Thalidomide for refractory hemorrhagic chronic radiation proctitis secondary to pelvic malignancy radiotherapy: A phase II clinical trial

Table 1 Clinical characteristics and demographic information on the study patients, n (%)/median (interquartile range)

Characteristic	Patients (n = 62)
Age, years	61.8 (9.1)
Sex
Male	4 (6.5)
Female	58 (93.5)
Primary cancer
Cervical	54 (87.1)
Endometrium	2 (3.2)
Prostatic	4 (6.5)
Rectal	1 (1.6)
Anal	1 (1.6)
Comorbidities
Coronary artery heart disease	1 (1.6)
Hypertension	5 (8.1)
Diabetes mellitus	2 (3.2)
History of abdominopelvic operation	13 (21.0)
Time from the end of radiotherapy to enrollment, months	16.2 (10.3, 23.7)
Time from ceasing radiotherapy to bleeding, months	8.2 (6.1, 13.2)
Duration of bleeding, months	5.3 (2.4, 13.1)
Transfusion dependent	8 (12.9)
Grade of bleeding (SOMA)	3 (3, 4)
Pre-enrollment hemoglobin, g/L	117 (100, 127)
Pre-enrollment VRS	3 (3, 3)
Mucosal congestion	2 (2, 2)
Telangiectasia	3 (2, 3)
Ulceration	0 (0, 1.5)
Stenosis	0 (0, 0)
Necrosis	0 (0, 0)

SOMA: Subjective Objective Management Analysis system; VRS: Vienna Rectoscopy Score.

Table 2 The efficacy of thalidomide on hemorrhagic chronic radiation proctitis as measured by the Subjective Objective Management Analysis system score

		Pre-treatment				Post-treatment
SOMA effect	62	1	2	3	4	0	1	2	3	4
Completely remitted	6	0	0	2	4	6	0	0	0	0
Alleviative	46	0	2	25	19	0	27	14	5	0
Unchanged	7	0	2	4	1	0	0	2	4	1
Aggravated	3	0	2	1	0	0	0	0	1	2
Efficacy rate (%)	83.9%

SOMA: Subjective Objective Management Analysis system.

Table 3 Before and after thalidomide treatment effects on hemorrhagic chronic radiation proctitis, median (interquartile range)

	Pre-treatment	Post-treatment	P value
SOMA (n = 62)	3 (3, 4)	1 (1, 2)	< 0.001
VRS (n = 35)	3 (3, 3)	3 (2, 3)	0.132
Mucosal congestion	2 (2, 2)	2 (1, 2)	0.007
Telangiectasia	3 (3, 3)	3 (2, 3)	0.257
Ulceration	0 (0, 3)	0 (0, 0)	0.177
Stenosis	0 (0, 0)	0 (0, 0)	0.317
Necrosis	0 (0, 0)	0 (0, 0)	1.000
Hemoglobin, g/L (n = 32)	117.5 (103, 125.5)	108.5 (103, 125.25)	0.199

SOMA: Subjective Objective Management Analysis system; VRS: Vienna Rectoscopy Score.

Table 4 Adverse events, n (%)

Event	Thalidomide treatment (n = 62)
	Grade 1	Grade 2	Total
Any adverse event	17 (27.4)	7 (11.3)	23 (37.1)
Nausea	3 (4.8)	0	3 (4.8)
Constipation	0	5 (6.5)	4 (6.5)
Dizziness	9 (14.5)	0	9 (14.5)
Somnolence	8 (12.9)	0	8 (12.9)
Blurred vision	1 (1.6)	0	1 (1.6)
Rash	3 (4.8)	0	3 (4.8)
Limb numbness	0	1 (1.6)	1 (1.6)
Peripheral edema	1 (1.6)	0	1 (1.6)
DVT of lower extremity	0	1 (1.6)	1 (1.6)

DVT: Deep venous thrombosis.