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Personalized Biomarker-Based Umbrella Trial for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: KCSG HN 15-16 TRIUMPH Trial

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Author(s)
Bhumsuk KeamMin Hee HongSeong Hoon ShinSeong Gu HeoJi Eun KimHee Kyung AhnYun-Gyoo LeeKeon-Uk ParkTak YunKeun-Wook LeeSung-Bae KimSang-Cheol LeeMin Kyoung KimSang Hee ChoSo Yeon OhSang-Gon ParkShinwon HwangByung-Ho NamSangwoo KimHye Ryun KimHwan Jung Yun
Keimyung Author(s)
Park, Keon Uk
Department
Dept. of Internal Medicine (내과학)
Journal Title
J Clin Oncol
Issued Date
2023
Volume
42
Issue
5
Abstract
Purpose:
A precise oncologic approach for head and neck squamous cell carcinoma (HNSCC) is necessary. We performed a genomic profile-based umbrella trial for the patients with platinum-refractory recurrent and/or metastatic HNSCC.

Methods:
In this multicenter, open-label, single-arm phase II trial, we performed targeted next-generation sequencing (NGS). Patients were assigned to each treatment arm on the basis of their matching genomic profiles: arm 1, alpelisib, a PIK3CA inhibitor; arm 2, poziotinib, an epidermal growth factor receptor/HER2 inhibitor; arm 3, nintedanib, an fibroblast growth factor receptor inhibitor; and arm 4, abemaciclib, a CDK4/6 inhibitor. If there was no matching target, patients were allocated to arm 5, duvalumab ± tremelimumab, anti-PD-L1/cytotoxic T-cell lymphocyte-4 inhibitor. When progressive disease (PD) occurred in arms 1-4, cross over to arm 5 was allowed. The primary end point was disease control rate (DCR) in arm 1 and overall response rate (ORR) in arms 2-5 by investigator assessment.

Results:
Between October 2017 and August 2020, 203 patients were enrolled, including crossover. In arm 1, the ORR was 21.2% and DCR was 65.6%. The ORR was 0% for arm 2, 42.9% for arm 3, 0% for arm 4, and 15.6% for arm 5. In the case of PD with durvalumab, tremelimumab was added, and the ORR for durvalumab + tremelimumab was 2.2%. The median progression-free survival was 3.4, 3.2, 5.6, 1.6, and 1.7 months for each arm, respectively. The median overall survival was 12.4, 6.1, 11.1, 9.1, and 12.7 months, respectively. Overall, the toxicity profiles were manageable, and there were no treatment-related deaths.

Conclusion:
To our knowledge, this study is the first biomarker-driven umbrella trial for platinum-refractory HNSCC using matched molecular targeted agents. We found that NGS-based genomic phenotyping was methodologically feasible and applicable.

Trial registration:
ClinicalTrials.gov NCT03292250.
Keimyung Author(s)(Kor)
박건욱
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
1527-7755
Source
https://ascopubs.org/doi/10.1200/JCO.22.02786
DOI
10.1200/JCO.22.02786
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/45239
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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