MedPage Today released an article on Sept.22, 2015 titled ‘Too Toxic’ Colorectal Cancer Drug Now OK’d – FDA approves tipiracil-trifluridine combo, to be sold as Lonsurf. John Gever, managing editor of MedPage Today wrote the article that was based upon the Food and Drug Administration (FDA) announcement of Lonsurf’s fast track testing and approval on Sept. 22, 2015.
Trifluridine was an early chemotherapy drug developed in the 1950s. It was abandoned because of the occurrence of severe adverse side effects. Trifluridine has now been combined with a newer drug, tipiracil, to create a new product called Lonsurf. Lonsurf will be used in stage 4 colorectal cancers where all other treatment approaches have failed. Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, justified the approval of the new chemotherapy drug combination that uses the previously discontinued drug.
“The past decade has brought a new understanding around colorectal cancer, in how we can both detect and treat this often devastating disease. But there are many patients who still need additional options, and today’s approval is a testament to the FDA’s commitment to work with companies to develop new drugs in disease areas where unmet needs remain.
“Although adding tipiracil to trifluridine appears to have improved the benefit-risk balance, the combination still comes with a long list of adverse effects, including a range of hematologic deficiencies, extreme fatigue, decreased appetite, fever, and gastrointestinal disruptions.”
The FDA provided a description of the international double-blind study on 800 patients with metastasized colon cancer, with some patients on Lonsurf and some on a placebo. The adverse side effects would be considered life threatening in healthy patients. For those with advanced colorectal cancer that has spread to other areas of the body, the major consideration is how bad the physical effects of Lonsurf are versus the documented extension of life for metastasized colon cancer patients.
“Study participants received Lonsurf plus best supportive care, or placebo plus best supportive care until their disease worsened or side effects became intolerable. The primary endpoint of the study was overall survival and the secondary endpoint was progression-free survival. Patients treated with Lonsurf lived an average of 7.1 months compared to 5.3 months for those treated with placebo. On average, the time to disease progression was two months for patients on Lonsurf compared to 1.7 months for patients receiving placebo.”
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.
For readers that need to determine the cost of chemotherapy, there is a site available to provide guidance on various drug costs. Colon cancer drugs are among the highest in price, with generic versions being as little as 10% of the newest drugs. Given the efficacy and side-effects of Lonsurf, which is the newest colon cancer drug therapy, resorting to generic drugs or no further treatments are choices to be considered.
Chemotherapy works much better with certain forms of cancer than for colon or lung cancer. Frequent checkups to provide early detection of polyps or cancers is the best survival mechanism. Those with a family history of cancer, or genetic markers with known links to cancer, should be tested frequently. As with all forms of cancer, prevention holds much greater success than attempts at cures. For those facing metastasized cancers of any type, the difficult choice of treatment or palliative care is a reality.