In a nutshell
This study investigated the effectiveness and safety of regorafenib (Stivarga) to treat patients with metastatic (spread to other parts of the body) colorectal cancer (mCRC) that progressed after initial treatment. Researchers suggested that regorafenib is a safe option to treat these patients.
Some background
The standard treatment for mCRC is chemotherapy combined with targeted therapy. Targeted therapy attacks specific proteins of cancer cells which stops their growth. This therapy is often used in combination with chemotherapy to improve treatment efficacy. Regorafenib is a targeted therapy.
A prior study showed that patients treated with regorafenib had a 23% improvement in the odds of a better survival. The most common negative side effects were skin reactions, tiredness, diarrhea, and hypertension. However, these studies were done on a small group of patients.Therefore, the safety of this treatment still needs to be assessed in a larger patient population.
Methods & findings
This study included 2864 patients with mCRC from 25 countries who did not respond to previous standard treatments. All patients received regorafenib 160 mg once daily for the first 3 weeks of each 4-week cycle. Side effects and progression-free survival (PFS; time from treatment to progression) were assessed. Patients were followed up for an average of 3.5 months.
The treatment dose was reduced in 46% of these patients and 9% stopped treatment due to side effects. Less than 1% of the patients had severe side effects. The most common mild side effects were high blood pressure (15%), skin reaction in the hands and in the feet (14%), tiredness (13%), diarrhea (5%) and low levels of phosphate (5%; which may cause weakness and impaired breathing).
Average PFS was 2.7 months. 23% of regorafenib-treated patients had a PFS longer than 4 months.
The bottom line
This study showed that regorafenib is an effective option to treat patients with mCRC, with manageable side effects.
The fine print
This study was funded by Bayer, the producer of regorafenib.
Published By :
The Oncologist
Date :
Sep 06, 2018
