Advanced Colorectal Cancer Treatment Approved

The US Food and Drug Administration (FDA) has approved the oral nucleoside TAS-102 (Lonsurf/ Taiho Pharmaceutical Co., Ltd) to treat patients with advanced colorectal cancer (CRC) who had not been responding to other treatments.

This approval was based on results from the phase III RECOURSE trial, which included 800 patients with refractory metastatic (mCRC) who were randomized to receive the best supportive care along with TAS-102 (n=534) or placebo (n=266).

All the patients had already received fluoropyrimidine, irinotecan, oxaliplatin, and bevacizumab, and 52% had received an EGFR inhibitor. Also, nearly 20% of the patient population had already received treatment with regorafenib.

Results indicated the median overall survival for mCRC patients administered TAS-102 was 7.1 months compared to that of the 5.3 months for the placebo group.

Additionally, the median progression-free survival (PFS) in the TAS-102 unit was two months compared with the 1.7 months of the placebo crowd.

TAS-102 was given at 35 mg/m2 twice daily with meals for five days, with two days of rest for two weeks followed by a 14-day rest period. The protocol allowed a maximum of 3 dose reductions of 5 mg/m2 each. The primary endpoint of the study was OS, with secondary endpoints focused on PFS, overall response rate (ORR), and disease control rate (DCR).

Researchers reported TAS-102 significantly delayed the severity of the disease for patients with mCRC. All patients were enrolled with an ECOG performance status (PS) of one (44%) or zero (56%).

The most commonly reported grade 3/4 adverse events of concern with TAS-102 versus placebo were anemia and thrombocytopenia along with nausea, vomiting, and diarrhea.

Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, commented in a release, “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.”

TAS-102 was approved in Japan on March 20, 2015, based on findings from a phase II study.