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多西他赛联合奈达铂和5-氟尿嘧啶治疗晚期食管癌的II期试验。

A phase II trial of docetaxel plus nedaplatin and 5-fluorouracil in treating advanced esophageal carcinoma.

作者信息

Guo Jing-Feng, Zhang Bo, Wu Feng, Wang Bing, Xing Hui, Zhu Guan-Yu, Nie Xiang-Yang, Peng Jing

机构信息

Hexian Memorial Hospital, Guangzhou, Guangdong 511400, P.R. China.

出版信息

Chin J Cancer. 2010 Mar;29(3):321-4. doi: 10.5732/cjc.009.10432.

DOI:10.5732/cjc.009.10432
PMID:20193118
Abstract

BACKGROUND AND OBJECTIVE

Accumulating data indicate that docetaxel plus cisplatin and 5-fluorouracil has certain effect on advanced gastric or gastro-oesophageal junction adenocarcinoma. This study was to evaluate the efficacy and toxicity of docetaxel plus nedaplatin and 5-fluorouracil (DNF regimen) in treating advanced esophageal carcinoma.

METHODS

Forty-three patients with pathologically confirmed advanced esophageal carcinoma treated by DNF regimen: intravenous infusion of docetaxel (75 mg/m(2)) over 1 h, intravenous infusion of nedaplatin (100 mg/m(2)) over 3 h, intravenous infusion of leucovorin (CF, 200 mg/m(2)) over 2 h, intravenous injection of 5-fluorouracil (375 mg/m(2)) over 10 min, followed by a 46-hour infusion of 5-fluorouracil (2.6 g/m(2)). The cycle was repeated every three weeks. Treatment efficacy was evaluated every two weeks according to the WHO standards. All patients received at least two cycles of chemotherapy.

RESULTS

Patients received a total of 144 cycles of treatment, and all were evaluable for efficacy and toxicity. Of the 43 patients, 2 (4.65%) achieved complete response (CR), 25 (58.14%) achieved partial response (PR), 9 (20.93%) had stable disease (SD), and 7 (16.28%) had progressive disease (PD). The overall response rate was 62.8%. The median time-to-progression (TTP) was 201 days and the median survival time (MST) was 310 days. Grade III/IV adverse events mainly included neutropenia (20.93%), febrile neutropenia (4.65%), thrombocytopenia (6.98%) and vomiting (9.30%). One patient died of grade IV thrombocytopenia.

CONCLUSION

DNF regimen is effective for and well tolerated by patients with advanced esophageal carcinoma.

摘要

背景与目的

越来越多的数据表明,多西他赛联合顺铂和5-氟尿嘧啶对晚期胃癌或胃食管交界腺癌有一定疗效。本研究旨在评估多西他赛联合奈达铂和5-氟尿嘧啶(DNF方案)治疗晚期食管癌的疗效和毒性。

方法

43例经病理确诊的晚期食管癌患者接受DNF方案治疗:多西他赛(75mg/m²)静脉滴注1小时,奈达铂(100mg/m²)静脉滴注3小时,亚叶酸钙(CF,200mg/m²)静脉滴注2小时,5-氟尿嘧啶(375mg/m²)静脉推注10分钟,随后46小时持续静脉滴注5-氟尿嘧啶(2.6g/m²)。每三周重复一个周期。每两周根据世界卫生组织标准评估治疗疗效。所有患者至少接受两个周期的化疗。

结果

患者共接受144个周期的治疗,所有患者均可评估疗效和毒性。43例患者中,2例(4.65%)达到完全缓解(CR),25例(58.14%)达到部分缓解(PR),9例(20.93%)病情稳定(SD),7例(16.28%)病情进展(PD)。总缓解率为62.8%。中位疾病进展时间(TTP)为201天,中位生存时间(MST)为310天。Ⅲ/Ⅳ级不良事件主要包括中性粒细胞减少(20.93%)、发热性中性粒细胞减少(4.65%)、血小板减少(6.98%)和呕吐(9.30%)。1例患者死于Ⅳ级血小板减少。

结论

DNF方案对晚期食管癌患者有效且耐受性良好。

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