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一项针对既往接受过治疗的转移性结直肠癌患者,使用改良的德格拉蒙方案(含5-氟尿嘧啶、亚叶酸钙和奥沙利铂)的II期研究。

A phase II study of modified deGramont 5-fluorouracil, leucovorin, and oxaliplatin in previously treated patients with metastatic colorectal cancer.

作者信息

Ryan David P, Clark Jeffrey W, Kulke Matthew H, Fuchs Charles S, Earle Craig C, Enzinger Peter C, Stuart Keith, Catarius Keith J, Winkelmann Jennifer, Mayer Robert J

机构信息

Dana-Farber/Partners Cancer Care Gastrointestinal Cancer Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, Boston, Massachusetts, USA.

出版信息

Cancer Invest. 2003;21(4):505-11. doi: 10.1081/cnv-120022359.

DOI:10.1081/cnv-120022359
PMID:14533439
Abstract

PURPOSE

To evaluate the toxicity and efficacy of a modified deGramont regimen of 5-fluorouracil (5-FU), leucovorin, and oxaliplatin in patients with advanced colorectal cancer who have progressed on at least one but not more than two prior chemotherapy regimens.

PATIENTS AND METHODS

Patients with stage 4 colorectal cancer were treated with oxaliplatin 85 mg/m2 by a 2-hour intravenous infusion, followed by leucovorin 500 mg/m2 by a 2-hour intravenous infusion, followed by 5-FU 400 mg/m2 by bolus injection, followed by 5-FU 2.4 g/m2 administered by a 46-hour continuous infusion. Cycles were administered every 2 weeks.

RESULTS

Seventy patients were treated and 68 patients had previously received irinotecan. Eleven percent of patients had a partial response, 33% of CEA-evaluable patients had a > or = 50% drop in their CEA level. The median time to progression was 6.2 months, and the median overall survival was 8.7 months. Toxicity was mild to moderate, as 14% of patients experienced grade 3 or 4 neutropenia and 3% of patients experienced grade 3 neuropathy.

CONCLUSION

The modified deGramont regimen of 5-FU, leucovorin, and oxaliplatin is tolerable and is associated with a modest degree of antitumor activity in patients who have progressed on both 5-FU and irinotecan.

摘要

目的

评估改良的德格拉蒙方案(5-氟尿嘧啶、亚叶酸钙和奥沙利铂)对至少接受过一种但不超过两种既往化疗方案后病情进展的晚期结直肠癌患者的毒性和疗效。

患者与方法

4期结直肠癌患者接受奥沙利铂85mg/m²静脉输注2小时,随后亚叶酸钙500mg/m²静脉输注2小时,接着5-氟尿嘧啶400mg/m²静脉推注,随后5-氟尿嘧啶2.4g/m²持续输注46小时。每2周进行一个周期的治疗。

结果

70例患者接受了治疗,68例患者先前接受过伊立替康治疗。11%的患者出现部分缓解,33%可评估癌胚抗原(CEA)的患者CEA水平下降≥50%。中位疾病进展时间为6.2个月,中位总生存期为8.7个月。毒性为轻至中度,14%的患者出现3或4级中性粒细胞减少,3%的患者出现3级神经病变。

结论

5-氟尿嘧啶、亚叶酸钙和奥沙利铂的改良德格拉蒙方案耐受性良好,对于5-氟尿嘧啶和伊立替康治疗后病情进展的患者具有一定程度的抗肿瘤活性。

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