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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

 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  ;  Sangwoo Kim  ;  Hye Ryun Kim  ;  Hwan Jung Yun  ;  KCSG TRIUMPH Investigators 
 JOURNAL OF CLINICAL ONCOLOGY, Vol.42(5) : 507-527, 2023-09 
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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, abemaciclinb, 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.
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1. College of Medicine (의과대학) > BioMedical Science Institute (의생명과학부) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Biomedical Systems Informatics (의생명시스템정보학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Sangwoo(김상우) ORCID logo https://orcid.org/0000-0001-5356-0827
Kim, Hye Ryun(김혜련) ORCID logo https://orcid.org/0000-0002-1842-9070
Heo, Seong Gu(허성구)
Hong, Min Hee(홍민희) ORCID logo https://orcid.org/0000-0003-3490-2195
Hwang, Shinwon(황신원) ORCID logo https://orcid.org/0000-0002-0202-7800
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