Sorry but today I am also getting into new and very difficult data to discuss but wanted to give it a shot since you may surf the Net and come across data which are shown to be negative leading to some stress if you are on similar or same therapy.
I attended the European Meeting for Medical Oncology in Berlin two weeks ago, and some new data were presented. Let’s start with the good news which is consistent with all the data we have. In a large randomized phase III trial called CRYSTAL comparing FOLFIRI with or without Erbitux® (cetuximab), the data showed that in patients with wild-type KRAS response rate went up to 60% and time to tumor progression increased about 30% but, so far no overall survival benefit was shown. The trial was criticized for that.
At the meeting in Berlin after more wild-type KRAS testing was completed there was significant survival benefit for patients treated with Erbitux supporting the impact of this drug in patients with wild-type KRAS for tumor shrinkage, prolongation of time to tumor growth and overall survival. Every patients should be tested for wild-type KRAS prior any treatment decisions.
There is however discussion whether overall survival is a valid endpoint because of many possibilities to receive the drug tested later on in another trial or if approved on the market since overall survival depends on what therapies are available beyond the first regimen. Many trials now look at response rates and time to tumor progression since this is not changed by other therapies following progression of disease with possible crossover of patients to the drug tested.
Disclosure: C3 has accepted funding for projects and educational programs from Bristol-Myers Squibb and ImClone Systems in the form of unrestricted educational grants. C3 has ultimate authority over website content.
Dr. Lenz also receives consultant fees, honoraria, and research funding from corporations, including ImClone, Bristol Myers Squibb, and Eli Lilly. See his full disclosures.