Dose escalation of radiotherapy (RT) for locally advanced head and neck carcinomas treated with concomitant chemotherapy (CT) and RT: Results of the GORTEC 2004-01 randomized trial.

Authors

null

Jean Bourhis

Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

Jean Bourhis , Anne Auperin , Marc Alfonsi , xu Shan Sun , Michel Rives , Yoann Pointreau , Cedrik Lafond , Pierre Boisselier , Pierre Graff , Juliette Thariat , Yungan Tao

Organizations

Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, Institut Gustave Roussy, Villejuif, France, Institut Sainte-Catherine, Avignon, France, CHRU Jean Minjoz, Besancon Cedex, France, Institut Claudius Regaud, IUCT-Oncopole, CRCT, Inserm, Toulouse, France, Centre Hospitalier et Régional Universitaire, Henry S. Kaplan Center, Clinique d’Oncologie et de Radiothérapie, Tours, France, Clinique Victor Hugo, Le Mans, France, Institut du Cancer de Montpellier, Montpellier, France, Centre Antoine Lacassagne, Nice, France

Research Funding

Other

Background: Concomitant CT-RT is a well established standard of care (SoC) in locally advanced (LA) squamous cell carcinomas of the head and neck (SCCHN). While there is a well established dose effect relationship for RT alone in these cancers, it is not known whether this also applies to concomitant CT-RT. Methods: Patients were randomized between 75 Gy/7 weeks (Arm A) versus 70 Gy/35F in 7 weeks (Arm B). A sequential boost of 10 times 2.5 Gy after 50Gy/25F was given to the initial gross tumor volume (GTV) in Arm A. IMRT was used for arm A and 3D conformal RT for arm B. In both arms, patients (pts) received during RT 3 cycles of cisplatin at 100 mg/m2. Inclusion criteria were pts fit for receiving high dose cisplatin, non metastatic, non operated stage III-IV SCC of oral cavity, oro/hypopharynx. A 1:1 randomization was done by minimization on centers, N & T stages & GTV uni/bilateral. To detect a hazard ratio (HR) of 0.56 in locoregional (LR) control, inclusion of 310 pts was required to observe 109 LR progressions and achieve 85% power at 2-sided significance level of 0.05. Results: Between 2005 and 2015, 188 pts were randomized: 82% males, median age 58 years, 85% oropharynx. The accrual rate was slower than expected, due to the fact that IMRT became a SoC and was only allowed in arm A. As a consequence the trial was discontinued after inclusion of 188 patients. The majority of pts had stage IVa (73% vs 72%). All initial characteristics were well balanced between arms. The median follow-up was 4.7 years, not different between arms. Acute and late xerostomia were markedly improved in arm A (IMRT arm). The 1-year grade 0-1 salivary toxicity (RTOG) was 81% and 34% (p< 0.0001) in arm A and B respectively. At 3 years these rates were 92% vs 53% (p=0.0003). The increase of the dose to the GTV with IMRT did not transfer in a higher LR control probability with an adjusted HR of 0.88 [95%CI 0.51-1.52] (p=0.63). PFS, overall survival were not significantly different between the 2 arms. Conclusions: The dose escalation of RT to the GTV did not improve LR control in patients treated with concomitant CT-RT. This trial adds some new evidence level 1 in favor of IMRT in LA SCCHN. Clinical trial information: NCT00158678

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Head and Neck Cancer

Track

Head and Neck Cancer

Sub Track

Local-Regional Disease

Clinical Trial Registration Number

NCT00158678

Citation

J Clin Oncol 35, 2017 (suppl; abstr 6015)

DOI

10.1200/JCO.2017.35.15_suppl.6015

Abstract #

6015

Poster Bd #

3

Abstract Disclosures