2-weekly versus 3-weekly docetaxel for metastatic castration-resistant prostate cancer: complete quality of life results from the randomised, phase-III PROSTY trial

Figures & data

Figure 1. Flowchart depicting included and excluded FACT-P questionnaires. Additional two forms were excluded from the in-group model only due to a missing baseline questionnaire. Arm A: docetaxel 50 mg/m² every two weeks; Arm B: docetaxel 75 mg/m² every three weeks.

Table 1. Forms by type of the visit for each Arm.

Arm A								Arm B
Month	Ongoing treatment		EoT evaluation		Control after TF		Total	Month	Ongoing treatment		EoT evaluation		Control after TF
	N	%	N	%	N	%	N		N	%	N	%	N	%	Total
1	50	98.0	1	2.0	0	0.0	51	1	51	94.4	3	5.6	0	0.0	54
2	82	95.3	3	3.5	1	1.2	86	2	80	90.9	8	9.1	0	0.0	88
3	105	88.2	14	11.8	0	0.0	119	3	102	86.4	15	12.7	1	0.8	118
4	62	89.9	6	8.7	1	1.4	69	4	63	78.8	15	18.8	2	2.5	80
5	35	68.6	14	27.5	2	3.9	51	5	17	47.2	16	44.4	3	8.3	36
6	46	69.7	15	22.7	5	10.6	66	6	43	63.2	18	26.5	7	10.3	68
7	33	70.2	10	21.3	4	8.5	47	7	24	55.8	9	20.9	10	23.3	43
8	18	58.1	7	22.6	6	19.4	31	8	9	34.6	11	42.3	6	23.1	26
9	18	60.0	5	16.7	7	23.3	30	9	7	36.8	5	26.3	7	36.8	19
10	17	53.1	6	18.8	9	28.1	32	10	8	66.6	0	0.0	4	33.3	12
11	8	47.1	4	23.5	5	29.4	17	11	3	37.5	3	37.5	2	25.0	8
12	7	70.0	1	10.0	2	20.0	10	12	5	45.5	2	18.2	4	36.4	11

Two patients in Arm A that had not filled the baseline forms were excluded from the Wilcoxon signed rank model but not from the Mann–Whitney U-tests. Only one form for each patient for time patient was allowed. If the patient returned more than one forms for a single month, the form included in the analysis was chosen by lot (N = 28), which are not separated for this qualitative table, but were excluded from the statistical analysis. Arm A: docetaxel 50 mg/m² every two weeks; Arm B: docetaxel 75 mg/m² every three weeks; EoT: End of Treatment; N: sample size; TF: Treatment Failure.

Table 2. Total FACT-P scores compared to the baseline values for months 1 − 7 and directly between groups for months 8 − 12.

	Docetaxel 50 mg/m^2 every 14 days					Docetaxel 75 mg/m^2 every 21 days
Mth.	N	Diff. (mean)	Diff. (median)	P (exact)	P (adj.)	N	Diff. (mean)	Diff. (median)	P (exact)	P (adj.)
1	51	−6.2	−5.3	.010	.120	54	−4.8	−4.9	<.001	<.012*
2	83	−3.0	+3.0	.072	.792	85	−6.1	−3.6	.033	.330
3	111	−1.6	+1.0	.284	>.999	117	−4.6	−3.0	.008	.088
4	69	−3.5	−0.3	.505	>.999	80	+0.9	+5.3	.823	>.999
5	51	−4.5	−6.0	.637	>.999	33	−0.1	+1.3	.995	>.999
6	65	−2.3	+0.0	.178	>.999	68	−1.7	−1.3	.479	>.999
7	46	−5.8	−5.5	.972	>.999	43	+2.3	+3.9	.718	>.999
Total FACT-P scores: head-to-head comparisons
	Docetaxel 50 mg/m^2 every 14 days				Docetaxel 75 mg/m^2 every 21 days
Mth.	N	Mean	Median	IQR	N	Mean	Median	IQR	p Value
8	30	39.9	41.5	[23.8 − 52.3]	26	51.5	51.0	[36.5 − 66.1]	.020*^,†
9	29	44.2	38.7	[29.0 − 61.1]	19	31.4	29.9	[25.0 − 43.0]	.043*^,†
10	32	44.2	45.8	[25.1 − 61.0]	12	43.7	45.5	[26.2 − 61.5]	.985
11	17	46.3	46.0	[32.0 − 59.2]	8	38.5	37.8	[25.0 − 55.6]	.344
12	10	45.4	45.0	[29.2 − 62.7]	10	31.9	30.0	[13.8 − 45.3]	.184

Both models were performed for all the timepoints, and complete results are available in the supplementary material. Statistically significant P-values (<.05) are marked with an asterisk (*). Both statistically and clinically significant differences are marked with a dagger symbol (†). Minimally clinically significant difference is ≥ 6 points of difference in means. Adj.: adjusted for multiplicity with Holm-Bonferroni method; diff.: difference; IQR: interquartile range; mth.: month; N: sample size; P: P value. Total FACT-P scores compared to the baseline.

Table 3. FAPSI-8 compared to the baseline values for months 1 − 7 and directly between groups for months 8 − 12.

FAPSI-8 scores compared to the baseline.
	Docetaxel 50 mg/m^2 every 14 days					Docetaxel 75 mg/m^2 every 21 days
Mth.	N	Diff. (mean)	Diff. (median)	P (exact)	P (adj.)	N	Diff. (mean)	Diff. (median)	P (exact)	P (adj.)
1	51	−2.7	−3.0	<.001	<.012*^,†	54	−2.6	−2.0	<.001	<.012*^,†
2	83	−1.9	−2.0	<.001	<.012*	85	−2.9	−3.0	.001	.012*^,†
3	111	−1.9	−2.0	<.001	<.012*	117	−2.9	−2.1	<.001	<.012*^,†
4	69	−2.5	−3.0	.049	.392	80	−1.6	−1.0	.006	.054
5	51	−3.9	−4.0	.024	.216	33	−1.9	−2.0	.099	.594
6	65	−1.8	−2.0	.839	>.999	68	−2.5	−3.0	.040	.320
7	46	−3.1	−3.0	.176	>.999	43	−1.6	−2.0	.083	.581
FAPSI-8: head-to-head comparisons
	Docetaxel 50 mg/m^2 every 14 days				Docetaxel 75 mg/m^2 every 21 days
Mth.	N	Mean	Median	IQR	N	Mean	Median	IQR	p Value
8	30	6.3	5.5	[2.0 − 10.3]	26	8.7	8.0	[5.0 − 12.3]	.053
9	29	7.7	7.0	[3.0 − 13.5]	19	5.6	5.0	[2.0 − 8.0]	.190
10	32	7.4	6.5	[3.0 − 11.8]	12	7.0	6.5	[4.0 − 10.3]	.974
11	17	7.1	6.0	[3.0 − 11.7]	8	6.3	6.0	[2.3 − 10.3]	.763
12	10	8.2	8.0	[3.8 − 11.0]	10	5.7	5.0	[0.0 − 9.5]	.286

Both models were performed for all the timepoints, and complete results are available in the supplementary material. Statistically significant p-values (< .05) are marked with an asterisk (*). Both statistically and clinically significant differences are marked with a dagger symbol (†). Minimally clinically significant difference is ≥ 2 points of difference in means. Adj.: adjusted for multiplicity with Holm-Bonferroni method; diff.: difference; IQR: interquartile range; mth.: month; N: sample size; P: p Value.

Table 4. Summary of the clinically and statistically significant results from both models.

	In-group			Head-to-head
	Months improved	Months deteriorated	Difference	Months superior to the other arm	‘Grade’
Total FACT-P
Arm A	0	0	0	1	1
Arm B	0	0	0	1	1
FAPSI-8
Arm A	0	1	−1	0	−1
Arm B	0	3	−3	0	−3
PWB
Arm A	0	0	0	2	2
Arm B	1	0	1	0	1
SWB
Arm A	0	0	0	1	1
Arm B	0	0	0	0	0
EWB
Arm A	0	2	−2	0	−2
Arm B	0	4	−4	1	−3
FWB
Arm A	0	0	0	0	0
Arm B	0	0	0	0	0
PCS
Arm A	0	2	−2	0	−2
Arm B	0	2	−2	1	−1

A grade for comparability was formed by calculating the difference of improved and deteriorated months compared to the baseline and the months the arm outranked the other (sum). PWB: physical well-being; SWB: social well-being; EWB: emotional well-being; FWB: functional well-being; PCS: prostate cancer subdomain in FACT-P.

Data availability statement

The anonymized version of the data presented in this are available on a reasonable request from the corresponding author. The data are not publicly available due to statutory reasons.