Oncotarget

Research Papers:

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

Seung Tae Kim, Jeeyun Lee, Mineui Hong, Kyunghee Park, Joon Oh Park, Tae Jin Ahn, Se Hoon Park, Young Suk Park, Ho Yeong Lim, Jong-Mu Sun, Jin Seok Ahn, Myung-Ju Ahn, Hee Cheol Kim, Tae Sung Sohn, Dong Il Choi, Jong Ho Cho, Jin Seok Heo, Wooil Kwon, Sang Won Uhm, Hyuk Lee, Byung-Hoon Min, Sung No Hong, Duk Hwan Kim, Sin Ho Jung, Woongyang Park, Kyoung-Mee Kim, Won Ki Kang _ and Keunchil Park

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Oncotarget. 2015; 6:33358-33368. https://doi.org/10.18632/oncotarget.5188

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Abstract

Seung Tae Kim1,*, Jeeyun Lee1,*, Mineui Hong2,3,*, Kyunghee Park4,5,*, Joon Oh Park1, Tae Jin Ahn3,4, Se Hoon Park1, Young Suk Park1, Ho Yeong Lim1, Jong-Mu Sun1, Jin Seok Ahn1, Myung-Ju Ahn1, Hee Cheol Kim6, Tae Sung Sohn6, Dong Il Choi7, Jong Ho Cho8, Jin Seok Heo6, Wooil Kwon6, Sang Won Uhm9, Hyuk Lee10, Byung-Hoon Min10, Sung No Hong10, Duk Hwan Kim5,11, Sin Ho Jung12, Woongyang Park4,5, Kyoung-Mee Kim2,3, Won Ki Kang1, Keunchil Park1,2

1Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

2Innovative Cancer Medicine Institute, Samsung Cancer Center, Samsung Medical Center, Seoul, Korea

3Department of Pathology & Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

4Samsung Genome Institute, Seoul, Korea

5Samsung Biological Research Institute, Seoul, Korea

6Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

7Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

8Department of Thoracic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

9Division of Pulmonology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

10Division of Gastroenterology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

11Medical Translational Research Center, Samsung Biological Research Institute, Seoul, Korea

12Biostatistics and Clinical Epidemiology, Samsung Medical Center, Seoul, Korea

*These authors have contributed equally to this work

Correspondence to:

Won Ki Kang, e-mail: wkkang@skku.edu

Kyoung-Mee Kim, e-mail: kkmkys@skku.edu

Keunchil Park, e-mail: kpark@skku.edu

Keywords: molecular profiling, genome, ampliseq

Received: July 01, 2015     Accepted: August 27, 2015     Published: September 09, 2015

ABSTRACT

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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