- Title
- Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial
- Creator
- Ribi, Karin; Luo, Weixiu; Ruhstaller, Thomas; Abdi, Ehtesham; Biganzoli, Laura; Müller, Bettina; Barbeaux, Annelore; Graas, Marie-Pascale; Rabaglio, Manuela; Francis, Prudence A.; Foukakis, Theodoros; Pagani, Olivia; Colleoni, Marco; Graiff, Claudio; Vorobiof, Daniel; Maibach, Rudolf; Di Leo, Angelo; Gelber, Richard D.; Goldhirsch, Aron; Coates, Alan S.; Regan, Meredith M.; Bernhard, Jürg; Karlsson, Per; Chirgwin, Jacquie; Aebi, Stefan; Jerusalem, Guy; Neven, Patrick; Di Lauro, Vincenzo; Gomez, Henry L.
- Relation
- British Journal of Cancer Vol. 120, Issue 10, p. 959-967
- Publisher Link
- http://dx.doi.org/10.1038/s41416-019-0435-4
- Publisher
- Nature Publishing Group
- Resource Type
- journal article
- Date
- 2019
- Description
- 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. Correction published: Ribi, K., Luo, W., Colleoni, M. et al. Correction: Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. Br J Cancer 122, 1119 (2020). https://doi.org/10.1038/s41416-019-0709-x
- Subject
- quality of life; letrozole; lymph node; breast cancer; SDG 3; Sustainable Development Goals
- Identifier
- http://hdl.handle.net/1959.13/1467113
- Identifier
- uon:47747
- Identifier
- ISSN:0007-0920
- Rights
- This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
- Language
- eng
- Full Text
- Reviewed
- Hits: 11342
- Visitors: 11580
- Downloads: 257
Collections
Goal 3: Good Health and Well-Being
| Thumbnail | File | Description | Size | Format | |||
|---|---|---|---|---|---|---|---|
| View Details Download | ATTACHMENT02 | Publisher version (open access) | 603 KB | Adobe Acrobat PDF | View Details Download |