Abstract
BackgroundIn the phase III SOLE trial, the extended use of intermittent versus continuous letrozole for 5 years did not improve disease-free survival in postmenopausal women with hormone receptor-positive breast cancer. Intermittent therapy with 3-month breaks may be beneficial for patients’ quality of life (QoL).MethodsIn the SOLE QoL sub-study, 956 patients completed the Breast Cancer Prevention Trial (BCPT) symptom and further QoL scales up to 24 months after randomisation. Differences in change of QoL from baseline between the two administration schedules were tested at 12 and 24 months using repeated measures mixed-models. The primary outcome was change in hot flushes at 12 months.ResultsThere was no difference in hot flushes at 12 months between the two schedules, but patients receiving intermittent letrozole reported significantly more improvement at 24 months. They also indicated less worsening in vaginal problems, musculoskeletal pain, sleep disturbance, physical well-being and mood at 12 months. Overall, 25–30% of patients reported a clinically relevant worsening in key symptoms and global QoL.ConclusionLess symptom worsening was observed during the first year of extended treatment with the intermittent administration. For women experiencing an increased symptom burden of extended adjuvant endocrine therapy, an intermittent administration is a safe alternative.Clinical trial informationClinical trial information: NCT00553410.
Highlights
In the phase III Study of Letrozole Extension (SOLE) trial, the extended use of intermittent versus continuous letrozole for 5 years did not improve disease-free survival in postmenopausal women with hormone receptor-positive breast cancer
In general, our results show less worsening of symptom-specific and global quality of life (QoL) in patients assigned to intermittent letrozole compared with those assigned to continuous letrozole
Differences in hot flushes, vaginal problems, musculoskeletal pain, sleep disturbances, physical well-being and mood were a result of small improvements in the intermittent group during the first or the second letrozole break, respectively
Summary
In the phase III SOLE trial, the extended use of intermittent versus continuous letrozole for 5 years did not improve disease-free survival in postmenopausal women with hormone receptor-positive breast cancer. RESULTS: There was no difference in hot flushes at 12 months between the two schedules, but patients receiving intermittent letrozole reported significantly more improvement at 24 months They indicated less worsening in vaginal problems, musculoskeletal pain, sleep disturbance, physical well-being and mood at 12 months. The recently published efficacy results showed no superiority in disease-free survival for the use of intermittent letrozole compared with the standard continuous administration.[2] Previous trials showed that patients suffer from symptoms related to endocrine therapy during the standard treatment duration of five years in postmenopausal women with early breast cancer.[3,4] An extension of endocrine treatment implies continuation of symptom burden with a potential physical and psychological impact on patients’ quality of life (QoL). The aim of the SOLE QoL substudy was to compare symptom-specific and global QoL in a subsample of patients randomly assigned to continuous or intermittent letrozole administration schedules and to compare the proportion of patients on each regimen who suffer from clinically-relevant symptom burden
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