Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial.

Ribi, Karin; Luo, Weixiu; Colleoni, Marco; Karlsson, Per; Chirgwin, Jacquie; Aebi, Stefan; Jerusalem, Guy; Neven, Patrick; Di Lauro, Vincenzo; Gomez, Henry L; Ruhstaller, Thomas; Abdi, Ehtesham; Biganzoli, Laura; Müller, Bettina; Barbeaux, Annelore; Graas, Marie-Pascale; Rabaglio, Manuela; Francis, Prudence A; Foukakis, Theodoros; Pagani, Olivia; ... (2019). Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. British journal of cancer, 120(10), pp. 959-967. Springer Nature 10.1038/s41416-019-0435-4

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Medical Oncology

UniBE Contributor:

Rabaglio, Manuela and Bernhard, Jürg

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1532-1827

Publisher:

Springer Nature

Language:

English

Submitter:

Rebeka Gerber

Date Deposited:

28 Nov 2019 12:24

Last Modified:

28 Nov 2019 12:32

Publisher DOI:

10.1038/s41416-019-0435-4

PubMed ID:

30967649

BORIS DOI:

10.7892/boris.134971

URI:

https://boris.unibe.ch/id/eprint/134971

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