6th ICHNO Abstract Book

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page 58 6th ICHNO
6 th ICHNO Conference
International Conference on innovative approaches in Head and Neck Oncology
16 – 18 March 2017
Barcelona, Spain
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PO-121 Fentanyl Pectin Nasal Spray in head and neck
cancer irradiation. First results of the PecDICO study
Y. Pointreau 1, G. Bera2, C. Sire2, A. Ruffier3, G. Janoray3,
G. Calais 3, R. Bensadoun4, M. Bollet5, B. Pinel 6, L.
Martin 7, X. Amores8
1Centre Jean Bernard - Clinique Victor Hugo - Institut
interrégionaL de Cancérologie, Radiothérapie, Le Mans,
France
2Bretagne Sud hospital, radiotherapy, Lorient, France
3Bretonneau university hospital, radiotherapy, Tours,
France
4Haute Energie Centre, radiotherapy, Nice, France
5Hartmann clinic, radiotherapy, Neuilly-sur-Seine,
France
6La Miletrie university hospital, radiotherapy, Poitiers,
France
7Radiotherapy center, radiotherapy, Le Havre, France
8Kyowa Kirin Pharma, Medical Department, Neuilly-sur-
Seine, France
Purpose or Objective
Previous pivotal clinical trials demonstrated efficacy and
safety of Fentanyl Pectin Nasal Spray (FPNS) in
breakthrough pain in cancer patients (BTPc). Considering
the specific profile of patients with head and neck (H&N)
cancer, this non-interventional study mainly aims to
describe the real-life satisfaction with FPNS in patients
treated with radiotherapy.
Material and Methods
PecDICO is an ongoing French non-interventional,
prospective, and multicentre study conducted in patients
receiving radiation therapy for H&N cancer and who
started FPNS treatment for BTPc at inclusion. Data
collection is mainly based on a patient BTPc diary and
medical visits. We present here the results from inclusion
data collected between November 2014 and June 2016.
Results
When introducing FPNS, the characteristics of the 93
patients enrolled in 7 centres were as follows: mean age
60±8 years, 80% male, 94% BMI ≥18.5 kg/m², 100% ECOG
score ≤2 , 77% at least one concomitant disease/risk factor
(past or current smoking 67%, past or current alcoholism
41%). The H&N cancer was located at oropharynx (44%),
oral cavity (25%), hypopharynx (19%), larynx (14%), and/or
other sites (3%); median time from initial diagnosis was
3.8 months (range: 1.8-30.9). At inclusion, disease stage
was III/IV in 19%/56% of the cases. Cancer treatments
included surgery (30%), chemotherapy (67%;
chemoradiotherapy: 54%), and/or cetuximab (23%).
Radiotherapy was started 4 weeks (median; range: 0.4-
7.9) prior to FPNS start. Patients’ nutritional assessment
showed dysphagia in 97% of the cases (grade 1/2/3/4:
20%/61%/7%/9%), oral food supplements (65%), feeding
tube (15%) or gastrostomy (15%). A weight loss >10% over
the last month was observed in 22% of patients. As opioid
therapy for chronic pain, 93% of patients received
transdermal fentanyl and rescue treatment was added in
40% of cases (morphine sulfate 18%, oxycodone 17%).
Other treatments with an analgesic effect were given in
94% of the patients (grade 1/2 analgesics 62%/26%,
lidocaine gel 43% and/or corticosteroids 19%). The first
BTPc episode occurred 4 days prior FPNS initiation
(median; range: 0-78). BTPc were nociceptive (45%) or
mixed pain (55%) and they were procedural, predictable
or spontaneous in 8%, 90% and/or 30% of the patients. The
duration of BTPc episodes was ≤20 minutes in 83% of the
cases. At FPNS initiation, BTPc intensity was assessed ≥5
by 60% of patients (30/50) on the basis of a 0-10 numerical
scale, with up to 4 daily episodes (86%; 37/43).
Conclusion
These first results provides detailed information about
patient characteristics receiving radiotherapy for H&N
cancer and starting FPNS for BTPc, as well as on cancer
management, BTPc episodes, and pain treatments. Real-
world data on patient satisfaction with FPNS (and then its
perceived efficiency and tolerability) are expected in
2017.
PO-122 Psychological profile of patients with head and
neck cancer during radiotherapy: preliminary data
M. Massaccesi1, L. Dinapoli1, A. Pesce1, F. Miccichè1, R.
Autorino 1, A. Tenore1, M. Balducci1, V. Valentini1
1Università Cattolica del Sacro Cuore -Policlinico A.
Gemelli, Radiation Oncology Gemelli ART, Rome, Italy
Purpose or Objective
Radiation treatment (RT) with radical intent for head and
neck (H&N) cancer is usually complex and burdensome.
The radiation course generally lasts 6 to 7 weeks and more
than half patients can experience relevant acute toxicity.
Toxic effects may be even more frequent in patients who
also receive concurrent chemotherapy (CT). Therefore the
experience of receiving RT can be both uncomfortable and
anxiety provoking. Aim of this study is to evaluate the
psychological profile of patients with H&N cancer during
RT.
Material and Methods
Consecutive patients with H&N cancer who underwent RT
with radical intent were included between January and
September 2016. Psychological support was available for
all patients and Distress Thermometer (DT) and Hospital
Anxiety and Depression Scale (HADS) were administered to
evaluate emotional distress and mood, respectively.
These tests were administered at the beginning (T0), the
middle (T1), and the end (T2) of the RT course.
Results
Fifty patients (36 male and 14 female, mean age 61,
range 14-82 years) who underwent radical RT for H&N
cancer were included. RT was post-operative in 22
patients (44.0%) and was delivered up to a medial total
dose of 68 Gy (range 50-70 Gy). Twenty-five (50.0%)
patients received concurrent CT.
All 50 patients underwent the T0 evaluation. The T1 and
T2 evaluations were done in 40 (80.0%) and 34 (68.0%)
patients, respectively.
At T0 evaluation, 32/50 patients (64.0%) were emotionally
distressed (cut off value DT score≥4) and 12/50 patients
(24%) showed anxiety/depression (cut off value HADS
score≥14).
At T1, 27/40 (67.5%) patients had significant emotional
distress and 9/40 (22.5%) patients had significant anxiety
and depression.
At T2, 25/34 (73.5%) patients had significant emotional
distress and 12/34 (35.3%) patients had significant anxiety
and depression.
During RT, patients who were distressed (32/50) or
anxious and depressed (12/50) at the beginning of
treatment did not show any significant variation of their
DT score, while HADS score significantly improved at T2
evaluation (median HADS score 19 and 15, at T0 and T2
respectively, p=0.03). Patients who were not distressed
(18/50) or anxious and depressed (38/50) at baseline,
showed a worsening of DT score at both T1 (p=0.02) and
T2 (p=0.01) as compared to baseline; HADS score remained
substantially stable at T1 while worsened at T2 (p=0.03).
Conclusion
In this small series of consecutive patients with H&N
cancer treated with RT, a psychological support during
treatment allowed to prevent any further deterioration in
distressed patients. However, it did not completely
prevent a worsening in patients who had initially normal
scores. The occurrence of acute treatment related toxic
effects could explain such deterioration and further
analysis is ongoing to test this hypothesis.