Patient assessed symptoms are poor predictors of objective findings. Results from a cross sectional study in patients treated with radiotherapy for pharyngeal cancer

Figures & data

Table I.  Characteristic of eligible patients.

	Participants (n = 35)	Non participants (n = 29)	p-value*
Age, mean (years (range))	61 (44–82)	60 (38–91)	N.S.
Gender (Male/Female (%))	25/10 (71/29)	16/13 (55/45)	N.S.
Site			N.S.
Nasopharynx	2	1
Oropharynx	30	27
Hypopharynx	3	1
Stage
T3–4	6 (17%)	11 (38%)	0.02
N +	21 (60%)	20 (69%)	N.S.
Stage I–II/III–IV	22 (63%)	23 (79%)	N.S.
Radiotherapy
Years after treatment, mean (range)	5.0 (2.6–7.6)	4,5 (3.0–7.7)	N.S.
66–68 Gy in 33–34 fx	33 (94%)	28 (97%)
Weekly fractions (5/6/10)	5/29/1	4/25/0	N.S.
Nimorazole	31 (89%)	25 (86%)	N.S.
Recurrence after radiotherapy^§	3 (9%)	2 (7%)	N.S.
Last recorded morbidity^#
Dysphagia (any)	57%	31%	N.S.
Dysphagia gr. III–IV	6%	3%	N.S.
Dryness (moderate/severe)	57%	37%	N.S.
Hoarseness (any)	38%	23%	N.S.
Oedema (any)	29%	21%	N.S.
Atrophy (any)	86%	90%	N.S.
Fibrosis (any)	86%	72%	N.S.

*T-test, χ², Fishers Exact Test or Kruskal Wallis test as appropriate.

§Successfully treated with surgery.

#DAHANCA score.

N.S.: Not significantly different.

Figure 1.  Scatterplot illustrating the correlation between the quality of life endpoints dry mouth and swallowing versus QoL and social eating in 35 recurrence free pharynx cancer patients. The dots each represent one observation. In case of multiple identical observations the dots are slightly displaced. The lines, based on linear regression, should only guide the eye. Spearmans correlation was used for the analysis. The endpoints are normalized to a 0–100 scale. One-hundred represent the best QoL or the worst symptoms.

Table II.  Selected scale scores and selected item scores from EORTC QLQ H&N35.

	Mean	Median	Percentile 25	Percentile 75
HN Pain	29	25	8	50
HN Swallowing	25	25	8	33
HN Social eating	30	17	0	58
HN Teeth	42	33	0	100
HN Opening mouth	51	67	0	75
HN Dry mouth	71	67	33	100
HN Sticky saliva	56	67	25	100
HN Coughed	39	33	0	67
HN Feeding tube	11	0	0	0

The Qol scores are normalized to a number between 0 and 100. Higher numbers means worse symptoms.

Table IIIA.  The distribution of comorbidity and socioeconomic status.

		Frequency	%
Charlsons Comorbidity Score	0	19	54
	1	8	23
	2	4	11
	3	3	9
	4	1	3
Education	None	4	11
	Vocational	14	40
	Higher	17	49
Profession	Employed/ self employed	13	37
	Retired/ education	11	31
	Unemployed	11	31
Marital Status	Married/ cohabiting	22	63
	Single	13	37
If you became ill, and had practical problems, can you count on other to help you?	Yes, definitely	29	85
	Yes, perhaps	3	9
	No	2	6
Does it ever happen that you are alone, even though you would like to be with others?	No	21	62
	Yes, rarely	6	18
	Yes, sometimes	5	15
	Yes, often	2	6
Do you have someone to confine in if you have problems?	Yes, many	14	41
	Yes, 2–4	10	29
	Yes, one	9	26
	No, none	1	3

Table IIIB.  The correlation between comorbidity and socioeconomic status and answers to quality of life questionnaire EORTC C30 and H&N 35, objective findings and patient related factors.

	Significant correlations (Spearman's test (p-value))
Endpoint	EORTC quality of life questionnaire	Patient related and objective endpoints
Charlson co-morbidity Index	HN Swallowing (0.04) Feeding Tube (0.01) “Have you had problems swallowing solid food” (0.05)	Smoking (0.05) Swallowing function (0.03) Objective Aspiration (0.04)
Education		Smoking (0.02)
Profession		Age (0.04) Smoking (0.03) Best parotid flow (0.02) Total parotid flow (0.04) Objective Aspiration (0.02)
Marital Status		Protection of airways index (0.02)
Help*	HN Social Eating (0.03)
Alone*	HN Dry Mouth (0.02) “Have you had problems swallowing liquids” (0.002)
Confine*	HN Swallowing (0.001) HN Social Eating (0.004) HN Teeth (0.03) HN Coughed (0.04 “Have you had problems swallowing liquids” (0.0006) “Have you had problems swallowing solid food” (0.02) “Have you choked when swallowing” (0.008)	Trismus (0.006)

Bold characters: p ≤ 0.01. All correlations are in the expected directions: Worse socio-economic/comorbidity status more symptoms/ worse quality of life.

*Refers to the questions of Table IIIA.

Table IV.  Functional Endoscopic Evaluation of Swallowing (FEES) in recurrence free pharyngeal cancer patients (n = 34).

Endpoint	%
Reduced sensitivity	97
Reduced mobility	76
Asymmetry (atrophy/oedema)	9
Leakage	9
Residues	88
Penetration	59
Aspiration	18
Silent aspiration	6
Overall assessment of swallowing§
Normal/Slight reduction	53
Moderate	18
Severely restricted	29
Overall assessment of protection of airways$
Normal	0
Moderate	56
Severely, therapy recommended	41
Enteral nutrition recommended	3

*: 81% needed water to clear residues of solid food.

§: Composite score of leakage, residues and laryngeal dysfunction.

@: One patient could not swallow solid food at all.

$: Composite score of coughing reflex and completeness of swallowing.

Table V.  Mean saliva flow (ml/min) and HN Dry Mouth score in 35 recurrence free pharynx cancer patients treated with radiotherapy.

		HN Dry Mouth
	Overall	Not at all (n = 1)	A little (n = 9)	Quite a bit (n = 9)	Very much (n = 16)	Spearman's correlation coefficient*
Whole mouth unstimulated	0.18	0.56	0.21	0.35	0.05	−0.59
Best parotid unstimulated	0.02	0.05	0.04	0.03	0.00	−0.48
Total parotid unstimulated	0.03	0.06	0.05	0.05	0.00	−0.47
Whole mouth stimulated	0.39	0.66	0.58	0.65	0.12	−0.58
Best parotid stimulated	0.04	0.04	0.07	0.05	0.02	−0.50
Total parotid stimulated	0.05	0.04	0.09	0.07	0.02	−0.52

*p < 0.01 in all cases.

Table VI.  Results of the dental examination.

	At risk	CTCAE 3.0 Scale	Observed (%)
Edentulous	33		7 (22%)
Prosthesis	14	0 No Problems	4 (29%)
		1 Discomfort	4 (29%)
		2 Discomfort and problems	4 (29%)
		3 Unable to wear	2 (14%)
Trismus	33	0 None	9 (27%)
		1 Some	14 (42%)
		2 Problems eating	7 (21%)
		3 Leading to insufficient oral intake	3 (9%)
Caries	27	0 None	18 (67%)
		1 Superficial	7 (26%)
		2 Extractions needed	2 (7%)
Periodontitis	27	0 None	14 (54%)
		1 Slight bleeding and recesses	11 (42%)
		3 Spontaneous bleeding, loose teeth	1 (4%)
Osteoradionecrosis	32	None	30 (94%)
		Asymptomatic, only on x-ray	2 (6%)
Conclusion	33	No further treatment needed	15 (47%)
		Referred to own dentist	17 (53%)

Figure 2.  Self reported choking (EORTC H&N35) depending on objective aspiration (endoscopic evaluation). Results from 34 pharynx cancer survivors. Percent of patients refers to percent within a group.

Table VII.  The value of the quality of life question to predict objective side effects.

Patient reported side effect	Objective finding	Sensitivity (95% C.I)	Specificity (95% C.I)	Positive predictive value (95% C.I)	Negative predictive value (95% C.I)
HN Teeth > < 0	Periodontitis or caries	0.67 (0.38; 0.88)	0.58 (0.28; 0.85)	0.67 (0.38; 0.88)	0.58 (0.28; 0.85)
HN Teeth > < 0	In need of further treatment	0.59 (0.33; 0.82)	0.40 (0.16; 0.68)	0.53 (0.29; 0.76)	0.46 (0.19; 0.75)
HN Opening mouth > 0	Inter-incisor distance = < 35 mm^$	0.93 (0.66; 1.0)	0.47 (0.23; 0.72)	0.59 (0.36; 0.79)	0.89 (0.52; 1.0)
HN Swallowing > < Median (17)*	Aspiration	0.83 (0.36; 1.0)	0.54 (0.34; 0.72)	0.28 (0.10; 0.53)	0.94 (0.70; 1.0)
HN Swallowing > < Median (17)*	Penetration	0.60 (0.36; 0.81)	0.57 (0.29; 0.82)	0.67 (0.41; 0.87)	0.50 (0.25; 0.75)
“Have you choked when swallowing?” > 0	Penetration	0.65 (0.41; 0.85)	0.43 (0.18; 0.71)	0.62 (0.38; 0.82)	0.46 (0.19; 0.75)
“Have you choked when swallowing?” > 0	Aspiration	0.83 (0.36; 1.0)	0.43 (0.24; 0.63)	0.24 (0.08; 0.47)	0.92 (0.64; 1.0)
HN Dry mouth > < median (67)*	CTC AE 3.0 Xerostomia = 3	0.68 (0.43; 0.87)	0.81 (0.54; 0.96)	0.81 (0.54; 0.96)	0.68 (0.43; 0.87)
HN Sticky Saliva > < median (33)*	CTC AE 3.0 Xerostomia = 3	0.78 (0.52; 0.94)	0.75 (0.48; 0.93)	0.78 (0.52; 0.94)	0.75 (0.48; 0.93)

*Groups divided by median score since to few patients had score = 0 to make a meaningful test.

$35 mm was determined by Dijkstra [28] as the best objective criteria for trismus compared with a questionnaire.

#Numbers of observations too low to make meaningful approximations of C.I.

Dijkstra PU, Huisman PM, Roodenburg JL. Criteria for trismus in head and neck oncology. Int J Oral Maxillofac Surg 2006; 35: 337–42

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