New treatment approved for advanced colorectal cancer

FDA has approved a combination oral therapy of trifluridine and tipiracil (Lonsurf, Taiho Oncology) for patients with metastatic colorectal cancer who were previously treated with chemotherapy and biological therapy.

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Colorectal cancer is the second-leading cause of cancer-related deaths in the United States and the third most common non-skin cancer that affects both men and women. In 2012, more than 134,000 individuals developed colorectal cancer and more than 51,000 died from the disease, according to the Centers for Disease Control and Prevention.

“Metastatic colorectal cancer cells often become resistant to previously effective treatment, underscoring the importance of identifying new therapeutic options for patients with the disease,” said Robert J. Mayer, MD, faculty vice president for academic affairs at the Dana Farber Cancer Institute and professor of medicine at Harvard Medical School. “In a pivotal clinical trial, Lonsurf demonstrated that it can extend overall survival, providing patients and their oncologists with a novel oral therapy.”

The approval of the combination oral therapy was based on data from the phase 3 RECOURSE trial, which included 800 patients who had been previously treated for metastatic colorectal cancer. There were 533 patients who received the single agent Lonsurf at a dose of 35 mg/m² twice daily on day 1 through 5 and day 8 through 12 for each 28-day treatment cycle and supportive care. The placebo-controlled group (266 patients) received placebo and supportive care.

Overall survival

The primary endpoint was overall survival and the secondary endpoint was progression-free survival. The median overall survival in the Lonsurf-treated group was 7.1 months compared to 5.3 months in the placebo-controlled group, which was statistically significant. Disease progression, on average, was two months in the Lonsurf-treated group and 1.7 months in the placebo-controlled group.

The most common adverse effects from Lonsurf treatment in the trial were anemia, neutropenia, thrombocytopenia, weakness, fatigue, nausea, little appetite, diarrhea, vomiting, abdominal pain, and fever.

“Data from the pivotal RECOURSE study demonstrated a significant survival benefit for patients with refractory metastatic colorectal cancer, whose disease had progressed after standard therapies, reducing the risk of death in these patients by 32 percent,” said Fabio Benedetti, MD, Taiho Oncology’s senior vice president and chief medical officer.

Due to the risk of severe myelosuppression, patients need to be monitored closely, with complete blood count before and on day 15 of the treatment cycle. Treatment must be withheld if the patient develops febrile neutropenia, grade 4 neutropenia, or platelets less than 50,000 mm³, according to the company.