吉西他滨每两周一次给药，随后给予奥沙利铂以及简化的48小时氟尿嘧啶/亚叶酸钙静脉滴注方案用于晚期胰腺癌的I期研究。

Phase I study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of fluorouracil/leucovorin for advanced pancreatic cancer.

作者信息

Ch'ang Hui-Ju, Wang Chuan-Cheng, Cheng Ann-Lii, Hsu Chiun, Lu Yen-Shen, Chang Ming-Chu, Lin Jaw-Town, Wang Hsiu-Po, Shiah Her-Shyong, Liu Tsang-Wu, Chang Jang-Yang, Whang-Peng Jacqueline, Chen Li-Tzong

机构信息

Division of Cancer Research, National Health Research Institutes, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.

出版信息

J Gastroenterol Hepatol. 2006 May;21(5):874-9. doi: 10.1111/j.1440-1746.2005.04022.x.

DOI:10.1111/j.1440-1746.2005.04022.x

PMID:16704539

Abstract

OBJECTIVES

To evaluate the feasibility and maximal tolerated dose (MTD) of oxaliplatin of a triplet regimen consisting of gemcitabine, oxaliplatin and infusional fluorouracil (5-FU)/leucovorin (LV) (GOFL) for advanced pancreatic cancer.

PATIENTS AND METHODS

Patients with histologically proven metastatic or unresectable, locally advanced pancreatic adenocarcinoma were eligible to take part in the study. The treatment consisted of fixed-rate infusion (10 mg/m2/minute) of 800 mg/m2 gemcitabine followed by 2-h infusion of oxaliplatin and then 48-h infusion of 5-FU/LV day 1 and day 15 every 4 weeks. The oxaliplatin would be evaluated at three dose levels, 65, 75 and 85 mg/m2.

RESULTS

A total of 15 patients were enrolled at three dose levels. Dose-limiting toxicity of neutropenic fever and grade 4 thrombocytopenia occurred in one of each six patients at oxaliplatin dose level of 65 mg/m2 and 85 mg/m2, respectively. The MTD of oxaliplatin for this combination was 85 mg/m2. After a median four cycles of treatment, grade 3/4 neutropenia occurred in 46.7% of patients and thrombocytopenia in 13.3%. Non-hematological toxicities were generally of grade 1/2. Objective tumor response was observed in five patients (33.3%, 95% confidence interval, 6.3-60.4%).

CONCLUSION

Biweekly GOFL is a feasible regimen for advanced pancreatic cancer. For further phase II studies, the recommended dose of oxaliplatin is 85 mg/m2.

摘要

目的

评估吉西他滨、奥沙利铂与持续静脉输注氟尿嘧啶（5-FU）/亚叶酸钙（LV）组成的三联方案（GOFL）治疗晚期胰腺癌时奥沙利铂的可行性及最大耐受剂量（MTD）。

患者与方法

经组织学证实为转移性或不可切除的局部晚期胰腺腺癌患者 eligible to take part in the study（符合参与本研究的条件）。治疗方案为以10mg/m²/分钟的固定速率输注800mg/m²吉西他滨，随后输注2小时奥沙利铂，然后在第1天和第15天每4周进行48小时的5-FU/LV输注。奥沙利铂将在三个剂量水平，即65、75和85mg/m²进行评估。

结果

共有15名患者在三个剂量水平入组。在奥沙利铂剂量水平为65mg/m²和85mg/m²时，每六名患者中分别有一名出现中性粒细胞减少性发热和4级血小板减少的剂量限制性毒性。该联合方案中奥沙利铂的MTD为85mg/m²。经过中位四个周期的治疗后，46.7%的患者出现3/4级中性粒细胞减少，13.3%的患者出现血小板减少。非血液学毒性一般为1/2级。五名患者（33.3%，95%置信区间，6.3 - 60.4%）观察到客观肿瘤反应。