PMID- 38494597
OWN - NLM
STAT- MEDLINE
DCOM- 20240410
LR  - 20240410
IS  - 1097-0347 (Electronic)
IS  - 1043-3074 (Linking)
VI  - 46
IP  - 5
DP  - 2024 May
TI  - Durvalumab in combination with chemoradiotherapy in patients with head and neck 
      squamous cell carcinoma: Results from the Phase 1 CLOVER study.
PG  - 1152-1159
LID - 10.1002/hed.27726 [doi]
AB  - BACKGROUND: The Phase 1 CLOVER study (NCT03509012) assessed durvalumab in 
      combination with concurrent chemoradiotherapy (cCRT) in patients with advanced 
      solid tumors; we report results from the head and neck squamous cell carcinoma 
      (HNSCC) cohort. METHODS: Patients with histologically/cytologically confirmed 
      locally advanced HNSCC, eligible for definitive cCRT and not considered for 
      primary surgery, received durvalumab plus cisplatin and concurrent external beam 
      radiation. Objectives were to assess safety/tolerability and preliminary 
      efficacy. RESULTS: Eight patients were enrolled. The most frequent any-cause 
      adverse events (AEs) were nausea and radiation skin injury (each n = 5); most 
      frequent grade 3/4 AEs were lymphopenia and stomatitis (each n = 3). No patients 
      had dose-limiting toxicities. Objective response rate was 71.4% (5/7 patients; 
      four complete responses, one partial response); disease control rate was 85.7% at 
      18 weeks and 83.3% at 48 weeks. CONCLUSIONS: Durvalumab plus cCRT was tolerable 
      and active in patients with unresected, locally advanced HNSCC.
CI  - (c) 2024 The Authors. Head & Neck published by Wiley Periodicals LLC.
FAU - Bauman, Julie E
AU  - Bauman JE
AUID- ORCID: 0000-0002-1398-6636
AD  - Department of Medicine, University of Arizona Cancer Center, Tucson, Arizona, 
      USA.
AD  - George Washington University Cancer Center, Washington, DC, USA.
FAU - Karam, Sana D
AU  - Karam SD
AUID- ORCID: 0000-0003-1676-5967
AD  - Department of Radiation Oncology, University of Colorado, Anschutz Medical 
      Campus, Aurora, Colorado, USA.
FAU - O'Brien, Cathy
AU  - O'Brien C
AD  - Oncology Biometrics, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.
FAU - Mak, Gabriel
AU  - Mak G
AD  - Late Development Oncology, Oncology R&D, AstraZeneca, Gaithersburg, Maryland, 
      USA.
FAU - Cho, Byoung Chul
AU  - Cho BC
AD  - Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of 
      Medicine, Seoul, South Korea.
LA  - eng
GR  - AstraZeneca/
PT  - Clinical Trial, Phase I
PT  - Journal Article
DEP - 20240317
PL  - United States
TA  - Head Neck
JT  - Head & neck
JID - 8902541
RN  - 28X28X9OKV (durvalumab)
RN  - 0 (Antibodies, Monoclonal)
SB  - IM
MH  - Humans
MH  - Squamous Cell Carcinoma of Head and Neck/therapy/etiology
MH  - *Head and Neck Neoplasms/therapy/etiology
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Chemoradiotherapy/adverse effects/methods
MH  - *Antibodies, Monoclonal
OTO - NOTNLM
OT  - CLOVER
OT  - HNSCC
OT  - Phase 1
OT  - chemoradiotherapy
OT  - durvalumab
EDAT- 2024/03/18 06:43
MHDA- 2024/04/10 06:42
CRDT- 2024/03/18 00:42
PHST- 2024/02/09 00:00 [revised]
PHST- 2023/09/21 00:00 [received]
PHST- 2024/02/27 00:00 [accepted]
PHST- 2024/04/10 06:42 [medline]
PHST- 2024/03/18 06:43 [pubmed]
PHST- 2024/03/18 00:42 [entrez]
AID - 10.1002/hed.27726 [doi]
PST - ppublish
SO  - Head Neck. 2024 May;46(5):1152-1159. doi: 10.1002/hed.27726. Epub 2024 Mar 17.