卡培他滨/奥沙利铂，一种用于老年转移性结直肠癌患者的安全有效的一线治疗方案：一项大型II期研究的事后分析

Capecitabine/oxaliplatin, a safe and active first-line regimen for older patients with metastatic colorectal cancer: post hoc analysis of a large phase II study.

作者信息

Twelves Chris J, Butts Charles A, Cassidy Jim, Conroy Thierry, Braud Fillippo de, Diaz-Rubio Eduardo, Tabernero Josep M, Schoffski Patrick, Figer Arie, Brunet Rene, Grossmann Johannes, Sobrero Alberto F, Van Cutsem Eric J

机构信息

University of Leeds and Bradford NHS Hospitals Trust, United Kingdom.

出版信息

Clin Colorectal Cancer. 2005 Jul;5(2):101-7. doi: 10.3816/ccc.2005.n.021.

DOI:10.3816/ccc.2005.n.021

PMID:16098250

Abstract

PURPOSE

The tumor-activated fluoropyrimidine capecitabine achieves response rates superior to those of bolus 5-fluorouracil/leucovorin (5-FU/LV) as first-line treatment for metastatic colorectal cancer (CRC), with favorable safety and fewer hospitalizations. Capecitabine is also at least as effective as bolus 5-FU/LV in the adjuvant setting, again with a favorable safety profile. Improved outcomes with capecitabine versus bolus 5-FU/LV in the adjuvant setting have been shown in overall trial populations and in patients aged >or= 70 years. Capecitabine/oxaliplatin (XelOx) is a safe and active combination for the first-line treatment of metastatic CRC.

PATIENTS AND METHODS

This post hoc analysis of a large phase II trial compared data from older and younger patients treated with first-line XelOx: oxaliplatin 130 mg/m(2) intravenously on day 1 followed by oral capecitabine 1,000 mg/m(2) twice daily for 14 days every 3 weeks.

RESULTS

The median age of the overall population (N = 96) was 64 years (range, 34-79 years), including 52 younger patients (< 65 years of age) and 44 older patients (>or= 65 years of age). Both age groups received a median of 8 cycles (range, 1-26 cycles) of XelOx. The XelOx regimen had similar high activity in both groups, with response rates of 58% (95% CI, 43%-71%) and 52% (95% CI, 37%-68%) in younger and older patients, respectively. In addition, time to disease progression and overall survival were similar in both groups (P > 0.5 for both outcomes). The XelOx regimen also had a favorable safety profile, with no clinically relevant differences between older and younger patients. The overall incidence of adverse events (including grade 3/4), dose reductions, and withdrawals because of adverse events were similar in both groups.

CONCLUSION

In the context of an aging population, XelOx provides a highly effective and tolerable first-line treatment for patients with metastatic CRC.

摘要

目的

肿瘤激活的氟嘧啶类药物卡培他滨作为转移性结直肠癌（CRC）的一线治疗药物，其缓解率优于大剂量5-氟尿嘧啶/亚叶酸钙（5-FU/LV），安全性良好，住院次数较少。在辅助治疗中，卡培他滨的疗效至少与大剂量5-FU/LV相当，安全性同样良好。在总体试验人群以及年龄≥70岁的患者中，卡培他滨在辅助治疗中对比大剂量5-FU/LV均显示出更好的疗效。卡培他滨/奥沙利铂（XelOx）是转移性CRC一线治疗的一种安全且有效的联合方案。

患者与方法

这项对一项大型II期试验的事后分析比较了接受一线XelOx治疗的老年和年轻患者的数据：第1天静脉注射奥沙利铂130mg/m²，随后口服卡培他滨1000mg/m²，每日2次，共14天，每3周重复一次。

结果

总体人群（N = 96）的中位年龄为64岁（范围34 - 79岁），其中包括52名年轻患者（<65岁）和44名老年患者（≥65岁）。两个年龄组接受XelOx治疗的中位周期数均为第8周期（范围1 - 26周期）。XelOx方案在两组中均具有相似的高活性，年轻患者和老年患者的缓解率分别为58%（95%CI，43% - 71%）和52%（95%CI，37% - 68%）。此外，两组的疾病进展时间和总生存期相似（两项结果的P均>0.5）。XelOx方案的安全性也良好，老年患者和年轻患者之间无临床相关差异。两组不良事件（包括3/4级）的总体发生率、因不良事件导致的剂量减少和停药情况相似。