Standard versus fractionated high-dose cisplatin plus radiation for locally advanced head and neck cancer: Results of the CisFRad (GORTEC 2015-02) randomized phase II trial.

Chemoradiotherapy Cisplatin Cisplatin pharmacokinetic Locally advanced Squamous Cell Carcinoma of Head and Neck

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:
18 May 2024
Historique:
received: 02 01 2024
revised: 28 04 2024
accepted: 01 05 2024
medline: 21 5 2024
pubmed: 21 5 2024
entrez: 20 5 2024
Statut: aheadofprint

Résumé

Chemoradiotherapy with high-dose cisplatin (HD-Cis: 100 mg/m Cisplatin fractionation may allow, by decreasing the peak serum concentration, to decrease toxicity. To date, no direct comparison was done of HD-Cis versus fractionated high dose cisplatin (FHD-Cis). This is a multi-institutional randomized phase II trial, stratified on postoperative or definitive chemoradiotherapy, comparing HD-Cis to FHD-Cis (25 mg/m Between December 2015 and April 2018, 124 patients were randomized. Median cisplatin cumulative delivered dose was 291 mg/m Although the primary endpoint was not met, FHD-Cis allowed more cycles of cisplatin to be delivered with lower toxicity, when compared to SOC. FHD-Cis concurrently with RT is a treatment option which deserves further consideration.

Sections du résumé

BACKGROUND BACKGROUND
Chemoradiotherapy with high-dose cisplatin (HD-Cis: 100 mg/m
AIM OBJECTIVE
Cisplatin fractionation may allow, by decreasing the peak serum concentration, to decrease toxicity. To date, no direct comparison was done of HD-Cis versus fractionated high dose cisplatin (FHD-Cis).
METHODS METHODS
This is a multi-institutional randomized phase II trial, stratified on postoperative or definitive chemoradiotherapy, comparing HD-Cis to FHD-Cis (25 mg/m
RESULTS RESULTS
Between December 2015 and April 2018, 124 patients were randomized. Median cisplatin cumulative delivered dose was 291 mg/m
CONCLUSION CONCLUSIONS
Although the primary endpoint was not met, FHD-Cis allowed more cycles of cisplatin to be delivered with lower toxicity, when compared to SOC. FHD-Cis concurrently with RT is a treatment option which deserves further consideration.

Identifiants

pubmed: 38768714
pii: S0167-8140(24)00599-1
doi: 10.1016/j.radonc.2024.110329
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

110329

Informations de copyright

Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Christian Borel (C)

Institut de Cancérologie Strasbourg Europe, Strasbourg, France. Electronic address: c.borel@icans.eu.

Xu-Shan Sun (XS)

Hôpital Nord Franche-Comté, Montbéliard, France; Centre Hospitalo-Universitaire Besançon, Besançon, France.

Alexandre Coutte (A)

Centre Hospitalo-Universitaire Amiens-Picardie-Site Sud, Amiens, France.

Guillaume Bera (G)

Centre Hospitalier Bretagne Sud, Lorient, France.

Christian Sire (C)

Centre Hospitalier Bretagne Sud, Lorient, France.

Sylvie Zanetta (S)

Centre Georges-François Leclerc, Dijon, France.

Marc Alfonsi (M)

Institut Sainte Catherine, Avignon, France.

Guillaume Janoray (G)

Centre Hospitalier Régional Universitaire Tours, Tours, France.

Thierry Chatellier (T)

Centre d'Oncologie de l'Estuaire, Saint-Nazaire, France.

Muriel Garcia-Ramirez (M)

Hôpital Robert Boulin, Libourne, France.

Elisabeta Gherga (E)

Hôpital Nord Franche-Comté, Montbéliard, France.

Yasser Hammoud (Y)

Centre Hospitalo-Universitaire Besançon, Besançon, France.

Mickaël Burgy (M)

Institut de Cancérologie Strasbourg Europe, Strasbourg, France; Laboratory of Bioimaging and Pathology, University of Strasbourg, UMR7021 CNRS, Illkirch, France.

Nelly Etienne-Selloum (N)

Institut de Cancérologie Strasbourg Europe, Strasbourg, France; Laboratory of Bioimaging and Pathology, University of Strasbourg, UMR7021 CNRS, Illkirch, France.

Adeline Pechery (A)

Groupe d'Oncologie Radiothérapie Tête Et Cou (GORTEC) - Centre Hospitalo-Universitaire Bretonneau, Tours, France.

Marie-Hélène Girard-Calais (MH)

Groupe d'Oncologie Radiothérapie Tête Et Cou (GORTEC) - Centre Hospitalo-Universitaire Bretonneau, Tours, France.

Michel Velten (M)

Institut de Cancérologie Strasbourg Europe, Strasbourg, France; Université de Strasbourg, UMR-S1113 IRFAC Inserm, Strasbourg, France.

Jean-Pierre Pignon (JP)

Service de Biostatistique et d'Epidémiologie, Gustave-Roussy Cancer Campus, Villejuif, France.

Mathilde Wanneveich (M)

Groupe d'Oncologie Radiothérapie Tête Et Cou (GORTEC) - Centre Hospitalo-Universitaire Bretonneau, Tours, France.

Jean Bourhis (J)

CHUV - Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.

Classifications MeSH