Late radiation effects to the rectum and anus after treatment for prostate cancer; validity of the LENT/SOMA score

Figures & data

Figure 1. Consort diagram.

Table I. Baseline characteristics for 103 patients diagnosed with prostate cancer treated by HT*+ RT^† versus HT alone in a randomized trial.

	HT + RT	HT
Mean age, years (95% CI)	69 (68–71)	71 (70–73)
T1 (n)	1	0
T2 (n)	0	4
T3 (n)	47	51
Present hormonal treatment	25	34
Months from treatment, mean (95% CI)	60 (56–64)	58 (56–61)
S-testosterone mean (95% CI)	17.6 (14.7–20.6)	20.0 (17.1–22.9)
Previous ano-rectal surgery	4	3
Previous ano-rectal trauma	0	2

*Hormonal therapy.

^†Radiotherapy.

Table II. Content of the European Organisation for Research and Treatment of Cancer and the Radiation Therapy Oncology Group (EORTC/RTOG) radiotherapy toxicity scoring system.

	EORTC/RTOG grade
Symptom/Item	Grade 0	Grade 1	Grade 2	Grade 3	Grade 4	Grade 5
Pain	“No pain”	“Mild colic pain”	Moderate colic	*	*	*
Stool consistency	“Normal”	“Loose”	Moderate diarrhea	*	*	*
Stool frequency	< 5/24 hours	5/24 hours	> 5/24 hours	*	*	*
Mucus	No mucus	Some mucus	Severe mucus	*	*	*
Blood	No blood	Some blood	Intermittent bleeding	Bleeding requiring surgery	*	*
Necrosis	*	*	*	*	Present	*
Perforation	*	*	*	*	Present	*
Obstruction	*	*	*	*	Present	*
Fistula	*	*	*	*	Present	*
Death	*	*	*	*	*	Death

*Symptom/Item not included.

Table III. Contents of the Subjective Objective Management/Late Effects Normal Tissue (SOMA/LENT) tables for rectum.

Domain/Item	Grade 0	Grade 1	Grade 2	Grade 3	Grade 4
Subjective
Tenesmus	No toxicity	Occasional urgency	Intermittent	Persistent	Refractory
Mucosal loss	No toxicity	Occasional	Intermittent	Persistent	Refractory
Sphincter control	No toxicity	Occasional	Intermittent	Persistent	Refractory
Stool frequency	No toxicity	2–4 per day	4–8 per day	> 8 per day	Uncontrolled diarrhea
Pain	No toxicity	Occasional & minimal	Intermittent & tolerable	Persistent & intense	Refractory & excruciating
Objective
Bleeding	No toxicity	Occult	Occasionally > 2/week	Persistant/daily	Gross hemorrhage
Ulceration	No toxicity	Superficial ≤ 1 cm^2	Superficial > 1 cm^2	Deep ulcer	Perforation, Fistulae
Stricture	No toxicity	> 2/3 normal diameter with dilatation	1/3-2/3 normal diameter with dilatation	< 1/3 normal diameter	Complete obstruction
Management
Tenesmus & frequency	No toxicity	Occasional, ≤ 2 antidiarrheals/week	Regular, > 2 antidiarrheals/week	Multiple, > 2 antidiarrheals/day	Surgical intervention/ Permanent colostomy
Pain	No toxicity	Occasional, non-narcotic	Regular, non-narcotic	Regular, narcotic	Surgical intervention
Bleeding	No toxicity	Stool softener, iron therapy	Occasional transfusion	Frequent transfusions	Surgical intervention/Permanent colostomy
Ulceration	No toxicity	Diet modification, stool softener	Occasional steroids	Steroids per enema, hyperbaric oxygen	Surgical intervention/Permanent colostomy
Stricture	No toxicity	Diet modification,	Occasional dilatation	Regular dilatation	Surgical intervention/Permanent colostomy
Sphincter control	No toxicity	Occasional use of incontinence pads	Intermittent use of incontinence pads	Persistent use of incontinence pads	Surgical intervention/Permanent colostomy
Analytic
Barium enema	Assessment of lumen and peristalsis
Proctoscopy	Assessment of lumen and mucosal surface
CT	Assessment of wall thickness, sinus and fistula formation
MRI	Assessment of wall thickness, sinus and fistula formation
Anal manometry	Assessment of rectal compliance
Ultrasound	Assessment of wall thickness, sinus and fistula formation

Table IV. Correlation coefficients (Spearman’s rho) for SOMA/LENT † vs QlQ-C30/QUFW-94†† single items in 103 patients randomiized to hormonal treatment alone or hormonal treatment + radiotherapy for prostate cancer.

	S Tenesma	S Frequency	S Pain	O Bleeding	M Tene/Freq	M Pain	M Bleeding
Have you had pain? (QLQ-C30)	0.309		0.470*			0.015
Did pain interefere with your daily activities?(QLQ-C30)	0.169		0.297		0.250	0.093
How many stools per 24 hours did you have?(QUFW-94)	0.276	0.760*			0.043
Did you have cramp/pain when passing stools?(QUFW-94)			0.300			0.087
Did you have blood in your stools?(QUFW-94)				0.671*			0.149

*Correlations with values above the pre-determined correlation limit highlighted.

^†Subjective Objective Management Analytic.

^††Health-related quality of life questionnaires EORTC QLQ-C30 and QUFW-94.

Table V. SOMA/LENT* and EORTC/RTOG† toxicity score for rectum in 103 patients randomized to hormonal therapy (HT) alone versus HT plus radiotherapy (RT).

	SOMA/LENT		EORTC/RTOG
Grade	HT (n)	HT + RT (n)	HT (n)	HT + RT (n)
0	38	4	42	33
1	12	19	10	12
2	4	15	1	5
3	1	4	0	0
4	0	6	0	0
5	NA	NA	0	0
Difference between groups
Mann-Whitney U (p)	< 0.001		0.138

*Subjective Objective Management Analytic/Late Effects Normal Tissue.

^†The European Organisation for Research and Treatment of Cancer and the Radiation Therapy Oncology Group.

Table VI. SOMA/LENT* score for rectum performed by doctor versus nurse in 103 patients treated for prostate cancer in a randomized trial comparing HT ^† versus HT + RT ^††.

	Doctor’s SOMA/LENT score
	Grade	0 (n)	1 (n)	2 (n)	3 (n)	4 (n)
Nurse’s	0 (n)	43	11	2	1	0
SOMA/LENT	1 (n)	2	21	3	0	0
score	2 (n)	3	2	5	1	0
	3 (n)	0	0	0	2	0
	4 (n)	1	0	1	0	0

Estimated weighted kappa of doctor’s vs. nurse’s SOMA/LENT score = 0.52 (p < 0.001).

*Subjective Objective Management/Late Effects Normal Tissue.

^†Hormonal therapy.

^††Radiotherapy.