PMID- 36974777
OWN - NLM
STAT- MEDLINE
DCOM- 20230329
LR  - 20230329
IS  - 1791-7530 (Electronic)
IS  - 0250-7005 (Linking)
VI  - 43
IP  - 4
DP  - 2023 Apr
TI  - Real-world Data Study of the Efficacy and Toxicity of Nivolumab vs. Cetuximab and 
      Predictors of Response to Nivolumab in Recurrent/Metastatic Squamous Cell 
      Carcinoma of the Head and Neck in a European Population.
PG  - 1681-1688
LID - 10.21873/anticanres.16320 [doi]
AB  - BACKGROUND/AIM: This study aimed to assess the effectiveness and safety of 
      nivolumab versus cetuximab in patients with Recurrent/Metastatic Squamous Cell 
      Carcinoma of the Head and Neck (R/M HNSCC), as well as to analyze possible 
      prognostic factors for response to treatment with nivolumab. PATIENTS AND 
      METHODS: We conducted an observational, retrospective, descriptive study of 
      patients with R/M HNSCC who initiated treatment with nivolumab or cetuximab 
      monotherapy in two periods of equivalent duration. Overall efficacy was measured 
      in terms of progression-free survival (PFS) and overall survival (OS). Safety was 
      evaluated using the Common Terminology Criteria for Adverse Events classification 
      version 5.0 of the National Cancer Institute. RESULTS: Median OS was 9.1 months 
      with nivolumab (n=34) and 6.3 months with cetuximab (n=12). PFS was 4.3 months 
      for nivolumab and 4.65 months for cetuximab. Any grade adverse events (AEs) were 
      reported in 97% and 100% of the patients treated with nivolumab and cetuximab. 
      Serious AEs were observed in 26% and 58% of the patients, respectively. Elevated 
      albumin values, lymphocytosis, neutropenia, and elevated neutrophil/lymphocyte 
      ratio values were found to have positive prognostic value on the response to 
      nivolumab in R/M HNSCC. CONCLUSION: Effectiveness of nivolumab in terms of OS 
      remains superior to cetuximab. OS, PFS and severe or any grade AEs were superior 
      in both arms of our study compared to those in clinical trials. The AEs profile 
      of nivolumab differed in our study from that in the clinical trials' 
      observations. We have identified four statistically significant prognostic 
      variables on the response to nivolumab in R/M HNSCC.
CI  - Copyright (c) 2023 International Institute of Anticancer Research (Dr. George J. 
      Delinasios), All rights reserved.
FAU - Macia-Rivas, Lola
AU  - Macia-Rivas L
AUID- ORCID: 0000-0003-2483-6497
AD  - Universidad de Santiago de Compostela, A Coruna, Spain; lolamaciarivas@gmail.com.
AD  - Pharmacy Department, Hospital Universitario Central de Asturias, Oviedo, Spain.
FAU - Fernandez-Laguna, Clara Luz
AU  - Fernandez-Laguna CL
AD  - Pharmacy Department, Hospital Universitario Central de Asturias, Oviedo, Spain.
FAU - Alvarez-Asteinza, Cristina
AU  - Alvarez-Asteinza C
AD  - Pharmacy Department, Hospital Universitario Central de Asturias, Oviedo, Spain.
FAU - Maray, Ivan
AU  - Maray I
AD  - Pharmacy Department, Hospital Universitario Central de Asturias, Oviedo, Spain.
FAU - Carbajales-Alvarez, Monica
AU  - Carbajales-Alvarez M
AD  - Pharmacy Department, Hospital Universitario Central de Asturias, Oviedo, Spain.
FAU - Lozano-Blazquez, Ana
AU  - Lozano-Blazquez A
AD  - Pharmacy Department, Hospital Universitario Central de Asturias, Oviedo, Spain.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PL  - Greece
TA  - Anticancer Res
JT  - Anticancer research
JID - 8102988
RN  - PQX0D8J21J (Cetuximab)
RN  - 31YO63LBSN (Nivolumab)
SB  - IM
MH  - Humans
MH  - Cetuximab/adverse effects
MH  - Squamous Cell Carcinoma of Head and Neck/drug therapy
MH  - *Nivolumab/adverse effects
MH  - Retrospective Studies
MH  - *Head and Neck Neoplasms/drug therapy
MH  - Neoplasm Recurrence, Local/drug therapy/pathology
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
OTO - NOTNLM
OT  - Nivolumab
OT  - cetuximab
OT  - head and neck cancer
OT  - immunotherapy
OT  - oral cancer
OT  - prognostic factor
OT  - squamous cell carcinoma
EDAT- 2023/03/29 06:00
MHDA- 2023/03/29 06:04
CRDT- 2023/03/28 05:33
PHST- 2023/01/23 00:00 [received]
PHST- 2023/02/06 00:00 [revised]
PHST- 2023/02/07 00:00 [accepted]
PHST- 2023/03/29 06:04 [medline]
PHST- 2023/03/28 05:33 [entrez]
PHST- 2023/03/29 06:00 [pubmed]
AID - 43/4/1681 [pii]
AID - 10.21873/anticanres.16320 [doi]
PST - ppublish
SO  - Anticancer Res. 2023 Apr;43(4):1681-1688. doi: 10.21873/anticanres.16320.