A multicenter phase II trial of paclitaxel, carboplatin, and cetuximab followed by chemoradiotherapy in patients with unresectable locally advanced squamous cell carcinoma of the head and neck.
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Carboplatin
/ administration & dosage
Cetuximab
/ administration & dosage
Chemoradiotherapy
/ adverse effects
Drug Eruptions
/ epidemiology
Feasibility Studies
Female
Head and Neck Neoplasms
/ mortality
Humans
Induction Chemotherapy
/ adverse effects
Male
Middle Aged
Mucositis
/ epidemiology
Neutropenia
/ epidemiology
Paclitaxel
/ administration & dosage
Prospective Studies
Radiation Injuries
/ epidemiology
Squamous Cell Carcinoma of Head and Neck
/ mortality
Treatment Outcome
carboplatin
cetuximab
chemoradiotherapy
induction chemotherapy
paclitaxel
unresectable locally advanced squamous cell carcinoma of the head and neck
Journal
Cancer medicine
ISSN: 2045-7634
Titre abrégé: Cancer Med
Pays: United States
ID NLM: 101595310
Informations de publication
Date de publication:
03 2020
03 2020
Historique:
received:
26
08
2019
revised:
19
11
2019
accepted:
03
01
2020
pubmed:
17
1
2020
medline:
24
4
2021
entrez:
17
1
2020
Statut:
ppublish
Résumé
Induction chemotherapy (IC) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) often compromises compliance with subsequent chemoradiotherapy (CRT), which negatively affects outcomes. Here, we assessed the combination of paclitaxel (PTX), carboplatin (CBDCA), and cetuximab (Cmab) as IC for unresectable LA-SCCHN. Induction chemotherapy consisted of weekly CBDCA area under the plasma concentration-time curve = 1.5, PTX 80 mg/m Thirty-five patients were enrolled. Cases were hypopharynx/oropharynx/larynx in 17/17/1 patients, all at Stage IV. Of 35 patients, 34 (97%) completed IC and 32 received CRT and met the criteria of full analysis set (FAS). In FAS, the %CRT completion was 96.9%, and PP was 99.9%, exceeding the prespecified boundary of 84%. Mean cumulative dose and relative to dose intensity of CDDP in CRT was 232.5 mg/m PCE as IC was feasible, with promising efficacy and no effect on compliance with subsequent CRT in unresectable LA-SCCHN.
Sections du résumé
BACKGROUND
Induction chemotherapy (IC) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) often compromises compliance with subsequent chemoradiotherapy (CRT), which negatively affects outcomes. Here, we assessed the combination of paclitaxel (PTX), carboplatin (CBDCA), and cetuximab (Cmab) as IC for unresectable LA-SCCHN.
METHODS
Induction chemotherapy consisted of weekly CBDCA area under the plasma concentration-time curve = 1.5, PTX 80 mg/m
RESULTS
Thirty-five patients were enrolled. Cases were hypopharynx/oropharynx/larynx in 17/17/1 patients, all at Stage IV. Of 35 patients, 34 (97%) completed IC and 32 received CRT and met the criteria of full analysis set (FAS). In FAS, the %CRT completion was 96.9%, and PP was 99.9%, exceeding the prespecified boundary of 84%. Mean cumulative dose and relative to dose intensity of CDDP in CRT was 232.5 mg/m
CONCLUSIONS
PCE as IC was feasible, with promising efficacy and no effect on compliance with subsequent CRT in unresectable LA-SCCHN.
Identifiants
pubmed: 31943834
doi: 10.1002/cam4.2852
pmc: PMC7050099
doi:
Substances chimiques
Carboplatin
BG3F62OND5
Paclitaxel
P88XT4IS4D
Cetuximab
PQX0D8J21J
Banques de données
GENBANK
['UMIN000014430']
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1671-1682Informations de copyright
© 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
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