Interim analysis of patient-reported outcome compliance and dosimetry in a phase 3 randomized clinical trial of oesophagus-sparing spinal radiotherapy

Figures & data

Table 1. Baseline characteristics of the first 100 patients of the ESO-SPARE trial.

Characteristic	No. (%) All patients (n = 100)	No. (%) PRO respondents (n = 66)	No. (%) PRO nonrespondents (n = 34)	P-value
Age
Median [range], years	71 [35,89]	70 [35,86]	74 [46,89]	.3*
Sex
Men	64 (64)	44 (67)	20 (59)
Women	36 (36)	22 (33)	14 (41)	.5**
WHO Performance
PS 0–1	60 (60)	49 (74)	11 (33)
PS 2–3	40 (40)	17 (26)	23 (67)	.001**
Tokuhashi score
0–8	55 (55)	31 (47)	24 (71)
9–15	45 (45)	35 (53)	10 (29)	.04**
Site of primary cancer
Prostate	23 (23)	15 (23)	8 (24)
Lung	27 (27)	16 (24)	11 (32)
Breast	12 (12)	9 (14)	3 (9)
Colorectal	6 (6)	4 (6)	2 (6)
Kidney	6 (6)	6 (9)	–
Bladder	2 (2)	–	2 (6)
Other	24 (24)	16 (24)	8 (24)
Fractionation
8–10 Gy / 1 F	8 (8)	4 (6)	4 (12)
25 Gy / 5 F	55 (55)	30 (45)	25 (74)
30 Gy / 10 F	37 (37)	32 (48)	5 (15)
No. of treated MSCC sites
Single	23 (23)	17 (26)	6 (18)
Multiple	77 (77)	49 (74)	28 (82)
No. of the treated vertebra	315	193	122
Median [range]	2 [1,8]	2 [1,8]	3 [1,8]
Anatomical location
Cervical	38 (12)	19 (10)	19 (16)
Thoracic	204 (65)	124 (64)	80 (66)
Lumbar	39 (12)	30 (16)	9 (7)
Sacral	34 (11)	20 (10)	14 (11)
Hospitalization during follow-up, % of days alive	_
Median [range]		9.5 [0,62]	30 [0,100]	.004*

p-values comparing PRO respondents and PRO nonrespondents are calculated using.

* Wilcoxon rank sum test and **Chi-squared test.

Figure 1. Overall survival in respondents and nonrespondents of PROMs in the first 100 patients of the ESO-SPARE trial.

Table 2. Dosimetry parameters of the first 100 patients in the ESO-SPARE trial.

	Conventional (n = 48)	Experimental (n = 52)	P-values*
Fractionations, No. (%)
30 Gy/10 fx	18 (37.5)	19 (36.5)	–
25 Gy/5 fx	27 (56.3)	28 (53.8)	–
8–10 Gy/1 fx	3 (6.3)	5 (9.6)	–
30 Gy/10 fx, Median [range]
PTV V90%, %	100 [99.3, 100]	95.7 [80.8, 99.4]	<.001
CTV V95%, %	100 [99.4, 100]	97 [78.8, 100]	<.001
EsoD0.027cc, Gy	28.2 [17.9, 30.7]	10 [8.6, 31.1]	<.001
EsoD0.027cc, %	99.1 [29.7, 102.3]	33.2 [28.6, 103.7]	<.001
EsoD1cc, Gy	25.6 [15.8, 29.6]	7.7 [4.9, 30.4]	<.001
EsoD1cc, %	89.5 [52.5, 98.7]	25 [7.1, 101.4]	<.001
25 Gy/ 5 fx, Median [range]
PTV V90%, %	100 [98.3, 100]	96.1 [89.7, 100]	<.001
CTV V95%, %	100 [99.2, 100]	98.7 [90.3, 100]	<.001
EsoD0.027cc, Gy	24.9 [19.9, 26.7]	7.9 [4.9, 25.5]	<.001
EsoD0.027cc, %	99.8 [49.5, 106.8]	31.6 [19.6, 102]	<.001
EsoD1cc, Gy	23.7 [15.3, 25.2]	6.4 [2.3, 25.2]	<.001
EsoD1cc, %	95 [61.3, 100.6]	25.5 [9.3, 100.8]	<.001
8, 10 Gy/1 fx, Median [range]
PTV V90%, %	100 [100, 100]	98 [91.4, 100]	.08
CTV V95%, %	100 [100, 100]	99.3 [94.7, 100]	.08
EsoD0.027cc, Gy	8 [5.4, 9.9]	4.6 [4.3, 8.3]	.37
EsoD0.027cc, %	98.8 [90.2, 100]	45.9 [42.7, 104.2]	.77
EsoD1cc, Gy	7.2 [4.8, 9.3]	3.9 [3, 7.7]	.14
EsoD1cc, %	90.4 [80.2, 93.4]	40 [29.9, 96.6]	.23

* p values were calculated using Wilcoxon Rank Sum Test.

Figure 2. Examples of a rapid arc plan. (A) Oesophagus-sparing plan, (B) Standard plan.

Data availability statement

The data that support the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author, AMN, upon reasonable request, after the termination of the ESO-SPARE trial.