Role of Kras status in patients with metastatic colorectal cancer receiving first-line chemotherapy plus bevacizumab: a TTD group cooperative study.

Role of Kras status in patients with metastatic colorectal cancer receiving first-line chemotherapy plus bevacizumab: a TTD group cooperative study.
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DOI:
10.1371/journal.pone.0047345
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发表时间:
2012
期刊:
影响因子:
3.7
通讯作者:
Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD)
Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD)
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Díaz-Rubio E;Gómez-España A;Massutí B;Sastre J;Reboredo M;Manzano JL;Rivera F;Safont MJ;Montagut C;González E;Benavides M;Marcuello E;Cervantes A;Martínez de Prado P;Fernández-Martos C;Arrivi A;Bando I;Aranda E;Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD)

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在宏观研究中,转移性结直肠癌(MCRC)患者被随机分为6个周期的一线治疗,卡培他滨和奥沙利铂(XELOX)+贝伐单抗,随后是单药贝伐单抗或XELOX+贝伐单抗,直到疾病进展。另外还进行了一项回顾性分析,以确定肿瘤KRAS状态对无进展生存期(PFS)、总生存期(OS)和应答率的预后价值。KRAS数据(肿瘤、KRAS状态和突变类型)通过问卷从执行KRAS分析的参与中心收集。然后将这些数据与宏观研究数据库中相关患者的疗效数据进行交叉参考。在宏观研究的480名患者中,有394名(82.1%)分析了KRAS状态。野生型(WT)KRAS肿瘤219例(56%),突变型(MT)KRAS 175例(44%)。WT KRAS患者和MT KRAS肿瘤患者的中位PFS分别为10.9个月和9.4个月(p = 0.0038;HR:1.4;95%CI:1.12-1.77)。两组患者的OS差异也非常显著:西医组26.7个月,MT组18.0个月(p = 0.0002;HR:1.55;95%CI:1.23~1.96)。单因素和多因素分析显示,KRAS是PFS和OS的自变量。WT KRAS肿瘤患者有效率为57.5%,MT KRAS肿瘤患者有效率为43.4%(P = 0.0054;OR:1.77;95%CI:1.18~2.64)。这项宏观研究的分析表明,在接受XELOX联合贝伐单抗治疗的mCRC患者中,肿瘤KRAS状态具有预后作用。对于PFS和OS,KRAS状态在单变量和多变量分析中都是一个独立因素。
In the MACRO study, patients with metastatic colorectal cancer (mCRC) were randomised to first-line treatment with 6 cycles of capecitabine and oxaliplatin (XELOX) plus bevacizumab followed by either single-agent bevacizumab or XELOX plus bevacizumab until disease progression. An additional retrospective analysis was performed to define the prognostic value of tumour KRAS status on progression-free survival (PFS), overall survival (OS) and response rates. KRAS data (tumour KRAS status and type of mutation) were collected by questionnaire from participating centres that performed KRAS analyses. These data were then cross-referenced with efficacy data for relevant patients in the MACRO study database. KRAS status was analysed in 394 of the 480 patients (82.1%) in the MACRO study. Wild-type (WT) KRAS tumours were found in 219 patients (56%) and mutant (MT) KRAS in 175 patients (44%). Median PFS was 10.9 months for patients with WT KRAS and 9.4 months for patients with MT KRAS tumours (p = 0.0038; HR: 1.40; 95% CI:1.12–1.77). The difference in OS was also significant: 26.7 months versus 18.0 months for WT versus MT KRAS, respectively (p = 0.0002; HR: 1.55; 95% CI: 1.23–1.96). Univariate and multivariate analyses showed that KRAS was an independent variable for both PFS and OS. Responses were observed in 126 patients (57.5%) with WT KRAS tumours and 76 patients (43.4%) with MT KRAS tumours (p = 0.0054; OR: 1.77; 95% CI: 1.18–2.64). This analysis of the MACRO study suggests a prognostic role for tumour KRAS status in patients with mCRC treated with XELOX plus bevacizumab. For both PFS and OS, KRAS status was an independent factor in univariate and multivariate analyses.
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