Evaluating the long-term effectiveness and safety of 3-month versus 6-month modified FOLFOX/CAPOX treatment after surgery in patients with stage 3 colon cancer.

This study evaluated the long-term effectiveness and safety of 3-month versus 6-month modified FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin) or CAPOX (capecitabine and oxaliplatin) treatment after surgery in patients with stage 3 colon cancer. The data showed that 3-month modified FOLFOX/CAPOX treatment was as effective and safe as the 6-month treatment over the long term in these patients.

Colorectal cancer (CRC) is one of the most common types of cancer worldwide. CRC involves the final part of the large intestine, colon, or rectum. The first choice for the treatment of CRC is usually surgery. Often, patients are given chemotherapy after surgery to make sure any remaining cancer cells are killed. This is called adjuvant chemotherapy (AC).

The current standard treatment for patients with stage 3 CRC is surgery followed by 6-months of FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin) or CAPOX (capecitabine and oxaliplatin) treatment. However, many patients develop peripheral sensory neuropathy (PSN; weakness, numbness, and pain in the hands and feet) during the 6 months of this therapy. A shorter 3-month FOLFOX/CAPOX treatment was shown to be as effective and safe as the 6-month treatment for patients with stage 3 CRC. However, the long-term effectiveness and safety of 3-month versus 6-month modified FOLFOX/CAPOX treatment after surgery in patients with stage 3 CRC is still unknown.

This study involved 1291 patients with stage 3 CRC. Patients were randomly assigned into 2 groups. Group 1 included 641 patients who received 6 months of treatment with modified FOLFOX/CAPOX. Group 2 included 650 patients who received 3 months of treatment with modified FOLFOX/CAPOX. The average follow-up time was 74.7 months.

After 5 years, 87% of the patients in the 3-month treatment group were alive compared to 86.4% of the patients in the 6-month treatment group. This difference was not considered statistically significant. 

16% of the patients experienced PSN in the 6-month treatment group compared to 8% of the patients in the 3-month treatment group. 14% of the patients who received modified FOLFOX experienced PSN compared to 11% of the patients who received CAPOX.

This study concluded that 3-month modified FOLFOX/CAPOX treatment was as effective as the 6-month treatment over the long term and reduced the rate of long-lasting PSN in patients with stage 3 CRC. The authors suggested that 3 months of CAPOX therapy is an appropriate adjuvant treatment option.

The patients knew which treatment they were getting. This study only included Asian patients treated at institutions in Japan.