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