TRIUMPH Trial: One Small Step Could Become One Giant Leap for Precision Oncology in Head and Neck Cancer

Bhumsuk Keam; Hye Ryun Kim; Hwan Jung Yun

doi:10.4143/crt.2018.335

Articles

Page Path: HOME > Cancer Res Treat > Volume 51(1); 2019 > Article

Correspondence TRIUMPH Trial: One Small Step Could Become One Giant Leap for Precision Oncology in Head and Neck Cancer: Bhumsuk Keam¹, Hye Ryun Kim², Hwan Jung Yun^3,; Cancer Research and Treatment : Official Journal of Korean Cancer Association 2019;51(1):413-414.
DOI: https://doi.org/10.4143/crt.2018.335
Published online: July 31, 2018

¹Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea

²Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea

³Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea

*Correspondence: Hwan Jung Yun, MD, PhD Department of Internal Medicine, Chungnam National University Hospital, 282 Munhwa-ro, Jung-gu, Daejeon 35015, Korea
Tel: 82-42-280-7157 Fax: 82-42-257-5753 E-mail: hjyun@cnuh.co.kr

• Received: June 4, 2018 • Accepted: July 27, 2018

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

6,693 Views
170 Download
6 Web of Science
7 Crossref
5 Scopus

Full Article

Download PDF

REFERENCES

Recent remarkable progress in the fields of cancer genomics, computational analysis and drug discovery have changed the whole paradigm in cancer research. So called precision oncology, defined as molecular profiling of tumors to identify druggable alterations, is rapidly developing and waiting for entering the mainstream of cancer research as well as practice [1]. In the era of precision oncology, traditional classification based on organ or pathology do not have clinical meaning anymore. Molecular subtype base on next-generation sequencing (NGS) will lead us to appropriate molecular targeted agents.

Head and neck squamous cell carcinoma (HNSCC) is not a specific disease entity, but rather a broad category of diverse tumor types arising from various anatomic structures including oral cavity, oropharynx, hypopharynx, larynx and paranasal sinus. HNSCC is highly heterogeneous group of disease arises from the mucosal lining of the upper aerodigestive tract, demonstrates squamous differentiation, and involves older men with a long history of smoking. The prognosis by anatomic subsite quite differ. Human papilloma virus positive oropharyngeal cancer showed very good prognosis while oral cavity cancer had worst prognosis. In the era of NGS, HNSCC become more heterogeneous by mutational status [2-4].

Traditional design of clinical trials has faced big challenge for these heterogeneity and rarity. One solution is umbrella trial. In an umbrella trial, patients with specified cancer type are centrally screened and assigned to one of several molecularly defined subtrials where they receive matched targeted agents [5]. Some novel umbrella trials such as BATTLE trial [6] or MOSCATO trial [7] suggest that such a biomarker driven clinical trial can give appropriate benefit to the patients. To perform an umbrella trial, precise NGS based molecular phenotyping should be practical and working in the level of clinic. To date, there was surprisingly few study deals with the feasibility of molecular phenotyping for umbrella trial. We should answer the questions whether precision oncology is just a theory or whether it is realistically feasible. We should answer how we implement the precision oncology into the clinic and prove the patients’ benefit.

In this issue of Cancer Research and Treatment, Lim et al. [8] reported the feasibility of targeted NGS to guide the treatment of HNSCC. The authors tested the feasibility from tissue sample process to analysis of NGS and mRNA expression at the practical level. Mutation profiles were similar with prior reports [2-4] and the authors found several targetable alterations such as PIK3CA, CDKN2A and CCND1.

Based on this success, KCSG (Korean Cancer Study Group) Head and Neck Cancer and Esophageal Cancer Committee launched novel umbrella trial: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH, NCT 03292250), which is the first umbrella trial for HNSCC in the world. TRIUMPH trial is for recurred/ metastatic HNSCC, consisting of 5 targeted therapies including phosphoinositide 3-kinase inhibitor BYL719, pan-HER inhibitor poziotinib, fibroblast growth factor receptor inhibitor nintedanib, CDK4/6 inhibitor abemaciclib, andd immune checkpoint inhibitor durvalumab+/- tremelimumab. TRIUMPH trial is investigator-initiated trial, and Korean Cancer Study Group affiliated 37 institutes participate. We think TRIUMPH trial is one small step for head and neck cancer, but hope to be one giant leap for precision oncology in HNSCC.

REFERENCES

1. Sheikine Y, Kuo FC, Lindeman NI. Clinical and technical aspects of genomic diagnostics for precision oncology. J Clin Oncol. 2017;35:929–33. Article PubMed
2. Agrawal N, Frederick MJ, Pickering CR, Bettegowda C, Chang K, Li RJ, et al. Exome sequencing of head and neck squamous cell carcinoma reveals inactivating mutations in NOTCH1. Science. 2011;333:1154–7. Article PubMed PMC
3. Stransky N, Egloff AM, Tward AD, Kostic AD, Cibulskis K, Sivachenko A, et al. The mutational landscape of head and neck squamous cell carcinoma. Science. 2011;333:1157–60. Article PubMed PMC
4. Cancer Genome Atlas Network. Comprehensive genomic characterization of head and neck squamous cell carcinomas. Nature. 2015;517:576–82. Article PubMed PMC PDF
5. Renfro LA, Sargent DJ. Statistical controversies in clinical research: basket trials, umbrella trials, and other master protocols: a review and examples. Ann Oncol. 2017;28:34–43. Article PubMed PDF
6. Kim ES, Herbst RS, Wistuba II, Lee JJ, Blumenschein GR Jr, Tsao A, et al. The BATTLE trial: personalizing therapy for lung cancer. Cancer Discov. 2011;1:44–53. Article PubMed PMC
7. Massard C, Michiels S, Ferte C, Le Deley MC, Lacroix L, Hollebecque A, et al. High-throughput genomics and clinical outcome in hard-to-treat advanced cancers: results of the MOSCATO 01 Trial. Cancer Discov. 2017;7:586–95. Article PubMed
8. Lim SM, Cho SH, Hwang IG, Choi JW, Chang H, Ahn MJ, et al. Implementation the feasibility of targeted next-generation sequencing to guide the treatment of head and neck squamous cell carcinoma. Cancer Res Treat. 2019;51:300–12.

Figure & Data

REFERENCES

Citations

Citations to this article as recorded by

Personalized Biomarker-Based Umbrella Trial for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: KCSG HN 15-16 TRIUMPH Trial
Bhumsuk Keam, Min Hee Hong, Seong Hoon Shin, Seong Gu Heo, Ji Eun Kim, Hee Kyung Ahn, Yun-Gyoo Lee, Keon-Uk Park, Tak Yun, Keun-Wook Lee, Sung-Bae Kim, Sang-Cheol Lee, Min Kyoung Kim, Sang Hee Cho, So Yeon Oh, Sang-Gon Park, Shinwon Hwang, Byung-Ho Nam, S
Journal of Clinical Oncology.2024; 42(5): 507. CrossRef
Comprehensive Analysis of Mutation-Based and Expressed Genes-Based Pathways in Head and Neck Squamous Cell Carcinoma
Bhumsuk Keam, Jin-Young Park, Jin-Pyo Kim, Gun-Do Kim, Yun-Suk Yu, Sang-Hee Cho, Sangwoo Kim, Hee-Kyung Ahn, Sang-Hoon Chun, Jung-Hye Kwon, Tak Yun, Ji-Won Kim, Ji-Eun Kim, Myung-Ju Ahn, Joo-Hang Kim, Hwan-Jung Yun
Processes.2021; 9(5): 792. CrossRef
Therapeutic implications of activating noncanonical PIK3CA mutations in head and neck squamous cell carcinoma
Nan Jin, Bhumsuk Keam, Janice Cho, Michelle J. Lee, Hye Ryun Kim, Hayarpi Torosyan, Natalia Jura, Patrick K.S. Ng, Gordon B. Mills, Hua Li, Yan Zeng, Zohar Barbash, Gabi Tarcic, Hyunseok Kang, Julie E. Bauman, Mi-Ok Kim, Nathan K. VanLandingham, Danielle
Journal of Clinical Investigation.2021;[Epub] CrossRef
What's New in Molecular Targeted Therapies for Head and Neck Cancer?
Seoyoung Lee, Hye Ryun Kim
Korean Society for Head and Neck Oncology.2021; 37(2): 11. CrossRef
Alterations and molecular targeting of the GSK-3 regulator, PI3K, in head and neck cancer
Michelle J. Lee, Nan Jin, Jennifer R. Grandis, Daniel E. Johnson
Biochimica et Biophysica Acta (BBA) - Molecular Cell Research.2020; 1867(6): 118679. CrossRef
Shifting, overlapping and expanding use of “precision oncology” terminology: a retrospective literature analysis
Audrey Tran, Quiana Klossner, Tyler Crain, Vinay Prasad
BMJ Open.2020; 10(6): e036357. CrossRef
Biostatistical and Logistical Considerations in the Development of Basket and Umbrella Clinical Trials
Laura M. Yee, Lisa M. McShane, Boris Freidlin, Margaret M. Mooney, Edward L. Korn
The Cancer Journal.2019; 25(4): 254. CrossRef

PubReader
ePub Link

Cite

CITE: export Copy Download Format; Close

Download Citation

Download a citation file in RIS format that can be imported by all major citation management software, including EndNote, ProCite, RefWorks, and Reference Manager.

Format:

RIS — For EndNote, ProCite, RefWorks, and most other reference management software
BibTeX — For JabRef, BibDesk, and other BibTeX-specific software

Include:

Citation for the content below
Citation and abstract for the content below

TRIUMPH Trial: One Small Step Could Become One Giant Leap for Precision Oncology in Head and Neck Cancer

Cancer Res Treat. 2019;51(1):413-414. Published online July 31, 2018

DOI: https://doi.org/10.4143/crt.2018.335

XML Download

TRIUMPH Trial: One Small Step Could Become One Giant Leap for Precision Oncology in Head and Neck Cancer