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1/26/2015 UPDATE: Great news for metastatic colon cancer patients refractory to or failing standard chemotherapy. Your team may be able to apply for expanded use for the sites that are currently offering the new drug TAS-102. More sites will be added soon. For teams that do not have access to the current sites, they can apply for compassionate use. Get more information about this update.

In November, the FDA granted a fast track designation to TAS-102, a new oral drug for metastatic colorectal cancer patients who have failed at least two previous treatments. We sat down with Patient Advocate Medical Consultant Dr. Laura Porter to learn what’s promising about this upcoming treatment option.

What is TAS-102?

TAS-102 is a nucleoside-analogue drug being developed by Taiho Oncology. It incorporates itself into the DNA of cancer cells, stopping them from growing.

What is compassionate use?

“Compassionate use” refers to the treatment of a seriously ill patient using a new, unapproved drug when no other treatments are available. Drugs that are being tested but have not yet been approved by the FDA are called investigational drugs. Learn more about the expanded access of TAS-102 for compassionate use.

[caption id="attachment_2431" align="alignright" width="194"]Dr. Laura Porter, MD, stage IV colon cancer survivor and Colon Cancer Alliance Patient Advocate Medical Consultant. Dr. Laura Porter, MD, stage IV colon cancer survivor and Colon Cancer Alliance Patient Advocate Medical Consultant.[/caption]

What does “fast track designation” mean?

The fast track designation was established by the FDA to facilitate the development and speed up the review of new drugs that are intended to treat serious or life-threatening conditions. Taiho Oncology plans to complete their submission to the FDA by the end of this year; however, there is no word on when it will be available. The only clinical trial in the US is currently closed.

What have been the results from studies on TAS-102?

The study results of RECOURSE – the study on TAS-102 – were presented at the European Society for Medical Oncology Congress last month. The study included 800 people with stage IV metastatic colorectal cancer (mCRC) and showed clinically meaningful improvements in performance status and survival.

All participants had failed at least two previous treatment regimens and at least 50% had failed or become tolerant on four or more treatment regimens.  The average age of the participants was 65 and the ECOG Performance Status was 0 or 1. Performance status measures the impact of disease on quality of life (QOL) and ranges from a score of 0 to 4, with 0 being the best score of minimal impact on quality of life.

The early results of the study showed that the group on TAS-102:

  • Reduced the risk of progression by 52% when compared with placebo
  • Extended survival by 32% when compared with placebo
  • Decreased in time to worsening of performance status of 40%
  • A 32% drop in mortality at 8 months.

The most noted side effects were reduced white blood cells, nausea, vomiting, fatigue and diarrhea.  

Why is this study so exciting?

First of all, the slower decline in performance status means that patients maintained a better quality of life longer than those with placebo. When we think of other treatment options that have been approved recently, this is fantastic news for patients who can’t afford the side effects.

In addition, the fact that half of the patients in the study had failed on four or more treatments is good news for those who may be out of other options.

Lastly, the disease control rate (DCR), which includes the disappearance of all signs of cancer (complete response), a decreasing in the size of the tumor/number of metastases (partial response), and cancer that is neither increasing nor decreasing (stable disease) is 44% in those treated with TAS-102 versus 16.3% in the placebo group.  For many with stage IV, new treatment options are often a slow waiting game. These early results show that TAS-102 may be a great option for controlling a patient’s cancer until the next thing arrives.

Are you a stage IV or mCRC long-term survivor 5+ years out from diagnosis? We want to know how you’re doing and how we can help! Check out Session I of our upcoming summit series Fighting a Smarter War on Colorectal Cancer. Register now. And don't forget - the Colon Cancer Alliance is here for you. Call our free Helpline at (877) 422-2030 if you have questions or are in need of support.

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