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Influence of patient and tumor characteristics on early therapy persistence with letrozole in postmenopausal women with early breast cancer: results of the prospective Evaluate-TM study with 3941 patients.
Annals of Oncology ( IF 56.7 ) Pub Date : 2018-01-01 , DOI: 10.1093/annonc/mdx630
N Nabieva 1 , S Kellner 1 , T Fehm 2, 3 , L Häberle 1, 4 , J de Waal 5 , M Rezai 6 , B Baier 5 , G Baake 7 , H-C Kolberg 8 , M Guggenberger 9 , M Warm 10, 11 , N Harbeck 10, 12 , R Wuerstlein 10, 12 , J-U Deuker 13 , P Dall 14 , B Richter 15 , G Wachsmann 16 , C Brucker 17 , J W Siebers 18 , N Fersis 19 , T Kuhn 20 , C Wolf 21 , H-W Vollert 22 , G-P Breitbach 23 , W Janni 24 , R Landthaler 25 , A Kohls 26 , D Rezek 27 , T Noesselt 28 , G Fischer 29 , S Henschen 30 , T Praetz 31 , V Heyl 32 , T Kühn 33 , T Krauss 34 , C Thomssen 35 , A Hohn 36 , H Tesch 37 , C Mundhenke 38 , A Hein 1 , C Rauh 1 , C M Bayer 1 , A Jacob 39 , K Schmidt 39 , E Belleville 40 , S Y Brucker 3 , S Kümmel 41 , M W Beckmann 1 , D Wallwiener 3 , P Hadji 42 , P A Fasching 1
Affiliation  

Background Patients' compliance and persistence with endocrine treatment has a significant effect on the prognosis in early breast cancer (EBC). The purpose of this analysis was to identify possible reasons for non-persistence, defined as premature cessation of therapy, on the basis of patient and tumor characteristics in individuals receiving adjuvant treatment with letrozole. Patients and methods The EvAluate-TM study is a prospective, multicenter, noninterventional study in which treatment with the aromatase inhibitor letrozole was evaluated in postmenopausal women with hormone receptor-positive EBC in the early therapy phase. Treatment persistence was evaluated at two pre-specified study visits after 6 and 12 months. As a measure of early therapy persistence the time from the start to the end of treatment (TTEOT) was analyzed. Cox regression analyses were carried out to identify patient characteristics and tumor characteristics predicting TTEOT. Results Out of the total population of 3941 patients with EBC, 540 (13.7%) events involving treatment cessation unrelated to disease progression were observed. This was due to drug-related toxicity in the majority of cases (73.5%). Persistence rates were 92.2%, 86.9%, and 86.3% after 6, 12, and 15 months, respectively. The main factors influencing premature treatment discontinuation were older age [hazard ratio (HR) 1.02/year], comorbidities (HR 1.06 per comorbidity), low body mass index, and lower tumor grade (HR 0.85 per grade unit). Conclusion These results support the view that older, multimorbid patients with low tumor grade and low body mass index are at the greatest risk for treatment discontinuation and might benefit from compliance and support programs.

中文翻译:

患者和肿瘤特征对围绝经后早期乳腺癌妇女使用来曲唑的早期治疗持续性的影响:一项针对3941名患者的前瞻性Evaluate-TM研究的结果。

背景患者对内分泌治疗的依从性和持久性对早期乳腺癌(EBC)的预后有重大影响。这项分析的目的是根据接受来曲唑辅助治疗的患者的患者和肿瘤特征,确定不持久的可能原因,定义为过早停止治疗。患者和方法EvAluate-TM研究是一项前瞻性,多中心,非干预性研究,其中在早期治疗阶段对激素受体阳性EBC的绝经后妇女评估了使用芳香酶抑制剂来曲唑的治疗。在6和12个月后的两次预先指定的研究访问中评估了治疗的持久性。为了衡量早期治疗的持久性,分析了从治疗开始到结束的时间(TTEOT)。进行Cox回归分析以鉴定预测TTEOT的患者特征和肿瘤特征。结果在3941例EBC患者中,观察到540例(13.7%)事件涉及与疾病进展无关的停止治疗。在大多数情况下,这是由于药物相关的毒性(73.5%)。在6、12和15个月后,持久性分别为92.2%,86.9%和86.3%。影响过早停药的主要因素是年龄[危险比(HR)1.02 /年],合并症(每合并症HR 1.06),低体重指数和较低的肿瘤分级(每等级单位HR 0.85)。结论这些结果支持以下观点:
更新日期:2017-10-10
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