A pilot study of Irinotecan plus raltitrexed as second-line treatment for advanced colorectal cancer.

Abstract

e15024 Background: This pilot study is aimed to evaluated the efficacy and safety of irinotecan plus raltitrexed as second-line treatment for advanced colorectal cancer patients. Methods: A pilot study was made among patients with advanced, previously treated colorectal cancer from June 2013 to April 2016 in the First Hospital, China Medical University,. A total of 13 patients eligible were enrolled to receive irinotecan at a dose of 180mg/m2 d1, plus raltitrexed at a dose of 3mg/m2 d1, every 3 weeks, until disease progression or un-tolerable adverse events. All statistical analyses were performed using the SPSS (21.0) software program. Kaplan–Meier analysis and Log-rank test were used for survival analysis. P < 0.05 was considered as statistically significant. The primary end point was time to progression (TTP) and objective response rate (ORR), the secondary end point was safety. Results:The median follow-up time was 10.1 months at data cut-off on Dec1, 2016. 11 patients were defined progression of disease (PD) based on the criteria of RECIST 1.1 and 6 patients died. The median TTP of second-line was 4.0 months. The rate of disease control rate (DCR) was 46.2% (6patients stable disease). In univariate analysis, sex (3.2months of 12male patients versus 4.6months of 1female patient, P = 0.926), body mass index (BMI) (3.2months of 5 patients BMI < = 24 versus 4.0months of 8 patients BMI > 24, P = 0.311), site of tumor (4.0months of left versus 3.2months of right, P = 0.555) were not associated with TTP. Safety was assessed within 10 patients including nausea (70%), vomiting (30%), diarrhea (60%), constipation (10%), fatigue (90%), fever (20%), hand foot syndrome (20%), rash (40%), alopecia (40%), palpitations (20%), oral mucositis (10%), neurotoxicity (50%). 2 of 9 patients (22.2%) had hematologic toxic. Liver injury occurred in 3 of 8 patients (37.5%) and no kidney injury was reported. Conclusions: In advanced colorectal cancer patients, irinotecan plus raltitrexed as second-line treatment showed encouraging clinical activity and a tolerable safety profile.