Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial.
Adult
Aged
Breast Neoplasms
/ drug therapy
Chemotherapy, Adjuvant
/ adverse effects
Disease-Free Survival
Drug Administration Schedule
Drug-Related Side Effects and Adverse Reactions
/ classification
Female
Humans
Letrozole
/ administration & dosage
Lymph Nodes
/ drug effects
Lymphatic Metastasis
Middle Aged
Neoplasm Staging
Quality of Life
Journal
British journal of cancer
ISSN: 1532-1827
Titre abrégé: Br J Cancer
Pays: England
ID NLM: 0370635
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
received:
30
08
2018
accepted:
07
03
2019
revised:
28
02
2019
pubmed:
11
4
2019
medline:
3
3
2020
entrez:
11
4
2019
Statut:
ppublish
Résumé
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. Intermittent therapy with 3-month breaks may be beneficial for patients' quality of life (QoL). In 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. 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 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. Less 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 information: NCT00651456.
Sections du résumé
BACKGROUND
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. Intermittent therapy with 3-month breaks may be beneficial for patients' quality of life (QoL).
METHODS
In 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.
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 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.
CONCLUSION
Less 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 INFORMATION
Clinical trial information: NCT00651456.
Identifiants
pubmed: 30967649
doi: 10.1038/s41416-019-0435-4
pii: 10.1038/s41416-019-0435-4
pmc: PMC6734915
doi:
Substances chimiques
Letrozole
7LKK855W8I
Banques de données
ClinicalTrials.gov
['NCT00651456']
Types de publication
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
959-967Commentaires et corrections
Type : ErratumIn
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