Phase II study of epirubicin, cisplatin, and capecitabline for advanced biliary tract adenocarcinoma
Phase II study of epirubicin, cisplatin, and capecitabline for advanced biliary tract adenocarcinoma
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作者：
Park, SH;Park, YH;Lee, JH
背景。晚期胆道癌（btc）的预后非常差。因此，需要新的治疗策略来提高疗效和生存率，本研究设计了一种新的、有效的药物组合。复发或转移性BTC患者在第1天接受表柔比星50mg /m(2)的剂量，顺铂60mg /m(2)的剂量，卡培他滨1000mg /m(2)的剂量，每日两次，持续2周。每3周重复治疗一次。共治疗43例患者，其中肝外胆管癌22例，肝内胆管癌15例，胆囊癌6例。中位年龄为53岁（范围36-69岁），5例患者的Zubrod表现状态为2。17例患者达到部分缓解（40%；95%可信区间[95% CI]， 21-49%）， 10例病情稳定。随访18个月，中位生存时间为8个月（95% CI， 6-10个月）。总共进行了187个化疗周期，每位患者中位数为5个周期（范围为1-9个周期）。毒副反应主要为骨髓抑制和粘膜炎，无患者因毒副反应死亡。这种联合表柔比星、顺铂和卡培他滨的化疗对晚期BTC患者有很好的抗肿瘤活性。(c) 2005年美国癌症协会。
BACKGROUND. Advanced biliary tract carcinomas (BTCs) are associated with a very poor prognosis. New therapeutic strategies therefore are needed to improve efficacy and survival, and the Current study was designed with a new, effective drug combination.METHODS. Patients with recurrent or metastatic BTC received a combination of epirubicin at a dose of 50 mg/m(2), cisplatin at a dose of 60 mg/m(2) on Day 1, and capecitabine at a dose of 1000 mg/m(2) twice daily for 2 weeks. Treatment was repeated every 3 weeks.RESULTS. A total of 43 patients (22 with extrahepatic cholangiocarcinoma, 15 with intrahepatic cholangiocarcinoma, and 6 with gallbladder carcinoma) were treated. The median age was 53 years (range, 36-69 yrs) and 5 patients had a Zubrod performance status of 2. Seventeen patients achieved a partial response (40%; 95% confidence interval [95% CI], 21-49%) and 10 had stable disease. With a follow-up duration of 18 months, the median survival time was 8 months (95% CI, 6-10 mos). In total, 187 chemotherapy cycles were delivered, with a median of 5 cycles per patient (range, 1-9 cycles). Toxicity was mainly myelosuppression and mucositis, but no patients died of toxicity.CONCLUSIONS. This combination chemotherapy with epirubicin, cisplatin, and capecitabine offered promising antitumor activity in patients with advanced BTC. (c) 2005 American Cancer Socieiy.