Fujii M, Tokumaru Y, Imanishi Y, Kanke M, Kanzaki J, Ohno Y
Dept. of Otolaryngology, Keio University School of Medicine.
Gan To Kagaku Ryoho. 1998 Jan;25(1):53-8.
Nedaplatin (CDGP), which is a CDDP analog, is an effective anticancer agent for head and neck cancer. The first-line chemotherapy for head and neck cancer is reported to be the combination of CDDP and 5-FU. We undertook a clinical trial for combination CDGP and 5-FU to determine whether this chemotherapy has the potential effect of combination with CDDP and 5-FU. First of all, we tried to determine the maximum dose and recommended dose of CDGP in the combination with CDGP and 5-FU by the dose finding regulation method used in combination phase I study. We determined the maximum dose of CDGP as 120 mg/m2, and the recommended dose as 100 mg/m2 with CDGP and 5-FU, 700 mg/m2/day for 5 days. Thirteen cases were treated with CDGP and 5-FU by the recommended dose. Three cases showed CR, and seven cases showed PR. The response rate was 76.9%. Two cases showed hematological toxicity, one grade 3 platelet decreasing and the other grade 3 leucopenia. Two cases showed renal toxicity less than grade 2. Nausea and vomiting were mild. The combination with CDGP and 5-FU seemed to have a strong effect and low toxicity. Further study will be needed to determine the efficacy against head and neck cancer.
奈达铂(CDGP)是顺铂类似物,是一种有效的头颈癌抗癌药物。据报道,头颈癌的一线化疗方案是顺铂与5-氟尿嘧啶联合使用。我们开展了一项关于CDGP与5-氟尿嘧啶联合使用的临床试验,以确定这种化疗方案是否具有与顺铂和5-氟尿嘧啶联合使用的潜在效果。首先,我们通过I期联合研究中使用的剂量探索调节方法,试图确定CDGP与5-氟尿嘧啶联合使用时的最大剂量和推荐剂量。我们确定CDGP的最大剂量为120mg/m²,推荐剂量为100mg/m²,与5-氟尿嘧啶联合使用,5-氟尿嘧啶剂量为700mg/m²/天,连用5天。13例患者按推荐剂量接受CDGP与5-氟尿嘧啶联合治疗。3例患者达到完全缓解(CR),7例患者达到部分缓解(PR)。缓解率为76.9%。2例患者出现血液学毒性,1例为3级血小板减少,另1例为3级白细胞减少。2例患者出现低于2级的肾毒性。恶心和呕吐症状较轻。CDGP与5-氟尿嘧啶联合使用似乎具有强效且低毒性的特点。需要进一步研究以确定其对头颈癌的疗效。