Preexisting musculoskeletal burden and its development under letrozole treatment in early breast cancer patients.
Клиническое исследование IV фазыСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Nabieva Naiba, Häberle Lothar, Brucker Sara Y, Janni Wolfgang, Volz Bernhard, Loehberg Christian R, Hartkopf Andreas D, Walter Christina-Barbara, Baake Gerold, Fridman Alexander, Malter Wolfram, Wuerstlein Rachel, Harbeck Nadia, Hoffmann Oliver, Kuemmel Sherko, Martin Bernhard, Thomssen Christoph, Graf Heiko, Wolf Christopher, Lux Michael P, Bayer Christian M, Rauh Claudia, Hack Carolin C, Almstedt Katrin, Gass Paul, Heindl Felix, Brodkorb Tobias, Lindner Christoph, Kolberg Hans-Christian, Krabisch Petra, Weigel Michael, Steinfeld-Birg Dieter, Kohls Andreas, Brucker Cosima, Schulz Volker, Fischer Gunnar, Pelzer Volker, Rack Brigitte, Beckmann Matthias W, Fehm Tanja, Rody Achim, Maass Nicolai, Hein Alexander, Fasching Peter A
Аннотация
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.