2017 Section 7 Green Book

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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

Table 1 Patient characteristics ( N Z 248). Characteristics

N (%)

Gender

Male/female

208 (83.9)/40 (16.1)

Age, years

61 (54 e 69) 144 (58.1) 173 (69.8)

Median (IQR)

Smoking, > 20 pack-year

Alcohol drinking, 1 drink per day

Site of primary tumour Oral cavity

62 (25.0) 56 (22.5) 99 (40.0) 31 (12.5)

Oropharynx

Larynx

Hypopharynx

Histological grade WD/MD/PD/NA

67 (27.0)/137 (55.2)/35 (14.1)/9 (3.7)

Treatment

Surgery alone

70 (28.2) 77 (31.0) 6 (2.4) 17 (6.9)

Surgery þ RT/CRT IC þ surgery RT/CRT IC þ CRT surgery 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)

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. 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. 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)

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