PMID- 37251944
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230531
IS  - 2234-943X (Print)
IS  - 2234-943X (Electronic)
IS  - 2234-943X (Linking)
VI  - 13
DP  - 2023
TI  - Efficacy and feasibility of Apatinib and S-1 as a novel oral induction therapy in 
      locally advanced head and neck squamous cell carcinoma: an exploratory phase 2 
      open-label, single-arm trial.
PG  - 1072538
LID - 10.3389/fonc.2023.1072538 [doi]
LID - 1072538
AB  - OBJECTIVES: The current standard nonsurgical treatment for locally advanced head 
      and neck squamous cell cancer (LA-HNSCC) is concomitant chemoradiotherapy (CRT). 
      Neoadjuvant chemotherapy combined with CRT has been explored in HNSCC patients 
      and is an acceptable strategy. However, the occurrence of adverse events (AEs) 
      restricts its application. We conducted a clinical study to explore the efficacy 
      and feasibility of a novel induction therapy with orally administered apatinib 
      and S-1 in LA-HNSCC. MATERIALS AND METHODS: This nonrandomized, single-arm, 
      prospective clinical trial included patients with LA-HNSCCs. The eligibility 
      criteria included histologically or cytologically confirmed HNSCC, with at least 
      one radiographically measurable lesion detected by magnetic resonance imaging 
      (MRI) or computerized tomography (CT) scan, age 18-75 years, and a diagnosis of 
      stage III to IVb according to the 7(th) edition of the American Joint Committee 
      of Cancer (AJCC). Patients received induction therapy with apatinib and S-1 for 
      three cycles (3 weeks/cycle). The primary endpoint of this study was the 
      objective response rate (ORR) to induction therapy. The secondary endpoints 
      included progression-free survival (PFS), overall survival (OS), and AEs during 
      induction treatment. RESULTS: From October 2017 to September 2020, 49 patients 
      with LA-HNSCC were screened consecutively and 38 were enrolled. The median age of 
      the patients was 60 years (range, 39-75). Thirty-three patients (86.8%) had stage 
      IV disease according to the AJCC staging system. The ORR after induction therapy 
      was 97.4% (95% confidence interval [CI]: 86.2%-99.9%). the 3-year OS rate was 
      64.2% (95% CI: 46.0%-78.2%) and 3-year PFS was 57.1% (95% CI: 40.8%-73.6%). The 
      most common AEs during induction therapy were hypertension and hand-foot 
      syndrome, which were manageable. CONCLUSION: Apatinib combined with S-1 as novel 
      induction therapy for LA-HNSCC patients resulted in a higher-than-anticipated ORR 
      and manageable adverse effects. With the associated safety profile and preferable 
      oral administration route, apatinib combined with S-1 is an attractive 
      exploratory induction regimen in outpatient settings. However, this regimen 
      failed to show a survival benefit. CLINICAL TRIAL REGISTRATION: 
      https://clinicaltrials.gov/show/NCT03267121, identifier NCT03267121.
CI  - Copyright (c) 2023 Jiang, Li, Zhang, Dou, Ye, Shao, Wu, Dong, Li and Zhu.
FAU - Jiang, Wen
AU  - Jiang W
AD  - Department of Oral and Maxillofacial-Head and Neck Oncology, Shanghai Ninth 
      People's Hospital, Shanghai Jiao Tong University School of Medicine, College of 
      Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, 
      National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of 
      Stomatology, Shanghai Research Institute of Stomatology, Shanghai Center of Head 
      and Neck Oncology Clinical and Translational Science, Shanghai, China.
FAU - Li, Rongrong
AU  - Li R
AD  - Department of Oral and Maxillofacial-Head and Neck Oncology, Shanghai Ninth 
      People's Hospital, Shanghai Jiao Tong University School of Medicine, College of 
      Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, 
      National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of 
      Stomatology, Shanghai Research Institute of Stomatology, Shanghai Center of Head 
      and Neck Oncology Clinical and Translational Science, Shanghai, China.
FAU - Zhang, Lin
AU  - Zhang L
AD  - Department of Oral and Maxillofacial-Head and Neck Oncology, Shanghai Ninth 
      People's Hospital, Shanghai Jiao Tong University School of Medicine, College of 
      Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, 
      National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of 
      Stomatology, Shanghai Research Institute of Stomatology, Shanghai Center of Head 
      and Neck Oncology Clinical and Translational Science, Shanghai, China.
FAU - Dou, Shengjin
AU  - Dou S
AD  - Department of Oral and Maxillofacial-Head and Neck Oncology, Shanghai Ninth 
      People's Hospital, Shanghai Jiao Tong University School of Medicine, College of 
      Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, 
      National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of 
      Stomatology, Shanghai Research Institute of Stomatology, Shanghai Center of Head 
      and Neck Oncology Clinical and Translational Science, Shanghai, China.
FAU - Ye, Lulu
AU  - Ye L
AD  - Department of Oral and Maxillofacial-Head and Neck Oncology, Shanghai Ninth 
      People's Hospital, Shanghai Jiao Tong University School of Medicine, College of 
      Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, 
      National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of 
      Stomatology, Shanghai Research Institute of Stomatology, Shanghai Center of Head 
      and Neck Oncology Clinical and Translational Science, Shanghai, China.
FAU - Shao, Ziyang
AU  - Shao Z
AD  - Department of Oral and Maxillofacial-Head and Neck Oncology, Shanghai Ninth 
      People's Hospital, Shanghai Jiao Tong University School of Medicine, College of 
      Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, 
      National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of 
      Stomatology, Shanghai Research Institute of Stomatology, Shanghai Center of Head 
      and Neck Oncology Clinical and Translational Science, Shanghai, China.
FAU - Wu, Sicheng
AU  - Wu S
AD  - Biostatistics Office of Clinical Research Center, Shanghai Ninth People's 
      Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
FAU - Dong, Minjun
AU  - Dong M
AD  - Department of Radiology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong 
      University School of Medicine, Shanghai, China.
FAU - Li, Jiang
AU  - Li J
AD  - Department of Oral Pathology, Shanghai Ninth People's Hospital, College of 
      Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
FAU - Zhu, Guopei
AU  - Zhu G
AD  - Department of Oral and Maxillofacial-Head and Neck Oncology, Shanghai Ninth 
      People's Hospital, Shanghai Jiao Tong University School of Medicine, College of 
      Stomatology, Shanghai Jiao Tong University, National Center for Stomatology, 
      National Clinical Research Center for Oral Diseases, Shanghai Key Laboratory of 
      Stomatology, Shanghai Research Institute of Stomatology, Shanghai Center of Head 
      and Neck Oncology Clinical and Translational Science, Shanghai, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT03267121
PT  - Journal Article
DEP - 20230512
PL  - Switzerland
TA  - Front Oncol
JT  - Frontiers in oncology
JID - 101568867
PMC - PMC10213222
OTO - NOTNLM
OT  - chemoradiotherapy
OT  - induction therapy
OT  - locally advanced head and neck cancer
OT  - oral agents for cancer
OT  - prospective and interventional study
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2023/05/30 13:07
MHDA- 2023/05/30 13:08
PMCR- 2023/01/01
CRDT- 2023/05/30 11:47
PHST- 2022/10/17 00:00 [received]
PHST- 2023/04/21 00:00 [accepted]
PHST- 2023/05/30 13:08 [medline]
PHST- 2023/05/30 13:07 [pubmed]
PHST- 2023/05/30 11:47 [entrez]
PHST- 2023/01/01 00:00 [pmc-release]
AID - 10.3389/fonc.2023.1072538 [doi]
PST - epublish
SO  - Front Oncol. 2023 May 12;13:1072538. doi: 10.3389/fonc.2023.1072538. eCollection 
      2023.