Cargando…
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1782414066483986432 |
---|---|
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. |
format | Online Article Text |
id | pubmed-4741771 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Impact Journals LLC |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT kimseungtae thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT leejeeyun thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT hongmineui thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT parkkyunghee thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT parkjoonoh thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT ahntaejin thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT parksehoon thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT parkyoungsuk thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT limhoyeong thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT sunjongmu thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT ahnjinseok thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT ahnmyungju thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT kimheecheol thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT sohntaesung thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT choidongil thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT chojongho thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT heojinseok thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT kwonwooil thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT uhmsangwon thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT leehyuk thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT minbyunghoon thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT hongsungno thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT kimdukhwan thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT jungsinho thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT parkwoongyang thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT kimkyoungmee thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT kangwonki thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT parkkeunchil thenext1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT kimseungtae next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT leejeeyun next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT hongmineui next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT parkkyunghee next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT parkjoonoh next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT ahntaejin next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT parksehoon next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT parkyoungsuk next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT limhoyeong next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT sunjongmu next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT ahnjinseok next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT ahnmyungju next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT kimheecheol next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT sohntaesung next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT choidongil next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT chojongho next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT heojinseok next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT kwonwooil next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT uhmsangwon next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT leehyuk next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT minbyunghoon next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT hongsungno next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT kimdukhwan next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT jungsinho next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT parkwoongyang next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT kimkyoungmee next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT kangwonki next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis AT parkkeunchil next1nextgenerationpersonalizedtxwithmultiomicsandpreclinicalmodeltrialprospectivemolecularscreeningtrialofmetastaticsolidcancerpatientsafeasibilityanalysis |