Efficacy and safety of apatinib for elderly patients with previously treated extensive-stage colorectal cancer patients and the prognostic significance of common adverse reactions.

Background: This study was designed to investigate the efficacy and safety of apatinib monotherapy in the treatment of elderly patients with advanced colorectal cancer (CRC) who have progressed on the standard regimens.

Methods: The data of 106 elderly patients with advanced CRC who have progressed on standard treatment were analyzed. The primary endpoint of this study was progression-free survival (PFS), the secondary endpoints were objective response rate (ORR), disease control rate (DCR), and overall survival (OS). The safety outcomes were assessed by the proportion and severity of adverse events.

Results: Efficacy was assessed using the best overall response of patients during treatment with apatinib, including 0 patients with complete response, 9 patients with partial response, 68 patients with stable disease, and 29 patients with progressive disease. ORR and DCR were 8.5 and 72.6%, respectively. The median PFS of 106 patients was 3.6 months, and the median OS was 10.1 months. The most frequent adverse reactions of elderly patients with advanced CRC receiving apatinib treatment were hypertension (59.4%) and hand-foot syndrome (HFS) (48.1%). The median PFS of patients with and without hypertension was 5.0 and 3.0 months, respectively ( P = 0.008). The median PFS of patients with and without HFS was 5.4 and 3.0 months, respectively ( P = 0.013).

Conclusions: The clinical benefit of apatinib monotherapy was observed in elderly patients with advanced CRC who have progressed on the standard regimens. The adverse reactions of hypertension and HFS were positively related to treatment efficacy.