Hlubocky Fay J, Ratain Mark J, Wen Ming, Daugherty Christopher K
Department of Medicine, Section of Hematology/Oncology, MacLean Center for Clinical Medical Ethics, the Cancer Research Center, The University of Chicago, Chicago, IL 60637, USA.
J Clin Oncol. 2007 Feb 10;25(5):548-54. doi: 10.1200/JCO.2005.03.9800.
We sought to describe complementary and alternative medicine (CAM) usage among phase I trial participants and to describe these patients' treatment decision-making preferences, awareness of prognosis, survival, and quality of life.
Advanced cancer patients enrolling onto phase I trials were surveyed regarding biologically based CAM use. Decision-making preferences and awareness of prognosis were assessed using validated and/or standardized instruments. The Functional Assessment of Cancer Therapy-General instrument was used to assess quality of life. Univariate and multivariate analyses were performed to detect differences between CAM users and nonusers.
Of 212 interviewed patients, 34% (n = 72) described taking biologically based CAM. Median age of those taking biologically based CAM was 55 years, compared with 62 years for nonusers (P < .005). There were no statistically significant differences found between CAM usage and preferences for degree of patient involvement in medical decision making. Those patients who acknowledged that their deaths were likely to occur within 1 year were more likely to admit to prior CAM use (70% v 34%; P = .02). CAM users had poorer overall quality of life compared with nonusers (87.0 +/- 12.4 v 91.2 +/- 14.7; P = .007). No differences in survival were identified.
Prior CAM use among phase I cancer trial patients studied was common and associated with age, stated acknowledgment of prognosis, and quality of life. Patients enrolling onto early-phase trials should be questioned about CAM use. Additional study is needed to determine the frequency of use of those biologically based CAM agents that threaten the accuracy of early-phase cancer trial data.
我们试图描述I期试验参与者使用补充和替代医学(CAM)的情况,并描述这些患者的治疗决策偏好、对预后的认知、生存率和生活质量。
对参加I期试验的晚期癌症患者进行了关于基于生物的CAM使用情况的调查。使用经过验证和/或标准化的工具评估决策偏好和对预后的认知。采用癌症治疗功能评估通用工具评估生活质量。进行单因素和多因素分析以检测CAM使用者和非使用者之间的差异。
在212名接受访谈的患者中,34%(n = 72)表示使用基于生物的CAM。使用基于生物的CAM的患者中位年龄为55岁,非使用者为62岁(P <.005)。CAM使用情况与患者参与医疗决策程度的偏好之间未发现统计学上的显著差异。那些承认自己可能在1年内死亡 的患者更有可能承认之前使用过CAM(70%对34%;P =.02)。与非使用者相比,CAM使用者的总体生活质量较差(87.0±12.4对91.2±14.7;P =.007)。未发现生存率有差异。
在所研究的I期癌症试验患者中,之前使用CAM的情况很常见,且与年龄、对预后的明确认知和生活质量有关。应询问参加早期试验的患者关于CAM使用的情况。需要进一步研究以确定那些可能威胁早期癌症试验数据准确性的基于生物的CAM药物的使用频率。