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一项关于5-氟尿嘧啶、阿霉素和顺铂联合治疗晚期上消化道腺癌的II期研究。

A phase II study of combined 5-fluorouracil, doxorubicin, and cisplatin in the treatment of advanced upper gastrointestinal adenocarcinomas.

作者信息

Moertel C G, Rubin J, O'Connell M J, Schutt A J, Wieand H S

出版信息

J Clin Oncol. 1986 Jul;4(7):1053-7. doi: 10.1200/JCO.1986.4.7.1053.

DOI:10.1200/JCO.1986.4.7.1053
PMID:3014083
Abstract

In a phase II study of 67 patients with upper gastrointestinal carcinomas and measurable disease without previous chemotherapy, we have evaluated the combination of intensive course 5-fluorouracil (5-FU) (300 mg/m2/d for five days) doxorubicin (40 mg/m2 on day 1), and cisplatin (60 mg/m2 on day 1). Courses were repeated every 5 weeks. Among 26 patients with gastric carcinoma, a 50% regression rate was obtained with a median survival for all patients of 9 months. Among 29 patients with pancreatic carcinoma, the regression rate was 21% and the median survival was 4 months. Regressions were also observed in smaller numbers of patients with carcinomas of the gallbladder and ampulla of Vater, as well as in cholangiocellular carcinoma of the liver. Toxic reactions were usually clinically tolerable and consisted primarily of nausea, vomiting, stomatitis, diarrhea, leukopenia, and alopecia. Phase III studies are in progress to place the value of this experimental regimen into clinical perspective.

摘要

在一项针对67例未曾接受过化疗且患有可测量病灶的上消化道癌患者的II期研究中,我们评估了强化疗程的5-氟尿嘧啶(5-FU)(300 mg/m²/天,共5天)、阿霉素(第1天40 mg/m²)和顺铂(第1天60 mg/m²)联合用药的效果。疗程每5周重复一次。在26例胃癌患者中,所有患者的中位生存期为9个月,缓解率为50%。在29例胰腺癌患者中,缓解率为21%,中位生存期为4个月。在少数胆囊癌、 Vater壶腹癌以及肝内胆管细胞癌患者中也观察到了缓解情况。毒性反应通常在临床上可以耐受,主要包括恶心、呕吐、口腔炎、腹泻、白细胞减少和脱发。III期研究正在进行,以从临床角度评估这一实验方案的价值。

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