目的探讨促性腺激素释放激素激动剂LY01005和诺雷得®在中国绝经前乳腺癌患者中的疗效和安全性。方法研究为前瞻性研究,2020年10月至2021年11月期间在34家医院入组188例绝经前乳腺癌患者,以1∶1的比例随机接受LY01005或诺雷得®治疗,每28 d 1次,连续给药3次,所有患者同时口服他莫昔芬治疗。研究的主要疗效终点为给药第29天至第85天血清雌二醇(E2)维持在绝经后水平(≤30 pg/ml)的患者比例。次要终点包括血清E2、促黄体生成素(LH)和促卵泡生成素(FSH)较基线的变化及安全性特征。研究也评价LY01005的药代动力学、药效学特征。结果共有188例乳腺癌患者随机入组,187例患者接受LY01005或诺雷得®治疗。LY01005组(n=93)和诺雷得®组(n=94)给药第29天至第85天维持在绝经后水平(E2≤30 pg/ml)的患者比例分别为93.1%及86.3%,两组累积概率的率差为6.8%(95%CI:-2.3%~15.9%),满足主要疗效指标率差的95%CI下限不低于-10%,达到非劣效标准。两组第29天给药前至第85天血清E2、LH、FSH与基线相比变化相当(E2:89.34%~90.23%和82.11%~85.02%;LH:88.89%~95.52%和89.70%~97.02%、FSH:75.36%~80.85%和73.07%~80.24%)。LY01005组受试者连续3次给药后,血清LH和FSH均在首次给药后呈现一过性升高,在第2天达峰,随后开始下降,第29天血清LH和FSH浓度达到较低浓度水平,之后维持在该浓度水平及以下直至第85天。两组安全性特征相似。结论LY01005每28 d 1次治疗绝经前乳腺癌患者,可持续有效维持血清E2至绝经后水平,临床疗效与诺雷得®相当,安全性特征相似,整体耐受性良好。
目的:该文旨在探讨乳腺恶性叶状肿瘤的临床表现、鉴别诊断及治疗现状。方法:对青岛大学附属烟台毓璜顶医院乳腺外科收治的1例乳腺恶性叶状肿瘤伴骨肉瘤分化的患者进行回顾性分析并复习相关文献。结果:乳腺恶性叶状肿瘤是一种含有腺上皮成分和间叶成分的双相性肿瘤,其发病率较低。针对乳腺恶性叶状肿瘤,尤其是伴有异源性分化者,应注意鉴别诊断,最终确诊依靠石蜡病理。手术为首选的治疗方法,且手术边缘的宽度与局部复发有关。Objective: The aim of this article is to investigate the clinical manifestations, differential diagnosis and treatment status of malignant phyllodes tumor of the breast. Methods: A case of malignant phyllodes tumor of the breast with osteosarcoma differentiation admitted to the Department of Breast Surgery of Affiliated Yantai Yuhuangding Hospital of Qingdao University was retrospectively analyzed and relevant studies were reviewed. Results: Malignant phyllodes tumors of the breast are biphasic neoplasms containing both epithelial and mesenchymal components, with a relatively low incidence. For malignant phyllodes tumors, particularly those exhibiting heterologous differentiation, careful differential diagnosis is essential, with definitive diagnosis relying on paraffin-embedded pathology. Surgical excision is the preferred treatment, and the width of surgical margins is closely associated with the risk of local recurrence.
