University of Colorado School of Medicine, Aurora, CO, USA.
Division of Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Cancer Med. 2020 Dec;9(23):8801-8808. doi: 10.1002/cam4.3487. Epub 2020 Oct 16.
Patients with metastatic breast cancer (MBC) refractory to standard of care therapies have a poor prognosis. The purpose of this study was to assess patient characteristics and clinical outcomes for patients with MBC treated on phase I clinical trials. We performed a retrospective review of all patients with MBC who were enrolled in phase I clinical trials at the University of Colorado Cancer Center from January 2012 to June 2018. A total of 208 patients were identified. Patients had a mean age of 57 years and received on average 2.1 (range 0-10) prior lines of chemotherapy. The majority of patients had hormone receptor-positive/HER2-negative breast cancer (58.6%) and 30.3% had triple-negative breast cancer. The median progression free survival (PFS) was 2.8 months (95% CI, 2.3-3.9) and median overall survival (OS) was 11.5 months (95% CI, 9.6-13.2). Independent factors associated with longer PFS in multivariable analysis were treatment in a breast cancer-selective trial or cohort (p = 0.016), age >50 years (p = 0.002), and ≤2 prior lines of chemotherapy in the metastatic setting (p = 0.025). Phase I clinical trials remain a valuable option for select patients with MBC and enrollment should be encouraged when available.
转移性乳腺癌（MBC）患者对标准治疗方案耐药预后较差。本研究旨在评估在科罗拉多大学癌症中心接受 I 期临床试验治疗的 MBC 患者的特征和临床结局。我们对 2012 年 1 月至 2018 年 6 月期间在科罗拉多大学癌症中心入组 I 期临床试验的所有 MBC 患者进行了回顾性分析。共确定了 208 例患者。患者平均年龄为 57 岁，平均接受过 2.1 线（范围 0-10 线）化疗。大多数患者为激素受体阳性/HER2 阴性乳腺癌（58.6%），30.3%为三阴性乳腺癌。中位无进展生存期（PFS）为 2.8 个月（95%CI，2.3-3.9），中位总生存期（OS）为 11.5 个月（95%CI，9.6-13.2）。多变量分析中与更长 PFS 相关的独立因素包括在乳腺癌选择性试验或队列中治疗（p=0.016）、年龄>50 岁（p=0.002）和转移性疾病中接受的化疗线数≤2 线（p=0.025）。I 期临床试验仍然是选择的 MBC 患者的有价值的选择，应在有机会时鼓励入组。
