注射用脱氧氟尿苷与5-氟尿嘧啶对照治疗恶性肿瘤121例

Evaluation of efficacy for 5'-deoxy-5-fluorouridine injection vs.5-fluorouridine in treatment of advanced cancers

目的:验证和比较注射用脱氧氟尿苷(5’-DFUR)和5-氟尿嘧啶(5-FU)抗肿瘤疗效和安全性。方法:121例晚期恶性肿瘤患者进行5’-DFUR单药(n=22)或联合化疗(n=99),后者随机分为治疗组(n=54)和5-FU对照组(n=45)。5’-DFUR用法为3000mg·m^(-2),静脉滴注,d1～d5;5-FU用法为750mg·m^(-2),静脉滴注,d1～d5;单药和联合化疗组均给药21～28d为1个周期,2个周期为1个疗程。结果:可评价疗效119例患者,单药组有效率13.6%(3/22),各病种之间差异无显著性。联合化疗中,对照组有效率为11.6%(5/43),治疗组有效率为20.4%(11/54),两组之间差异无显著性,既往治疗与否与疗效无明显相关性。单药组主要不良反应为白细胞下降、恶心呕吐、乏力、腹泻、口腔溃疡等。联合化疗组的不良反应主要为骨髓抑制、恶心呕吐、乏力、神经毒性及口腔黏膜损伤等,治疗组和对照组差异无显著性。结论:5’-DFUR单药和联合其他药物对乳腺癌、胃肠道肿瘤均有一定疗效,但与5-FU对照组之间差异无显著性。

Objective: To evaluate the efficacy and safety of 5'-deoxy-5-fluorouridine (5'-DFUR) injection versus 5-fluorouridine (5-FU) for the treatment of patients with advanced malignant carcinoma. Methods: One hundred twenty-one patients with advance metaslignancy were randomized to i. v. infuse either 5'-DFUR alone (arm A, n=22) or combination of 5'-DFUR with triple regimens (arm B, n=54), or combination of 5-FU with the same regimens(arm C, n=45) every 21～28 days for 2 cycles. 5'-DFUR was given at 3000mg·m^(-2)(d1～5), and 5-FU at 750mg·m^(-2)(d1～5). Results: Response rate after treatment was 13.6% (3/22) in arm A, 20.4% (11/54) in arm B and 11.6% (5/43) in arm C. The common adverse events in arm A were neutropenia, nausea, vomiting, fatigue, diarrhea and stomatocace and in arm B and C were arrest of bone morrow, nausea, vomiting, fatigue, nervous toxicity and oral mucositis. No difference in response rate and adverse events rate was observed between arm B and C (P>0.05). Conclusion: 5'-DFUR monotherapy or combination therapy is as effective as 5-FU in the treatment of advanced breast, stomach and colon cancer.