Abstract:

Objective To investigate the efficacy and safety of apatinib combined with PD⁃1 blockades for patients with advanced colorectal cancer（CRC）who failed in the therapy with the standard regimens and explored the potential prognostic factors. Methods In this retrospective study，a total of 43 patients with advanced CRC who were treated with apatinib plus PD⁃1 blockades were included in this study. The initial dosage of apatinib was 250 mg or 500 mg，and PD⁃1 blockades were the available PD⁃1 inhibitors approved in China. The data on the efficacy and safety were collected using the electronic medical record system of the hospital and all the patients were followed up regularly to assess the long⁃term prognostic data. Association analysis between progression free survival（PFS）and baseline characteristic subgroups was performed to explore the potential risk factors for prognosis. Results The best overall response of the combination regimen indicated that partial response was observed in 11 patients，the disease was noted stable in 20 patients and progressive 12 patients，yielding an objective response rate（ORR）of 25.6%（95%CI：13.5% ~ 41.2%）and a disease control rate（DCR）of 72.1%（95%CI：56.3% ~ 84.7%）. Furthermore，the prognostic data obtained from the subsequent follow ⁃ up suggested that the median PFS of the 43 patients was 5.8 months（95%CI：3.81 ~ 7.79）and the median overall survival（OS）was 10.3 months （95%CI：5.75 ~ 14.85）. The most common adverse reactions were fatigue，hypertension，diarrhea and hand⁃foot syndrome. Furthermore，the association analysis suggested that ECOG performance status and left ⁃ and right ⁃side colorectal cancer might be independent factors to predict the PFS. Conclusion The regimen of apatinib plus PD⁃1 blockades is potential in efficacy and acceptable in safety for patients with advanced CRC in subsequent⁃line therapy.ECOG performance status and tumor location might be potential risk factors to predict the PFS. The conclusion should be confirmed in prospective clinical trials subsequently.

Key words:

advanced colorectal cancer, apatinib, PD?1 blockades, efficacy, safety