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多西他赛和顺铂化疗在氟尿嘧啶/顺铂预处理食管癌中的 II 期研究。

Phase II study of docetaxel and cisplatin chemotherapy in 5-fluorouracil/cisplatin pretreated esophageal cancer.

机构信息

Department of Internal medicine, Center for Biomedical Human Resources, Chonnam National University Medical School, Gwangju, Korea.

出版信息

Am J Clin Oncol. 2010 Dec;33(6):624-8. doi: 10.1097/COC.0b013e3181bead92.

DOI:10.1097/COC.0b013e3181bead92
PMID:20142726
Abstract

BACKGROUND

This study was performed to determine the feasibility and safety of salvage chemotherapy, using docetaxel and cisplatin in 5-fluorouracil (5-FU) and cisplatin-pretreated esophageal cancer.

METHODS

Patients with metastatic or recurrent esophageal squamous cell carcinoma that had previously been treated with 5-FU and cisplatin chemotherapy or chemoradiotherapy were eligible for this study. Docetaxel (70 mg/m²) and cisplatin (75 mg/m²) were given as a 1-hour intravenous infusion on day 1, and the treatment was repeated every 3 weeks.

RESULTS

Thirty-eight male patients were enrolled, and 35 patients were available for evaluation. The median age was 64.5 years; Eastern Cooperative Oncology Group performance status was 0/1/2 = 2/18/18. The median and total numbers of cycles delivered were 3.5 (range, 1-9 cycles) and 162, respectively. One patient (2.6%) achieved complete response, 12 (31.6%) achieved partial response, 12 (31.6%) had stable disease, and 10 (26.3%) had progressive disease. The overall response rate was 34.2% (95% confidence interval, 19.6-51.3). The median progression-free survival and overall survival times were 4.5 ± 1.3 months (95% CI, 4.1-4.9) and 7.4 ± 0.4 months (95% CI, 7.3-7.5), respectively. The main hematological toxicities greater than grade 3 were neutropenia and leucopenia in 20 (52.6%) and 18 patients (47.3%), respectively. Nonhematological toxicities greater than grade 3 included asthenia in 12 patients (31.6%), nausea in 7 patients (18.4%), and peripheral neuropathy in 6 patients (15.8%).

CONCLUSIONS

Chemotherapy with docetaxel and cisplatin was an effective and feasible treatment following treatment with 5-FU and cisplatin, and would be considered as a salvage option for patients with refractory esophageal cancer.

摘要

背景

本研究旨在确定多西他赛和顺铂在氟尿嘧啶(5-FU)和顺铂预处理的食管癌患者中的挽救化疗的可行性和安全性。

方法

符合条件的患者为转移性或复发性食管鳞状细胞癌,既往接受过 5-FU 和顺铂化疗或放化疗。多西他赛(70mg/m²)和顺铂(75mg/m²)静脉输注 1 小时,每 3 周重复一次。

结果

38 名男性患者入组,35 名患者可进行评估。中位年龄为 64.5 岁;东部肿瘤协作组表现状态为 0/1/2=2/18/18。中位和总周期数分别为 3.5(范围为 1-9 周期)和 162。1 例(2.6%)患者完全缓解,12 例(31.6%)患者部分缓解,12 例(31.6%)患者病情稳定,10 例(26.3%)患者疾病进展。总缓解率为 34.2%(95%置信区间,19.6-51.3)。中位无进展生存期和总生存期分别为 4.5±1.3 个月(95%CI,4.1-4.9)和 7.4±0.4 个月(95%CI,7.3-7.5)。大于 3 级的主要血液学毒性是中性粒细胞减少症和白细胞减少症,分别有 20 例(52.6%)和 18 例(47.3%)患者。大于 3 级的非血液学毒性包括乏力 12 例(31.6%)、恶心 7 例(18.4%)和周围神经病变 6 例(15.8%)。

结论

氟尿嘧啶和顺铂治疗后,多西他赛和顺铂化疗是一种有效且可行的治疗方法,可作为难治性食管癌患者的挽救治疗选择。

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