Clinical determinants of survival in patients with 5-fluorouracil-based treatment for metastatic colorectal cancer:: results of a multivariate analysis of 3825 patients
Clinical determinants of survival in patients with 5-fluorouracil-based treatment for metastatic colorectal cancer:: results of a multivariate analysis of 3825 patients
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DOI：
10.1093/annonc/mdf034
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发表时间：
2002-02-01
影响因子：
50.5
通讯作者：
Hecker, H
中科院分区：
文献类型：
--
作者：
Köhne, CH;Cunningham, D;Hecker, H
背景：转移性结直肠癌患者通常接受全身化疗作为姑息治疗。患者和方法：在19个前瞻性随机试验和3个II期试验中，共3825名接受5-FU治疗的患者被分成学习样本(n=2549)和验证样本(n=1276)。使用递归分割合并方法(RECPAM)对数据进行树分析。仅当缺失值的患者数=400×10(9)/L、碱性磷酸酶=300U/L、白细胞计数和GT；=10×10(9)/L，血红蛋白10×10(9)/L。验证样本中好、中、高危患者的中位生存期分别为14.7、10.5和6.4个月。结论：根据患者的临床表现状态、白细胞计数、碱性磷酸酶和转移灶数目这四个基线临床参数，患者至少可以分为三个危险组。任何分子或生物标记物都应该根据这些临床参数进行验证，并且可以在这三个风险组中分别研究强化治疗或强化治疗的决定。此外，临床试验应根据三个风险组进行分层。
Background: Patients with metastatic colorectal cancer are usually offered systemic chemotherapy as palliative treatment. A multivariate analysis was performed in order to identify predictors and their constellation that allow a valid prediction of the outcome in patients treated with 5-fluorouracil (5-FU)-based therapy.Patients and methods: A total of 3825 patients treated with 5-FU within 19 prospective randomised and three phase II trials were separated into learning (n = 2549) and validation (n = 1276) samples. Data were analysed by tree analysis using the recursive partition and amalgamation method (RECPAM). A predictor could only enter the RECPAM analysis if the number of patients with missing values was = 400 x 10(9)/l, alkaline phosphatase >= 300 U/l, white blood cell (WBC) count >= 10 x 10(9)/l and haemoglobin 10 x 10(9)/l. The median survival times for the good, intermediate and high risk groups in the validation sample were 14.7, 10.5 and 6.4 months, respectively.Conclusions: Patients can be divided into at least three risk groups depending on the four baseline clinical parameters: performance status, WBC count, alkaline phosphatase and number of metastatic sites. Any molecular or biological marker should be validated against these clinical parameters and decisions for more or less intensive treatments may be studied separately in these three risk groups. Also, clinical trials should be stratified according to the three risk groups.