Departments of Investigational Cancer Therapeutics-a Phase I Clinical Trials Program.
Departments of Investigational Cancer Therapeutics-a Phase I Clinical Trials Program.
Ann Oncol. 2012 Aug;23(8):1963-1967. doi: 10.1093/annonc/mds027. Epub 2012 Feb 29.
This study assessed toxicity in advanced cancer patients treated in a phase I clinic that focuses on targeted agents.
An analysis of database records of 1181 consecutive patients with advanced cancer who were treated in the phase I program starting 1 January 2006 was carried out.
All patients were treated on at least 1 of the 82 phase I clinical trials. Overall, 56 trials (68.3%) had only targeted agents, 13 (15.9%) only cytotoxics, and 13 (15.9%) targeted and cytotoxic agents. Rates of grade 3 and 4 toxicity that were at least possibly drug related were 7.1% and 3.2%, respectively, and 5 of the 1181 patients (0.4%) died from toxicity that was at least possibly drug related. The most common grade 3 or more toxic effects were neutropenia, thrombocytopenia, anemia, dehydration, infection, altered mental status, bleeding, vomiting, nausea, and diarrhea. Eastern Cooperative Oncology Group (ECOG) performance status greater than zero and use of a cytotoxic agent were selected as independent factors associated with serious toxicity.
Phase I trials of primarily targeted agents showed low rates of toxicity, with 10.3% of patients experiencing grade 3 or 4 toxicity and a 0.4% rate of death, at least possibly drug related.
本研究评估了专注于靶向药物的 I 期临床中治疗晚期癌症患者的毒性。
对 2006 年 1 月 1 日开始的 I 期计划中治疗的 1181 例晚期癌症连续患者的数据库记录进行了分析。
所有患者均至少接受了 82 项 I 期临床试验中的 1 项治疗。总体而言，56 项试验（68.3%）仅使用靶向药物，13 项（15.9%）仅使用细胞毒性药物，13 项（15.9%）使用靶向和细胞毒性药物。至少可能与药物相关的 3 级和 4 级毒性发生率分别为 7.1%和 3.2%，1181 例患者中有 5 例（0.4%）因至少可能与药物相关的毒性而死亡。最常见的 3 级或更高级别的毒性作用包括中性粒细胞减少症、血小板减少症、贫血、脱水、感染、精神状态改变、出血、呕吐、恶心和腹泻。东部肿瘤协作组（ECOG）表现状态大于 0 和使用细胞毒性药物被选为与严重毒性相关的独立因素。
主要靶向药物的 I 期试验显示出较低的毒性发生率，10.3%的患者发生 3 级或 4 级毒性，至少有 0.4%的患者因至少可能与药物相关的毒性而死亡。
