Five-year changes in ovarian function restoration in premenopausal patients with breast cancer taking tamoxifen after chemotherapy: An ASTRRA study report.

BACKGROUND: Adding ovarian function suppression (OFS) after chemotherapy improves survival in young women with moderate- and high-risk breast cancer. Assessment of ovarian function restoration after chemotherapy becomes critical for subsequent endocrine treatment and addressing fertility issues. PATIENTS AND METHODS: In the adding OFS after chemotherapy trial, patients who resumed ovarian function up to 2 years after chemotherapy were randomised to receive either 5 years of tamoxifen or adding 2 years of OFS with tamoxifen. Ovarian function was evaluated from enrolment to randomisation, and patients who did not randomise because of amenorrhoea for 2 years received tamoxifen and were followed up for 5 years. Prospectively collected consecutive hormone levels (proportion of patients with premenopausal follicle-stimulating hormone [FSH] levels <30 mIU/mL and oestradiol [E2] levels ≥40 pg/mL) and history of menstruation were available for 1067 patients with breast cancer. RESULTS: Over 5 years of tamoxifen treatment, 69% of patients resumed menstruation and 98% and 74% of patients satisfied predefined ovarian function restoration as per serum FSH and E2 levels, respectively. Menstruation was restored in 91% of patients younger than 35 years at baseline, but in only 33% of 45-year-old patients over 5 years. Among these patients, 41% experienced menstruation restoration within 2 years after chemotherapy and 28% slowly restored menstruation after 2-5 years. Younger age (<35 years) at baseline, anthracycline without taxanes and ≤90 days of chemotherapy were predictors of menstruation restoration. CONCLUSIONS: During 5 years of tamoxifen treatment after chemotherapy, two-thirds of the patients experienced menstruation restoration, especially patients younger than 35 years. Young age, Adriamycin without taxanes and short duration of chemotherapy appeared to have a positive effect on ovarian reserves in the long term. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00912548.

Korean translation and validation of the functional assessment of cancer therapy-breast (FACT-B) scale version 4.

We undertook to translate and cross-culturally adapt the Functional Assessment of Cancer Therapy-Breast (FACT-B) scale into Korean and to evaluate its reliability and validity. The translation procedure followed the standard Functional Assessment of Chronic Illness Therapy translation methodology. A total of 201 breast cancer patients (mean age, 43.87 years) were studied for psychometric properties of the FACT-B scale. A pre-test of 20 Korean breast cancer patients indicated that the Korean FACT-B scale provided good content coverage and overall comprehensibility. Our results indicated high internal consistency of the FACT-B scale, with Cronbach's alpha coefficients ranging from 0.79 to 0.90. The only exception was the Breast Cancer Scale (BCS), which had a Cronbach's alpha coefficient of 0.67. We can consider that most of the patients in this study had not resumed sexual activity after surgery and found it difficult to comment on this aspect. We also considered that contents of the BCS may have been somewhat heterogeneous. After performing a factor analysis of the BCS data from this study, we identified three factors, accounting 58.8%: psychological distress (5 items, with explained variances of 27.5%), feminine satisfaction (2 items, with explained variances of 17.1%), and physical complaints (2 items, with explained variances of 14.2%). The FACT-B scale also demonstrated good convergent and divergent validity when correlated with the shortened forms of the Profile of Mood States and the Functional Living Index-Cancer (FLIC). We can now evaluate the Quality of Life (QoL) of Korean breast cancer patients using this reliable and valid instrument. Nevertheless our study has the limitation that it did not evaluate the sensitivity to the changes of the patients' QoL in the long term follow-up, and we will supplement it in our further study.