摘要
目的研究卡培他滨联合沙利度胺在晚期胰腺癌二线治疗中的临床疗效，探讨沙利度胺在胰腺癌治疗中的疗效和安全性。方法采用随机数字法将含吉西他滨一线治疗的61例晚期胰腺癌患者随机分为两组，分别给予单药卡培他滨（单药组）以及卡培他滨联合沙利度胺（联合组）治疗，评价两组患者的疗效和毒副反应。结果单药组和联合组患者的的无进展生存时间（PFS）分别为2．8个月（95％CI为2．4～3．2个月）和3．1个月（95％CI为2．6—3．6个月），差异有统计学意义（P〈0．05）；总生存时间（OS）分别为6．1个月（95％CI为5．3～6．9）和6．3个月（95％C1为5．2—7．4，P〉0．05）。31例单药组患者部分缓解（PR）1例，疾病稳定（SD）10例，疾病进展（PD）20例；30例联合组患者PR2例，SD11例，PD17例。单药组和联合组患者的疾病控制率分别为35．5％和43．3％，差异无统计学意义（19=0．272）。两组患者的毒副反应主要为Ⅲ～Ⅳ度腹泻。结论卡培他滨联合沙利度胺能够延长晚期胰腺癌患者的PFS，且毒副反应耐受性良好，是一种安全有效的方案。
Objective This study investigates the efficacy and tolerability of capecitabine plus thalidomide in patients with advanced pancreatic cancer who previously underwent gemcitabine-based therapy. Methods Sixty-one patients with unresectable or metastatic PC who had progressed on single-agent Gem or a Gem-containing regimen were enrolled. The patients were randomly divided into two groups. One group （31 patients） was treated with capecitabine alone, and another group was treated with capecitabine plus thalidomide. Capecitabine was administered orally twice a day at a dose of 1,250 mg/m2 for 14-day followed by 7-day rest and oral thalidomide 100 mg was given daily without interruption until disease progression or occurrence of unacceptable toxicity. Results The PFS was 2.8 months （95% CI 2.4-3.2） vs. 3.1 months （95% C12.6-3.6, P〈0.05） and the OSwas6.1 months （95% C15.3-6.9） vs. 6.3 months （95% CI 5.2-7.4, P = 0.426）. In the capecitabine alone group, one patient experienced a partial response （PR）, 10 patients showed stable disease （SD） and 20 patients had progressive disease （PD）. The another group, two patients experienced a partial response （PR）, 11 patients SD, and 17 patients PD. The disease control rates were 35.5% and 43.3% , respectively. The major adverse reaction in the two groups was grade 3 diarrhea. Conclusion Capecitabine plus thalidomide regimen is marginally effective and well tolerated in the second-line settin~ in patients with ~emcitabine-refractorv advanced pancreatic cancer.
出处
《中华肿瘤杂志》
CAS
CSCD
北大核心
2013年第4期301-304,共4页
Chinese Journal of Oncology
关键词
胰腺肿瘤
二线治疗
卡培他滨
沙利度胺
Pancreatic neoplasms
Second line treatment
Capecitabine
Thalidomide
