New advances in the treatment of pre-treated metastatic colorectal cancer3 Jul 2015
Regorafenib proved to be beneficial for patients with previously treated metastatic colorectal cancer (mCRC), a new phase 3b study confirmed.
The CONSIGN study was a prospective, observational study that was initiated to allow patients with mCRC access to regorafenib before marketing authorization and to assess safety. The previous randomized phase 3 CORRECT trial showed that regorafenib significantly improves survival in patients with pre-treated mCRC and led to regulatory approval.
Similar clinical characteristics to daily practice
CONSIGN included more than 2,800 patients at 188 sites in 25 countries who received regorafenib for a median of 2.5 months. Grade >3 adverse events occurred in 80% of patients.
According to the study’s lead author Prof Eric Van Cutsem, University Hospitals Leuven, Belgium, this study conducted in a real world population of metastatic colorectal cancer patients, shows a similar safety profile and progression-free survival with regorafenib as shown in the randomized CORRECT trial.
Commenting on the data, Dr Dirk Arnold, ESMO spokesperson, director of the Department of Medical Oncology, Klinik für Tumorbiologie in Freiburg, Germany said that the merit of this study is that patients had similar characteristics and pre-treatment to what we see in daily practice.
Class specific and likely manageable adverse events
On the adverse events, Dr Dirk reported that they were within the scope of expectation and comparable to the CORRECT trial adding that “until now nothing has been found that would allow prediction of the benefit of regorafenib for a specific group of patients.”
Arnold concluded: “The main difference between the two trials is the ethnicity of the patients. It’s not clear whether it is ethnicity or pre-treatment that brings the difference in benefit, but very likely it’s the pre-treatment.”
TAS-102 proved effective also in largely pre-treated patients
In addition, a subgroup analysis of the phase 3 RECOURSE trial in metastatic colorectal cancer has shown that TAS-102 was associated with improved overall survival and progression-free survival in patients with KRAS wild type and mutant tumors.
However, the overall survival benefit in patients with KRAS mutant tumors did not reach statistical significance.
No differences in adverse events between mutant and wild type groups
Commenting on the data, Dirk Arnold said: “Overall there were no large differences in efficacy or in the incidence of adverse events according to KRAS status. However, patients with wild type status had a better outcome than those with mutant status.
The analysis of the results underlined the scientists’ knowledge that that the mutation confers a poorer prognosis also in largely pre-treated patients, and not that TAS-102 is less effective in these patients.
There were no differences in adverse events between mutant and wild type groups.Source: eCancer News