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

Artikel i vetenskaplig tidskrift
Författare Karin Ribi
Weixiu Luo
Marco Colleoni
Per Karlsson
Jacquie Chirgwin
Stefan Aebi
Guy Jerusalem
Patrick Neven
Vincenzo Di Lauro
Henry L Gomez
Thomas Ruhstaller
Ehtesham Abdi
Laura Biganzoli
Bettina Müller
Annelore Barbeaux
Marie-Pascale Graas
Manuela Rabaglio
Prudence A Francis
Theodoros Foukakis
Olivia Pagani
Claudio Graiff
Daniel Vorobiof
Rudolf Maibach
Angelo Di Leo
Richard D Gelber
Aron Goldhirsch
Alan S Coates
Meredith M Regan
Jürg Bernhard
Publicerad i British journal of cancer
Volym 120
Sidor 959–967
ISSN 1532-1827
Publiceringsår 2019
Publicerad vid Institutionen för kliniska vetenskaper, Avdelningen för onkologi
Sidor 959–967
Språk en
Länkar dx.doi.org/10.1038/s41416-019-0435-...
www.ncbi.nlm.nih.gov/entrez/query.f...
Ämneskategorier Cancer och onkologi

Sammanfattning

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.

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