Graf W, Westlin J E, Påhlman L, Glimelius B
Department of Surgery, Akademiska Sjukhuset, Uppsala, Sweden.
Int J Colorectal Dis. 1994 Apr;9(1):35-9. doi: 10.1007/BF00304298.
Fifty patients were randomized to receive adjuvant intraperitoneal 5-fluorouracil (5-FU, 500 mg/m2/day) and intravenous leucovorin (60 mg/m2/day) and 51 to receive placebo after curative surgery for colorectal cancer. Treatment started on the day after surgery and continued for 6 days. One case of stomatitis, one of leucopenia and one case of abnormal liver function tests were the only chemotherapy-related toxic effects. From the second day of treatment, pain during intraperitoneal infusions occurred more frequently in the 5-FU group, although statistical significance was only attained on day 2 (P < 0.05). The groups did not differ substantially regarding any other adverse effects, the incidence of surgical complications, second laparotomies, time from surgery to discharge, or premature treatment terminations. The postoperative course after intraperitoneal 5-FU and intravenous leucovorin was thus not more complicated than that in patients treated with placebo. The tolerance was acceptable and chemotherapy-related toxicity was rare. Thus important prerequisites exist for more widespread use of the present regimen in order to evaluate its impact on survival.
50例患者在接受结直肠癌根治性手术后被随机分配接受腹腔内注射氟尿嘧啶（5-FU，500mg/m²/天）和静脉注射亚叶酸钙（60mg/m²/天），51例患者接受安慰剂。治疗在术后第一天开始，持续6天。1例口腔炎、1例白细胞减少和1例肝功能检查异常是仅有的与化疗相关的毒性反应。从治疗第二天起，5-FU组腹腔内输注期间疼痛发生更频繁，尽管仅在第2天达到统计学显著性（P<0.05）。两组在任何其他不良反应、手术并发症发生率、二次剖腹手术、从手术到出院的时间或治疗提前终止方面无显著差异。因此，腹腔内注射5-FU和静脉注射亚叶酸钙后的术后过程并不比接受安慰剂治疗的患者更复杂。耐受性可接受，与化疗相关的毒性罕见。因此，为了评估其对生存的影响，广泛使用本方案存在重要前提条件。
