Five-Year Data and Prognostic Factor Analysis of Oxaliplatin and Irinotecan Combinations for Advanced Colorectal Cancer: N9741
Five-Year Data and Prognostic Factor Analysis of Oxaliplatin and Irinotecan Combinations for Advanced Colorectal Cancer: N9741
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DOI：
10.1200/jco.2008.17.7147
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发表时间：
2008-12-10
影响因子：
45.3
通讯作者：
Goldberg, Richard M.
中科院分区：
文献类型：
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作者：
Sanoff, Hanna K.;Sargent, Daniel J.;Goldberg, Richard M.
在这份报告中，我们更新了组间试验N9741的生存（OS）和疾病进展时间（TTP）数据，在中位数为5年的随访后，通过使用风险分层和预后因素分析来确定治疗结果是否在特定的患者亚组中存在差异。和含伊立替康的方案。按治疗组和基线风险组计算OS和TTP（基于WBC、体能状态、疾病部位数量和碱性磷酸酶）。多变量预后因素分析用于评估临床因素与OS，TTP，反应和毒性的关系，通过使用考克斯和logistic回归models.ResultsThe观察到的5年生存率与氟尿嘧啶，亚叶酸和奥沙利铂（FOLFOX）的9.8%优于伊立替康加推注氟尿嘧啶和亚叶酸（IFL; 3.7%; P = 0.04）或与推注伊立替康/奥沙利铂（IROX; 5.1%; P = 0.128）。FOLFOX组的OS和TTP（分别为20.2个月和8.9个月）显著长于IFL组（分别为14.6个月和6.1个月; P <0.001）或IROX组（分别为17.3个月和6.7个月; P <0.001）。不同风险组的OS不同：低风险组为20.7个月，中等风险组为17.4个月，高风险组为9.4个月（P <0.001）。FOLFOX治疗是优越的上级在所有的风险组，是最强大的预后因素OS，TTP，反应率，和toxic.ConclusionThe 9.8%5年OS的转移性结直肠癌患者谁与一线FOLFOX治疗设置了一个新的基准。无论是基线风险组还是检查的任何预后因素都不能预测治疗特异性结局。然而，治疗效果和患者寿命因风险组而异。
PurposeIn this report, we update survival (OS) and time-to-progression (TTP) data for the Intergroup trial N9741 after a median 5 years of follow-up by using risk-stratified and prognostic factor analyses to determine if treatment outcomes differ in specific patient subgroups.Patients and MethodsA total of 1,691 patients were randomly assigned to one of seven fluorouracil-, oxaliplatin-, and irinotecan-containing regimens. OS and TTP were calculated by treatment arm and baseline risk group (on the basis of WBC, performance status, number of sites of disease, and alkaline phosphatase). Multivariate prognostic factor analysis was used to assess clinical factors for their relationships to OS, TTP, response, and toxicity by using Cox and logistic regression models.ResultsThe observed 5-year survival with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX) of 9.8% was better than with irinotecan plus bolus fluorouracil and leucovorin (IFL; 3.7%; P = .04) or with bolus irinotecan/oxaliplatin (IROX; 5.1%; P = .128). OS and TTP were significantly longer for FOLFOX (20.2 months and 8.9 months, respectively) than for IFL (14.6 months and 6.1 months, respectively; P < .001 for both) or for IROX (17.3 months and 6.7 months, respectively; P < .001 for both). OS differed by risk group: 20.7 months for low risk, 17.4 months for intermediate risk, and 9.4 months for high risk (P < .001). FOLFOX treatment was superior in all risk groups and was the most powerful prognostic factor for OS, TTP, response rate, and toxicity.ConclusionThe 9.8% 5-year OS in patients with metastatic colorectal cancer who were treated with first-line FOLFOX sets a new benchmark. Neither baseline risk group nor any prognostic factor examined was predictive of treatment-specific outcome. However, treatment efficacy and patient longevity varied as a function of risk group.