6th ICHNO Abstract Book

6th ICHNO 6 th ICHNO Conference International Conference on innovative approaches in Head and Neck Oncology 16 – 18 March 2017 Barcelona, Spain __________________________________________________________________________________________ page 71

trials. We developed a large prospective clinical program planned to enroll 448 pts not suitable for surgery in 3 distinct trials to improve the multidisciplinary management of elderly SCCHN pts. The main objectives of this study are to demonstrate that a geriatric evaluation is feasible in daily practice for SCCHN pts and to improve older adults’ treatment by setting standards of care in this population. Material and Methods To be enrolled in one of the three trials, elderly SCCHN pts must first enter the ELAN-ONCOVAL study, which aims to classify pts as fit or unfit using an adapted geriatric evaluation usable in daily practice by oncologists. G8 score is also done, and Comprehensive Geriatric Assessment (CGA) is optional. Fit pts with recurrent and/or metastatic (R/M) SCCHN may enroll onto a phase II trial evaluating the clinical benefit of cetuximab/carboplatin/5FU (EXTREME regimen) as first line treatment (ELAN FIT-NCT01884623). Eighty pts are planned to demonstrate efficacy (objective response at 12 weeks) and safety (absence of grade ≥ 4 toxicity and preservation of autonomy) of treatment. Unfit R/M pts may enroll onto a randomized phase III trial of cetuximab (500mg/m 2 every 2 weeks) or methotrexate (40 mg/m²/week) monotherapy as first-line therapy (ELAN UNFIT-NCT01864772). The main endpoint is failure free survival (defined as death, progression, treatment stop or loss of at least 2 points in ADL scale). Hundred and sixty- four pts are planned. In curative situation, unfit pts may enroll onto a randomized, non-inferiority trial comparing standard radiotherapy (70Gy, 35 fractions, 7 weeks) and hypofractionated split course schedule (30Gy in 10 fractions, 2 weeks stop, 25Gy in 10 fractions, total 6 weeks). Main endpoint is the rate of alive pts with local control 6 months after treatment. Two hundred and two pts are planned to be randomized (ELAN-RT- NCT01864850). Assessments of efficacy, toxicity, autonomy (ADL, IADL scales) and health related quality of life (EORTC QLQ-C30 and HN35 questionnaires) are performed in clinical trials. Results Inclusions are underway since June 2013. Currently, 58 centers are opened in France. Four hundred and thirty-one pts are registered in ELAN ONCOVAL study. At now, 80% of geriatric evaluation has been done by physicians, and CGA performed for 52% of pts. Approximately 55% have been then enrolled in a clinical trial: ELAN-RT (125, 61.9%), ELAN-FIT (57, 70%), ELAN-UNFIT (57, 34.7%). Interim safety analysis of ELAN FIT study did not reveal safety issues. Conclusion Just over half of the program, we are already experiencing a strong support of the french medical community to geriatric assessment of elderly SCCHN pts. Based on ELAN consortium, pts may benefit from adapted care and innovation. PO-148 Hypofractionated radiotherapy for head and neck cancer patients unfit for standard treatment I. Desideri 1 , P. Bonomo 1 , C. Ciabatti 1 , C. M untoni 1 , M. Lo Russo 1 , M. Loi 1 , D. Greto 1 , I. Meattini 1 , L. Livi 1 1 University of Florence, Radiotherapy, Firenze, Italy Purpose or Objective With prolongation of life expectancy the proportion of elderly HNSCC patients is also increasing with most cases occurring in the sixth or seventh decade of life. The purpose of our study was to report on the toxicity and response to moderately hypofractionated, “involved-

field” radiotherapy (HIRT) in patients deemed unfit to receive standard curative treatment due to impaired, baseline performance status and/or high burden of comorbidity whit a palliative regimen that provide symptom control, minimal treatment-related toxicity and improve quality of life (QoL). Material and Methods A total of 34 patients affected by HNSCC treated with HIRT were included in or analysis. Patients treated at the Radiation Oncology Unit of the University of Florence between December 2011 and July 2016 was retrospectively analyzed. At clinical evaluation, HIRT was selected when patients were considered unsuitable for standard treatment with curative intent (concurrent CTRT or high-dose, conventionally fractionated radiotherapy). In 50% of cases the disease was localized in the oral cavity; in 15% at the level of the oropharynx and 20% larynx; in 15% in the nasopharynx, salivary glands, skin and soft tissues. The dose/fractionation prescribed in all cases was 40 Gy/2.5 Gy per fraction delivered to gross tumor and nodal disease without inclusion of elective target volumes. Acute toxicity was scored according to NCI – CTCAE v.4. Clinical assessment was performed at 25 days from the end of treament, while response to treatment was evaluated between 45 and 60 days with appropriate morphologic and/or metabolic imaging. Progression-free survival (PFS) was calculated from the end of treatment to the date of first event of disease progression Results All patients are evaluable for acute toxicity assessment while clinical outcome has been analyzed in 32/34 (94%) patients, with a median follow-up of 6 months (range 2- 45). Median age of the cohort was 77,5 years (48-91). The majority of patients underwent 3-D conformal radiotherapy, namely 29/34 patients (85%), while in 4 cases (15%) IMRT was delivered. Only one patient didn’t complete HIRT due to worsened clinical conditions at 32.5 Gy. In terms of acute toxicity, the rate of G2 mucositis and dysphagia were 29% and 23,5%, respectively; the G3 rate were 18% and 6%. No G4 toxicity was reported. Early efficacy assessment was favorable: absence of local progression was achieved in 26 patients (76%): complete response was attained in 3 case (9 %), partial response in 16 (47%) and stable disease in 3 (9%), respectively.Median PFS was 6 months (range 2 – 45). 20 of 34 patients (59%) were alive at last follow Conclusion In our experience, HIRT was associated with a favorable acute toxicity profile and proved to be effective in terms of local disease control. Longer follow-up is needed to confirm the long-term benefit and to evaluate the incidence of late toxicity in this frail cohort of patients PO-149 Survival outcomes for very elderly patients after definitive radiotherapy for head and neck cancer L.M. Dixon 1 , K. Garcez 1 , L.W. Lee 1 , A.J. Sykes 1 , N.J. Slevin 1 , D.J. Thomson 1 1 The Christie NHS Foundation Trust, Clinical Oncology, Manchester, United Kingdom Purpose or Objective At our institution between 2011 and 2015, 25% and 6% of radically treated head and neck cancers were respectively in patients aged ≥70 and ≥80 years. There is lack of trial data describing clinical outcomes for these patient groups. This retrospective review describes our experience in patients aged ≥80 years. Material and Methods 62 patients aged ≥80 years with oropharynx, larynx, hypopharynx and oral cavity squamous cell carcinoma treated with definitive radiotherapy between January 2011 and December 2015 were included. All patients were