Antitumor agent improves survival of patients with treatment-resistant metastatic colorectal cancer

  • An international phase III study published in the New England Journal of Medicine (NEJM), in which the Vall d’Hebron University Hospital and the Vall d’Hebron Institute of Oncology (VHIO) both participated, shows that TAS-102, an oral antitumor agent combining two drugs, improves overall survival by two months for patients who have exhausted all other standard therapies for this type of cancer.
  • Colorectal cancer is the second most common tumor type at global level, with an estimated incidence of 1.36 million new cases each year. 50% of colorectal cancer patients eventually develop metastases and, in many cases, fail to respond to standard treatments.

Barcelona, May 18, 2015. A multicenter, randomized, phase III study has shown that using the oral antitumor agent TAS-102 in patients with metastatic colorectal cancer who are resistant to standard therapies, improves overall survival by two months. The results of this trial, although modest in terms of benefit, are important since they offer these patients an alternative therapy against the advancement of their disease – whereas previously no other option existed.

Currently under drug development for the treatment of patients with metastatic colorectal cancer, TAS-102 is a novel orally administered antitumor agent containing a duo of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is the active component of TAS-102 and is itself incorporated directly into tumor DNA, inhibiting the growth of tumor cells. When taken orally, however, it loses some of its anticancer activity and is thus combined with TPI to preserve its efficacy. Its mechanism of action differs from that of fluoropyrimidines (standard chemotherapy regimens), and this study shows TAS-102 to be effective in the treatment of these patients when fluoropyrimidine therapies have previously failed.

This international phase III study, in which the Vall d’Hebron University Hospital, the Vall d’Hebron Institute of Oncology (VHIO), and the Virgen del Rocío University Hospital have participated, included 800 patients with metastatic colorectal cancer who were subsequently treated with either TAS-102 (534) or placebo (266). Mean overall survival increased from 5.3 months (placebo) to 7.1 months (TAS-102).

The next step will be to establish whether the use of this agent in earlier stages of disease will result in greater benefits for patients with metastatic colorectal cancer. Josep Tabernero, Head of the Medical Oncology Department at the Vall d’Hebron Hospital, Director of VHIO, and one of the study co-authors, observes, We believe that this agent benefits patients with colorectal cancer who have exhausted all other standard therapies, and although the gains are modest in this particular setting, we now need to establish whether there are greater gains for patients with less advanced disease.”

About colorectal cancer

Colorectal cancer (CRC) is the second most common type of cancer globally, with an estimated incidence of more than 1.36 million new cases every year and death toll of around 694,000 annually. CRC represents 8.5% of all cancer deaths and ranks fourth among the most common causes of death from cancer. Almost 55% of colorectal cancer cases are diagnosed in developed regions and incidence and mortality rates are considerably higher in men than in women.


For more information please contact: Amanda Wren, Director of Communication, Vall d´Hebron Institute of Oncology (VHIO), Email: 

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