Phase I clinical trial of combined therapy with 5‐FU (NSC 19893) and cis‐platinum (II) diaminedichloride (NSC 119875)
Phase I clinical trial of combined therapy with 5‐FU (NSC 19893) and cis‐platinum (II) diaminedichloride (NSC 119875)
复制标题
5-FU (NSC 19893) 和顺铂 (II) 二氯化二胺 (NSC 119875) 联合治疗的 I 期临床试验
作者：
Richard A. Ellerby;H. Davis;F. Ansfield;G. Ramírez
对27例患有各种恶性肿瘤的患者进行了31个负荷疗程的5-FU和顺铂（II）二胺二氯化物（CPD）。5-FU剂量高达16 mg/kg/天，铂剂量高达2.5 mg/kg，毒性最小。恶心（27/31）和呕吐（23/31）是最常见的症状，很少有人出现腹泻（5）或口腔炎（1）。尿液异常为一过性，通常在治疗完成时恢复至基线水平。与每周一次5-FU和每月一次CPD维持治疗相比，负荷治疗期间白细胞减少症的发生率较低。维持期间血小板计数始终保持在100，000至200，000之间。2例患者通过重复听力图检测到无症状性高频听力损失。虽然该计划的主要目的是确定联合毒性，但观察到4例短暂反应和5例持续反应。
Thirty‐one loading courses of 5‐FU and cis‐platinum (II) diaminedichloride (CPD) were given to 27 patients with a variety of malignancies. Up to 16 mg/kg/day of 5‐FU and 2.5 mg/kg of the platinum were reached with minimal toxicity. Nausea (27/31) and vomiting (23/31) were the most frequent symptoms, with few experiencing diarrhea (5) or stomatitis (1). Urinary abnormalities were transient, generally returning to baseline levels by completion of therapy. Leukopenia appeared less commonly during the loading courses than during weekly 5‐FU and monthly CPD maintenance. Platelet counts consistently remained between 100,000 and 200,000 during maintenance. Asymptomatic high‐tone hearing losses were detected by repeat audiograms in 2 patients. Although the primary objective of the program was to determine combined toxicity, four brief and five continuing responses were noted.