Quality of Life in a Randomized Breast Cancer Prevention Trial of Low-Dose Tamoxifen and Fenretinide in Premenopausal Women.
Davide SerranoSara GandiniAliana Guerrieri-GonzagaIrene FeroceHarriet JohanssonDebora MacisValentina AristarcoBernardo BonanniAndrea DeCensiPublished in: Cancer prevention research (Philadelphia, Pa.) (2018)
Menopausal symptoms are the main reason for withdrawal in tamoxifen prevention trials. Here, we present Menopause Quality of Life (MenQoL) assessment within a randomized 2 × 2 phase II clinical trial of low-dose tamoxifen and the synthetic retinoid fenretinide. A total of 235 premenopausal women at higher risk for breast cancer were randomized to either tamoxifen 5 mg daily, fenretinide 200 mg daily, their combination, or placebo. Climacteric symptoms were investigated using the MenQoL questionnaire which was self-administered at each visit for 2 years of treatment and for 1 year of follow-up. CYP2D6 was genotyped in subjects taking tamoxifen to study the association with menopausal symptoms. The MenQoL effect size analysis showed no statistically significant difference among the four treatment arms for all four domains (vasomotor, physical, psychosocial, and sexual). Vasomotor symptoms only slightly increased under tamoxifen, with a score at year two of 1.45, 1.21, 0.58, and 1.17 in the combined, tamoxifen, fenretinide, and placebo arms, respectively. Compared with the slow metabolizers, a higher percentage of subjects with CYP2D6 extensive metabolizer genotype complained of a ≥3 score in the vasomotor, psychosocial, and sexual domain in the tamoxifen arms (P value = 0.01, 0.007, and 0.007, respectively). QoL in premenopausal or perimenopausal women was not significantly worsened by low-dose tamoxifen or fenretinide. Our findings suggest that a low dose of tamoxifen may increase its acceptability for breast cancer prevention.
Keyphrases
- low dose
- breast cancer cells
- estrogen receptor
- positive breast cancer
- phase ii
- clinical trial
- phase iii
- breast cancer risk
- double blind
- open label
- postmenopausal women
- mental health
- high dose
- placebo controlled
- polycystic ovary syndrome
- physical activity
- randomized controlled trial
- sleep quality
- young adults
- high resolution
- pregnant women
- metabolic syndrome
- cross sectional
- type diabetes
- skeletal muscle
- single molecule