Cetuximab, fluorouracil and cisplatin with or without docetaxel for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (CeFCiD): an open-label phase II randomised trial (AIO/IAG-KHT trial 1108).
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Cetuximab
/ administration & dosage
Cisplatin
/ administration & dosage
Disease-Free Survival
Docetaxel
/ administration & dosage
Drug Administration Schedule
Female
Fluorouracil
/ administration & dosage
Humans
Male
Middle Aged
Prospective Studies
Squamous Cell Carcinoma of Head and Neck
/ drug therapy
Cetuximab
Chemotherapy
Docetaxel
Head and neck cancer
Randomised trial
Journal
European journal of cancer (Oxford, England : 1990)
ISSN: 1879-0852
Titre abrégé: Eur J Cancer
Pays: England
ID NLM: 9005373
Informations de publication
Date de publication:
11 2019
11 2019
Historique:
received:
22
06
2019
revised:
21
08
2019
accepted:
28
08
2019
pubmed:
17
10
2019
medline:
29
5
2020
entrez:
17
10
2019
Statut:
ppublish
Résumé
The combination of cisplatin, 5-fluorouracil (5-FU) and cetuximab (PFC) is the reference first-line treatment for recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). We analysed whether treatment intensification by the addition of docetaxel to PFC improved efficacy in R/M SCCHN. A total of 180 patients with R/M SCCHN (1:1) were assigned to receive either cisplatin (40 mg/m A preplanned interim analysis for toxicity after 20 patients/arm revealed excessive grade 3 and 4 gastrointestinal (65%) and infectious toxicities (35%) in arm A, which led to dose reduction of cisplatin to 30 mg/m DPFC failed to improve efficacy in R/M SCCHN. On the contrary, a high toxicity and mortality rate was detected in both arms, which underscores the vulnerability of patients with R/M SCCHN, and research on the need for further optimisation of the front-line chemotherapy backbone is ongoing.
Sections du résumé
BACKGROUND
The combination of cisplatin, 5-fluorouracil (5-FU) and cetuximab (PFC) is the reference first-line treatment for recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). We analysed whether treatment intensification by the addition of docetaxel to PFC improved efficacy in R/M SCCHN.
METHODS
A total of 180 patients with R/M SCCHN (1:1) were assigned to receive either cisplatin (40 mg/m
RESULTS
A preplanned interim analysis for toxicity after 20 patients/arm revealed excessive grade 3 and 4 gastrointestinal (65%) and infectious toxicities (35%) in arm A, which led to dose reduction of cisplatin to 30 mg/m
CONCLUSIONS
DPFC failed to improve efficacy in R/M SCCHN. On the contrary, a high toxicity and mortality rate was detected in both arms, which underscores the vulnerability of patients with R/M SCCHN, and research on the need for further optimisation of the front-line chemotherapy backbone is ongoing.
Identifiants
pubmed: 31618704
pii: S0959-8049(19)30478-2
doi: 10.1016/j.ejca.2019.08.018
pii:
doi:
Substances chimiques
Docetaxel
15H5577CQD
Cetuximab
PQX0D8J21J
Cisplatin
Q20Q21Q62J
Fluorouracil
U3P01618RT
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
53-60Informations de copyright
Copyright © 2019 Elsevier Ltd. All rights reserved.