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序贯大剂量甲氨蝶呤(MTX)和5-氟尿嘧啶(F)与表柔比星(E)和顺铂(P)交替使用的II期研究[FEMTX-P]在晚期胃癌中的应用

Phase II study of sequential high-dose methotrexate (MTX) and 5-fluorouracil (F) alternated with epirubicin (E) and cisplatin (P) [FEMTX-P] in advanced gastric cancer.

作者信息

Roelofs E J, Wagener D J, Conroy T, Wils J, Burghouts J T, Fickers M, de Graeff A, Lalisang F, Paillot B

机构信息

University Hospital St. Radboud, Nijmegen, The Netherlands.

出版信息

Ann Oncol. 1993 May;4(5):426-8. doi: 10.1093/oxfordjournals.annonc.a058526.

DOI:10.1093/oxfordjournals.annonc.a058526
PMID:8353077
Abstract

BACKGROUND

FAMTX (5-fluorouracil, adriamycin, methotrexate) is one of the most effective drug combinations in gastric cancer. Therefore, modifications of FAMTX appear of interest and the FEMTX-P regiment was conceived.

PATIENTS AND METHODS

Fifty patients with unresectable locally advanced and/or metastatic gastric carcinoma were treated with methotrexate 1500 mg/m2 i.v. and 5-fluorouracil 1500 mg/m2 i.v. on day 1; leucovorin rescue 15 mg/m2 orally every 6 hours for 8 doses on days 2 and 3; epirubicin 60 mg/m2 i.v. and cisplatin 50 mg/m2 i.v. on day 15, q 4 weeks.

RESULTS

Of forty-seven patients evaluable for response, five (11%) achieved complete responses and seventeen (36%) partial responses (total response rate 47%). The median duration of response was 8+ months (range: 5-25+ months). Four of 14 patients with locally advanced disease were successfully downstaged and subsequently resected. The median duration of survival of all patients was 10 months (range: 1-25+ months). Leukopenia grade 4 occurred in 18% of patients and thrombocytopenia grade 4 and mucositis grade 4 in 4% and 2%, respectively. Treatment postponement for hematologic toxicity was necessary in 54% of patients.

CONCLUSIONS

The FEMTX-P regimen is an active regimen in advanced gastric carcinoma, with acceptable toxicity.

摘要

背景

FAMTX(5-氟尿嘧啶、阿霉素、甲氨蝶呤)是胃癌治疗中最有效的联合用药方案之一。因此,对FAMTX方案进行改良显得很有意义,于是设计了FEMTX-P方案。

患者与方法

50例无法切除的局部晚期和/或转移性胃癌患者接受如下治疗:第1天静脉注射甲氨蝶呤1500mg/m²和5-氟尿嘧啶1500mg/m²;第2天和第3天,每6小时口服亚叶酸钙解救剂15mg/m²,共8剂;第15天静脉注射表柔比星60mg/m²和顺铂50mg/m²,每4周重复一次。

结果

47例可评估疗效的患者中,5例(11%)达到完全缓解,17例(36%)达到部分缓解(总缓解率47%)。缓解持续时间的中位数为8+个月(范围:5 - 25+个月)。14例局部晚期疾病患者中有4例成功降期并随后接受了手术切除。所有患者的生存时间中位数为10个月(范围:1 - 25+个月)。18%的患者发生4级白细胞减少,4%的患者发生4级血小板减少,2%的患者发生4级黏膜炎。54%的患者因血液学毒性需要推迟治疗。

结论

FEMTX-P方案是晚期胃癌的一种有效方案,毒性可接受。

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引用本文的文献

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