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

K. Ribi, W. Luo, M. Colleoni, P. Karlsson, J. Chirgwin, S. Aebi, G. Jerusalem, P. Neven, V. Di Lauro, H.L. Gomez, T. Ruhstaller, E. Abdi, L. Biganzoli, B. Müller, A. Barbeaux, M.-P. Graas, M. Rabaglio, P.A. Francis, T. Foukakis, O. PaganiC. Graiff, D. Vorobiof, R. Maibach, A. Di Leo, R.D. Gelber, A. Goldhirsch, A.S. Coates, M.M. Regan, J. Bernhard, on behalf of the SOLE Investigators

Research output: Contribution to journalArticle

Abstract

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. © 2019, Cancer Research UK.
Original languageEnglish
Pages (from-to)959-967
Number of pages9
JournalEur. J. Cancer
Volume120
Issue number10
DOIs
Publication statusPublished - 2019

Keywords

  • letrozole
  • adjuvant chemotherapy
  • adjuvant therapy
  • adult
  • aged
  • arm disease
  • Article
  • bladder disease
  • body weight disorder
  • breast cancer
  • cancer patient
  • cancer survival
  • cognitive defect
  • continuous infusion
  • controlled study
  • disease free survival
  • drug withdrawal
  • early cancer
  • fatigue
  • female
  • follow up
  • hot flush
  • human
  • lymph node
  • major clinical study
  • middle aged
  • mood
  • multicenter study
  • musculoskeletal pain
  • nausea
  • open study
  • phase 3 clinical trial
  • physical well-being
  • priority journal
  • quality of life
  • randomized controlled trial
  • sexual arousal disorder
  • sexual dysfunction
  • sleep disorder
  • vagina disease

Fingerprint Dive into the research topics of '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'. Together they form a unique fingerprint.

  • Cite this

    Ribi, K., Luo, W., Colleoni, M., Karlsson, P., Chirgwin, J., Aebi, S., Jerusalem, G., Neven, P., Di Lauro, V., Gomez, H. L., Ruhstaller, T., Abdi, E., Biganzoli, L., Müller, B., Barbeaux, A., Graas, M-P., Rabaglio, M., Francis, P. A., Foukakis, T., ... Investigators, O. B. O. T. SOLE. (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. Eur. J. Cancer, 120(10), 959-967. https://doi.org/10.1038/s41416-019-0435-4