Preexisting musculoskeletal burden and its development under letrozole treatment in early breast cancer patients

Abstract

One of the most common adverse events (AEs) occurring during treatment with aromatase inhibitors (AIs) is musculoskeletal pain. The aim of our study was to analyze the influence of preexisting muscle/limb pain and joint pain on the development of AI‐induced musculoskeletal AEs. Women eligible for upfront adjuvant endocrine therapy with letrozole were included in the PreFace study, a multicenter phase IV trial. During the first treatment year, they were asked to record musculoskeletal AEs monthly by answering questions regarding pain symptoms and rating the pain intensity on a numeric rating scale from 0 (no pain) to 10 (very strong pain). Pain values were compared using nonparametric statistical tests. Overall, 1,416 patients were evaluable. The average pain value over all time points in women with preexisting muscle/limb pain was 4.3 (median 4.3); in those without preexisting pain, it was 2.0 (median 1.7). In patients without preexisting muscle/limb pain, pain levels increased relatively strongly within the first 6 months (mean increase +0.9, p < 0.00001) in comparison with those with preexisting pain (mean increase +0.3, p < 0.001), resulting in a statistically significant difference (p < 0.00001) between the two groups. The development of joint pain was similar in the two groups. Women without preexisting muscle/limb pain or joint pain have the greatest increase in pain after the start of adjuvant AI therapy. Women with preexisting pain have significantly higher pain values. The main increase in pain values takes place during the first 6 months of treatment.

Systemic Therapy of Premenopausal Patients with Early Stage Hormone Receptor-Positive, HER2-Negative Breast Cancer – Controversies and Standards in Healthcare

“…Auch wenn der Nutzen einer adjuvanten endokrinen Therapie konsistent beschrieben ist, bricht ein relevanter Anteil von Patientinnen die Therapie frühzeitig ab. Neben Patientinnen-und Tumorcharakteristika ist hierbei das Auftreten von Nebenwirkungen einer der wichtigsten Prädiktoren für das frühzeitige Abbrechen einer Therapie [73,74,75].…”

Update Breast Cancer 2022 Part 2 – Advanced Stage Breast Cancer

“…With a large number of SERDs currently in clinical development 6 , 7 , the first phase III trial, the EMERALD trial, has now been published 8 . This study is of particular interest not only in terms of whether SERD treatment can overcome endocrine resistance based on an ESR1 mutation, but also in terms of a comparison between the oral SERD elacestrant and fulvestrant.…”

“…Bei einer Vielzahl an SERDs, welche sich gerade in der klinischen Entwicklung befinden 6 , 7 , wurde nun mit der EMERALD-Studie die erste Phase-III-Studie veröffentlicht 8 . Nicht nur aufgrund der Frage, ob durch eine SERD-Therapie eine auf einer ESR1 -Mutation beruhende, endokrine Resistenz überwunden werden kann, sondern auch in Bezug auf einen Vergleich zwischen dem oralen SERD Elacestrant und Fulvestrant ist diese Studie von besonderem Interesse.…”

Neuro-immune-endocrine mechanisms with poor adherence to aromatase inhibitor therapy in breast cancer

“…A multicenter phase IV clinical trial showed that musculoskeletal pain during AI treatment occurred primarily in the first six months of treatment, with a higher incidence in patients without a pre-treatment history of musculoskeletal pain and greater post-treatment pain intensity in patients with a prior history of pain ( 16 ). Joint pain increased significantly during the first year of AI treatment and the health-related quality of life decreased.…”