Choi J S, Lee K H, Ahn M J, Lee J S, Lee J H, Zang D Y, Suh C W, Kim S W, Kim W G, Kim J C, Kim S K, Park K C, Lee M S, Kim S H
Section of Hematology-Oncology, College of Medicine, University of Ulsan, Seoul, Korea.
Korean J Intern Med. 1997 Jun;12(2):155-62. doi: 10.3904/kjim.1997.12.2.155.
To determine the effectiveness and toxicity when levamisole was added to the adjuvant combination chemotherapy in patients with operable gastric cancer.
After en bloc resection of gastric cancer without gross or microscopic evidence of residual disease from April 1991 to December 1992, 100 patients were randomized to 6 months of 5-fluorouracil 1,000 mg/m2/day administered as continuous infusion for 5 days, cisplatin 60 mg/m2/day as intravenous infusion for 1 day with or without levamisole (50 mg every eight hours P.O for a period of three days every 2 weeks for 6 months). This chemotherapy treatment was begun within 2 to 4 weeks after the surgery. The chemotherapy consisted of discrete 5-day courses administered at 4-weeks intervals. All 100 patients are assessable.
The fifty patients were assigned to each treatment group. There was no statistical difference and no bias in the distribution of characteristics of the 100 evaluable patients between the two groups. A total of 274 courses of treatment were given in the levamisole group and 260 courses of treatment in non-levamisole group. Eleven patients in each group did not finish planned 6 courses of treatment mainly due to non-compliance. At median follow up of 39 months, 32 patients relapsed 19 in the levamisole group and 13 in the non-levamisole group (p = 0.284). Twenty five patients died of relapsed diseases, 15 in the levamisole group and 10 in the non-levamisole group. The levamisole group tended to show more risk of overall death rate and recurrence than the non-levamisole group. However, this result was not statistically significant at 3 years. The treatment was well tolerated in both treatment groups. The grade 2-3 toxicities were nausea/ vomiting (levamisole, non-levamisole group; 31.7%, 29.3% of treatment courses respectively), diarrhea (7.6%, 8.4%), mucositis (11.6%, 12.3%), and leukopenia (9.8%, 9.6%).
Levamisole had negative effects on disease-free survival and overall survival when added to adjuvant combination chemotherapy of cisplatin and 5-fluorouracil in patients with operable gastric cancer. Both treatment arms were generally well tolerated and the toxicity profile was similar with or without levamisole.
确定左旋咪唑添加到可手术胃癌患者辅助联合化疗中的有效性和毒性。
1991年4月至1992年12月，对100例胃癌整块切除且无肉眼或显微镜下残留疾病证据的患者进行随机分组，一组接受6个月的5-氟尿嘧啶（1000mg/m²/天，持续静脉输注5天）和顺铂（60mg/m²/天，静脉输注1天）联合治疗，另一组在此基础上加用左旋咪唑（每8小时口服50mg，每2周服用3天，共6个月）。化疗在术后2至4周内开始。化疗由每4周间隔进行的5天离散疗程组成。所有100例患者均可评估。
每组分配50例患者。两组100例可评估患者的特征分布无统计学差异且无偏倚。左旋咪唑组共进行了274个疗程的治疗，非左旋咪唑组进行了260个疗程的治疗。每组各有11例患者未完成计划的6个疗程治疗，主要原因是未遵医嘱。中位随访39个月时，32例患者复发，左旋咪唑组19例，非左旋咪唑组13例（p = 0.284）。25例患者死于复发疾病，左旋咪唑组15例，非左旋咪唑组10例。左旋咪唑组总体死亡率和复发风险倾向于高于非左旋咪唑组。然而，3年时该结果无统计学意义。两个治疗组对治疗的耐受性均良好。2-3级毒性反应包括恶心/呕吐（左旋咪唑组、非左旋咪唑组分别为治疗疗程的31.7%、29.3%）、腹泻（7.6%、8.4%）、粘膜炎（11.6%、12.3%）和白细胞减少（9.8%、9.6%）。
在可手术胃癌患者的顺铂和5-氟尿嘧啶辅助联合化疗中添加左旋咪唑对无病生存期和总生存期有负面影响。两个治疗组总体耐受性良好，有无左旋咪唑时毒性特征相似。
