Patients with advanced colorectal cancer respond well to the new combined therapy -
In an aggressive disease known for low response rate, researchers from the University of Texas MD Anderson cancer Center found patients with advanced colorectal cancer responded well to a combination of vemurafenib therapy drugs, cetuximab and irinotecan.
The Phase I trial presented Saturday, May 31 in a discussion poster at the American Society 2014 Annual Clinical Oncology meeting in Chicago, examines a specific mutation in the BRAF gene, which is present in 5 to 10 percent of patients with colorectal cancer.
previous research identified this mutation as a target for therapy, but response rates with single agent vemurafenib were poor, leading researchers to learn more about the combination with different drugs.
"Patients with BRAF mutation in colorectal cancer are known to have aggressive disease that generally do not respond to standard chemotherapy," said David Hong, MD, associate professor, Investigational Cancer Therapeutics and principal. "So when BRAF inhibitors initially started there was excitement which could become the new standard of care, but we found they did not work very well."
in the study, the researchers combined increasing doses of vemurafenib (V) and cetuximab (C) and irinotecan (I), two drugs already used to treat metastatic. Twelve patients colorectal cancer were enrolled in both dose levels including seven at the dose of one (V-480 mg, 250 mg and C-I-180 mg) and five at the two dose with vemurafenib increased to 720 mg.
radiographic images were evaluated every four cycles in a cycle of 14 days of treatment. Patients were evaluated for adverse events with the most common, including rashes, diarrhea and nausea.
The results show better responses
Of the nine evaluable patients, partial responses or stable disease was seen in eight patients with colorectal cancer having undergone restaging examinations following the start of treatment. The rate for colorectal eight patients response was 50 percent, while response rates with single agent vemurafenib is less than 10 percent.
"What is promising is that we see these high response rates in early studies suggesting this could become a new standard of care in line," said Hong. "There is clearly a kind of synergistic activity with the combination."
US A randomized cooperative trial phase II of this association in colorectal cancer BRAF mutated begin later this summer led by Scott Kopetz, MD, Ph.D., In Gastrointestinal Medical Oncology is the lead author of the phase I.
"Although early, the exciting aspect is that we see significant response rates, but questions remain as to the duration of these responses and mechanisms resistance are "Kopetz said. "By expanding our initial findings and move to cooperative group network, we will be able to quickly conduct studies that could lead to get this approved combination."
EmoticonEmoticon