Treatment recommendations to cancer patients in the context of FDA guidance for next generation sequencing

Dy, Grace K.; Nesline, Mary K.; Papanicolau-Sengos, Antonios; DePietro, Paul; LeVea, Charles M.; Early, Amy; Chen, Hongbin; Grand’Maison, Anne; Boland, Patrick; Ernstoff, Marc S.; Edge, Stephen; Akers, Stacey; Opyrchal, Mateusz; Chatta, Gurkamal; Odunsi, Kunle; Pabla, Sarabjot; Conroy, Jeffrey M.; Glenn, Sean T.; DeFedericis, Hanchun T.; Burgher, Blake; Andreas, Jonathan; Giamo, Vincent; Qin, Maochun; Wang, Yirong; Kanehira, Kazunori; Lenzo, Felicia L.; Frederick, Peter; Lele, Shashikant; Galluzzi, Lorenzo; Kuvshinoff, Boris; Morrison, Carl

doi:10.1186/s12911-019-0743-x

BMC Medical Informatics and Decision Making

Table 2 Level 1 and 2 evidence therapeutic variant associations tested by OmniSeq Comprehensive® (June 2017)

From: Treatment recommendations to cancer patients in the context of FDA guidance for next generation sequencing

Level 1 (Companion Diagnostics)
Genomic Variant(s)	Tumor Type	Therapy(ies)
ALK fusion	Lung	alectinib, brigatinib, ceritinib, crizotinib
BRAF V600E or BRAF V600K mutation	Melanoma	cobimetinib + vemurafenib; dabrafenib; dabrafenib + trametinib; trametinib; vemurafenib
BRAF V600E or BRAF V600K mutation	Lung	dabrafenib + trametinib
BRCA mutation	Ovarian	olaparib, rucaparib
EGFR exon 19 deletion	Lung	afatinib; bevacizumab + erlotinib; erlotinib; gefitinib; osimertinib
EGFR exon 20 insertion^a	Lung	gefitinib
EGFR G719 mutation	Lung	afatinib; gefitinib
EGFR L858R mutation	Lung	afatinib; bevacizumab + erlotinib; erlotinib; gefitinib; osimertinib
EGFR L861Q mutation	Lung	afatinib; gefitinib
EGFR S768I mutation	Lung	afatinib; gefitinib
EGFR T790 M mutation^a	Lung	gefitinib
EGFR T790 M mutation	Lung	osimertinib
ERBB2 amplification	Breast	ado-trastuzumab emtansine; lapatinib + aromatase inhibitor; lapatinib + chemo; lapatinib + trastuzumab; neratinib; pertuzumab + trastuzumab + chemo; trastuzumab; trastuzumab + aromatase inhibitor; trastuzumab + chemo
ERBB2 amplification	Esophageal	trastuzumab; trastuzumab + chemo
ERBB2 amplification	Gastric/GEJ	trastuzumab; trastuzumab + chemo
KRAS A146 or KRAS A59 mutation^a	Colorectal	cetuximab; panitumumab
KRAS exon 2, 3 or 4 mutation^a	Colorectal	cetuximab; cetuximab + chemo; panitumumab + chemo
KRAS G12, KRAS G13, KRAS K117, or KRAS Q61 mutation^a	Colorectal	cetuximab; panitumumab
NRAS A146 or NRAS A59 mutation^a	Colorectal	cetuximab; panitumumab
NRAS exon 2, 3 or 4 mutation^a	Colorectal	cetuximab; cetuximab + chemo; panitumumab + chemo
NRAS G12, NRAS G13, NRAS K117, or NRAS Q61 mutation^a	Colorectal	cetuximab; panitumumab
ROS1 fusion	Lung	crizotinib
Level 2 (Professional Practice Guidelines)
Genomic Variant	Tumor Type	Therapy
ALK fusion	Sarcoma	ceritinib, crizotinib
ALK fusion^a	Lung	EGFR tyrosine kinase inhibitor
BRAF mutation	Thyroid	vemurafenib
BRAF V600E mutation	Colorectal	cetuximab + vemurafenib + chemo; panitumumab + vemurafenib + chemo
BRAF V600E mutation	Lung	dabrafenib; vemurafenib
ERBB2 mutation	Lung	ado-trastuzumab emtansine
ERBB2 mutation	Head and Neck	trastuzumab
ERBB2 mutation	Breast	trastuzumab + chemo
KIT exon 9 mutation	Sarcoma	imatinib
KIT exon 11 mutation	Sarcoma	imatinib
KIT exon 11 or KIT exon 13 mutation	Melanoma	imatinib
KRAS mutation^a	Lung	EGFR tyrosine kinase inhibitor (afatinib; erlotinib; erlotinib; gefitinib; osimertinib)
MET amplification or MET exon 14 skipping mutation	Lung	crizotinib
NF1 mutation^a	Sarcoma	imatinib
PDGFRA D842V mutation^a	Sarcoma	dasatinib; imatinib
RET fusion	Lung	cabozantinib; vandetanib
RET mutation	Thyroid	vandetanib
ROS1 fusion	Lung	alectinib; ceritinib
ROS1 fusion^a	Lung	EGFR tyrosine kinase inhibitor (afatinib; erlotinib; erlotinib; gefitinib; osimertinib)

^aThese mutations confer resistance to the associated therapeutic (contraindication)

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ISSN: 1472-6947

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