Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial.

Details

Serval ID
serval:BIB_A2CE5DA53CCF
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial.
Journal
Radiotherapy and oncology
Author(s)
Tao Y., Auperin A., Blanchard P., Alfonsi M., Sun X.S., Rives M., Pointreau Y., Castelli J., Graff P., Wong Hee Kam S., Thariat J., Veresezan O., Heymann S., Renard-Oldrini S., Lafond C., Cornely A., Casiraghi O., Boisselier P., Lapeyre M., Biau J., Bourhis J.
ISSN
1879-0887 (Electronic)
ISSN-L
0167-8140
Publication state
Published
Issued date
09/2020
Peer-reviewed
Oui
Volume
150
Pages
18-25
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
Concurrent chemoradiotherapy (CRT) is the standard of care (SoC) in locally advanced (LA) head and neck squamous cell carcinomas (HNSCC). This trial was designed to test whether dose-escalated IMRT and cisplatin could improve locoregional control without increasing complications over 3D-radiotherapy.
Patients were randomized between 70 Gy/35F in 7 weeks with 3D-RT (Arm A) versus 75 Gy/35F with IMRT (Arm B). Both arms received 50 Gy in 25 fractions followed by a sequential boost of 20 Gy/10F in Arm A and 25 Gy/10F to gross tumor volume in Arm B, as well as 3 cycles of cisplatin at 100 mg/m2 during RT. The primary endpoint was locoregional progression (LRP).
188 patients were randomized: 85% oropharynx and 73% stage IVa. P16 status was documented for 137 oropharyngeal tumors with P16+ in 53 (39%) patients; and 90% were smokers. Median follow-up was 60.5 months. Xerostomia was markedly decreased in arm B (p < 0.0001). The 1-year grade ≥2 xerostomia (RTOG criteria) was 63% vs 23% and 3-year 45% vs 11% in arms A and B, respectively. Xerostomia LENT-SOMA scale was also reduced in arm B. Dose-escalated IMRT did not reduce LRP with an adjusted HR of 1.13 [95%CI = 0.64-1.98] (p = 0.68). Survival was not different (adjusted HR: 1.19 [95%CI = 0.78-1.81], p = 0.42). No interaction between p16 and treatment effect was found.
Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT. This trial reinforces the evidence showing IMRT reduces xerostomia in LA-HNSCC treated with radiotherapy. Clinicaltrial.gov: NCT00158678.
Keywords
Head and neck cancer, IMRT, Intensity-modulated radiotherapy, cisplatin, concurrent chemoradiotherapy, dose escalation, Cisplatin, Concurrent chemoradiotherapy, Dose escalation
Pubmed
Create date
14/06/2020 20:04
Last modification date
24/10/2020 5:21
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