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A trial designed from mouse avatars: screening 914 patients found 48 with HER2-amplified bowel cancer, and blocking HER2 two ways shrank tumours in 30 percent of the 27 who were treated.
Sartore-Bianchi, Trusolino, Martino and colleagues ran HERACLES as a proof-of-concept, multicentre, open-label phase 2 trial at four Italian academic cancer centres, after finding that dual HER2 blockade inhibited tumour growth in patient-derived xenografts of HER2-amplified metastatic colorectal cancer. Adults with KRAS exon 2 wild-type, HER2-positive metastatic colorectal cancer refractory to standard of care including cetuximab or panitumumab received intravenous trastuzumab and oral lapatinib 1,000 mg daily until progression. HER2 positivity used colorectal-specific immunohistochemistry and fluorescence in-situ hybridisation criteria the group had validated. The primary endpoint was objective response by independent central review.
Screening 914 patients identified 48 (5 percent) with HER2-positive tumours, of whom 27 were eligible and treated.
The first demonstration that HER2 is actionable in colorectal cancer, and the trial that defined the colorectal-specific HER2 scoring criteria every later trial has used.
The first United States approval of a HER2-directed regimen in colorectal cancer, and the basis for MOUNTAINEER-03, which is testing the combination with chemotherapy in the first line.
The antibody-drug conjugate route into HER2-positive colorectal cancer, extended by DESTINY-CRC02 at a lower dose; interstitial lung disease is the class risk that defines how the drug is monitored.
Shares Salvatore Siena, 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, KRAS, Monoclonal antibodies 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, The Lancet Oncology, KRAS, Monoclonal antibodies and the tag colorectal-evidence.
Shares Comprehensive molecular characterization of human colon and rectal cancer, 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, KRAS, Colorectal cancer 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, KRAS, Monoclonal antibodies, Colorectal cancer 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, KRAS, Monoclonal antibodies, Colorectal cancer 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, The Lancet Oncology, Colorectal cancer 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, KRAS, Monoclonal antibodies, Colorectal cancer 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, Monoclonal antibodies, Small-molecule kinase inhibitors, Colorectal cancer and the tag colorectal-evidence.