FOLFOX4方案的治疗用途和毒性概况

B. Fernández-Lobato , M.S. Díaz-Carrasco , A. Pareja , M. Marín , N. Vila , A. de la Rubia
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引用次数: 4

摘要

自2004年MOSAIC试验结果发表以来,FOLFOX4方案已被确立为推荐用于III期结直肠癌的辅助治疗。本研究的目的是评估该方案在我们领域的使用,并描述其毒性。方法对2005年4月至2007年3月间使用FOLFOX4治疗的病例进行描述性研究。数据来自Farhos Oncología®项目和临床记录。收集以下资料:年龄、性别、诊断、疾病分期(TNM分类)、不良反应,按照通用毒性标准2.0表达严重程度。结果39例患者采用FOLFOX4方案治疗,其中男性24例,女性15例,平均年龄59岁。诊断为:28例结肠癌(4例II期,17例III期,7例IV期),10例直肠癌(1例II期,4例III期,5例IV期),1例IV期胃癌。最常见的不良反应是周围神经病变(82%)、中性粒细胞减少(56.4%)和腹泻(53.9%)。当研究完成时,9名患者继续积极治疗该方案(平均,6.8周期)。在剩下的30名患者中,只有16人完成了计划的12个周期。14例患者因毒副作用停药10例(平均8.1周期),3例临床进展,1例死亡。在总共368个疗程中,68个疗程出现给药延迟,22个疗程剂量减少。结论FOLFOX4方案的使用已经有了一些可靠的科学依据,但其毒性限制了其使用,并使其难以达到计划剂量水平。
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Therapeutic use and profile of toxicity of the FOLFOX4 regimen

Introduction

Since the publication of the MOSAIC test results in 2004, the FOLFOX4 regimen has been established as an adjuvant treatment which is recommended in stage III colorectal cancer. The aim of this study is to assess the use of this regimen in our field and to describe its toxicity.

Methods

Descriptive study of treatments with FOLFOX4 prescribed between April 2005 and March 2007. The data was obtained from the Farhos Oncología® programme and clinical records. The following data was collected: age, gender, diagnosis, stage of the illness (TNM classification), and adverse reactions, expressing severity according to Common Toxicity Criteria 2.0.

Results

The FOLFOX4 regimen was prescribed for 39 patients (24 men and 15 women) with an average age of 59. The diagnoses were: 28 colon cancer (4 stage II, 17 stage III, and 7 stage IV), 10 rectal cancer (1 stage II, 4 stage III, and 5 stage IV), and 1 stage IV gastric cancer. The most frequent adverse reactions were peripheral neuropathy (82%), neutropaenia (56.4%), and diarrhoea (53.9%). When the study was completed, 9 patients continued active treatment with the regimen (average, 6.8 cycles). Of the 30 remaining patients only 16 people completed the 12 planned cycles. Forteen patients stopped their treatment (average, 8.1 cycles) due to toxicity in 10 cases, clinical progression in 3 cases, and 1 patient died. Of the total 368 cycles administered, 68 suffered administration delays and 22 had the dosage reduced.

Conclusion

The use of the FOLFOX4 regimen has been adjusted to uses with some solid scientific evidence, but its toxicity has limited its use and has made administering the planned dosage levels difficult.

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