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.

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State: Public
Version: Final published version
License: CC BY 4.0
Serval ID
serval:BIB_F5AFF8A3C19B
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
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.
Journal
Radiotherapy and oncology
Author(s)
Borel C., Sun X.S., Coutte A., Bera G., Sire C., Zanetta S., Alfonsi M., Janoray G., Chatellier T., Garcia-Ramirez M., Gherga E., Hammoud Y., Burgy M., Etienne-Selloum N., Pechery A., Girard-Calais M.H., Velten M., Pignon J.P., Wanneveich M., Bourhis J.
ISSN
1879-0887 (Electronic)
ISSN-L
0167-8140
Publication state
Published
Issued date
08/2024
Peer-reviewed
Oui
Volume
197
Pages
110329
Language
english
Notes
Publication types: Journal Article ; Clinical Trial, Phase II ; Randomized Controlled Trial ; Multicenter Study ; Comparative Study
Publication Status: ppublish
Abstract
Chemoradiotherapy with high-dose cisplatin (HD-Cis: 100 mg/m <sup>2</sup> q3w for three cycles) is the standard of care (SOC) in locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Cumulative delivered dose of cisplatin is prognostic of survival, even beyond 200 mg/m <sup>2</sup> but high toxicity compromises its delivery.
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 <sup>2</sup> /d d1-4 q3w for 3 cycles) in patients with LA-HNSCC. The primary endpoint was the cumulative delivered cisplatin dose.
Between December 2015 and April 2018, 124 patients were randomized. Median cisplatin cumulative delivered dose was 291 mg/m <sup>2</sup> (IQR: 251;298) in the FHD-Cis arm and 274 mg/m <sup>2</sup> (IQR: 198;295) in the HD-Cis arm (P = 0.054). The proportion of patients receiving a third cycle of cisplatin was higher, with a lower proportion of grade 3-4 acute AEs in the FHD-Cis arm compared to the HD-Cis arm: 81 % vs. 64 % (P = 0.04) and 10 % vs. 17 % (P = 0.002), respectively. With a median follow-up of 48 months (IQR: 41;55), locoregional failure rate, PFS and OS were similar between the two arms.
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.
Keywords
Humans, Cisplatin/administration & dosage, Male, Middle Aged, Female, Head and Neck Neoplasms/radiotherapy, Head and Neck Neoplasms/pathology, Head and Neck Neoplasms/therapy, Head and Neck Neoplasms/drug therapy, Dose Fractionation, Radiation, Chemoradiotherapy/methods, Aged, Squamous Cell Carcinoma of Head and Neck/radiotherapy, Squamous Cell Carcinoma of Head and Neck/therapy, Squamous Cell Carcinoma of Head and Neck/drug therapy, Squamous Cell Carcinoma of Head and Neck/pathology, Antineoplastic Agents/therapeutic use, Antineoplastic Agents/administration & dosage, Adult, Chemoradiotherapy, Cisplatin, Cisplatin pharmacokinetic, Locally advanced, Squamous Cell Carcinoma of Head and Neck
Pubmed
Web of science
Open Access
Yes
Create date
24/05/2024 8:54
Last modification date
27/07/2024 6:19
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