PARADIGM Trial: Recent Data on EGFR-Targeting Therapy for mCRC
Arvind Dasari, MD, MS, reviews the PARADIGM study on EGFR-targeting therapy in metastatic colorectal cancer.
Transcript:
Cathy Eng, MD, FACP, FASCO: Dr Dasari, in talking about what is available for our patients, can you briefly mention recent data regarding the PARADIGM study [NCT02394795], which is focused on the role of EGFR therapy? I know it’s a little bit different from what we started off with, but that’s another option obviously for a newly diagnosed patient. What does this mean?
Arvind Dasari, MD, MS: As you mentioned, the PARADIGM study was done in patients with newly diagnosed metastatic colorectal cancer who had RAS wild-type tumors. They were randomized to first-line chemotherapy with FOLFOX [folinic acid, fluorouracil, and oxaliplatin] plus bevacizumab vs FOLFOX plus panitumumab with a primary end point of overall survival. With emerging data around sidedness being a strong biomarker, the protocol was amended to allow only left-sided tumors. The trial overall enrolled about 800 patients, of which about 600 were left-sided. The study design had a hierarchical approach first evaluating the left-sided tumors and, if positive, evaluating the entire study population.
The study did meet its primary end point with improvement in overall survival in the panitumumab arm over the bevacizumab arm, I think with a hazard ratio of about 0.7, improving from 34 months to around 38 months. Similar results were also seen in the whole cohort. I think this in many ways validates what was already proven through analysis of phase 3 trials that were done previously. In that, patients with RAS wild-type tumors that are left-sided should be strongly considered for EGFR monoclonal antibody therapy, especially if they are BRAF wild type and do not have HER2 [human epidermal growth factor receptor 2]-amplified tumors.
Cathy Eng, MD, FACP, FASCO: Thank you so much. I think that really is something our European colleagues adopted earlier on, and we were a bit reluctant. But I think we’re a little bit swayed given some of this recent data. But it’s also important to keep in mind the progression-free survival regarding the PARADIGM trial was fairly equivalent between the 2 arms.
Arvind Dasari, MD, MS: You raise a great point. The progression-free survival is pretty similar between the 2 arms, but the response rate was higher in the panitumumab arm, and so were the rates of curative resection.
Cathy Eng, MD, FACP, FASCO: Very valid points.
Transcript edited for clarity.
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