Background

The bCTC count is a well-established prognostic biomarker in mCRC, as well as in other tumor types. The aim of this analysis was to evaluate the prognostic/predictive role of the bCTC count (≥3 vs. <3) in previously untreated mCRC.

Patients and Methods

The study involved 589 untreated mCRC patients included in the intention-to-treat population of 2 randomized clinical trials (phase III VISNU-1 [NCT01640405] and phase II VISNU-2 [NCT01640444] studies).

Results

Of the 589 patients, 349 (59.2%) had bCTC≥3 and 240 (40.7%) had bCTC<3. Multivariate analysis showed that the bCTC count is an independent prognostic factor for overall survival (OS) (HR 0.59, 95% CI 0.48-0.72; P = 0.000) and potential for progression-free survival (PFS) (P = 0.0549). Median OS was 32.9 and 19.5 months in patients with bCTC<3 and bCTC≥3 (P <0.001), respectively. This effect was also observed comparing OS in RASwt patients from both studies. Other prognostic factors were: ECOG-PS, primary tumor site, number of metastatic sites and surgery of the primary tumor. Median OS was lower for patients treated with anti-VEGF versus anti-EGFR (22.3 vs. 33.3 months, P <0.0001) while there were no significant differences in PFS according to the targeted treatment received.

Conclusion

This post-hoc analysis of 2 randomized studies confirms the poor prognosis of patients with bCTC≥3 but this is not associated with other adverse independent prognostic factors such as RAS/BRAF mutations.

中文翻译：

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循环肿瘤细胞和肿瘤分子谱与既往未经治疗的转移性结直肠癌患者临床结果的关联：III 期 VISNÚ-1 和 II 期 VISNÚ-2 随机试验的汇总分析

背景

bCTC 计数是 mCRC 以及其他肿瘤类型中公认的预后生物标志物。该分析的目的是评估 bCTC 计数（≥3 与 <3）在既往未经治疗的 mCRC 中的预后/预测作用。

患者和方法

该研究涉及 589 名未经治疗的 mCRC 患者，包括 2 项随机临床试验（III 期 VISNU-1 [NCT01640405] 和 II 期 VISNU-2 [NCT01640444] 研究）的意向治疗人群。

结果

在589名患者中，349名（59.2%）bCTC≥3，240名（40.7%）bCTC<3。多变量分析显示，bCTC 计数是总生存期 (OS)（HR 0.59，95% CI 0.48-0.72；P  = 0.000）和无进展生存期（PFS）潜力（P  = 0.0549）的独立预后因素。bCTC<3 和 bCTC≥3 患者的中位 OS 分别为 32.9 个月和 19.5 个月（P <0.001）。通过比较两项研究中 RASwt 患者的 OS，也观察到了这种效应。其他预后因素包括：ECOG-PS、原发肿瘤部位、转移部位数量和原发肿瘤手术。接受抗 VEGF 治疗的患者与抗 EGFR 治疗的患者相比，中位 OS 较低（22.3 个月与 33.3 个月，P<0.0001），而根据接受的靶向治疗，PFS 没有显着差异。

结论

这项对 2 项随机研究的事后分析证实了 bCTC≥3 的患者预后不良，但这与其他不良独立预后因素（例如 RAS/BRAF 突变）无关。