Anti-epidermal growth factor receptor therapy in combination with chemoradiotherapy for the treatment of locally advanced anal canal carcinoma: Results of a phase I dose-escalation study with panitumumab (FFCD 0904).
Aged
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Anus Neoplasms
/ therapy
Chemoradiotherapy
ErbB Receptors
/ antagonists & inhibitors
Female
Fluorouracil
/ administration & dosage
Humans
Male
Middle Aged
Mitomycin
/ administration & dosage
Panitumumab
/ administration & dosage
Prospective Studies
Anal cancer
Chemoradiotherapy
Epidermal growth factor receptor
Immunotherapy
Panitumumab
Squamous cell carcinoma
Journal
Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
ISSN: 1879-0887
Titre abrégé: Radiother Oncol
Pays: Ireland
ID NLM: 8407192
Informations de publication
Date de publication:
11 2019
11 2019
Historique:
received:
20
12
2018
revised:
14
05
2019
accepted:
15
05
2019
pubmed:
12
6
2019
medline:
29
4
2020
entrez:
12
6
2019
Statut:
ppublish
Résumé
Standard treatment of epidermoid anal cancer is 5-fluorouracil (5FU) and mitomycin C (MMC) based chemoradiotherapy (CRT). This phase I study aims to evaluate the addition of panitumumab (Pmab) to CRT and to determine the maximum tolerated dose (MTD) of Pmab and 5-FU in combination with CRT. Immunocompetent patients with locally advanced tumour without metastases (Stage T2, T3 or T4, whatever N stage; Stage N1-N3 whatever T stage) followed two RT periods (45 Gy in 5 weeks and 20 Gy in 2 weeks, separated by a 2-week break) with concomitant CT sessions of 5FU/MMC at RT weeks 1, 5 and 8. Pmab was administered on RT weeks 1, 3, 5, 8 and 10 according to a predefined dose escalation schedule. Ten patients were enroled. One was excluded due to unmet dose constraints respect. Three patients received dose level (DL) 0 (Pmab 3 mg/kg + 5FU 600 mg/m The MTD is 5FU at 400 mg/m
Sections du résumé
BACKGROUND AND PURPOSE
Standard treatment of epidermoid anal cancer is 5-fluorouracil (5FU) and mitomycin C (MMC) based chemoradiotherapy (CRT). This phase I study aims to evaluate the addition of panitumumab (Pmab) to CRT and to determine the maximum tolerated dose (MTD) of Pmab and 5-FU in combination with CRT.
MATERIALS AND METHODS
Immunocompetent patients with locally advanced tumour without metastases (Stage T2, T3 or T4, whatever N stage; Stage N1-N3 whatever T stage) followed two RT periods (45 Gy in 5 weeks and 20 Gy in 2 weeks, separated by a 2-week break) with concomitant CT sessions of 5FU/MMC at RT weeks 1, 5 and 8. Pmab was administered on RT weeks 1, 3, 5, 8 and 10 according to a predefined dose escalation schedule.
RESULTS
Ten patients were enroled. One was excluded due to unmet dose constraints respect. Three patients received dose level (DL) 0 (Pmab 3 mg/kg + 5FU 600 mg/m
CONCLUSIONS
The MTD is 5FU at 400 mg/m
Identifiants
pubmed: 31185328
pii: S0167-8140(19)32919-6
doi: 10.1016/j.radonc.2019.05.018
pii:
doi:
Substances chimiques
Mitomycin
50SG953SK6
Panitumumab
6A901E312A
ErbB Receptors
EC 2.7.10.1
Fluorouracil
U3P01618RT
Types de publication
Clinical Trial, Phase I
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
84-89Informations de copyright
Copyright © 2019 Elsevier B.V. All rights reserved.