Loehrer P J, Turner S, Kubilis P, Hui S, Correa J, Ansari R, Stephens D, Woodburn R, Meyer S
Hoosier Oncology Group, Walther Medical Research Institute, Indianapolis, IN 46208.
J Clin Oncol. 1988 Apr;6(4):642-8. doi: 10.1200/JCO.1988.6.4.642.
From May 1984 through December 1986, 141 patients with metastatic adenocarcinoma of the colon or rectum were entered on this Hoosier Oncology Group (HOG) trial evaluating the role of cisplatin in systemic therapy. Patients were stratified by the presence or absence of hepatic metastases and by performance status, and were subsequently randomized to receive fluorouracil (5-FU) (15 mg/kg/wk) alone or the same dose of 5-FU plus cisplatin (60 mg/m2 every 3 weeks). The total duration of treatment was six cycles (18 weeks). In 132 fully evaluable patients the objective response rates were 19% for 5-FU and 22% for 5-FU plus cisplatin. Statistically, the median survival times of 40 and 39 weeks were not significantly different (P = .62). However, the median duration of remission (MDR) was superior (P = .05) for 5-FU alone. This study fails to confirm clinically significant synergy of 5-FU plus cisplatin in the treatment of metastatic colorectal cancer.
从1984年5月至1986年12月，141例结肠或直肠癌转移性腺癌患者参与了印第安纳肿瘤协作组（HOG）的这项试验，该试验旨在评估顺铂在全身治疗中的作用。患者按有无肝转移及体能状态进行分层，随后随机分为两组，分别接受单纯氟尿嘧啶（5-FU）（15mg/kg/周）或相同剂量的5-FU加顺铂（每3周60mg/m²）。治疗总疗程为6个周期（18周）。在132例可全面评估的患者中，5-FU组的客观缓解率为19%，5-FU加顺铂组为22%。从统计学角度看，两组的中位生存时间分别为40周和39周，差异无统计学意义（P = 0.62）。然而，单纯5-FU组的中位缓解持续时间（MDR）更优（P = 0.05）。本研究未能证实5-FU加顺铂在治疗转移性结直肠癌方面具有临床上显著的协同作用。
