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The NEXT-1 (Next generation pErsonalized tX with mulTi-omics and preclinical model) trial: prospective molecular screening trial of metastatic solid cancer patients, a feasibility analysis

We conducted a prospective genomic screening trial with high throughput sequencing and copy number variation (CNV) assay, and immunohistochemistry array in metastatic solid cancer patients. We used Ion AmpliSeq Cancer Hotspot Panel v2 and nCounter Copy Number Variation Assay (21 genes) to identify m...

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Autores principales: Kim, Seung Tae, Lee, Jeeyun, Hong, Mineui, Park, Kyunghee, Park, Joon Oh, Ahn, Tae Jin, Park, Se Hoon, Park, Young Suk, Lim, Ho Yeong, Sun, Jong-Mu, Ahn, Jin Seok, Ahn, Myung-Ju, Kim, Hee Cheol, Sohn, Tae Sung, Choi, Dong Il, Cho, Jong Ho, Heo, Jin Seok, Kwon, Wooil, Uhm, Sang Won, Lee, Hyuk, Min, Byung-Hoon, Hong, Sung No, Kim, Duk Hwan, Jung, Sin Ho, Park, Woongyang, Kim, Kyoung-Mee, Kang, Won Ki, Park, Keunchil
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Impact Journals LLC 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4741771/
https://www.ncbi.nlm.nih.gov/pubmed/26396172
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author Kim, Seung Tae
Lee, Jeeyun
Hong, Mineui
Park, Kyunghee
Park, Joon Oh
Ahn, Tae Jin
Park, Se Hoon
Park, Young Suk
Lim, Ho Yeong
Sun, Jong-Mu
Ahn, Jin Seok
Ahn, Myung-Ju
Kim, Hee Cheol
Sohn, Tae Sung
Choi, Dong Il
Cho, Jong Ho
Heo, Jin Seok
Kwon, Wooil
Uhm, Sang Won
Lee, Hyuk
Min, Byung-Hoon
Hong, Sung No
Kim, Duk Hwan
Jung, Sin Ho
Park, Woongyang
Kim, Kyoung-Mee
Kang, Won Ki
Park, Keunchil
author_facet Kim, Seung Tae
Lee, Jeeyun
Hong, Mineui
Park, Kyunghee
Park, Joon Oh
Ahn, Tae Jin
Park, Se Hoon
Park, Young Suk
Lim, Ho Yeong
Sun, Jong-Mu
Ahn, Jin Seok
Ahn, Myung-Ju
Kim, Hee Cheol
Sohn, Tae Sung
Choi, Dong Il
Cho, Jong Ho
Heo, Jin Seok
Kwon, Wooil
Uhm, Sang Won
Lee, Hyuk
Min, Byung-Hoon
Hong, Sung No
Kim, Duk Hwan
Jung, Sin Ho
Park, Woongyang
Kim, Kyoung-Mee
Kang, Won Ki
Park, Keunchil
author_sort Kim, Seung Tae
collection PubMed
description We conducted a prospective genomic screening trial with high throughput sequencing and copy number variation (CNV) assay, and immunohistochemistry array in metastatic solid cancer patients. We used Ion AmpliSeq Cancer Hotspot Panel v2 and nCounter Copy Number Variation Assay (21 genes) to identify molecular targets for potential matched therapy. Metastatic solid tumor patients were prospectively consented for molecular profiling tests. The primary outcome for this trial was the feasibility of molecular tests and response rate (matched vs non-matched treatment). Between November 2013 and August 2014, a total of 428 metastatic solid tumor patients were enrolled on to this study. The mutational profiles were obtained for 407 (95.1%) patients. CNV 21-gene assays were successfully performed in 281 (65.7%) of 428 patients. Of the 407 patients with molecular profiling results, 342 (84.0%) patients had one or more aberrations detected. Of the 342 patients, 103 patients were matched to molecularly targeted agents in the context of clinical trials or clinical practice. The response rate was significantly higher in the genome-matched treated group for gastrointestinal/hepatobiliary/rare tumors (matched vs non-matched treatment, 42.6% vs 24.3%, P = .009) and lung cancer cohort (matched vs non-matched treatment, 61.2% vs 28.6% < P = .001) when compared with the non-matched group. In this trial, we demonstrate that genome-matched treatment based on molecular profiling result in better treatment outcome in terms of response rate.
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spelling pubmed-47417712016-03-11 The NEXT-1 (Next generation pErsonalized tX with mulTi-omics and preclinical model) trial: prospective molecular screening trial of metastatic solid cancer patients, a feasibility analysis Kim, Seung Tae Lee, Jeeyun Hong, Mineui Park, Kyunghee Park, Joon Oh Ahn, Tae Jin Park, Se Hoon Park, Young Suk Lim, Ho Yeong Sun, Jong-Mu Ahn, Jin Seok Ahn, Myung-Ju Kim, Hee Cheol Sohn, Tae Sung Choi, Dong Il Cho, Jong Ho Heo, Jin Seok Kwon, Wooil Uhm, Sang Won Lee, Hyuk Min, Byung-Hoon Hong, Sung No Kim, Duk Hwan Jung, Sin Ho Park, Woongyang Kim, Kyoung-Mee Kang, Won Ki Park, Keunchil Oncotarget Research Paper We conducted a prospective genomic screening trial with high throughput sequencing and copy number variation (CNV) assay, and immunohistochemistry array in metastatic solid cancer patients. We used Ion AmpliSeq Cancer Hotspot Panel v2 and nCounter Copy Number Variation Assay (21 genes) to identify molecular targets for potential matched therapy. Metastatic solid tumor patients were prospectively consented for molecular profiling tests. The primary outcome for this trial was the feasibility of molecular tests and response rate (matched vs non-matched treatment). Between November 2013 and August 2014, a total of 428 metastatic solid tumor patients were enrolled on to this study. The mutational profiles were obtained for 407 (95.1%) patients. CNV 21-gene assays were successfully performed in 281 (65.7%) of 428 patients. Of the 407 patients with molecular profiling results, 342 (84.0%) patients had one or more aberrations detected. Of the 342 patients, 103 patients were matched to molecularly targeted agents in the context of clinical trials or clinical practice. The response rate was significantly higher in the genome-matched treated group for gastrointestinal/hepatobiliary/rare tumors (matched vs non-matched treatment, 42.6% vs 24.3%, P = .009) and lung cancer cohort (matched vs non-matched treatment, 61.2% vs 28.6% < P = .001) when compared with the non-matched group. In this trial, we demonstrate that genome-matched treatment based on molecular profiling result in better treatment outcome in terms of response rate. Impact Journals LLC 2015-09-09 /pmc/articles/PMC4741771/ /pubmed/26396172 Text en Copyright: © 2015 Kim et al. http://creativecommons.org/licenses/by/2.5/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Paper
Kim, Seung Tae
Lee, Jeeyun
Hong, Mineui
Park, Kyunghee
Park, Joon Oh
Ahn, Tae Jin
Park, Se Hoon
Park, Young Suk
Lim, Ho Yeong
Sun, Jong-Mu
Ahn, Jin Seok
Ahn, Myung-Ju
Kim, Hee Cheol
Sohn, Tae Sung
Choi, Dong Il
Cho, Jong Ho
Heo, Jin Seok
Kwon, Wooil
Uhm, Sang Won
Lee, Hyuk
Min, Byung-Hoon
Hong, Sung No
Kim, Duk Hwan
Jung, Sin Ho
Park, Woongyang
Kim, Kyoung-Mee
Kang, Won Ki
Park, Keunchil
The NEXT-1 (Next generation pErsonalized tX with mulTi-omics and preclinical model) trial: prospective molecular screening trial of metastatic solid cancer patients, a feasibility analysis
title The NEXT-1 (Next generation pErsonalized tX with mulTi-omics and preclinical model) trial: prospective molecular screening trial of metastatic solid cancer patients, a feasibility analysis
title_full The NEXT-1 (Next generation pErsonalized tX with mulTi-omics and preclinical model) trial: prospective molecular screening trial of metastatic solid cancer patients, a feasibility analysis
title_fullStr The NEXT-1 (Next generation pErsonalized tX with mulTi-omics and preclinical model) trial: prospective molecular screening trial of metastatic solid cancer patients, a feasibility analysis
title_full_unstemmed The NEXT-1 (Next generation pErsonalized tX with mulTi-omics and preclinical model) trial: prospective molecular screening trial of metastatic solid cancer patients, a feasibility analysis
title_short The NEXT-1 (Next generation pErsonalized tX with mulTi-omics and preclinical model) trial: prospective molecular screening trial of metastatic solid cancer patients, a feasibility analysis
title_sort next-1 (next generation personalized tx with multi-omics and preclinical model) trial: prospective molecular screening trial of metastatic solid cancer patients, a feasibility analysis
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4741771/
https://www.ncbi.nlm.nih.gov/pubmed/26396172
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