Medical Oncology Division, National Cancer Center Hospital, Tokyo; Faculty of Pharmaceutical Science, Josai University, Saitama; Medical Oncology Division, Aichi Cancer Central, Aichi; Medical Oncology Division, Oita University, Oita; Investigative Treatment Division, Research Center for Innovative Oncology, National Cancer Center Hospital East, Chiba; Cancer Information Services and Surveillance Division, Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan.
J Oncol Pract. 2011 May;7(3):148-53. doi: 10.1200/JOP.2010.000106.
There is insufficient data to verify whether participation in clinical trials in itself can lead to better clinical outcomes. We have analyzed the characteristics and outcomes of patients who declined to participate in a randomized trial in comparison with those who participated in the trial.
A randomized trial for naive advanced gastric cancer was offered to 286 patients. The trial investigated the superiority of irinotecan plus cisplatin and the noninferiority of S-1 compared with continuous fluorouracil infusion. We retrospectively reviewed the characteristics and outcomes for both participants and nonparticipants in this trial.
Of the 286 patients, 98 (34%) declined to participate in the trial. The rate of declining was significantly higher among younger patients (P = .003), and it varied significantly between attending physicians (range, 23% to 58%; P = .004). There were no other significant correlations between rate of declining and patient characteristics. No significant differences were observed in the clinical outcomes between the participants and nonparticipants, for whom the median survival times were 367 versus 347 days, respectively. The hazard ratio for overall survival, adjusted for other confounding variables, was 1.21 (95% CI, 0.91 to 1.60). No interaction was observed between participation and the various regimens.
There was no difference in clinical outcomes between participants and nonparticipants. However, the patient's age and the doctor-patient relationship may have an effect on patient accrual to randomized trials.
目前尚缺乏数据证实参与临床试验本身是否能改善临床结局。我们分析了拒绝参与随机试验与参与试验患者的特征和结局。
一项针对初治晚期胃癌的随机试验纳入了 286 例患者。该试验旨在比较伊立替康联合顺铂与 S-1 方案的优势及非劣效性。我们对该试验的参与者和非参与者的特征和结局进行了回顾性分析。
286 例患者中，98 例（34%）拒绝参与试验。年轻患者的拒绝率显著更高（P =.003），不同主治医生间的差异也有统计学意义（范围为 23%至 58%；P =.004）。拒绝率与患者特征之间无其他显著相关性。参与者和非参与者的临床结局之间无显著差异，中位生存时间分别为 367 天和 347 天。调整其他混杂因素后，总生存的风险比为 1.21（95%CI，0.91 至 1.60）。未观察到参与和各种方案之间存在交互作用。
参与者和非参与者的临床结局无差异。然而，患者年龄和医患关系可能会影响随机试验的患者入组。
