Evaluating the effectiveness and safety of anlotinib for unresponsive metastatic colorectal cancer.

This study investigated the effectiveness and safety of anlotinib (AL3818) for the treatment of patients with unresponsive metastatic colorectal cancer (mCRC). The data showed that anlotinib was safe and significantly improved survival without cancer progression for these patients.

Colorectal cancer (CRC) is one of the most common types of cancer worldwide. Some patients do not report symptoms with the initial tumor. These patients are often only diagnosed when the cancer has spread to other areas (metastatic CRC). The standard treatment for these patients is chemotherapy combined with targeted therapy. A high number of patients with mCRC are unresponsive to the disease (refractory). Treatment options for refractory mCRC are limited.

Anlotinib is a tyrosine kinase inhibitor (TKI). TKIs block enzymes that are responsible for many cellular functions in the body. Anlotinib works by blocking tumor growth and spread through blocking many enzymes. Anlotinib has been shown to improve survival outcomes in patients with non-small cell lung cancer (NSCLC). However, studies investigating the effectiveness and safety of anlotinib for the treatment of patients with unresponsive mCRC remain under investigation.

This study involved 419 patients with unresponsive mCRC. They were randomly assigned to receive either anlotinib (282 patients) or a placebo (137 patients) and supportive treatments. The average follow-up time for anlotinib was 31 months and for placebo was 31.8 months.

The average survival without cancer progression was significantly higher in the anlotinib group (4.1 months) compared to the placebo group (1.5 months). Anlotinib significantly decreased the risk of disease progression by 66% compared to the placebo.

The average overall survival was similar between the 2 groups (8.6 months with anlotinib and 7.2 months with placebo). 4.26% of the patients in the anlotinib group had partial disappearance of the cancer compared to 0.73% of the patients in the placebo group. Disease control (the tumor does not grow or spread) rate was significantly higher in the anlotinib group (75.9%) compared to the placebo group (30.7%).

Overall, 52.5% of patients in the anlotinib group experienced side effects compared to 19.5% in the placebo group. The most common anlotinib related side effects were high blood pressure (20.92%), increased liver blood tests (7.09%), and redness, swelling, and pain on the palm of the hand and sole of the foot (6.38%).

This study concluded that anlotinib was safe and significantly improved survival without cancer progression for the treatment of patients with unresponsive advanced CRC.

This study was carried out only on Chinese patients which may not translate to different populations. Also, this trial was funded by Chia-Tai Tianqing Pharmaceutical Group Co. Ltd, the manufacturers of anlotinib.