Radiological tumor size decrease at week 6 is a potent predictor of outcome in chemorefractory metastatic colorectal cancer treated with cetuximab (BOND trial)

Radiological tumor size decrease at week 6 is a potent predictor of outcome in chemorefractory metastatic colorectal cancer treated with cetuximab (BOND trial)
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DOI:
10.1093/annonc/mdp011
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发表时间:
2009-08-01
期刊:
影响因子:
50.5
通讯作者:
Tejpar, S.
Tejpar, S.
中科院分区:
医学1区
文献类型:
--
作者:
Piessevaux, H.;Buyse, M.;Tejpar, S.

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患者和方法:在329例患者中,289例在基线和第6周进行了测量。肿瘤缩小表示为与基线相比的相对减少,并根据先前报告的临界值进行分类(类似于10%)或用作连续变量。中位至疾病进展时间(TTP)为6.1 [95%置信区间(CI)5.1-7.2] vs 1.5个月(95% CI 1.4-1.7)[风险比(HR)0.23(95% CI 0.17-0.32)]。中位总生存期(OS)分别为13.7(CI NA)和6.9个月(95% CI 6.1-7.7)[HR 0.21(95% CI 0.14-0.32)]。在多变量模型中,早期肿瘤减少优于皮肤毒性作为长期outcome.Conclusions的预测因子:肿瘤收缩在6周是一个强有力的预测TTP和OS的cmCRC患者与西妥昔单抗治疗或不伊立替康。这表明早期肿瘤缩小是西妥昔单抗疗效的标志,并可靠地识别对药物敏感的亚群。早期肿瘤缩小可用作临床实践中疗效的标志物,本身或组合。
Patients and methods: Of the 329 patients, 289 had a measurement both at baseline and week 6. Tumor shrinkage was expressed as a relative decrease compared with baseline and categorized according to a previously reported cut-off value (similar to 10%) or used as a continuous variable.Results: Median time to progression (TTP) was 6.1 [95% confidence interval (CI) 5.1-7.2] versus 1.5 months (95% CI 1.4-1.7) in patients with [99 patients (34.3%)] or without [190 patients (65.7%)] tumor shrinkage, respectively, at week 6 [hazard ratio (HR) 0.23 (95% CI 0.17-0.32)]. The median overall survival (OS) was 13.7 (CI NA) versus 6.9 months (95% CI 6.1-7.7) [HR 0.21 (95% CI 0.14-0.32)], respectively. In a multivariate model, early tumor decrease outperformed skin toxicity as a predictor of long-term outcome.Conclusions: Tumor shrinkage at 6 weeks is a strong predictor of TTP and OS in cmCRC patients treated with cetuximab with or without irinotecan. This suggests early tumor shrinkage is the hallmark of efficacy of cetuximab and reliably identifies the subpopulation that is sensitive to the drug. Early tumor shrinkage can be used as a marker of efficacy in clinical practice, as such or in combination.