Fernández-Lobato B, Díaz-Carrasco M S, Pareja A, Marín M, Vila N, de la Rubia A
Servicio de Farmacia, Hospital Universitario Virgen de la Arrixaca, Murcia, España.
Farm Hosp. 2009 Mar-Apr;33(2):89-95.
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.
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.
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 %), neutropenia (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. 14 patients stopped their treatment (an average of 8.1 cycles) due to toxicity in 10 cases, clinical progression in 3 cases and one patient died. Of the total 368 cycles administered, 68 suffered administration delays and 22 had the dosage reduced.
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.
自2004年MOSAIC试验结果公布以来，FOLFOX4方案已被确立为III期结直肠癌的推荐辅助治疗方案。本研究旨在评估该方案在我们地区的使用情况并描述其毒性。
对2005年4月至2007年3月期间开具的FOLFOX4治疗进行描述性研究。数据来自Farhos肿瘤学项目和临床记录。收集了以下数据：年龄、性别、诊断、疾病分期（TNM分类）和不良反应，并根据通用毒性标准2.0表示严重程度。
39例患者（24例男性和15例女性）接受了FOLFOX4方案治疗，平均年龄59岁。诊断结果为：28例结肠癌（4例II期、17例III期和7例IV期）、10例直肠癌（1例II期、4例III期和5例IV期）和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%）。研究结束时，9例患者继续接受该方案的积极治疗（平均6.8个周期）。在其余30例患者中，只有16人完成了计划的12个周期。14例患者停止治疗（平均8.1个周期），其中10例因毒性反应、3例因疾病进展，1例患者死亡。在总共给药的368个周期中，68个周期出现给药延迟，22个周期减少了剂量。
FOLFOX4方案的使用已根据一些可靠的科学证据进行了调整，但其毒性限制了其使用，并使计划剂量水平的给药变得困难。
