Engle Jeff A, Traynor Anne M, Campbell Toby C, Wisinski Kari B, LoConte Noelle, Liu Glenn, Wilding George, Kolesar Jill M
1 School of Pharmacy, University of Wisconsin-Madison, Madison, WI, USA.
2 Carbone Cancer Center, University of Wisconsin, Madison, WI, USA.
J Oncol Pharm Pract. 2018 Jul;24(5):348-353. doi: 10.1177/1078155217704989. Epub 2017 Apr 29.
Background/Aims Oral chemotherapy is increasingly utilized leaving the patient responsible for self-administering an often complex regimen where adverse effects are common. Non-adherence and reduced relative dose intensity are both associated with poorer outcomes in the community setting but are rarely reported in clinical trials. The purpose of this study is to quantify adherence and relative dose intensity in oncology clinical trials and to determine patient and study related factors that influence adherence and relative dose intensity. Methods Patients were identified from non-industry-funded clinical trials conducted between 1 January 2009 and 31 March 2013 at the University of Wisconsin Carbone Cancer Center. Data were extracted from primary research records. Descriptive statistics and linear regression modeling was performed using SAS 9.4. Results A total of 17 clinical trials and 266 subjects were included. Mean adherence was greater than 97% for the first eight cycles. Mean relative dose intensity was less than 90% for the first cycle and declined over time. Male gender, a performance status of 1 or 2, metastatic disease, and traveling more than 90 miles to reach the cancer center were associated with higher relative dose intensity. Conclusions Patients with cancer enrolled in clinical trials are highly adherent but unlikely to achieve protocol specified relative dose intensity. Given that determining the phase II dose is the primary endpoint of phase I trials, incorporating relative dose intensity into this determination should be considered.
背景/目的 口服化疗的应用日益广泛，这使得患者需自行管理通常较为复杂的治疗方案，而不良反应很常见。在社区环境中，治疗依从性差和相对剂量强度降低均与较差的治疗结果相关，但在临床试验中却鲜有报道。本研究旨在量化肿瘤学临床试验中的依从性和相对剂量强度，并确定影响依从性和相对剂量强度的患者及研究相关因素。方法 从2009年1月1日至2013年3月31日在威斯康星大学卡本癌症中心进行的非行业资助临床试验中识别患者。数据从原始研究记录中提取。使用SAS 9.4进行描述性统计和线性回归建模。结果 共纳入17项临床试验和266名受试者。前八个周期的平均依从性大于97%。第一个周期的平均相对剂量强度小于90%，且随时间下降。男性、体力状况为1或2、转移性疾病以及前往癌症中心的路程超过90英里与较高的相对剂量强度相关。结论 参加临床试验的癌症患者依从性很高，但不太可能达到方案规定的相对剂量强度。鉴于确定II期剂量是I期试验的主要终点，应考虑将相对剂量强度纳入这一确定过程。
