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The trial that added an EGFR antibody to first-line chemotherapy and, in the same paper, showed the benefit belongs only to patients whose KRAS gene is normal. It is the first negative predictive biomarker in bowel cancer.
Van Cutsem, Köhne, Hitre and colleagues randomly assigned patients with EGFR-positive colorectal cancer and unresectable metastases to FOLFIRI alone or with cetuximab, with progression-free survival as the primary end point, and sought associations between tumour KRAS mutation status and response. A total of 599 patients received cetuximab plus FOLFIRI and 599 received FOLFIRI alone.
Grade 3 or 4 skin reactions occurred in 19.7 percent of the cetuximab group against 0.2 percent, infusion-related reactions in 2.5 against 0 percent and diarrhoea in 15.7 against 10.5 percent.
Biomarker-directed treatment in colorectal cancer starts here: RAS testing became mandatory before an EGFR antibody, and the corpus's updated CRYSTAL analysis (paper-kras-colorectal-j-clin-oncol-2011) carries the mature survival figures in the wild-type group.
Extended RAS testing (KRAS and NRAS exons 2, 3 and 4) became the standard before any EGFR antibody, and about one in six patients who would previously have been treated is now spared a drug that would have made things worse.
One of the most cited trial reports Europe PMC returns for KRAS in Colorectal cancer, so it is a natural first reading for anyone weighing the idea it is linked from. The record was linked automatically by title and abstract; read the abstract above and the paper itself before relying on any figure.
This trial opened anti-angiogenic therapy as a class, and bevacizumab went on to approvals in lung, kidney, ovarian, cervical and brain cancers. It also set the pattern of modest but real survival gains from adding a biologic to chemotherapy, and introduced hypertension, proteinuria and perforation as the signature side effects clinicians now monitor.
Shares CRYSTAL & FIRE-3, Sidedness (left vs right colon), Irinotecan (and liposomal irinotecan), FOLFIRI (5-FU, leucovorin, irinotecan) and the tag colorectal-evidence.
Shares Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer (PRIME), CRYSTAL & FIRE-3, Eric Van Cutsem, Sidedness (left vs right colon) and the tag colorectal-evidence.
Shares Eric Van Cutsem, Irinotecan (and liposomal irinotecan), FOLFIRI (5-FU, leucovorin, irinotecan), Cetuximab and the tag colorectal-evidence.
Shares Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer (PRIME), Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation, RAS / RAF / MEK / ERK (MAPK), EGFR and the tag colorectal-evidence.
Shares Sidedness (left vs right colon), FOLFIRI (5-FU, leucovorin, irinotecan), Cetuximab, Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation and the tag colorectal-evidence.
Shares Irinotecan (and liposomal irinotecan), FOLFIRI (5-FU, leucovorin, irinotecan), Fluorouracil (5-FU), KRAS and the tag colorectal-evidence.
Shares Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation, Fluorouracil (5-FU), New England Journal of Medicine, Colorectal cancer and the tag colorectal-evidence.
Shares Eric Van Cutsem, Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation, New England Journal of Medicine, Colorectal cancer and the tag colorectal-evidence.