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奥沙利铂联合5-氟尿嘧啶和亚叶酸钙(OFF方案)用于吉西他滨预处理的晚期胰腺癌:一项II期研究。

Oxaliplatin plus 5-fluorouracil and folinic acid (OFF) in gemcitabine-pretreated advanced pancreatic cancer: a phase II study.

作者信息

El-Hadaad Hend Ahmed, Wahba Hanan Ahmed

机构信息

Department of Clinical Oncology and Nuclear Medicine, Faculty of Medicine, Mansoura University, Mansoura, Egypt.

出版信息

J Gastrointest Cancer. 2013 Sep;44(3):313-7. doi: 10.1007/s12029-013-9495-5.

DOI:10.1007/s12029-013-9495-5
PMID:23606201
Abstract

BACKGROUND

Despite median survival of less than 6 months, there is a significant proportion of advanced pancreatic cancer patients who progress on gemcitabine that remains fit, and these patients are candidates for second-line treatment.

OBJECTIVE

The objective of this study is to evaluate the efficacy and safety of oxaliplatin plus 5-fluorouracil and folinic acid in patients with gemcitabine-pretreated advanced pancreatic cancer.

PATIENTS AND METHODS

Thirty patients with advanced pancreatic cancer who were pretreated with gemcitabine received oxaliplatin (85 mg/m(2)) on days 1 and 15 followed by leucovorin (20 mg/m(2)) and 5-fluorouracil (500 mg/m(2)) on days 1, 8, and 15. The cycle was repeated every 3 weeks.

RESULTS

The majority of patients (80 %) had locally advanced disease. Median age was 63 years, and 60 % were males. The liver was the most common site of metastasis. Partial response was observed in 2 patients (6.7 %) and stable disease in 6 patients (20 %), while 12 patients progressed (40 %). Improved performance status was reported in 10 patients (33.3 %). The median duration of response was 13 weeks, and median overall survival was 22 weeks. There was no grade 4 toxicity apart from grade 4 neutropenia in 6.6 % of patients. Neutropenia (46.5 %) and neuropathy (43.2 %) were the most common toxicities, while hand-foot syndrome was the least frequent one (20 %). There were no treatment-related deaths. The 6-month survival rate was 30 %.

CONCLUSION

This regimen is feasible and active with an acceptable toxicity; however, further investigation in phase III trial is needed.

摘要

背景

尽管晚期胰腺癌患者的中位生存期不足6个月,但仍有相当一部分接受吉西他滨治疗后病情进展但身体状况尚佳的患者,这些患者是二线治疗的候选对象。

目的

本研究旨在评估奥沙利铂联合5-氟尿嘧啶和亚叶酸钙用于吉西他滨预处理的晚期胰腺癌患者的疗效和安全性。

患者和方法

30例接受过吉西他滨预处理的晚期胰腺癌患者在第1天和第15天接受奥沙利铂(85 mg/m²)治疗,随后在第1、8和15天接受亚叶酸钙(20 mg/m²)和5-氟尿嘧啶(500 mg/m²)治疗。每3周重复1个周期。

结果

大多数患者(80%)为局部晚期疾病。中位年龄为63岁,60%为男性。肝脏是最常见的转移部位。2例患者(6.7%)出现部分缓解,6例患者(20%)病情稳定,12例患者(40%)病情进展。10例患者(33.3%)的体能状态得到改善。中位缓解持续时间为13周,中位总生存期为22周。除6.6%的患者出现4级中性粒细胞减少外,无4级毒性反应。中性粒细胞减少(46.5%)和神经病变(43.2%)是最常见的毒性反应,而手足综合征最不常见(20%)。无治疗相关死亡。6个月生存率为30%。

结论

该方案可行且有效,毒性可接受;然而,需要进行III期试验进一步研究。

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