2017 Section 7 Green Book

B. Sethugavalar et al. / Oral Oncology 59 (2016) 80–85

The baseline matched and unmatched characteristics, along with treatment details and pre-treatment diet and shown in Table 1 . With regard to the matched factors, the T stage distribu- tion was similar between the two groups. For the purposes of matching analysis, N0 and N1 were grouped together; Table 1 shows that there was a small excess of patients with N0 disease in the group of patients managed with a prophylactic gastrostomy, although there is no statistically significant difference in N stage between the two groups. With regard to unmatched factors, Table 1 shows that there were no statistically significant differences in baseline characteristics between the matched groups, including

Pre-treatment and post-treatment care All patients underwent pre-treatment nursing, dietetic and speech and language therapy pre-treatment assessments as part of routine practice. During chemoradiotherapy treatment, all patients were routinely reviewed twice weekly by medical and nursing teams, with additional reviews with the dietetic and speech and language therapy teams as required. Post-treatment, all patients were offered ongoing dietetic and speech and language therapy support in post-treatment rehabilitation clinics. Statistical analysis Statistical analyses were performed using STATA software ver- sion 12 (Statacorp, Texas, USA) and GraphPad Prism version 5. Pro- phylactic gastrostomy versus NG tube as required matching was performed using T stage (grouped as T1/2 and T3/4) and N stage (grouped as N0/1, N2a/b, and N2c/3). Unmatched variables were compared using the Student t -test, Fisher’s exact test and test for trend. A t -test and chi-squared test were used as appropriate to test for differences in the subgroups analysed. MDADI scores were compared using a non-parametric Mann-Whitney U test. Univari- ate non-parametric analyses were performed to determine if there was any correlation between MDADI scores with clinical parame- ters. Variables included were: age, T stage, N stage, use of induction chemotherapy, number of induction chemotherapy cycles, type of concurrent chemotherapy, number of concurrent chemotherapy cycles, mean contralateral parotid dose, pre-radiotherapy diet. Sta- tistical significance was declared at p < 0.05. A multivariate MAN- OVA was performed on factors with a p -value < 0.20 on univariate analysis (N-stage, number of induction chemotherapy cycles, concurrent chemotherapy type, number of concurrent chemotherapy cycles, pre-treatment oral intake and mean con- tralateral parotid gland dose) The natural logarithm of MDADI scores were used for the multivariate analysis to normalise the data. From review of electronic records, 94 patients with a diagnosis of squamous cell carcinoma of the oropharynx who had received definitive concurrent chemoradiotherapy with curative intent were identified. Of these patients the following were excluded: 18 patients had experienced disease recurrence, 3 patients had died post-treatment with no evidence of disease recurrence, 5 had commenced therapeutic enteral feeding pre-treatment. Of the remaining 68 patients, completed MDADI questionnaires were received from 59 (87%) patients. 31/59 (53%) had been managed with a prophylactic gastrostomy tube, and 28/59 (47%) had been managed with a reactive approach with insertion of a nasogastric tube if required during treatment. A retrospective matched pair analysis was performed, matching 26/31 patients managed with a prophylactic gastrostomy with 26/28 managed with a nasogastric tube if required, on the basis of T and N stage. On review of case notes, 24 of these matched 56 patients (43%) were documented as being offered a choice of either a prophylactic gastrostomy or a reactive approach; 12/24 (50%) opted for a prophylactic gastrostomy. Of the 26 patients managed with a prophylactic gastrostomy tube, the tube was doc- umented as being used for at least supplemental nutrition in all patients. Within the reactive NG tube if required group, 17/26 (65%) patients had an NG tube inserted and commenced enteral feeding during treatment; no gastrostomies were used in this group. Mean follow up from the last day of radiotherapy was 36 months (range 24–59) and 34 months (range 24–59) for patients managed with a prophylactic gastrostomy or NG tube as required respectively. Results

Table 1 Patient, tumour and treatment details.

Prophylactic gastrostomy ( N = 26)

NG as needed ( N = 26)

p - value

34

30

0.31 0.55

Median follow up Age ( Mean , range )

56 (36–66)

55 (38–68)

Sex

Male

20 (76.9%) 6 (23.1%)

22 (84.6%) 4 (15.4%)

0.48

Female

WHO PS 0

14 (53.8%) 4 (15.4%) 8 (30.8%)

20 (76.9%) 2 (7.7%) 4 (15.4%)

0.22

1

Not recorded

Smoking Never

10 (38.5%)

10 (38.5%) 11 (42.3%) 3 (11.5%)

0.87

Ex

13 (50%) 2 (7.7%) 1 (3.8%)

Current

Not recorded

2 (7.7%)

Oropharynx subsite Tonsil

13 (50.0%) 12 (46.2%)

15 (57.7%) 11 (42.3%)

0.55

BOT

Posterior pharynx

1 (3.8%)

0 (0%)

T stage T1

5 (19.2%) 13 (50%) 2 (7.7%) 6 (23.1%) 5 (19.2%) 1 (3.8%) 2 (7.7%) 15 (57.7%) 3 (11.5%)

6 (23.1%) 12 (46.2%) 3 (11.5%) 5 (19.2%)

0.94

T2 T3 T4

Nodal stage N0

0 (0%)

0.11

N1

5 (19.2%) 2 (7.7%) 16 (61.5%)

N2a N2b N2c

2 (7.7%) 1 (3.8%)

N3

0 (0%)

Induction chemotherapy None

18 (69.2%) 6 (23.1%)

24 (92.3%)

0.09

TPF

2 (7.7%)

PF

2 (7.7%)

0 (0%)

RT dose 65 Gy in 30 fractions 70 Gy in 35 fractions Mean contralateral parotid dose ( range )/ Gy Concurrent chemotherapy Cisplatin

1 (3.8%)

1 (3.8%)

0.6

24 (92.3%) 37 (24–54)

24 (92.3%) 33 (21–57)

0.06

22 (96.2%)

24 (92.3%)

0.39

Carboplatin

4 (3.8%)

2 (7.7%)

No. of concurrent chemotherapy cycles 1 4 (15.4%)

6 (23.1%) 19 (73.1%)

0.45

2 3

22 (84.6%)

0 (0%)

1 (3.8%)

Pre-treatment oral intake NBM

0 (0%) 0 (0%)

0 (0%) 0 (0%) 0 (0%)

0.38

Sips

Pureed

2 (7.7%) 3 (11.5%) 21 (80.8%)

Soft

3 (11.5%) 21 (80.8%)

Normal

Not recorded

0 (0%)

2 (7.7%)

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