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The team also determines which treatment is appropriate
on the basis of the CWU stage, and then the decision was
written in medical records. Depending on the location of
the primary tumour and clinical stage, the treatment op-
tions are definitive definite radiotherapy (RT), chemo-
radiotherapy (CRT), induction chemotherapy (ICT),
and/or surgery.
During the study period, all patients underwent
18
F-
FDG PET/CT using a Biograph Sensation 16 or True
Point 40 System (Siemens Medical Systems, Knoxville,
TN) after CWU. Patients were required to fast for an
average time of 13.6 h (standard deviation [SD], 16.0;
range, 7
e
20). The average patient blood glucose level
was 102 (SD, 16.1; range, 67
e
149) mg/dL. Patients were
injected with an average of 398.6 (SD, 216.5; range,
372
e
555) MBq of
18
F-FDG and incubated for an
average period of 60.2 min (SD, 6.2; range, 51
e
70).
Before acquiring the PET emission data, spiral CT
scanning was performed in spiral mode from the skull
base to the proximal thigh at 100 mAs and 120 kV, with
a section width of 5 mm and collimation of 0.75 mm. No
oral or intravenous contrast medium was used. The PET
results were reconstructed using CT attenuation
correction, an attenuation-weighted algorithm (2 itera-
tions and 16 subsets), and a post-reconstruction
smoothing Gaussian filter (full width at half
maximum
Z
6 mm). Images were reconstructed using a
168 168 matrix (pixel size
Z
5.3 mm).
The PET/CT findings were then reviewed on the
workstation by an experienced nuclear medicine physi-
cian (J.S.K.) who was blinded to the CWU findings.
Increased focal
18
F-FDG uptake in the tumour and
metastatic nodes were graded from 1 to 4, where grades
3 and 4 were regarded as evidence of tumour involve-
ment. Visual and semiquantitative analyses were used to
determine abnormally increased focal
18
F-FDG uptake
in comparison with the background and blood-pool
activity in the mediastinum. But strict standardised up-
take value cutoffs were not used. The CT signs for
assessing nodal metastases are based on nodal size
(shortest axial diameter
>
11 mm in the jugulodigastric
regions or
>
10 mm in other cervical regions) and shape,
the presence of central necrosis, and the presence of a
localised group of nodes in an expected node-draining
area for a specific primary tumour. The cartilage or
bone destruction by tumour was also used for image
interpretation.
The PET/CT results were added to the CWU findings
during the separate decision-making meeting. Whether
this changed the TNM classification (i.e. the T, N, and/
or M stage was altered) and management plan was then
recorded prospectively. The impact of PET/CT on the
management plan was classified as follows
[10]
: high
(change in planned treatment modality or purpose,
e.g. surgery to CRT, curative to palliative), moderate
(change in delivery within the same treatment modality,
e.g. a change in the RT target volume or a change in
extent of surgical resection), low (no change in proposed
management), or no (PET/CT result ignored).
The validation was determined by assessing the his-
topathology for the only cases in which there was the
discrepant staging and/or management change between
CWU and CWU
þ
PET/CT results. For some patients
who underwent nonsurgical treatment, subsequent serial
imaging and clinical follow-up were also considered
when histopathologic diagnosis was not obtained
because of difficulty in approaching the suspicious ma-
lignant lesions. Of these, the validation by clinical
follow-up was regarded as ‘not assessable’ in some cases
of the use of treatment intervention (e.g. RT/CRT was
applied both neck side in case of advanced T stage) that
could alter disease extent. The latter cases were not
included in the analysis.
After the initial treatment, all patients underwent
physical and endoscopic examinations at each clinic
visit, and serial imaging workups were performed
regularly.
Table 1
Patient characteristics (
N
Z
248).
Characteristics
N
(%)
Gender
Male/female
208 (83.9)/40 (16.1)
Age, years
Median (IQR)
61 (54
e
69)
Smoking,
>
20 pack-year
144 (58.1)
Alcohol drinking, 1 drink per day
173 (69.8)
Site of primary tumour
Oral cavity
62 (25.0)
Oropharynx
56 (22.5)
Larynx
99 (40.0)
Hypopharynx
31 (12.5)
Histological grade
WD/MD/PD/NA
67 (27.0)/137 (55.2)/35
(14.1)/9 (3.7)
Treatment
Surgery alone
70 (28.2)
Surgery
þ
RT/CRT
77 (31.0)
IC
þ
surgery RT/CRT
6 (2.4)
IC
þ
CRT surgery
17 (6.9)
RT/CRT/CT alone
37 (14.9)/40 (16.2)/1 (0.4)
Treatment intention
Curative
241 (97.2)
Palliative
7 (2.8)
Follow-up
Follow-up period, median (range),
months
38.0 (12.3
e
55.3)
Disease progression
68 (27.4)
Last status, NED/AWD/DOD/DOC 191 (77.0)/11 (4.4)/37
(15.0)/9 (3.6)
Synchronous SPC found at initial staging 18 (7.3)
The data are shown as number (%) unless otherwise indicated.
Abbreviations: AWD, alive with disease; CRT, chemoradiotherapy;
CT, chemotherapy; DOC, died of other cause; DOD, died of disease
(index cancer); ICT, induction chemotherapy; IQR, interquartile
range; MD, moderated differentiated; NA, not available; NED, no
evidence of disease; PD, poorly differentiated; RT, radiotherapy; SPC,
second primary cancer; WD, well differentiated.
I.S. Ryu et al. / European Journal of Cancer 63 (2016) 88
e
96
36