Palliative pelvic radiotherapy for symptomatic rectal cancer – a prospective multicenter study

Figures & data

Figure 1. Inclusion and follow-up of patients.

Table 1. Patient characteristics at baseline.

Parameter	Value
Gender (n)
Male	24
Female	27
Age (years)
Median (range)	79 (51–96)
ECOG Performance status (n)
0	11
1	24
2	12
3	3
4	1
Laboratory values, median (range)
CEA (μg/l)	20 (2–4075)
Albumin (g/l)	40 (17–48)
Hemoglobin (g/dl)	11.5 (7.7–15.6)
Stage of disease (n)
Primary tumor only	7
Primary tumor with distant metastases	32
Local recurrence only^a	3
Local recurrence with distant metastases	9
Number of metastatic sites documented (n)
None	10
Single metastatic site	12
≥2 metastatic sites	29
Previous treatments of metastatic/recurrent disease (n)
No prior oncologic treatment	32
Surgical resection of metastases	4
Radiotherapy (other site)	1
Colostomy/ileostomy^b	23
Rectal stent	2
Chemotherapy:
1 line	9
2 lines	6
3 lines	3
Patients’ target symptom (n)
Pain	24
Rectal dysfunction	16
Hematochezia	9
Other	2
Analgesic use^c (n)
No analgesics	23
Non-opioid	7
Mild opioid	9
Strong opioid	12

^a 2/3 operable but patient decision not to operate; ^bthree of these patients with pelvic recurrences had stoma that had been there since their primary, curative surgery; ^cclassified according to the World Health Organization analgesic ladder (http://www.who.int/cancer/palliative/painladder/en/).

Table 2. Palliative pelvic radiotherapy.

Radiotherapy delivered (n)
6 Gy in 2 f	1
21 Gy in 6 f	1
30 Gy in 10 f	20
33 Gy in 11 f	1
36 Gy in 12 f	13
39 Gy in 13 f	15
Radiotherapy target (n)
Primary tumor only	26
Primary tumor and pathologically enlarged lymph nodes	13
Recurrence only	9
Recurrence and pathologically enlarged lymph nodes	3
Volume treated (90% target dose, in cm^3)
Median (range)	1190 (200–4438)
Number of treatment fields
Median (range)	3 (2–5)

f: fractions; Gy: Gray.

Figure 2. Patient-reported target symptom severity over time compared with baseline for the three major target symptoms.

Figure 3. Toxicity. Percent of patients reporting various symptoms at each of the four study visits [B = baseline (n = 51); E = end of treatment (n = 47); 6 = 6-week follow-up (n = 38); 12 = 12-week follow-up (n = 28)]. Symptoms graded according to NCI-CTCAE 3.0. There were no grade 4 symptoms reported.

Table 3. Target symptom response and QOL compared to baseline.

Number of patients with target symptom at Baseline		End of radiotherapy	6-week follow-up	12-week follow-up
Proportion of evaluable patients reporting target symptom improved or resolved (95% CI)
Pelvic pain	n = 24	14/21 67% (0.46–0.88)	14/18 78% (0.58–0.98)	10/13 77% (0.54–1.0)
Rectal dysfunction^a	n = 16	4/15 27% (0.04–0.50)	10/12 83% (0.61–1.0)	9/10 90% (0.71–1.0)
Hematochezia	n = 9	9/9 100%	9/9 100%	8/8 100%
Other^b	n = 2	½ 50% (0–1.0)	2/2 100%	½ 50% (0–1.0)
Total	n = 51	28/47 60% (0.46–0.74)	35/41 85% (0.74–0.96)	28/33 85% (0.73–0.97)
Global QOL compared to baseline:		End of radiotherapy	6-week follow-up	12-week follow-up
Proportion of the evaluable patients (95% CI)
Clinically significant improvement^c		17/45 38% (0.24–0.52)	14/35 40% (0.24–0.56)	10/25 40% (0.21–0.59)
Stable^d		18/45 40% (0.26–0.54)	10/35 29% (0.14–0.44)	7/25 28% (0.13–0.43)
Clinically significant deterioration^e		10/45 22% (0.10–0.24)	11/35 31% (0.16–0.46)	8/25 32% (0.14–0.50)
Global QOL score	Baseline	End of radiotherapy	6-week follow-up	12-week follow-up
QOL: Global health status score Median (IQR); p-value^f
	50 (37.5–67) n = 49	60 (50–67) n = 45 p = 0.146	50 (33–83) n = 35 p = 0.837	67 (50–83) n = 25 p = 0.569

CI: confidence interval; IQR: interquartile range; QOL: quality of life. ^aIncludes rectal obstruction (n = 6), diarrhea (n = 2), incontinence (n = 6), mucous production (n = 2); ^bEdema, urinary incontinence; ^cIncrease ≥10 points; ^dValues within 9 points of baseline score; ^eDecrease ≥10 points; ^fScore compared to baseline.