Home Blog Resources FDA Approves TAS-102 FDA Approves TAS-102 September 22, 2015 • By Fight CRC Resources Share on Facebook Share on LinkedIn Share on Twitter Copy this URL Share via Email ** Updated 10/6/15 with patient support information. See below! Good news! The FDA approved the use of the drug TAS-102 (brand name LONSURF® (trifluridine and tipiracil hydrochloride)) on September 22, 2015, for patients with metastatic colorectal cancer. This means there’s a new treatment option for some patients fighting late-stage colorectal cancer. TAS-102 is now approved for patients whose cancer progressed after receiving standard therapies or for patients who couldn’t tolerate them. See below for the following information: Clinical Trial Results Treatment Schedule Comparison to 5-FU Side Effects How to Get the Drug Patient Support More Information & Resources on TAS-102 Clinical Trial (RECOURSE Trial) Results TAS-102 was approved after the international, multicenter, phase III RECOURSE trial showed improved survival (from 5.3 to 7.1 months on average) for patients, including those with both non-mutated and mutated KRAS genes. Some patients with metastatic colorectal cancer may achieve long-term survival when they are diagnosed with very limited metastatic disease that can be surgically removed. For most patients, there is no cure for metastatic CRC, but the amount of time they survive can be lengthened with treatment. Treatment schedule Download our free app that helps you keep track of your medications schedule. TAS-102 is an oral chemotherapy. Patients are advised to always follow the instructions of a doctor. The common schedule for taking TAS-102 is as follows: Day 1 – 5: twice daily after breakfast and dinnerDay 6 – 7; no pillsDay 8 – 12: twice dailyDay 13-14: no pillsDay 15-28: no pills This cycle is continued under the direction of the health care provider. GET IT NOW: Download our FREE iCancerHealth app to manage your medications and pill schedules. Compared to 5-FU The drug works similarly to the 5-fluorouracil (5-FU) drug in that it binds to DNA and stops cancer cells from dividing. Unlike 5-FU, TAS-102 also appears to affect the growth of blood vessels into tumors. Laboratory studies show that TAS-102 is active in tumors that are resistant to 5-FU and that the drug inhibits tumor growth more effectively than 5-FU in some tumors sensitive to 5-FU. Side Effects of TAS-102 Almost all of the RECOURSE trial participants received every approved drug for colorectal cancer before they received TAS-102, including: 5-FU; oxaliplatin; irinotecan; bevacizumab; and EGFR inhibitors (cetuximab, panitumumab) for patients without a KRAS mutation. It’s important to note that the tumors in these patients were very resistant to drugs and that they may have experienced symptoms due to their advanced disease that made treatment harder to tolerate. Side effects of TAS-102 proved to center around low white cell counts (risk of infection) and anemia (fatigue). Overall, patients who received nearly every drug available tolerated these pills well, a prerequisite to getting any benefit from a new drug. Furthermore, TAS-102 may combine well with other chemotherapy or biological agents, and research looking at these combinations is currently underway. The FDA reports that, The most common side effects of treatment with Lonsurf are anemia, a decrease in infection-fighting white blood cells (neutropenia) or blood platelets (thrombocytopenia), physical weakness, extreme tiredness and lack of energy (fatigue), nausea, decreased appetite, diarrhea, vomiting, abdominal pain and fever. It’s important to note: If a patient begins taking this drug and experiences a fever of 100.4F or above, or develops any other signs of infection, contact a health care provider right away. All side effects should be reported to your health care provider. How To Get TAS-102 Metastatic colorectal cancer patients can now ask their doctors about this new treatment option. It is important to discuss all of your treatment options and ask many questions. Discuss the risks and benefits of each treatment option, as well as any side effects. Develop a plan with your health care team. Upon FDA approval, TAS-102 should be available globally and throughout all cancer centers. Patient Support Here are a few resources and numbers to call for patient support on this drug: Toll-free: (844) TAIHO-4U (844-824-4648)Toll-free Fax: (844) 287-2559www.TaihoPatientSupport.com Get More Information of TAS-102 Fight Colorectal Cancer has been monitoring this drug for several months. Please see below for links and resources for additional information: Fight Colorectal Cancer Trial Review of TAS-102 Read the FDA Press Release about drug approval Prescribing Information Study Abstract and Results Patient Assistance Programs Find a Clinical Trial For more resources on late-stage colon and rectal cancer, please download Guide in the Fight and join our Patient Resource Group on Facebook. Disclosure: Fight Colorectal Cancer has received funding from Taiho Oncology, the producers of TAS-102, in the form of unrestricted educational grants. We maintain ultimate authority over website content and the content written in this article. 8 thoughts on “FDA Approves TAS-102” My mom is now 75 years old and was diagnosed in 2012 with stage 4 colon cancer. It spreaded to her liver. She was told that she couldn’t have surgery because the size of the tumor was too large and she had small spots surrounded the colon and to remove it they would have to gut her to try and get it all. She really wanted to have surgery but it would have been very risky. I didn’t want to take that chance of having surgery and the cancer returning spreading all over her body. It’s been 4 1/2 years now and her Doctor told that all the chemo she has taken isn’t working anymore and the tumor on her colon is growing back. She is taking Lonsorf, which is the pill and I am hoping this will shrink the tumor again. I know we all got to die of something, just praying and hoping she will be here with us a while longer. I never give up. Continue to trust in the man above. He is in control. I’m 53 years old. Diagnosed with stage 4 colon cancer at 45. I had colectomy to remove cancer (lost a foot of colon) and also had thoracic surgery to remove cancer from lung. I then did 6 months of preventative chemo and lived healthy life for next 5.8 years, working full time and raising family. My cancer returned in early 2015 to lymph nodes. Did another 6 months of chemo and radiation then had major surgery to remove cancer from risky area. After long recovery I returned to work in ja n 2016, only to find out 6 weeks later that cancer back and spread to both lungs. I have talked to my oncologist about TAS-102 and will be starting shortly. I’d love to hear from folks who were part of trial. Thanks!! Stay strong Monica! Thanks for sharing your story with us! This online patient community might have some feedback for you: https://www.inspire.com/groups/fight-colorectal-cancer/ My mother has colon rectal cancer with mets to the liver and now longsMy mom tooknthe 1st 2 weeks of this drug but while on the break she was in a lot of pain and endednup being hospitalized. Her potassium had decresed she had a loss of appetite and her electrolytes were down. She became weak and very confused. Her kidney function had decreased but God. As they replaced fluids and electrolytes lost her kidney functions increased and she has began to get stronger. She would have been scheduled to begin treatment again this up coming Monday but of course it has been put on hold. Dr don’t knownif it was the chemo drug or the fact that she wasn’t eating or the progression of the cancer. Its hard but we know God is able. She is now at a rehab facility. My wife has been fighting colorectal for 6-1/2 years now — resection, spread to lung (one lobe removed), spread to piraformis (radiation) and now spread to liver. She has been through all the drugs noted in the first paragraph of side effects above and starts this drug tomorrow. Would love to see posts from or about anyone who has taken this. Thank you and stay strong, all — one day at a time, and laugh every day no matter what. Colon cancer survivor. 2 years this month. Stage 4. Had the 5-fu and other chemo drugs, was allergic and only received not guite 3 months tx. So glad new tx. Are becoming available. Looks like I got an early birthday present!! I’m hoping to take this drug!! I been fighting this for 2 yr,6 mo. I was also excited until I read that it increases your life expectancy for 2 months. Don’t get me wrong 2 months is two months. Expressly when some quack doctor at Washington Hospital gave me 2 months. My doctor at Georgetown Hospital wear I go for treatment went off. Guess im still hoping for a cure. Good luck to every body, stay tuff. Comments are closed.
My mom is now 75 years old and was diagnosed in 2012 with stage 4 colon cancer. It spreaded to her liver. She was told that she couldn’t have surgery because the size of the tumor was too large and she had small spots surrounded the colon and to remove it they would have to gut her to try and get it all. She really wanted to have surgery but it would have been very risky. I didn’t want to take that chance of having surgery and the cancer returning spreading all over her body. It’s been 4 1/2 years now and her Doctor told that all the chemo she has taken isn’t working anymore and the tumor on her colon is growing back. She is taking Lonsorf, which is the pill and I am hoping this will shrink the tumor again. I know we all got to die of something, just praying and hoping she will be here with us a while longer. I never give up. Continue to trust in the man above. He is in control.
I’m 53 years old. Diagnosed with stage 4 colon cancer at 45. I had colectomy to remove cancer (lost a foot of colon) and also had thoracic surgery to remove cancer from lung. I then did 6 months of preventative chemo and lived healthy life for next 5.8 years, working full time and raising family. My cancer returned in early 2015 to lymph nodes. Did another 6 months of chemo and radiation then had major surgery to remove cancer from risky area. After long recovery I returned to work in ja n 2016, only to find out 6 weeks later that cancer back and spread to both lungs. I have talked to my oncologist about TAS-102 and will be starting shortly. I’d love to hear from folks who were part of trial. Thanks!!
Stay strong Monica! Thanks for sharing your story with us! This online patient community might have some feedback for you: https://www.inspire.com/groups/fight-colorectal-cancer/
My mother has colon rectal cancer with mets to the liver and now longsMy mom tooknthe 1st 2 weeks of this drug but while on the break she was in a lot of pain and endednup being hospitalized. Her potassium had decresed she had a loss of appetite and her electrolytes were down. She became weak and very confused. Her kidney function had decreased but God. As they replaced fluids and electrolytes lost her kidney functions increased and she has began to get stronger. She would have been scheduled to begin treatment again this up coming Monday but of course it has been put on hold. Dr don’t knownif it was the chemo drug or the fact that she wasn’t eating or the progression of the cancer. Its hard but we know God is able. She is now at a rehab facility.
My wife has been fighting colorectal for 6-1/2 years now — resection, spread to lung (one lobe removed), spread to piraformis (radiation) and now spread to liver. She has been through all the drugs noted in the first paragraph of side effects above and starts this drug tomorrow. Would love to see posts from or about anyone who has taken this. Thank you and stay strong, all — one day at a time, and laugh every day no matter what.
Colon cancer survivor. 2 years this month. Stage 4. Had the 5-fu and other chemo drugs, was allergic and only received not guite 3 months tx. So glad new tx. Are becoming available.
I been fighting this for 2 yr,6 mo. I was also excited until I read that it increases your life expectancy for 2 months. Don’t get me wrong 2 months is two months. Expressly when some quack doctor at Washington Hospital gave me 2 months. My doctor at Georgetown Hospital wear I go for treatment went off. Guess im still hoping for a cure. Good luck to every body, stay tuff.