Pooled analysis of safety and efficacy of oxaliplatin plus fluorouracil/leucovorin administered bimonthly in elderly patients with colorectal cancer
Pooled analysis of safety and efficacy of oxaliplatin plus fluorouracil/leucovorin administered bimonthly in elderly patients with colorectal cancer
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DOI：
10.1200/jco.2006.06.9039
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发表时间：
2006-09-01
影响因子：
45.3
通讯作者：
Sargent, Daniel J.
中科院分区：
文献类型：
--
作者：
Goldberg, Richard M.;Tabah-Fisch, Isabelle;Sargent, Daniel J.
目的奥沙利铂、氟尿嘧啶和亚叶酸钙是治疗晚期结直肠癌的常用药物。本分析比较了奥沙利铂加氟尿嘧啶/亚叶酸钙（FOLFOX 4）的安全性和有效性，患者的年龄小于和至少70 years.Patients和MethodsThis回顾性分析包括3,742结直肠癌患者（614年龄>= 70）从四个临床试验测试FOLFOX 4在辅助，第一，和第二线设置。终点包括≥ 3级不良事件，反应率（在晚期疾病），进展或复发的生存率，剂量强度，和总生存率在研究中与成熟的生存data.ResultsGrade ≥ 3血液毒性（中性粒细胞减少[43%v 49%; P = 0.04]和血小板减少[2%v 5%; P = 0.04]）是显着较高的老年患者。年龄较大与严重神经系统不良事件、腹泻、恶心/呕吐、感染、≥ 3级毒性的总体发生率（63% vs 67%; P = 0.15）或60天死亡率（1.1% vs 2.3%; P = 0.20）的增加无关。FOLFOX 4与对照组相比，在缓解率、进展或无复发生存期方面的相对获益在年龄方面没有差异（年龄< 70岁，FOLFOX 4与对照组的风险比为0.70，年龄>= 0为0.65; P = 0.42），或总生存期（风险比，0.77年龄< 70，0.82年龄>= 70; P = 0.79）。在第1、3、6、12周期，不同年龄组的剂量强度无差异。结论FOLFOX 4方案在老年结直肠癌患者中维持其有效性和安全性。尽管80岁以上患者的数据很少，但应考虑其明智使用，而不考虑患者年龄。
PurposeOxaliplatin, fluorouracil, and leucovorin are commonly used to treat advanced and resected colorectal cancer. This analysis compares the safety and efficacy of oxaliplatin plus fluorouracil/leucovorin administered bimonthly (FOLFOX4) in patients age younger than and at least 70 years.Patients and MethodsThis retrospective analysis included 3,742 colorectal cancer patients (614 age >= 70) from four clinical trials testing FOLFOX4 in the adjuvant, first-, and second-line settings. End points included grade >= 3 adverse events, response rate (in advanced disease), progression or relapse-free survival, dose-intensity, and overall survival in the studies with mature survival data.ResultsGrade >= 3 hematologic toxicity (neutropenia [43% v 49%; P = .04] and thrombocytopenia [2% v 5%; P = .04]) were significantly higher in older patients. Older age was not associated with increased rates of severe neurologic adverse events, diarrhea, nausea/vomiting, infection, overall incidence of grade >= 3 toxicity (63% v 67%; P = .15), or 60-day mortality (1.1% v 2.3%; P = .20). The relative benefit of FOLFOX4 versus control did not differ by age for response rate, progression or recurrence free-survival (hazard ratio, 0.70 for FOLFOX4 v control for age < 70, 0.65 for age >= 0; P = .42), or overall survival (hazard ratio, 0.77 age < 70, 0.82 age >= 70; P = .79). Dose-intensity did not differ by age at cycles 1, 3, 6, or 12.ConclusionFOLFOX4 maintains its efficacy and safety ratio in selected elderly patients with colorectal cancer. Its judicious use should be considered without regard to patient age, although scant data are available among patients older than 80 years.