Cascinu S, Fedeli A, Catalano G
Servizio di Oncologia, Ospedali Riuniti, Pesaro, Italy.
Cancer Chemother Pharmacol. 1994;34(1):72-4. doi: 10.1007/BF00686115.
A total of 23 advanced gastric cancer patients older than 65 years received 500 mg/m2 5-fluorouracil i.v. on days 2-4, 120 mg/m2 vepesid i.v. on days 2-4, 150 mg/m2 6S-leucovorin on days 2-4, and 5 MU/m2 interferon alpha-2b on days 1-5, with cycles being repeated every 3 weeks. Toxicity was severe at an interferon (IFN) dose of 5 MU/m2; only one patient tolerated this dose. In 18 patients an IFN dose of 3 MU/m2 and in 3 other patients a dose of 4 MU/m2 could be given without producing toxicity. At an IFN dose of 5 MU/m2 the most common toxicities encountered were stomatitis (grade 4 in 1 patient and grade 3 in 12 patients), leukopenia (grade 4 in 1 patient and grade 3 in 5 patients), and thrombocytopenia (grade 3 in 3 patients). Two patients achieved a complete response and eight showed a partial response, resulting in an overall response rate of 45% [95% confidence interval (CI), 25%-64%]. The median survival was 7 months for all patients and 9 months for responding patients. In conclusion, without substantially increasing the toxicity, IFN can be added to the etoposide/leucovorin/5-fluorouracil combination, at a dose of 3 MU/m2. To verify the possible enhancement by IFN of the activity of this combination, a randomized trial is under way.
共有23例65岁以上的晚期胃癌患者，在第2 - 4天接受500mg/m²的静脉注射5-氟尿嘧啶，在第2 - 4天接受120mg/m²的静脉注射依托泊苷，在第2 - 4天接受150mg/m²的6S-亚叶酸，在第1 - 5天接受5MU/m²的α-2b干扰素，每3周重复一个周期。干扰素（IFN）剂量为5MU/m²时毒性严重；只有1例患者能耐受该剂量。18例患者可给予3MU/m²的IFN剂量，另外3例患者可给予4MU/m²的剂量而不产生毒性。IFN剂量为5MU/m²时，最常见的毒性反应为口腔炎（1例4级，12例3级）、白细胞减少（1例4级，5例3级）和血小板减少（3例3级）。2例患者达到完全缓解，8例患者部分缓解，总缓解率为45%[95%置信区间（CI），25% - 64%]。所有患者的中位生存期为7个月，缓解患者的中位生存期为9个月。总之，在不显著增加毒性的情况下，可将剂量为3MU/m²的IFN添加到依托泊苷/亚叶酸/5-氟尿嘧啶联合方案中。为验证IFN是否可能增强该联合方案的活性，一项随机试验正在进行。
