A feasibility analysis from the patient preference randomized phase III clinical trial of second-line chemotherapy (SLC) in advanced gastric cancer (AGC) patients pretreated with both fluoropyrimidines and platinum.

Abstract

4147 Background: There is no evidence that SLC in AGC patients will result in substantial prolongation of survival when compared to best supportive care (BSC), and there is potential for toxicity from the treatment. However, SLC is often offered to pretreated AGC patients for anecdotal reasons. Methods: The study comprises two parts: patient preference trial (PPT) and randomized controlled trial (RCT). In a prospective, multicenter trial, pretreated AGC patients with a performance status (PS) ≤ 1 were first offered randomization. If willing to participate RCT, the patient was randomly assigned 2:1 to SLC or BSC. If the patient refused randomization, but nevertheless agreed to receive treatment of their preferences, the patient received their treatment of choice (SLC or BSC). In the SLC regimen, single-agent docetaxel or irinotecan was selected at the discretion of investigator. Primary endpoint is the overall survival in the RCT patients, and the target sample size is 200 RCT patients. The main outcome measure in this feasibility analysis is the proportion of patients enrolled onto RCT compared with the proportion of those enrolled onto PPT. Results: As of Dec 2009, a total of 182 eligible patients were entered onto this study. Eighty-one patients entered RCT (SLC, n = 55; BSC, n = 28), and 101 patients received treatment of their preferences (SLC, n = 70; BSC, n = 29). The degree of RCT refusal was more pronounced in patients with a PS of 0 (vs. 1; p = 0.04). In the PPT patients, those without measurable disease (p < 0.01) and aged > 55 years (p < 0.01) declined SLC. Conclusions: This analysis suggests that pretreated AGC patients clearly prefer SLC. The high degree of RCT refusal is, at least in part, due to concern about random assignment or difficulty with accepting BSC without the possibility of anticancer effects. No significant financial relationships to disclose.