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Phase 2 drug trial offers hope to patients with advanced colorectal cancer

29 Aug 2012
Phase 2 drug trial offers hope to patients with advanced colorectal cancer

A new drug treatment could offer hope to patients with advanced colorectal cancer who were intolerant of or did not respond to standard treatments, according to an article published in The Lancet Oncology.

 

The drug – called TAS-102 – was tested on 169 patients in Japan with inoperable, metastatic (spreading) colorectal cancer.

 

The patients had already undergone several rounds of standard chemotherapy, to no effect, or were intolerant of standard drug treatments (which include irinotecan, oxaliplatin, and a group of drugs known as fluoropyrimidines).

 

Researchers found that, compared to placebo, patients treated with TAS-102 experienced improved survival time, reduced risk of death and better overall disease control, leading to hopes that the drug might one day be used as an effective treatment for advanced inoperable colorectal cancer.

 

Patients who received TAS-102 had a median overall survival of 9 months, as compared to 6.6 months for the placebo group. The TAS-102 group were also 44% less likely to die during the trial period than those given placebo.

 

Importantly, TAS-102 appears to be relatively safe, being well tolerated by most patients. While some patients experienced adverse reactions to the drug (mostly blood disorders), in all cases they were able to resume treatment after the blood disorder had been addressed.

 

Colorectal cancer accounts for around 10% of all cancer cases, and is the fourth-leading cause of cancer-related deaths worldwide. There are currently no clinically proven treatment options available for patients with advanced, inoperable colorectal cancer who do not respond to, or are intolerant of, the standard drug treatments for the disease.

 

According to lead author Dr Takayuki Yoshino, of the National Cancer Center Hospital East in Kashiwa, Chiba, Japan, “Treatments that confer a survival benefit in patients with heavily pretreated metastatic colorectal cancer are urgently needed. Our results show that TAS-102 has a promising efficacy and an easily manageable safety profile for a group of patients who have virtually no other treatment options available to them.”*

 

In a linked Comment, Dr Alberto Sobrero of the Ospedale San Martino in Genoa, Italy, welcomes the results, while emphasising that further work will be needed to confirm the results, adding that “With the assumption that the results represent the true effect of TAS-102, a new important advance in the treatment of colorectal cancer will have been made.”

 

Source: The Lancet