[发明专利]检测奥沙利铂对于结直肠癌有效性的试剂盒

说明书

[技术领域]

本发明涉及检测奥沙利铂对于结直肠癌有效性的试剂盒。

[背景技术]

结直肠癌(CRC)是世界第三大常见的恶性肿瘤，也是由癌症引起死亡的第二大原因，严重威胁人类健康(Jemal A,Bray F,Center MM,Ferlay J,Ward E,Forman D.Global cancer statistics.CA:a cancer journal for clinicians.2011；61(2):69-90.)。近几十年来，结直肠癌的临床结果已有显著改善，不仅是由于外科技术的进步，还要归因于化疗和靶向药物的介入疗法(Moertel CG,Fleming TR,Macdonald JS,et al.Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma.The New England journal of medicine.1990；322(6):352-358；Andre T,Boni C,Navarro M,et al.Improved overall survival with oxaliplatin,fluorouracil,and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial.Journal of clinical oncology:official journal of the American Society of Clinical Oncology.2009；27(19):3109-3116；Hurwitz HI,Fehrenbacher L,Hainsworth JD,et al.Bevacizumab in combination with fluorouracil and leucovorin:an active regimen for first-line metastatic colorectal cancer.Journal of clinical oncology:official journal of the American Society of Clinical Oncology.2005；23(15):3502-3508；Van Cutsem E,Kohne CH,Lang I,et al.Cetuximab plus irinotecan,fluorouracil,and leucovorin as first-line treatment for metastatic colorectal cancer:updated analysis of overall survival according to tumor KRAS and BRAF mutation status.Journal of clinical oncology:official journal of the American Society of Clinical Oncology.2011；29(15):2011-2019.)。依据美国国家综合癌症网络指南，建议Ⅱ期和Ⅲ期结直肠癌高危患者在经根治性切除术后进行辅助性化疗。MOSAIC和NSABP C-07临床试验结果证明采用奥沙利铂作为一线辅助化疗的方案得到认可(Andre T,Boni C,Navarro M,et al.Improved overall survival with oxaliplatin,fluorouracil,and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial.Journal of clinical oncology:official journal of the American Society of Clinical Oncology.2009；27(19):3109-3116；Kuebler JP,Wieand HS,O'Connell MJ,et al.Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer:results from NSABP C-07.Journal of clinical oncology:official journal of the American Society of Clinical Oncology.2007；25(16):2198-2204.)。然而，在Ⅲ期结直肠癌患者接受含有奥沙利铂的辅助性化疗法后的三年无病生存率依旧仅有65％(Uncu D,Aksoy S,Cetin B,et al.Results of adjuvant FOLFOX regimens in stage III colorectal cancer patients:retrospective analysis of 667patients.Oncology.2013；84(4):240-245)。一个有效的治疗策略就是区分奥沙利铂辅助性化疗法中可能获益较多或获益较少的患者群体，对CRC患者进行个性化药物治疗，但目前仍缺少预测标记奥沙利铂敏感性和耐药性的临床验证。为此，临床研究急需能够简便准确地进行预后及疗效预测的方法，为结直肠癌患者术后用药提供重要参考。