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卡培他滨联合沙利度胺二线治疗晚期胰腺癌的 II 期临床试验。

Phase II trial of capecitabine combined with thalidomide in second-line treatment of advanced pancreatic cancer.

机构信息

Department of Internal MedicineⅤ, Shang Dong Tumor Hospital, Jinan 250117, PR China.

出版信息

Pancreatology. 2012 Nov-Dec;12(6):475-9. doi: 10.1016/j.pan.2012.09.007. Epub 2012 Oct 6.

DOI:10.1016/j.pan.2012.09.007
PMID:23217281
Abstract

BACKGROUND

To evaluate the efficacy and tolerability of capecitabine combined with thalidomide in patients with advanced pancreatic cancer (APC) who have previously received gemcitabine-based therapy.

METHODS

A total of 31 patients were recruited prospectively in Shandong Tumor Hospital from May 2007 to April 2009. Capecitabine was offered to patients twice a day at a dose of 1250 mg/m(2) for 14-day then followed by 7-day rest. Thalidomide was administered 100 mg/day without interruption until disease progression or occurrence of unacceptable toxicity.

RESULTS

Two patients presented partial response (PR), 11 patients showed stable disease (SD) and eighteen patients presented progressive disease (PD). The median progression-free survival (PFS) was 2.7 months (95% confidence interval (CI), 2.4-3.3) and the median overall survival (OS) was 6.1 months (95% CI, 5.3-6.9). In the subgroup analysis, PFS had a significant difference between the serum CA19-9 level decreasing >25% and decreasing <25%, with 3.0 months (95% CI, 2.5-3.6) and 2.5 months (95% CI, 1.8-3.2), (Log Rank = 0.02), respectively. Hematological toxicity included leukocytopenia, anemia and neutropenia. Non-hematological toxicities included diarrhea, skin rash, nausea/vomiting, hand-foot syndrome, fatigue, dizziness, drowsiness and constipation.

CONCLUSION

Capecitabine combined with thalidomide is a well-tolerated second-line regimen, in patients with APC refractory to gemcitabine.

摘要

背景

评估卡培他滨联合沙利度胺治疗既往接受吉西他滨为基础的治疗的晚期胰腺癌(APC)患者的疗效和耐受性。

方法

2007 年 5 月至 2009 年 4 月,山东肿瘤医院前瞻性地招募了 31 名患者。卡培他滨每天两次给药,剂量为 1250mg/m(2),连用 14 天,然后休息 7 天。沙利度胺每天 100mg 不间断给药,直至疾病进展或出现不可接受的毒性。

结果

2 例患者部分缓解(PR),11 例患者病情稳定(SD),18 例患者病情进展(PD)。中位无进展生存期(PFS)为 2.7 个月(95%置信区间(CI),2.4-3.3),中位总生存期(OS)为 6.1 个月(95%CI,5.3-6.9)。亚组分析显示,血清 CA19-9 水平下降>25%与下降<25%的患者之间 PFS 有显著差异,分别为 3.0 个月(95%CI,2.5-3.6)和 2.5 个月(95%CI,1.8-3.2)(Log Rank = 0.02)。血液学毒性包括白细胞减少症、贫血和中性粒细胞减少症。非血液学毒性包括腹泻、皮疹、恶心/呕吐、手足综合征、疲劳、头晕、嗜睡和便秘。

结论

卡培他滨联合沙利度胺是一种耐受性良好的二线方案,可用于对吉西他滨耐药的 APC 患者。

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