Nakazato H, Koike A, Saji S, Ogawa N, Sakamoto J
Yokoyama Gastrointestinal Hospital, Japan.
Lancet. 1994 May 7;343(8906):1122-6. doi: 10.1016/s0140-6736(94)90233-x.
In Japan the standard adjuvant treatment after resection of gastric cancer is intravenous mitomycin plus oral fluorouracil. We have assessed the efficacy of protein-bound polysaccharide (PSK) in addition to standard chemotherapy in patients who had undergone curative gastrectomy at 46 institutions in central Japan. 262 patients were randomly assigned standard treatment alone or with PSK. The minimum follow-up time was 5 years (range 5-7 years). PSK improved both the 5-year disease-free rate (70.7 vs 59.4% in standard treatment group, p = 0.047) and 5-year survival (73.0 vs 60.0%, p = 0.044). The two regimens had only slight toxic effects, consisting of nausea, leucopenia, and liver function impairment, and there were no significant differences between the groups. The treatments were clinically well tolerated and compliance was good. Addition of PSK to adjuvant chemotherapy with mitomycin and fluorouracil is beneficial as treatment after curative gastrectomy.
在日本，胃癌切除术后的标准辅助治疗是静脉注射丝裂霉素加口服氟尿嘧啶。我们评估了在日本中部46家机构中，接受根治性胃切除的患者在标准化疗基础上加用蛋白结合多糖（PSK）的疗效。262例患者被随机分配接受单纯标准治疗或联合PSK治疗。最短随访时间为5年（范围5 - 7年）。PSK提高了5年无病生存率（标准治疗组为59.4%，联合PSK组为70.7%，p = 0.047）和5年生存率（标准治疗组为60.0%，联合PSK组为73.0%，p = 0.044）。两种治疗方案仅有轻微的毒性作用，包括恶心、白细胞减少和肝功能损害，两组之间无显著差异。治疗在临床上耐受性良好，依从性也较好。在丝裂霉素和氟尿嘧啶辅助化疗中加用PSK作为根治性胃切除术后的治疗是有益的。
