- The SOLE trial previously found that intermittent adjuvant letrozole did not adversely affect DFS in postmenopausal women with node-positive, hormone receptor-positive early breast cancer (eBCa).
- This SOLE substudy of QoL found that at 12 months, intermittent was no better than continuous letrozole for hot flushes, but at 24 months it was. At 12 months, intermittent letrozole improves vaginal problems and musculoskeletal pain, among other symptoms.
Why this matters
- Findings suggest that intermittent administration of letrozole is beneficial for QoL.
- Multicenter, phase 3 randomized controlled SOLE trial (n=955) of intermittent (2.5 mg/day except for 3-month treatment holidays during years 1-4 of 5 years) vs continuous (2.5 mg/day for 5 years) letrozole.
- QoL assessed by the Breast Cancer Prevention trial symptom scales, QoL symptoms used in previous SOLE trials, and global QoL (including overall treatment burden).
- Funding: Novartis; other.
- At 12 months, there was no difference between groups in hot flushes (P=.11), but at 24 months, intermittent was superior to continuous letrozole (P=.025).
- At 12 months, intermittent vs continuous letrozole displayed less symptom worsening of:
- vaginal problems (P=.017),
- musculoskeletal pain (P=.023),
- sleep disturbance (P=.007),
- physical well-being (P=.008), and
- mood (P=.026).
- At 12 and 24 months, no difference in treatment burden.
- Open-label design.