Queisser W, Schnitzler G, Schaefer J, Arnold H, Drings P, Fritze D, Geldmacher J, Hartwich G, Herrmann R, Kempf P, König H, Meiser R J, Nedden R, von Oldershausen H F, Pappas A, Sievers H, Wahrendorf J, Westerhausen M, Witte S
Recent Results Cancer Res. 1981;79:82-92. doi: 10.1007/978-3-642-81681-9_9.
The aim of the study was to compare the combination 5-FU-carmustine with ftorafur-carmustine in the treatment of advanced gastrointestinal cancer. To this end, a prospective, multicenter, randomized trial was initiated. Part I of this trial showed that similar response rates can be obtained with 5-FU-carmustine and ftorafur-carmustine in 109 patients (32.7% versus 26.3%). However, median survival was better in patients treated with 5-FU-carmustine (307 days versus 163 days). Part II of the trial revealed that neither a higher dosage of ftorafur (2 g/m2/day X 5 days) nor the addition of vincristine to both regimens changed the previously obtained results significantly. Again, median survival was found to be better in patients treated with 5-FU combination chemotherapy (304 days versus 144 days). Both the 5-FU and the ftorafur combination were tolerated reasonably well. The results suggest that combination chemotherapy including 5-FU is superior to ftorafur at the applied dosages in terms of survival.
本研究的目的是比较5-氟尿嘧啶-卡莫司汀联合用药与替加氟-卡莫司汀联合用药在晚期胃肠道癌治疗中的效果。为此,开展了一项前瞻性、多中心、随机试验。该试验的第一部分显示,109例患者使用5-氟尿嘧啶-卡莫司汀和替加氟-卡莫司汀可获得相似的缓解率(分别为32.7%和26.3%)。然而,接受5-氟尿嘧啶-卡莫司汀治疗的患者中位生存期更长(307天对163天)。试验的第二部分表明,较高剂量的替加氟(2 g/m²/天×5天)或在两种治疗方案中添加长春新碱均未显著改变先前获得的结果。同样,接受5-氟尿嘧啶联合化疗的患者中位生存期更长(304天对144天)。5-氟尿嘧啶和替加氟联合用药的耐受性均较好。结果表明,在所应用的剂量下,含5-氟尿嘧啶的联合化疗在生存期方面优于替加氟。