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Background In a previous phase II study an immunonutrient supplement was found to reduce severe acute toxicities for head and neck squamous cell cancer (HNSCC) patients treated with concomitant cisplatin and radiotherapy. Objectives The primary objective of the present study was to evaluate efficacy of the same immunonutrient supplement on severe mucositis. Secondary objectives included tolerance, compliance to oral supplementation, chemotherapy interruptions and delays, quality of life, and progression-free survival (PFS) and overall survival (OS) at 1, 2, and 3 y. Methods Between November 2009 and June 2013, 180 HNSCC patients eligible for adjuvant chemotherapy after surgery with curative intent were included in our double-blind phase III multicenter trial. They were assigned to receive oral supplementation (3 sachets/d) of either a formula enriched with l-arginine and omega-3 (n-3) fatty and ribonucleic acids (experimental arm), or an isocaloric isonitrogenous control (control arm), for 5 d before each of 3 cycles of cisplatin. Intention-to-treat (ITT) and per-protocol (PP) analyses were undertaken, along with subgroup analyses of ≥75% compliant patients, to compare the incidence of acute mucositis (Radiation Therapy Oncology Group and WHO scales) and 36-mo survival. Results At 1 mo after terminating chemoradiotherapy (CRT), no differences were observed in the incidence of grade 3-4 mucositis between treatment groups, in the ITT, PP (172 patients), and subgroup (≥75% compliance, n = 112) analyses. The immunomodulating supplement did not significantly improve survival in the ITT and PP analyses at 3 y after CRT. Among ≥75% compliant patients, however, OS at 3 y was significantly improved in the immunomodulating formula group (81%; 95% CI: 67%, 89%) compared with controls (61%; 95% CI: 46%, 73%; P = 0.034), as well as PFS (73%; 95% CI: 58%, 83% compared with 50%; 95% CI: 36%, 63%; P = 0.012). Conclusions Although this immunomodulating formula failed to reduce severe mucositis during CRT, the findings suggest that the long-term survival of compliant HNSCC patients was improved.This trial was registered at clinicaltrials.gov as NCT01149642.

Purpose Intensity-modulated radiation therapy (IMRT) has shown its interest for head and neck cancer treatment. In parallel, cetuximab has demonstrated its superiority against exclusive radiotherapy. The objective of this study was to assess the acute toxicity, local control and overall survival of cetuximab associated with different IMRT modalities compared to platinum-based chemotherapy and IMRT in the ARTORL study ( NCT02024035 ). Patients and method This prospective, multicenter study included patients with epidermoid or undifferentiated nasopharyngeal carcinoma, epidermoid carcinoma of oropharynx and oral cavity (T1–T4, M0, N0–N3). Acute toxicity, local control and overall survival were compared between groups (patients receiving cetuximab or not). Propensity score analysis at the ratio 1:1 was undertaken in an effort to adjust for potential bias between groups due to non-randomization. Results From the 180 patients included in the ARTORL study, 29 patients receiving cetuximab and 29 patients treated without cetuximab were matched for the analysis. Ten patients (34.5%) reported acute dermal toxicity of grade 3 in the cetuximab group versus three (10.3%) in the non-cetuximab group obtained after matching ( P = 0.0275). Cetuximab was not significantly associated with more grade 3 mucositis ( P = 0.2563). There were no significant differences in cutaneous or oral toxicity for patients treated with cetuximab between the different IMRT modalities ( P = 1.000 and P = 0.5731, respectively). There was no significant difference in local relapse-free survival ( P = 0.0920) or overall survival ( P = 0.4575) between patients treated with or without cetuximab. Conclusion Patients treated with cetuximab had more cutaneous toxicities, but oral toxicity was similar between groups. The different IMRT modalities did not induce different toxicity profiles.

Purpose This cost analysis aimed to prospectively assess differences in costs between TomoTherapy and volumetric modulated arc therapy (VMAT) in patients with head and neck cancer. Methods and Materials Economic data were gathered from a multicenter study. However, randomization was not possible due to the availability of equipment. Costs were calculated using the microcosting technique from the hospital's perspective (in 2013 euros), and the time horizon was radiation therapy. Only resources that entered the hospital production process and which were likely to vary between the strategies being compared were considered. Acute adverse events observed within the time horizon were also assessed. Results The cost analysis was based on a total of 173 patient treatments given between 2010 and 2012 in 14 French cancer centers: 73 patients were treated with TomoTherapy, 92 with VMAT RapidArc, and 8 with VMAT SmartArc. Estimated costs of SmartArc were removed from the comparison due to the small sample size. The mean ± SD cost per patient of the treatment planning phase was €314 (±€214) for TomoTherapy and €511 (±€590) for RapidArc. Mean costs ± SD per patient of irradiation reached €3144 (±€565) for TomoTherapy and €1350 (±€299) for RapidArc. The most sensitive parameter of irradiation was the annual operating time of accelerators. Ninety-five percent confidence intervals for the mean costs of irradiation were €3016 to €3272 for TomoTherapy and €1281 to €1408 for RapidArc. The number of acute adverse events during radiation therapy was not significantly different between strategies. Conclusions TomoTherapy appeared to be more expensive than RapidArc mainly due to the higher price of the accelerator, the higher costs of maintenance, and the longer duration of treatment sessions. Because strategies were not significantly different in clinical effect, RapidArc appeared to be the strategy to be recommended at this stage of knowledge.

This article reviews the concept of selectivity in peritumoral microscopic disease to be included in the Clinical Target Volume (CTV) for elective treatment for oral cavity and oropharyngeal squamous cell carcinoma, using the local tumoral spread. The objective of the present article is to present a procedure for the delineation of the target volumes, required for an appropriate application of 3-DCRT and IMRT for head and neck cancers. These propositions are for the delineation of microscopic peritumoral target volumes when external beam irradiation is required. CTVs are illustrated on CT sections.

Objectifs ART-ORL est un essai multicentrique qui a evalue d’une part les couts de la mise en œuvre de la radiotherapie conformationnelle avec modulation d’intensite (RCMI) par differentes techniques d’arctherapie volumetrique modulee en France et d’autre part l’efficacite et la toxicite de ce traitement. Les implications de l’utilisation du cetuximab chez des patients recevant une arctherapie volumetrique modulee ne sont pas encore bien decrites. Cette etude est une analyse exploratoire a partir des donnees prospectives et multicentriques de cet essai soutenu par l’Institut national du cancer (Inca). Patients et methodes Les criteres d’inclusion etaient les patients atteints d’un carcinome epidermoide ou indifferencie du cavum, de l’oropharynx ou de la cavite buccale, de stade I a IV, sans metastase, non opere, avec une irradiation des aires ganglionnaires cervicales bilaterale. Resultats Cent quatre-vingt patients ont ete inclus. L’âge median etait de 56 ans. Cent dix-huit patients etaient pris en charge pour un carcinome epidermoide de l’oropharynx (67,8 %), 38 pour un carcinome indifferencie du cavum (21,8 %), 17 pour un carcinome epidermoide de la cavite buccale (9,8 %) et un pour une double localisation oro- et nasopharyngee. Vingt neuf patients ont recu du cetuximab. Ces patients etaient plus âges (p Conclusion Aucune difference significative de survie ou de toxicite n’a ete mise en evidence entre les patients traites par une technique d’arctherapie volumetrique modulee, avec ou sans cetuximab. Ces resultats doivent etre interpretes en tenant compte du faible nombre de patients traites par cetuximab dans l’essai ART-ORL.

6066 Background: A previous phase II study showed that an oral immunomodulating formula could reduce severe toxicities and increased survival for HNSCC with concomitant cisplatin and irradiation tr...

Objectif Evaluation medico-economique prospective soutenue par l’Institut national du cancer (Inca) visant a estimer un differentiel de couts entre deux modalites : la tomotherapie et l’arctherapie volumetrique modulee. Les objectifs cliniques etaient d’evaluer la toxicite salivaire, le controle local et la survie globale a 18 mois. Patients et methodes Au total, 174 patients ont ete inclus entre fevrier 2010 et fevrier 2012 dans 14 centres, Le traitement etait pour 52 % ont une arctherapie volumetrique modulee (RapidArc®), pour 42,5 % une tomotherapie et pour 4,6 % une l’arctherapie volumetrique modulee (VMAT®). L’âge median etait de 56 ans (21–100). Les tumeurs etaient oropharyngees (68 %), nasopharyngees (21,8 %), de la cavite buccale (9,8 %), 33 et etaient de stade T4, 30 % T3, 24 % T2, 13 % T1 ; 29 % N0, 14 % N1, 51 % N2, toutes M0. La dose prescrite (boost integre) etait 70 Gy en 35 fractions de 2 Gy dans le volume tumoral macroscopique (PTV70), 63 Gy en 35 fractions de 1,8 Gy dans volume a risque intermediaire, 56 Gy en 35 fractions de 1,6 Gy dans le volume a bas risque avec une chimiotherapie concomitante (89 %) par platine (72 %) ou Erbitux® (17 %). Resultats La duree mediane de suivi etait de 20,6 mois (intervalle de confiance a 95 % : 20,4–20,9). Cinquante-huit tumeurs (33,3 %) ont progresse, 69 % dans le volume tumoral macroscopique. Le taux de controle local etait pour la tomotherapie de 82,2 %, l’arctherapie volumetrique modulee (RapidArc®) de 72,3 % et l’arctherapie volumetrique modulee (VMAT®) de 75 % (p = NS), la probabilite de survie globale respectivement de 82 %, 83,3 % et 71,4 % (p = NS). Quatre-vingt-onze patients ont souffert d’une toxicite grade 3 ou plus, respectivement, 46, 42 et 3 (p = NS), essentiellement des mucites (26 %). Vingt-neuf patients (16,6 %) ont souffert d’une toxicite tardive, essentiellement salivaire, de grade 2 ou plus, respectivement 13, 16 et 0 (p = NS). Sur le plan economique, le surcout moyen de la tomotherapie etait de 1598 € comparativement a l’arctherapie volumetrique modulee (RapidArc®), et de 604 € comparativement a l’arctherapie volumetrique modulee (VMAT®). Le surcout moyen l’arctherapie volumetrique modulee (VMAT®) etait de 994 € comparativement a l’arctherapie volumetrique modulee (RapidArc®). Conclusions Ce travail confirme l’apport de la radiotherapie conformationnelle avec modulation d’intensite, et ce quelle que soit la technologie, pour limiter la toxicite salivaire, cutanee et muqueuse lors d’une irradiation ORL. L’analyse medico-economique montre que la mise en œuvre de la tomotherapie conduit a une consommation accrue de ressources par rapport a l’arctherapie volumetrique modulee.