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Head and neck carcinomas are initially metastatic in about 15% of cases. Radiotherapy is a cornerstone in the multimodal strategy at the locoregional phase. In patients with head and neck cancer, often heavily pretreated and with comorbidities, who relapse locoregionally or at distant sites, radiotherapy has also become increasingly important at the metastatic phase. Data on the optimal sequence of systemic treatments and metastasis-directed treatments including stereotactic irradiation are still lacking. Several randomized head and neck trials have been initiated that should provide important answers, including one recent GORTEC trial. [ABSTRACT FROM AUTHOR]

The phase 3 KEYNOTE-412 study (NCT03040999), pembro + CRT (pembro arm) showed a trend toward improved EFS vs placebo + CRT (pbo arm) in pts with LA HNSCC, although the difference was not statistically significant (HR, 0.83 [95% CI, 0.68-1.03]; P =0.0429 [superiority threshold, P =0.0242]). Prespecified HRQoL outcomes from KEYNOTE-412 are presented. Pts aged ≥18 yrs with LA HNSCC were randomly assigned 1:1 to pembro 200 mg IV once Q3W or matching pbo + CRT. Pts received 1 priming dose of pembro/pbo 1 week before CRT followed by 2 doses of pembro/pbo during CRT and maintenance pembro/pbo for up to 14 doses. Prespecified secondary end points were mean change from baseline (BL) in EORTC QLQ-C30 global health status/quality of life (GHS/QoL) and physical functioning scores as well as EORTC QLQ-H&N35 pain, problems with swallowing, and speech scores. Prespecified exploratory end points included rate of improvement, stability, and deterioration, and mean change from BL in other prespecified scales of QLQ-C30, QLQ-H&N35, and EQ-5D VAS. Analysis population included pts who received ≥1 dose of treatment and completed ≥1 HRQoL assessment for a specific end point. Analysis was done at week 45 when respective completion and compliance rates of ≥60% and ≥80% were met per blinded data review. Treatment difference (least squares mean [LSM] change from BL) was estimated from a constrained longitudinal data analysis method. Completion and compliance rates were >95% at BL for all measures. Completion rates were >60% and compliance rates were >80% for all measures at week 45. LSM change from BL to week 45 for pembro vs pbo was 1.95 (95% CI, −0.10 to 4.00) vs 6.08 (95% CI, 4.02 to 8.13) for QLQ-C30 GHS/QoL (LSM difference: −4.13 [95% CI, −6.73 to −1.53]) and −5.54 (95% CI, −7.34 to −3.73) vs −3.46 (95% CI, −5.26 to −1.66) for QLQ-C30 physical functioning (LSM difference: −2.07 [95% CI: −4.51 to 0.36]). No meaningful differences in LSM change from BL to week 45 were observed between treatment arms for QLQ-H&N35 pain (1.44 [95% CI, −1.27 to 4.15]), problems with speech (−1.27 [95% CI, −4.60 to 2.07]), and swallowing (−0.31 [95% CI, −3.75 to 3.13]) scales or in EQ-5D VAS (−1.44 [95% CI, −3.74 to 0.85]). Similar percentages of pts for the pembro vs pbo arms had improved or stable scores for QLQ-C30 GHS/QoL (43.0% vs 47.6%) and QLQ-H&N35 pain (49.9% vs 50.3%), problems with speech (40.3% vs 41.4%), and swallowing (34.4% vs 34.3%) scales. Patient-reported outcomes and disease symptom scores were generally similar between pembro and pbo arms, suggesting addition of pembro to CRT did not meaningfully impact HRQoL at week 45 in pts with LA HNSCC. [ABSTRACT FROM AUTHOR]

We present the update of the recommendations of the French society of radiotherapy and oncology on the indications and the technical methods of carrying out radiotherapy of sinonasal cancers. Sinonasal cancers (nasal fossae and sinus) account for 3 to 5% of all cancers of the head and neck. They include carcinomas, mucosal melanomas, sarcomas and lymphomas. The management of sinonasal cancers is multidisciplinary but less standardized than that of squamous cell carcinomas of the upper aerodigestive tract. As such, patients with sinonasal tumors can benefit from the expertise of the French expertise network for rare ENT cancers (Refcor). Knowledge of sinonasal tumour characteristics (histology, grade, risk of lymph node involvement, molecular characterization, type of surgery) is critical to the determination of target volumes. An update of multidisciplinary indications and recommendations for radiotherapy in terms of techniques, target volumes and radiotherapy fractionation of the French society of radiotherapy and oncology (SFRO) was reported in this manuscript. [ABSTRACT FROM AUTHOR]

A Benchmark Case (BC) was performed as part of the quality assurance process of the randomized phase 2 GORTEC 2014-14 OMET study, testing the possibility of multisite stereotactic radiation therapy (SBRT) alone in oligometastatic head and neck squamous cell carcinoma (HNSCC) as an alternative to systemic treatment and SBRT. Compliance of the investigating centers with the prescription, delineation, planning and evaluation recommendations available in the research protocol was assessed. In addition, classical dosimetric analysis was supplemented by quantitative geometric analysis using conformation indices. Twenty centers participated in the BC analysis. Among them, four major deviations (MaD) were reported in two centers. Two (10%) centers in MaD had omitted the satellite tumor nodule and secondarily validated after revision. Their respective DICE indexes were 0.37 and 0 and use of extracranial SBRT devices suboptimal There were significant residual heterogeneities between participating centers, including those with a similar SBRT equipment, with impact of plan quality using standard indicators and geometric indices. A priori QA using a BC conditioning the participation of the clinical investigation centers showed deviations from good SBRT practice and led to the exclusion of one out of the twenty participating centers. The majority of centers have demonstrated rigorous compliance with the research protocol. The use of quality indexes adds a complementary approach to improve assessment of plan quality. [ABSTRACT FROM AUTHOR]

Background: Cetuximab in combination with platinum and 5-fluorouracil is the standard of care in the first-line treatment of patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Cetuximab and taxane combinations have shown promising activity. This study evaluated the efficacy and safety of four cycles of docetaxel associated with cisplatin and cetuximab (TPEx), followed by maintenance with cetuximab every 2 weeks. Patients and methods: Patients with a histologically confirmed HNSCC with metastasis or recurrence unsuitable for locoregional curative treatment received docetaxel and cisplatin (75 mg/m² both) at day 1 and weekly cetuximab 250 mg/m² (loading dose of 400 mg/m²), repeated every 21 days for four cycles, followed by maintenance cetuximab 500 mg/m2 every 2 weeks until progression or unacceptable toxicity. Prophylactic administration of granulocyte colony-stimulating factor was done systematically after each chemotherapy cycle. Patients had a good general status (performance status ≤1) and were under 71 years. Prior total doses of cisplatin exceeding 300 mg/m² were not allowed. The primary end point was objective response rate (ORR) after four cycles. Results: Fifty-four patients were enrolled. The primary end point was met with an ORR of 44.4% (95% CI 30.9-58.6). Median overall and progression-free survivals were, respectively, 14 months (95% CI 11.3-17.3) and 6.2 months (95% CI 5.4-7.2). The most common grade 3/4 adverse events were skin rash (16.6%) and non-febrile neutropenia (20.4%). There were one pulmonary embolism and two infectious events leading to death. Conclusions: The TPEx regimen showed promising activity as first-line treatment in fit patients with recurrent/metastatic HNSCC. Further studies are needed to compare the TPEx versus EXTREME regimen in this population. [ABSTRACT FROM AUTHOR]