Study into the use of cetuximab in metastatic colorectal cancer in a third level hospital

J.F. Marín Pozo, B. Oya Álvarez de Morales, I. Caba Porras, J. Aranda García
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引用次数: 3

Abstract

Objectives

In this study we will analyse the use of cetuximab in the treatment of metastatic colorectal cancer (MCC) in a third level hospital. We will establish the usage conditions in our centre in keeping with those approved in current technical records. We will also record the treatment duration under the different usage conditions and use the information available in material that has been published to date.

Methods

An indication-prescription study of cetuximab in MCC was carried out on all patients treated with cetuximab for colorectal cancer in the period between 2004 and 2007 in our hospital. The number of prescriptions that do not fit the approved recommendations for cetuximab in MCC treatment (and why they do not fit) is determined. Descriptive statistical analysis was carried out for the different variables collected, and a Kaplan-Meier analysis was carried out for the treatment duration variable, so as to determine whether there is a difference in effectiveness for the common uses in our hospital.

Results

Data was recorded for 74 patients treated with cetuximab. The average cost per patient was €14 399 and on average, 15.3 dosages were administered per patient. The average initial dosage was 710 mg with an average dosage of 446 mg after that. The average duration of the treatments was 15.4 weeks. cetuximab was administered to 7 patients as first-line treatment and to 32 patients who had not used irinotecan previously. Irinotecan was not associated with cetuximab treatment in 9 patients, and it was used in 14 patients resulting in a negative outcome for the EFGR test. Treatment duration was longer in the case of its use as first-line treatment (27.7 weeks), if irinotecan had not been used before (23.3 weeks), if irinotecan was used (20.5 weeks) and in patients with positive EFGR results (19.6 weeks.) The median treatment duration, under the different conditions, was less than the average but with no major differences between them. 70.3% of prescriptions did not fit with the data sheet.

Conclusions

The use of cetuximab under different conditions to those approved on the technical data sheet creates an increase in the number of patients treated and a longer duration of the treatments which implies an increase in intake. The average and the mean treatment times for the usage conditions found did not present any significant statistical differences. There are a small number of patients who benefit from this treatment which can be seen by the large average, in comparison with the mean, without any of the conditions in which the analysis was carried out seeming to determine a higher response. The treatment duration in our study was similar to the durations recorded in relevant literature for these usage conditions.

西妥昔单抗在三甲医院转移性结直肠癌治疗中的应用研究
目的分析西妥昔单抗在某三级医院治疗转移性结直肠癌(MCC)中的应用情况。我们将根据当前技术记录中批准的使用条件在本中心建立使用条件。我们还将记录不同使用条件下的治疗持续时间,并使用迄今为止已发表的材料中提供的信息。方法对我院2004 ~ 2007年接受西妥昔单抗治疗的结直肠癌患者进行MCC的适应症处方研究。确定了不符合批准的西妥昔单抗治疗MCC建议的处方数量(以及不符合的原因)。对收集到的不同变量进行描述性统计分析,对治疗持续时间变量进行Kaplan-Meier分析,以确定我院常用药物的疗效是否存在差异。结果记录了74例西妥昔单抗治疗患者的数据。每位患者的平均费用为14399欧元,每位患者平均服用15.3剂。平均初始剂量为710 mg,之后平均剂量为446 mg。平均治疗时间为15.4周。7例患者给予西妥昔单抗作为一线治疗,32例患者先前未使用伊立替康。在9例患者中,伊立替康与西妥昔单抗治疗不相关,在14例患者中使用伊立替康导致EFGR试验结果为阴性。使用伊立替康作为一线治疗(27.7周)、未使用伊立替康(23.3周)、使用伊立替康(20.5周)和EFGR阳性患者(19.6周)的治疗时间更长。不同条件下的中位治疗时间均小于平均值,但两者之间无显著差异。70.3%的处方与说明书不符。结论西妥昔单抗在不同于技术数据表批准的条件下的使用会导致治疗人数的增加和治疗持续时间的延长,这意味着摄入量的增加。所发现的使用条件的平均和平均处理时间没有任何显著的统计学差异。有一小部分患者从这种治疗中受益,这可以从大的平均值中看出,与平均值相比,没有任何进行分析的条件似乎决定了更高的反应。本研究的治疗持续时间与相关文献中记录的这些使用条件的持续时间相似。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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