Dataset Information

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

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.

SUBMITTER: Ribi K

PROVIDER: S-EPMC6734915 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Publications

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 K Luo Weixiu W Colleoni Marco M Karlsson Per P Chirgwin Jacquie J Aebi Stefan S Jerusalem Guy G Neven Patrick P Di Lauro Vincenzo V Gomez Henry L HL Ruhstaller Thomas T Abdi Ehtesham E Biganzoli Laura L Müller Bettina B Barbeaux Annelore A Graas Marie-Pascale MP Rabaglio Manuela M Francis Prudence A PA Foukakis Theodoros T Pagani Olivia O Graiff Claudio C Vorobiof Daniel D Maibach Rudolf R Di Leo Angelo A Gelber Richard D RD Goldhirsch Aron A Coates Alan S AS Regan Meredith M MM Bernhard Jürg J

British journal of cancer 20190410 10

<h4>Background</h4>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).<h4>Methods</h4>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. ...[more]

PMID: 30967649

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Dataset Information

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

Background

Methods

Results

Conclusion

Clinical trial information

Publications

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

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