Patients who are receiving concomitant medications should not systematically be excluded from phase I studies.
Patients who are receiving concomitant medications should not systematically be excluded from phase I studies.
复制标题
接受伴随药物治疗的患者不应被系统性地排除在 I 期研究之外。
DOI：
10.1097/00001813-199901000-00001
复制
发表时间：
1999
影响因子：
2.3
通讯作者：
Clark,GM
中科院分区：
文献类型：
--
作者：
Genre,D;Viens,P;VonHoff,DD;Clark,GM
这项回顾性研究旨在评价I期试验中治疗第一天给予患者的合并用药数量和类型与人口统计学特征、结局指标和毒性之间的可能关系。根据1993年美国医院处方集服务，将1985年8月至1996年1月期间参加28项I期试验的690例患者接受的合并用药分为31类。这些患者接受了1650个周期的研究药物治疗（每例患者的中位数为2个周期）。中位研究持续时间为49天（范围1-776天）。临床反应率（完全、部分、轻微）为3.8%，仅发生3例中毒性死亡（0.4%）。几乎和患者（90.9%）在治疗第一天接受至少一种伴随药物。合并用药的数量与不良体能状态直接相关（r sp= 0.27，p< 0.0001），与研究持续时间间接相关（r sp=-0.18，p< 0.0001）。第一个疗程期间给予的研究药物剂量与治疗第一天的合并用药无关。最重要的是，未观察到合并用药与毒性或治疗临床反应之间存在任何关系。我们的结论是，接受合并用药的患者不应被系统地排除在I期研究之外，[r 1999 Lippincott威廉姆斯& Willkins。]
This retrospective study was designed to evaluate possible relationships between the number and types of concomitant medications administered to patients on the first day of therapy in phase I trials and demographic characteristics, outcome measures and toxicities. Concomitant medications received by 690 patients enrolled on 28 phase I trials between August 1985 and January 1996 were grouped into 31 categories based on the American Hospital Formulary Service 1993. These patients received 1650 cycles of treatment with investigational agents (median 2 cycles per patient). Median duration on-study was 49 days (range 1–776 days). Clinical response rate (complete, partial, minor) was 3.8% Only three toxic deaths occurred (0.4%). Nearly and patients (90.9%) received at least one concomitant medication on the first day of therapy. The number of concomitant medications directly correlated with poor performance status (r sp= 0.27, p< 0.0001) and indirectly with duration on-study (r sp=-0.18, p< 0.0001). The dose of the investigational agent administered during the first course of therapy was not related to concomitant medications on the first day of therapy. Most importantly, no relationships were observed between concomitant medications and either toxicities or clinical response to therapy. We conclude that patients who are receiving concomitant medications should not systematically be excluded from phase I studies,[r 1999 Lippincott Williams & Willkins.]