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6th ICHNO
6
th
ICHNO Conference
International Conference on innovative approaches in Head and Neck Oncology
16 – 18 March 2017
Barcelona, Spain
__________________________________________________________________________________________
received neck dissection and those who did not receive
neck dissection. We will also analyse the determinants of
overall quality of life and of swallowing including factors
such as neck dissection and HPV status. In addition we will
also report on the functional and survival outcomes of
different types of neck dissection in the context of
definitive chemoradiotherapy.
SP-012 Update of neck dissection trial
A.D'Cruz
1
1
Tata Memorial Hospital, Mumbai, India
Abstract text
BACKGROUND: Appropriate management of the neck in
clinically node negative early oral cancer has been a
matter of debate for decades. A prospective phase III
randomized controlled trial (RCT) was designed to address
the issues of: 1. The superiority of elective neck dissection
(END) over the wait and watch (WW) policy followed by
therapeutic neck dissection (TND) when needed 2. The
addition of ultrasonography to routine physical
examination on follow up would help in earlier detection
of neck metastasis influencing salvage and survival.
METHODS: Patients with lateralized T1 or T2 squamous
carcinoma of oral cavity, amenable to peroral excision
were included in the trial. At initial surgery all patients
underwent a wide local excision of the primary with
appropriate margins. They were randomized to either END
or WW policy for the neck management. Patients were
randomized a second time to follow up with physical
examination plus neck ultrasound (PE+USG) versus
physical examination (PE) alone. Stratification was based
on size, site, gender and preoperative neck ultrasound.
The primary end point was overall survival (OS) and
secondary end point was disease-free survival (DFS). The
trial was planned to demonstrate a 10% superiority (α =
0.05 and β = 0.2) in OS for END vs. TND, assuming 60% 5-
year OS in TND arm, with a planned sample size of 710.
RESULTS: This study was terminated after 596 patients
were randomized between January 2004 and June 2014.
An interim intent-to-treat analysis of initial 500 patients
(255 in TND, 245 END) was performed as mandated by Data
and Safety Monitoring Committee based on the number of
observed deaths in each arm. Both arms were balanced for
site and stage. There were 427 tongue, 68 buccal mucosa
and 5 floor of mouth tumours; 221 were TI and 279 T2. At
a median follow-up of 39 months 146 recurred in TND and
81 in END arms. The 3-year OS was significantly higher in
END compared to TND arm (80.0% vs. 67.5%, HR = 0.64;
95% CI, 0.45 to 0.92; P=0.01) as was 3-year DFS (69.5% vs.
45.9%, HR = 0.45; 95% CI, 0.34 to 0.59; P<0.001). After
adjusting for stratification factors in Cox regression, END
continued to be significantly superior to TND for both OS
and
DFS.
In the follow up randomization 252 patients were
allocated to PE+USG and 244 to PE. In addition to the
stratification factors both arms were balanced for the
surgical procedure (END vs. TND) as well. There were 118
recurrences with 67 deaths in PE+USG and 109 recurrences
with 62 deaths in PE, respectively. There was no OS
difference between PE+USG and PE in unadjusted analysis
(3-year OS 73.3% and 73.8%, respectively, HR = 1.02, 95%CI
0.73-1.45, p = 0.89) and after adjustment (HR = 0.81,
95%CI 0.51-1.29, p = 0.37) for stratification factors,
prognostic factors, surgical treatment (END vs. TND) and
an interaction term between two study questions, in a Cox
model. END vs. TND continued to be highly significant for
OS in this model (HR = 0.54, 95%CI 0.32 - 0.92, p = 0.02).
Within TND (wait and watch) arm there was no significant
difference between PE+USG and PE (3-year OS 67.3% and
67.6% respectively, HR = 0.96, 95%CI 0.62–1.5, p = 0.86).
CONCLUSIONS: There were 8 excess deaths for every 15
excess recurrences in the TND arm. Elective neck
dissection in patients with early oral SCC results in 36%
reduction in mortality and should be considered the
standard of care. Neck ultrasound confers no survival
advantage over physical examination in postoperative
follow-up of clinically node negative early stage oral
cancer
patients.
N Engl J Med 2015;373:521-9
SP-013 Update on the ARCON study
J. Kaanders
1
, W. Bots
1
, C. Terhaard
2
, M. Vergeer
3
, P.
Doornaert
2
, H. Bijl
4
, P. Van den Ende
5
, M. De Jong
6
, G.
Janssens
2
,
P.
Span
1
1
Radboud umc, Radiation Oncology, Nijmegen, The
Netherlands
2
UMC Utrecht, Radiation Oncology, Utrecht, The
Netherlands
3
VUMC Amsterdam, Radiation Oncology, Amsterdam, The
Netherlands
4
UMC Groningen, Radiation Oncology, Groningen, The
Netherlands
5
Maastro Clinic, Radiation Oncology, Maastricht, The
Netherlands
6
Leiden UMC, Radiation Oncology, Leiden, The
Netherlands
Abstract text
Purpose: "ARCON" combines accelerated radiotherapy to
counteract tumor repopulation with carbogen breathing
and nicotinamide to reduce chronic and acute hypoxia. We
report the long-term results from a randomized phase III
trial comparing accelerated radiotherapy (AR) with
accelerated radiotherapy plus carbogen and nicotinamide
(ARCON) in laryngeal
cancer.
Methods and Materials: From April 2001 to February 2008,
345 patients with clinical stage T2-4 squamous cell
laryngeal cancer were randomized to AR (N=174) and
ARCON (N=171). AR was given to a total dose of 68 Gy in 2
Gy fractions within 36-38 days on the primary tumor and
the pathological lymph nodes. In the experimental arm, a
dose reduction to 64 Gy on the laryngeal cartilage was
required and radiotherapy was combined with carbogen
breathing during irradiation and administration of
nicotinamide (60 mg/kg) 1-1.5 h before the first fraction
of
every day.
Results: After a median follow-up of 72 months, local
control rate at 5 years was 78% with no difference
between the study arms. The 5-year regional control was
significantly better with ARCON (93% for ARCON versus 86%
for AR, p=0.04). Analysis of late radiation morbidity did
not reveal significant differences between the AR and
ARCON treatment arms with respect to skin and
subcutaneous tissues (severe telangiectasia, 8%
v
8%;
P
=
.56; severe subcutaneous fibrosis, 7%
v
9%;
P
= .26; severe
subcutaneous edema, 8%
v
4%;
P
= .09) and mucous
membranes (mucosal ulceration, 8%
v
6%;
P
= .36;
nasogastric tube feeding, 6%
v
6%;
P
= .61, respectively).
Twelve patients in the AR group and six patients in the
ARCON group required a tracheostomy for severe edema
with dyspnea and/or stridor. All patients who developed a
cartilage necrosis could be managed conservatively. Four
of the patients received a tracheostomy (n = 1 for AR, n =
3 for ARCON), and there was no need for laryngectomy.
One year after diagnosis, 3% of patients in both groups
needed nasogastric tube feeding (
P
= .88). At ≥2 years
from baseline, the percentage of patients reporting
moderate to severe complaints of dry mouth, sticky saliva,
or changes in taste/smell was 30%, 22% and 18%,
respectively, while the majority of patients had no or few
complaints of swallowing (79%) or speech (64%).
Conclusion: Long-term morbidity was mild and quality of
life was high with no difference between the study arms.