Budd G Thomas, Cristofanilli Massimo, Ellis Mathew J, Stopeck Allison, Borden Ernest, Miller M Craig, Matera Jeri, Repollet Madeline, Doyle Gerald V, Terstappen Leon W M M, Hayes Daniel F
Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.
Clin Cancer Res. 2006 Nov 1;12(21):6403-9. doi: 10.1158/1078-0432.CCR-05-1769.
The presence of >or=5 circulating tumor cells (CTC) in 7.5 mL blood from patients with measurable metastatic breast cancer before and/or after initiation of therapy is associated with shorter progression-free and overall survival. In this report, we compared the use of CTCs to radiology for prediction of overall survival.
One hundred thirty-eight metastatic breast cancer patients had imaging studies done before and a median of 10 weeks after the initiation of therapy. All scans were centrally reviewed by two independent radiologists using WHO criteria to determine radiologic response. CTC counts were determined approximately 4 weeks after initiation of therapy. Specimens were analyzed at one of seven laboratories and reviewed by a central laboratory.
Interreader variability for radiologic responses and CTC counts were 15.2% and 0.7%, respectively. The median overall survival of 13 (9%) patients with radiologic nonprogression and >or=5 CTCs was significantly shorter than that of the 83 (60%) patients with radiologic nonprogression and <5 CTCs (15.3 versus 26.9 months; P=0.0389). The median overall survival of the 20 (14%) patients with radiologic progression and <5 CTCs was significantly longer than the 22 (16%) patients with >or=5 CTCs that showed progression by radiology (19.9 versus 6.4 months; P=0.0039).
Assessment of CTCs is an earlier, more reproducible indication of disease status than current imaging methods. CTCs may be a superior surrogate end point, as they are highly reproducible and correlate better with overall survival than do changes determined by traditional radiology.
可测量转移性乳腺癌患者在治疗开始前和/或开始治疗后7.5 mL血液中循环肿瘤细胞（CTC）≥5个与无进展生存期和总生存期缩短相关。在本报告中，我们比较了使用CTC与放射学检查预测总生存期的情况。
138例转移性乳腺癌患者在治疗开始前及开始治疗后中位10周时进行了影像学检查。所有扫描结果均由两名独立的放射科医生按照世界卫生组织标准进行集中评估，以确定放射学反应。在治疗开始后约4周测定CTC计数。标本在7个实验室之一进行分析，并由中央实验室进行审核。
放射学反应和CTC计数的阅片者间变异性分别为15.2%和0.7%。13例（9%）放射学无进展且CTC≥5个患者的中位总生存期显著短于83例（60%）放射学无进展且CTC＜5个患者（15.3个月对26.9个月；P = 0.0389）。20例（14%）放射学进展且CTC＜5个患者的中位总生存期显著长于22例（16%）放射学进展且CTC≥5个患者（19.9个月对6.4个月；P = 0.0039）。
与目前的影像学方法相比，评估CTC是一种更早、更具可重复性的疾病状态指标。CTC可能是一个更好的替代终点，因为它们具有高度可重复性，并且与总生存期的相关性优于传统放射学所确定的变化。
