In a nutshell
This trial investigated the effectiveness and safety of a combination treatment for colorectal cancer resistant to chemotherapy.
Some background
Cancer evolves as it progresses in patients. Sometimes, this leads to resistance to treatment. In this case, the cancer is termed “refractory”. TAS-102 (Lonsurf) is a combination treatment with several anti-cancer components. Studies have shown that treatment with TAS-102 led to an average overall survival time (time from treatment until death from any cause) of 9.0 months, compared to 6.6 months in patients recieving a placebo (substance with no effect on the body). The effectiveness and safety of TAS-102 in patients with refractory, metastatic (spread to other areas of the body) colorectal cancer is not yet clear.
Methods & findings
This trial investigated the effectiveness and safety of TAS-102 in colorectal cancer patients who had previously been treated with chemotherapy without success. 534 patients were treated with TAS-102 and 266 were treated with a placebo. Patients were treated and assessed for an average of 12 weeks.
TAS-102 decreased the risk of death by 32% compared to placebo. The average survival time with TAS-102 was 7.1 months. Placebo patients survived for an average of 5.3 months. 27% of TAS-102 patients survived for one year, in comparison to 18% of placebo patients.
Disease progression was 52% less likely in TAS-102 patients. TAS-102 patients survived for an average of 2.0 months without disease. In comparison, placebo patients survived for 1.7 months on average without disease. More TAS-102 patients (44%) than placebo patients (16%) achieved disease control (complete or partial response to the drug, or stabilization).
Severe side effects were experienced by more TAS-102 patients (69%) than placebo patients (52%). Low blood cell counts were the most common side effects. TAS-102 patients were also more likely to experience severe nausea (2%), vomiting (2%) or diarrhea (3%) than placebo patients (1% or less for each effect). One TAS-102 patient died due to septic shock caused by the treatment.
The bottom line
The authors concluded that TAS-102 was associated with increased survival in refractory colorectal cancer.
The fine print
This study was funded by Taiho Pharmaceuticals, the manufacturers of TAS-102.
What’s next?
Consult your doctor if you are considering further treatments.
Published By :
The New England Journal of Medicine
Date :
May 14, 2015
