Queisser W, Schaefer J, Arnold H, Drings P, Geldmacher J, Hartwich G, Kredel L, Mayer M, Neidhardt B, von Oldershausen H F, Rösch W, Wahrendorf J
Dtsch Med Wochenschr. 1979 Aug 31;104(35):1231. doi: 10.1055/s-0028-1129076.
In a prospective, multi-centre, randomized study of 109 patients with metastatic gastro-intestinal adenocarcinomas the response rate, survival time and side-effects of two drug combinations, carmustin +5-fluorouracil and carmustin + ftorafur, were compared (same carmustin dosage in both groups). Response to the treatment was 32.7% in those receiving carmustin +5-fluorouracil, 26.3% in those on carmustin + ftorafur. This difference occurred among the 42 patients with gastric adenocarcinoma (33.3% compared with 25%), as well as in 11 with pancreatic adenocarcinoma, and in 56 with colorectal adenocarcinoma (32.1% and 28.6%). Median survival time for 5-fluorouracil + carmustin was 330 days, double that for ftorafur + carmustin (163 days). Bone-marrow toxicity (leukopenia, thrombopenia) was below 10% for both drug combinations. Alopecia occurred in only a few patients. Gastro-intestinal toxicity was common (20% and 18.5%, respectively), but there was no difference between the two groups. The somewhat lower effectiveness of ftorafur compared with 5-fluorouracil was probably due to the deliberately smaller dosage of the former.
在一项针对109例转移性胃肠道腺癌患者的前瞻性、多中心、随机研究中，比较了两种药物组合（卡莫司汀+5-氟尿嘧啶和卡莫司汀+替加氟，两组卡莫司汀剂量相同）的缓解率、生存时间和副作用。接受卡莫司汀+5-氟尿嘧啶治疗的患者缓解率为32.7%，接受卡莫司汀+替加氟治疗的患者缓解率为26.3%。这种差异在42例胃腺癌患者中出现（分别为33.3%和25%），在11例胰腺腺癌患者以及56例结肠直肠癌患者中也出现（分别为32.1%和28.6%）。5-氟尿嘧啶+卡莫司汀组的中位生存时间为330天，是替加氟+卡莫司汀组（163天）的两倍。两种药物组合的骨髓毒性（白细胞减少、血小板减少）均低于10%。脱发仅发生在少数患者中。胃肠道毒性很常见（分别为20%和18.5%），但两组之间没有差异。替加氟的疗效略低于5-氟尿嘧啶，可能是因为前者的剂量有意较小。
