Fontein D B Y, Charehbili A, Nortier J W R, Putter H, Kranenbarg E Meershoek-Klein, Kroep J R, Linn S C, van de Velde C J H
Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands; Department of Clinical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
Eur J Surg Oncol. 2017 Apr;43(4):619-624. doi: 10.1016/j.ejso.2016.07.146. Epub 2016 Dec 10.
In the adjuvant setting, specific adverse events (AEs) such as vasomotor symptoms (VMS) and musculoskeletal AEs are associated with relapse-free survival in aromatase inhibitor (AI)-treated patients. In the neoadjuvant setting, specific AEs may be associated with tumor response to AIs as well.
Between 2007 and 2012, 107 patients participated in the prospective TEAMIIA trial, a prospective, phase II trial investigating 6 months of neoadjuvant exemestane in patients with strongly ER-positive breast cancer. Radiological response (≥30% decrease in tumor size) was studied in relation to VMSs and MSAEs. Pearson's Chi-Square tests and multivariate logistic regression analyses were used to evaluate of statistical significance (p < 0.05).
Out of 102 patients 26 patients (25.4%) experienced at least one episode of VMS and 27 patients (26.4%) experienced MSAE. Out of 240 reported adverse events, 71 were specific AEs (40 MSAEs, 31 VMSs). Radiological response was greater in patients who reported VMSs compared to patients who did not (70.8% vs. 49.3%, multivariate OR 2.91, 95% C.I. 1.03-8.26, P = 0.045). No significant advantage towards better response was observed in patients who experienced MSAEs (60.0% vs. 53.3%, univariate OR 1.33, 95% C.I. 0.53-3.38, P = 0.545).
VMSs are associated with tumor response to neoadjuvant exemestane and may be useful for predicting treatment outcomes of AI treatment at an early stage in patients treated with neoadjuvant AIs.
在辅助治疗中，血管舒缩症状（VMS）和肌肉骨骼不良事件等特定不良事件与接受芳香化酶抑制剂（AI）治疗的患者的无复发生存相关。在新辅助治疗中，特定不良事件可能也与肿瘤对AI的反应相关。
2007年至2012年期间，107名患者参与了前瞻性TEAMIIA试验，这是一项前瞻性II期试验，研究了强雌激素受体（ER）阳性乳腺癌患者接受6个月新辅助依西美坦治疗的情况。研究了放射学反应（肿瘤大小减少≥30%）与VMS和肌肉骨骼不良事件（MSAE）的关系。采用Pearson卡方检验和多因素逻辑回归分析来评估统计学意义（p<0.05）。
102名患者中，26名患者（25.4%）经历了至少一次VMS发作，27名患者（26.4%）经历了MSAE。在报告的240例不良事件中，71例为特定不良事件（40例MSAE，31例VMS）。报告VMS的患者的放射学反应优于未报告的患者（70.8%对49.3%，多因素比值比2.91，95%置信区间1.03-8.26，P=0.045）。经历MSAE的患者未观察到对更好反应的显著优势（60.0%对53.3%，单因素比值比1.33，95%置信区间0.53-3.38，P=0.545）。
VMS与新辅助依西美坦的肿瘤反应相关，可能有助于预测接受新辅助AI治疗患者早期AI治疗的疗效。
