BACKGROUND:It has not yet been defined if KRAS has a prognostic value or is a predictive biomarker for the efficacy of erlotinib in advanced pancreatic cancer (PC).
METHODS:AIO-PK0104 was a phase III trial comparing gemcitabine/erlotinib followed by capecitabine with capecitabine/erlotinib followed by gemcitabine in advanced PC. For this post hoc subgroup analysis, biomarker data on the KRAS exon 2 mutation status were correlated with objective response to 1st-line therapy and with overall survival after start of 2nd-line chemotherapy (OSc).
RESULTS:KRAS codon 12 was mutated in 121 of 173 (70 %) patients. The KRAS status showed no association with objective response (p = 0.40), but KRAS wildtype patients had an improved OS (HR 1.68, p = 0.005). A trend for a survival benefit was also observed during (non-erlotinib containing) 2nd-line chemotherapy, with a HR of 1.47 (p = 0.10) for the OSc.
CONCLUSION:This post hoc analysis of AIO-PK0104 supports the assumption that KRAS is rather a prognostic than a predictive biomarker in PC.
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【KRAS mutation status is not predictive for objective response to anti-EGFR treatment with erlotinib in patients with advanced pancreatic cancer.].
【对于晚期胰腺癌患者，KRAS突变状态不能预测厄洛替尼抗EGFR治疗的客观反应。】
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DOI：10.1007/s00535-013-0767-4文章类型：杂志文章
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背景：尚未确定KRAS对厄洛替尼在晚期胰腺癌（PC）中的疗效是否具有预后价值或是否为预测性生物标志物。
方法：AIO-PK0104是一项III期试验，在晚期PC机中比较吉西他滨/厄洛替尼，卡培他滨，卡培他滨/厄洛替尼，吉西他滨。对于此事后亚组分析，有关KRAS外显子2突变状态的生物标记数据与对一线治疗的客观反应以及与二线化疗（OSc）开始后的总体生存率相关。
结果：在173名患者中，有121名（70％）患者的KRAS密码子12被突变。 KRAS状态显示与客观反应无关（p = 0.40），但KRAS野生型患者的OS改善（HR 1.68，p = 0.005）。在（不含厄洛替尼的）二线化疗期间也观察到生存获益的趋势，OSc的HR为1.47（p = 0.10）。
结论：AIO-PK0104的事后分析支持以下假设：KRAS在PC中是一种预后指标，而不是预测性生物指标。
方法：AIO-PK0104是一项III期试验，在晚期PC机中比较吉西他滨/厄洛替尼，卡培他滨，卡培他滨/厄洛替尼，吉西他滨。对于此事后亚组分析，有关KRAS外显子2突变状态的生物标记数据与对一线治疗的客观反应以及与二线化疗（OSc）开始后的总体生存率相关。
结果：在173名患者中，有121名（70％）患者的KRAS密码子12被突变。 KRAS状态显示与客观反应无关（p = 0.40），但KRAS野生型患者的OS改善（HR 1.68，p = 0.005）。在（不含厄洛替尼的）二线化疗期间也观察到生存获益的趋势，OSc的HR为1.47（p = 0.10）。
结论：AIO-PK0104的事后分析支持以下假设：KRAS在PC中是一种预后指标，而不是预测性生物指标。
