Colorectal cancer: cetuximab with FOLFOX improve patient outcomes5 Jul 2016
Results from the pivotal Phase 3 TAILOR study in patients from China, the first prospective trial to evaluate an anti-EGFR antibody in the first-line therapy of patients with RAS wild-type metastatic colorectal cancer (mCRC), demonstrate that cetuximab plus FOLFOX statistically significantly improves outcomes, including progression-free survival, overall survival and best overall response rate compared with FOLFOX alone.
“There are currently limited first-line options available in China for patients with RAS wild-type metastatic colorectal cancer,” said Professor Shukui Qin from Nanjing Bayi Hospital, China, Coordinating Investigator in the TAILOR study. “The results of the TAILOR study strongly support the benefit of cetuximab in the treatment of these patients, and we are hopeful it will soon be approved so that patients in this country will be able to access treatment options that they so desperately need.”
Safety profile of cetuximab: no unexpected safety findings
The TAILOR study randomized 393 patients from China with RAS wild-type mCRC, and the results demonstrate that adding cetuximab to FOLFOX, as a first-line treatment, significantly improves progression-free survival and overall survival. The safety profile of cetuximab observed in TAILOR is similar to that seen in prior randomized clinical trials, with no unexpected safety findings.
Notably, compared with those receiving FOLFOX alone, patients in the study receiving cetuximab plus FOLFOX experienced:
- A best overall response rate of 61.1%, which is in line with international studies,
- A 31% decrease in the risk of disease progression
- A 24% reduction in the risk of death
Cetuximab plus FOLFOX: an effective treatment regimen
“The results of the TAILOR study further reaffirm that cetuximab plus FOLFOX as chemotherapy backbone is an effective treatment regimen for patients with RAS wild-type mCRC, as we have seen in previous international pivotal studies, such as OPUS,” said Prof. Carsten Bokemeyer, University Medical Center, Hamburg–Eppendorf, Germany and primary investigator of the OPUS study. “As the first prospective trial evaluating cetuximab in RAS wild-type patients, the TAILOR results reinforce the value and importance of RAS biomarker testing in order to determine the appropriate targeted therapy for individual patients, based on their tumor’s genetic make-up.”
Both the National Comprehensive Cancer Network (U.S.) and the European Society for Medical Oncology clinical guidelines recommend first-line treatment with cetuximab plus either FOLFOX or FOLFIRI for patients with RAS wild-type mCRC.Source: eCancer News