ASCO GI 2023 | DEEPER: m-FOLFOXIRI and cetuximab versus bevacizumab in mCRC
Yu Sunakawa, MD, PhD, St. Marianna University School of Medicine, Kawasaki, Japan, presents data from a survival analyses of the Phase II DEEPER trial (NCT02515734) of cetuximab versus bevacizumab in combination with modified (m)-FOLFOXIRI in patients with previously untreated metastatic colorectal (mCRC) with RAS wild-type tumors. Addition of cetuximab resulted in longer progression-free survival (PFS) in patients with left-sided tumors, compared to the PARADIGM trial (NCT02394795), where PFS was similar in the panitumumab and bevacizumab arms. This interview took place at the American Society of Clinical Oncology (ASCO) 2023 Gastrointestinal Cancers (GI) Symposium in San Francisco, CA.
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Transcript (edited for clarity)
I’d like to introduce the clinical trial data of the DEEPER trial. The DEEPER trial is a randomized Phase II trial to evaluate modified FOLFOXIRI plus cetuximab versus modified FOLFOXIRI plus bevacizumab in initial therapy for RAS wild-type metastatic colorectal cancer. Last year, the Japanese Phase III trial PARADIGM study indicated OS benefit of FOLFOX plus panitumumab compared to the FOLFOX plus bevacizumab in RAS wild-type left-sided primary tumor metastatic colorectal cancer...
I’d like to introduce the clinical trial data of the DEEPER trial. The DEEPER trial is a randomized Phase II trial to evaluate modified FOLFOXIRI plus cetuximab versus modified FOLFOXIRI plus bevacizumab in initial therapy for RAS wild-type metastatic colorectal cancer. Last year, the Japanese Phase III trial PARADIGM study indicated OS benefit of FOLFOX plus panitumumab compared to the FOLFOX plus bevacizumab in RAS wild-type left-sided primary tumor metastatic colorectal cancer. The PARADIGM study PFS was similar between two arms. In DEEPER trial, the primary endpoint is depth of response, which were already presented at ASCO meeting two years ago. Actually, DpR was significantly better in cetuximab arm compared to bevacizumab.
In this time ASCO GI meeting, sub-analysis indicated PFS data of the DEEPER trial. So actually, RAS wild-type patient, PFS was similar between cetuximab and bevacizumab arm, but in RAS wild-type on the left-sided primary tumor, PFS was longer in cetuximab plus modified FOLFOXIRI compared to bevacizumab plus modified FOLFOXIRI. So actually in RAS/BRAF wild-type left-sided primary tumor, PFS was significantly statistically longer in cetuximab arm compared to bevacizumab. Also, the median PFS was 50.3 months in cetuximab arm. On the other hand, median PFS was 11.7 months in bevacizumab arm. So actually, the DEEPER trial demonstrated PFS was significantly longer in cetuximab compared to bevacizumab in combination with modified FOLFOXIRI for RAS/BRAF wild-type on the left-sided primary tumor. So this trial, this is a first report to show prospectively superiority of cetuximab combination chemotherapy compared to bevacizumab in terms of PFS. Also, this trial demonstrated the association between DpR and survival in colorectal cancer. So from this trial, modified FOLFOXIRI plus cetuximab could be a good option as initial therapy for RAS/BRAF wild-type and left-sided primary tumor.
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