Department of Investigational Cancer Therapeutics, The University of Texas M. D. Anderson Cancer Center, Houston, TX 77230-1402, USA.
Clin Breast Cancer. 2010 Feb;10(1):46-51. doi: 10.3816/CBC.2010.n.006.
Patients with metastatic breast cancer (MBC) refractory to standard therapy have a poor prognosis. We assessed prognostic factors and clinical outcomes for patients with MBC referred to a phase I clinic focused primarily on targeted agents.
We reviewed the medical records of sequential patients with MBC who presented to our phase I clinic between September 2004 and May 2008 to assess baseline patient characteristics, overall survival (OS), and clinical benefit.
A total of 92 patients were identified, with a median age of 53 years (range, 28-83 years). The median number of previous therapies was 5 (range, 1-16 therapies). Of 92 patients, 78 were eligible for and offered > or = 1 phase I clinical trial. With a median follow-up of 7.4 months, the median OS was 6.7 months (95% CI, 5.2-9.7). In multivariate analysis, independent factors predicting shorter survival were > or = 10 previous treatments (vs. < 10 previous treatments; hazard ratio [HR], 3.27; 95% CI, 1.37-7.81; P = .008), Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2/3 (vs. 0/1; HR, 2.92; 95% CI, 1.28-6.66; P = .01), and albumin level < 3.5 g/dL (vs. > 3.5 g/dL; HR, 2.88; 95% CI, 1.41-5.89; P = .004).
Patients with locally advanced or metastatic breast cancer referred for our phase I studies had a median survival of 6.7 months. Heavily pretreated disease, poor ECOG PS, and/or low albumin levels were associated with significantly shorter survival in a multivariate analysis.
转移性乳腺癌（MBC）患者对标准治疗耐药预后较差。我们评估了主要针对靶向药物的 I 期临床试验中入组的 MBC 患者的预后因素和临床结局。
我们回顾了 2004 年 9 月至 2008 年 5 月期间连续入组到我们 I 期临床试验的 MBC 患者的病历，以评估基线患者特征、总生存期（OS）和临床获益。
共入组 92 例患者，中位年龄 53 岁（范围 28-83 岁）。中位治疗线数为 5 线（范围 1-16 线）。92 例患者中，78 例有资格接受并接受了≥1 项 I 期临床试验。中位随访 7.4 个月，中位 OS 为 6.7 个月（95%CI，5.2-9.7）。多因素分析显示，独立预测生存时间较短的因素为：治疗线数≥10 次（与治疗线数＜10 次相比；风险比[HR]，3.27；95%CI，1.37-7.81；P=0.008）、ECOG 体力状况（PS）2/3（与 0/1 相比；HR，2.92；95%CI，1.28-6.66；P=0.01）和白蛋白水平＜3.5g/dL（与＞3.5g/dL 相比；HR，2.88；95%CI，1.41-5.89；P=0.004）。
入组我们 I 期研究的局部晚期或转移性乳腺癌患者的中位生存期为 6.7 个月。多因素分析显示，大量预处理疾病、ECOG PS 差和/或低白蛋白水平与生存时间显著缩短相关。
