. Nam4, S. Kang5, J. Kim6, Y. Bae7, H. Park8, S. Cho9, S.H. Jung10, H.Y. Park11, J.H. Yoon12, L.S. Kim13, Y.S. Jung14
  • 1Breast Cancer Center, Inje Unversity Sanggye Paik Hospital, 139-707 - Seoul/KR
  • 2Surgery, Yungnam University Hospital, Daegu/KR
  • 3Surgery, Korea Cancer Center Hospital, Seoul/KR
  • 4Surgery, Samsung Medical Center, Seoul/KR
  • 5Surgery, Jeil Hospital, Seoul/KR
  • 6Surgery, Chungnam National University Hospital, Daejun/KR
  • 7Surgery, Busan National University Hospital, Busan/KR
  • 8Surgery, Inchon Gil Hospital, Inchon/KR
  • 9Surgery, Donga University Hospital, Busan/KR
  • 10Surgery, Chonbuk National University Hospital, Chonju/KR
  • 11Surgery, Kyungpook National University Medical Center, 702210 - DAEGU/KR
  • 12Surgery, Chonnam University Whasoon Cancer Center Hospital, Kwangju/KR
  • 13Surgery, Pyeongchon Sacred Heart Hospital, Pyeongchon/KR
  • 14Surgery, Ajou University Hospital, Suwon/KR



There has been little report about the long-term results of AI in adjuvant treatment of the breast cancer from Asian countries.This observational study (NCT:00913016) was performed to evaluate the long-term effect of letrozole (Femara®) in Korean women with operable breast cancer.


Self-reported Quality of Life (QoL) scores during adjuvant letrozole treatment was serially assessed using Korean version of the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaires (version 3) for 3 years. We also analyzed the change of bone mineral density (BMD) and serum cholesterol level during adjuvant letrozole treatment. Eight hundred and ninety-seven women from 32 institutes participated in the study.


All the 897 patients received documented informed consent form to participate in the study and completed a baseline questionnaire before adjuvant letrozole trearment. Seventy percent (n = 624) underwent adjuvant chemotherapy. Forty hundred and ten (45.8%) had stage 1 breast cancer and 396 (44.3%) had stage 2 disease. Follow-up questionnaires were completed by individual patient without help of medical person before the patients visited the clinician at 3, 6, 12, 18, 24, 30, and 36 months after the entry to the study. Of total 897 patient, 749 patients (83.5%) completed the study. Drop-out rate was 16.5%. Main reasons of dropout were recurrence of breast cancer (n = 35; 3.9%), severe arthralgia (n = 41; 4.5%) and follow-up loss (n = 52; 5.9%). The serial trial outcome index (TOI) which is the sum of the physical, functional well-being and breast cancer specific subscales was gradually and significantly increased from baseline during the letrozole treatment (p < 0.001). Mean value of serum cholesterol level increased from 199 at the initial phase to 205 after 36 months later. The difference was statistically not significant. Mean value of bone mineral density (BMD) was -0.39 at the beginning of the study and was decreased to -0.87 after the 36 months. The change of BMD was statistically significant (p < 0.001).


The QoL was gradually improved during the letrozole treatment. Changing profiles of BMD and serum cholesterol level was not different from those of western countries. The results of this study indicate that adjuvant letrozole treatment is well tolerated in Korean women with minimal ethnic variation.


All authors have declared no conflicts of interest.