[發明專利]檢測奧沙利鉑對于結直腸癌有效性的試劑盒

有效

• 申請號: 201510097019.7
• 申請日: 2015-03-04
• 公開（公告）號: CN104878084B
• 公開（公告）日: 2018-01-09
• 發明（設計）人: 李華光;林謀斌;湯二將;嵇承棟;尹路;李阿健;江慧紅
• 申請（專利權）人: 上海市楊浦區中心醫院
• 主分類號: C12Q1/68
• 分類號: C12Q1/68
• 代理公司: 上海三方專利事務所31127
• 代理人: 吳瑋,單大義

[技術領域]

本發明涉及檢測奧沙利鉑對于結直腸癌有效性的試劑盒。

[背景技術]

結直腸癌(CRC)是世界第三大常見的惡性腫瘤，也是由癌癥引起死亡的第二大原因，嚴重威脅人類健康(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.)。近幾十年來，結直腸癌的臨床結果已有顯著改善，不僅是由于外科技術的進步，還要歸因于化療和靶向藥物的介入療法(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.)。依據美國國家綜合癌癥網絡指南，建議Ⅱ期和Ⅲ期結直腸癌高危患者在經根治性切除術后進行輔助性化療。MOSAIC和NSABP C-07臨床試驗結果證明采用奧沙利鉑作為一線輔助化療的方案得到認可(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期結直腸癌患者接受含有奧沙利鉑的輔助性化療法后的三年無病生存率依舊僅有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)。一個有效的治療策略就是區分奧沙利鉑輔助性化療法中可能獲益較多或獲益較少的患者群體，對CRC患者進行個性化藥物治療，但目前仍缺少預測標記奧沙利鉑敏感性和耐藥性的臨床驗證。為此，臨床研究急需能夠簡便準確地進行預后及療效預測的方法，為結直腸癌患者術后用藥提供重要參考。