Sep 5, 2018 - A sample size of 211 patients is required to detect a difference of ⥠0.5 .... employee of PAREXEL International Czech Republic s.r.o, on behalf ...
Six-Month Patient-Reported Outcome (PRO) Results From AQUARiUS, a Prospective, Observational, Multicenter Phase 4 Study in Patients (Pts) With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Receiving Abiraterone Acetate + Prednisone (AAP) or Enzalutamide (ENZ) Antoine Thiery Vuillemin1, Mads Hvid Poulsen2, Louis-Marie Dourthe3, Redas Trepiakas4, Edouard Lagneau5, Elias Pintus6, Dominique Beal-Ardisson7, Alison Birtle8, Guillaume Ploussard9, Hervé Besson10, Martin Lukac11, Paul Robinson12, Alison Reid13 CHU Jean MINJOZ, Franche-Comté, France; 2Odense Hospital, Odense, Denmark; 3Clinique Sainte Anne, Strasbourg, France; 4Zealand University Hospital, Naestved, Denmark; 5Institut de Cancérologie de Bourgogne, Dijon, France; 6Frimley Health NHS Foundation Trust, Slough, UK; 7Hôpital prive Jean Mermoz, Lyon, France; 8Royal Lancaster Infirmary and Rosemere Cancer Centre, Royal Preston Hospital, Preston, UK; 9Clinique Saint Jean Languedoc, Toulouse, France; 10Janssen Pharmaceutica NV, Beerse, Belgium; 11PAREXEL International Czech Republic s.r.o, on behalf of Janssen Pharmaceutica NV, Beerse, Belgium; 12Janssen EMEA, High Wycombe, UK; 13The Royal Marsden NHS Foundation Trust, Sutton, UK 1
GS1610 237377-CR01_Janssen EU zytiga AQUARIUS ASCO 2300x1100 S07.indd 1
228.0 (158.0-837.0)
0.588
ALP at baseline, median IU/L (range) PSA at baseline, median ng/mL (range)
93.5 (13.0-2435.0)
92.0 (33.0-4344.0)
0.514
22.0 (1.1-588.0
34.0 (0.2-450.0)
0.932
Gleason score at initial diagnosis, n (%) ≤7 ≥8 Missing
52 (49.5) 45 (42.9) 8 (7.6)
ECOG performance status, n (%) 0/1 ≥2 Missing
46 (43.4) 49 (46.2) 11 (10.4)
90 (85.7) 8 (7.6) 7 (6.7)
Any visceral metastases, n (%) No Yes
Opioid use at baseline No Yes
17%
17%
7%
11%
12%
19%
80%
6%
10%
4%
7%
13%
5%
62% 72%
64%
80%
65%
76%
76%
76%
60%
40%
0.9891
41% 32%
92%
85%
FACT-Cog 1. Perceived cognitive impairments
BFI – Severity
2. Comments from others
1. Your fatigue right now
2. Your usual level of fatigue
80% 60%
44% 73%
61%
58%
45%
60%
45%
11%
AAP ENZ Month 2 0.21 (0.09-0.48)
19%
16%
7%
8%
0%
AAP ENZ Month 3 0.19 (0.06-0.55)
AAP ENZ Month 4-6 0.49 (0.24-0.99)
20%
19%
80%
6%
AAP ENZ Month 1 0.39 (0.15-0.99)
AAP ENZ Month 2 0.28 (0.10-0.79)
AAP ENZ Month 3 0.08 (0.01-0.61)
AAP ENZ Month 4-6 0. 54 (0.22-1.35)
20%
27%
20%
39%
42%
55%
p Value
0.0023
0.0463
Worsening
0.0484 No change
0.0164
0.1880
0.0146
Improvement
Figure 3. Mean Difference Between Treatment Groups in the Change From Baseline for All PRO Scores at Months 1, 2, 3, and 4-6 PRO
Month 1
Month 2
Month 3
Month 4-6
4.
Impact on QoL (+)
0.74 [-0.28-1.75]
0.09 [-1.03-1.22]
1.03 [-0.09-2.15]
0.28 [-0.65-1.21]
1.
Your fatigue right now (-)
-0.71 [-1.31 to -0.11]
-0.82 [-1.50 to -0.14]
-0.99 [-1.74 to -0.23]
-0.08 [-0.79-0.63]
2.
Your usual level of fatigue (-)
-0.70 [-1.30 to -0.10]
-1.04 [-1.70 to -0.37]
-1.24 [-2.02 to -0.46]
-0.32 [-0.96-0.32]
3.
Your worst level of fatigue (-)
-0.89 [-1.51 to -0.27]
-1.00 [-1.74 to -0.25]
-1.32 [-2.10 to -0.53]
-0.09 [-0.82-0.63]
4.
Fatigue interference (-)
-0.33 [-0.84-0.19]
-0.71 [-1.25 to -0.18]
-0.90 [-1.56 to -0.24]
-0.35 [-0.94-0.24]
1.
Pain at its worst (-)
0.06 [-0.63-0.76]
-0.54 [-1.29-0.21]
-0.66 [-1.46-0.14]
-0.05 [-0.75-0.65]
Diff. [95% CI]
2.
Pain at its least (-)
-0.13 [-0.68-0.41]
-0.58 [-1.15 to -0.01]
-0.50 [-1.09-0.08]
-0.30 [-0.89-0.28]
p Value
3.
Pain on the average (-)
0.29 [-0.24-0.83]
-0.64 [-1.25 to -0.04]
-0.66 [-1.32 to -0.01]
-0.04 [-0.71-0.63]
4.
Pain right now (-)
-0.08 [-0.67-0.52]
-0.34 [-0.97-0.30]
-0.24 [-0.83-0.36]
-0.21 [-0.81-0.39]
5.
Pain interference (-)
-0.13 [-0.65-0.40]
-0.12 [-0.72-0.47]
-0.53 [-1.23-0.16]
0.06 [-0.60-0.72]
1.
Physical functioning (+)
2.37 [-1.64-6.38]
1.30 [-3.26-5.87]
6.80 [1.81-11.80]
3.75 [-1.07-8.56]
QLQ-C30 – Symptom scales
2.
Role functioning (+)
6.33 [-0.95-13.61]
8.95 [1.99-15.91]
9.20 [1.78-16.62]
2.28 [-5.72-10.29]
6. Fatigue
3.
Emotional functioning (+)
4.55 [0.36-8.75]
1.33 [-4.19-6.86]
7.05 [2.88-11.23]
2.71 [-1.80-7.22]
4.
Cognitive functioning (+)
4.25 [0.55-7.95]
7.13 [2.40-11.86]
7.79 [1.21-14.37]
2.25 [-2.41-6.90]
5.
Social functioning (+)
4.20 [-1.75-10.16]
6.74 [0.77-12.70]
9.02 [2.78-15.26]
4.00 [-2.47-10.47]
6.
Fatigue (-)
-10.58 [-15.92 to -5.24]
-7.95 [-13.90 to -1.99]
-15.35 [-22.69 to -8.00]
-7.27 [-13.92 to -0.62]
7.
Nausea and vomiting (-)
-3.41 [-7.34-0.52]
-1.25 [-5.26-2.76]
-5.67 [-9.71 to -1.62]
-3.33 [-7.98-1.32]
8.
Pain (-)
-3.16 [-9.37-3.05]
-3.73 [-11.26-3.79]
-9.79 [-16.98 to -2.61]
-0.51 [-7.58-6.56]
9.
Dyspnea (-)
-0.65 [-6.15-4.86]
-1.52 [-8.18-5.14]
-1.41 [-8.33-5.51]
0.69 [-6.78-8.17]
10. Insomnia (-)
-3.83 [-10.70-3.04]
4.08 [-3.09-11.24]
-1.88 [-9.75-5.99]
6.86 [0.14-13.58]
11. Appetite loss (-)
-10.06 [-16.01 to -4.11]
-5.55 [-12.43-1.34]
-13.51 [-20.59 to -6.42]
-7.84 [-14.63 to -1.05]
12. Constipation (-)
-4.31 [-10.86-2.24]
1.46 [-5.78-8.69]
-4.48 [-11.57-2.60]
-2.73 [-10.01-4.55]
13. Diarrhea (-)
-1.02 [-7.02-4.99]
-3.97 [-9.82-1.88]
-2.42 [-7.97-3.12]
3.21 [-2.00-8.41]
14. Financial difficulties (-)
0.65 [-3.30-4.60]
-2.37 [-6.74-1.99]
-0.73 [-4.44-2.98]
-1.91 [-5.86-2.04]
15. Global health status/QoL (+)
0.22 [-5.14-5.58]
6.94 [0.52-13.37]
6.51 [-0.44-13.47]
1.94 [-3.73-7.62]
FACT-Cog
BFI
BPI
QLQ-C30
AAP ENZ
AAP ENZ
AAP ENZ
AAP ENZ
AAP ENZ
0.27 (0.13-0.56)
0.38 (0.17-0.85)
0.46 (0.22-0.95)
0.42 (0.20-0.86)
0.36 (0.18-0.73)
0.28 (0.13-0.61)
0.0004
0.0191
0.0365
0.0174
0.0047
0.0013
PRO Score
Worse Better
PRO Score
1.67 [-0.88-4.22]
AAP ENZ
59 64 -0.565 -9.524
78 80 -2.381 -4.852
0.003 Month 2
0.021 Month 3
0.58 [0.00-1.17]
0.003 Month 1
0.006 Month 2
0.004 Month 3
0.050 Month 4-6
1.0 0.5
Diff. [95% CI] p Value
85 91 0.024 0.511
72 70 -0.394 0.362
57 64 -0.123 0.667
78 79 0.247 0.171
-0.71 [-1.31 to -0.11]
-0.82 [-1.50 to -0.14]
-0.99 [-1.74 to -0.23]
-0.08 [-0.79-0.63]
0.021 Month 1
0.019 Month 2
0.011 Month 3
0.825 Month 4-6
Time (Months) F. BFI-SF Significant differences favoring AAP over ENZ were seen for mean change from baseline for “worst level of fatigue” at Months 1, 2, and 3
0.5
-0.5
72 71 -0.521 0.594
57 62 -0.456 0.672
78 80 -0.052 0.329
N Mean change from BL
-1.04 [-1.70 to –0.37] 0.002 Month 2
-1.24 [-2.02 to –0.46] 0.002 Month 3
-0.32 [-0.96-0.32] 0.320 Month 4-6
Diff. [95% CI] p Value
87 91 -0.523 0.411
72 72 -0.611 0.507
57 62 -0.702 0.492
78 80 -0.064 0.117
-0.89 [-1.51 to -0.27]
-1.00 [-1.74 to –0.25]
-1.32 [-2.10 to –0.53]
-0.09 [-0.82-0.63]
0.005 Month 1
0.009 Month 2
0.001 Month 3
0.796 Month 4-6
Significant difference in favor of AAP
Trend in favor of AAP
Trend in favor of ENZ
Significant difference in favor of ENZ
Interpretation of the PRO items: for FACT-Cog, higher scores are favorable; for EORTC QLQ-C30 functional scales and global health status/QoL, higher scores are favorable, for EORTC QLQ-C30 symptom scales, lower scores are favorable; for BPI-SF and BFI-SF, lower scores are favorable.
Time (Months)
AAP
ENZ
0 -5 -10 88 91 -4.798 5.800
72 72 -4.244 3.241
-10.58 -7.95 [-15.92 to –5.24] [-13.90 to –1.99] < 0.001 Month 1
0.009 Month 2
59 64 -6.968 4.861
79 83 -2.672 4.685
-15.35 [-22.69 to -8.00]
-7.27 [-13.92 to -0.62]
< 0.001 Month 3
0.032 Month 4-6
• The 6-month interim results from the full sample of 211 patients in the AQUARiUS study suggest more favorable outcomes for cognitive- and fatigue-related end points for patients treated with AAP compared with those treated with ENZ. These results are consistent with findings from the previously reported 3-month analyses based on 105 patients.
References 1. R yan CJ, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013;368:138-148. 2. B eer TM, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014;371:424-433. 3. T hiery Vuillemin A, et al. Initial results from AQUARiUS, a prospective, observational, multi-centre phase 4 study assessing patient-reported outcomes (PROs) in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) treated with abiraterone acetate plus prednisone (AAP) or enzalutamide (ENZ). Presented at: the ESMO 2017 Congress, September 8-12, 2017, Madrid, Spain. 4. P arimi S, et al. Effects of abiraterone (ABI) and enzalutamide (ENZA) on cognitive impairment and depressive symptoms in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol. 2016;34:(suppl; abstr 5059).
0
5
N Mean change from BL
CONCLUSIONS
-0.5
1.0
86 92 -0.143 0.478
• These findings were further supported by the cognitive functioning and fatigue aspects of the QLQ-C30 questionnaire. • These results are consistent with previously reported data from a phase 2 randomized trial that demonstrated favorable effects of AAP over ENZ on cognitive impairment and QoL.4,5 • The final analysis of the AQUARiUS study (12 months of follow-up) will provide valuable long‑term PRO data in the real-world setting. • Strengths of the study include its prospective, multinational, and multicenter design and the consistency of data collected to date, as well as its longer duration and larger patient population than reported previously. • Limitations of the study include a lack of randomization. A multivariate modeling approach correcting for all relevant baseline characteristics was used to minimize bias.
0
N Mean change from BL
0.342 Month 4-6
10
-0.65 [-3.30-2.00]
20%
0.95 [0.30-1.60]
G. EORTC QLQ-30 Significant differences favoring AAP over ENZ were seen for mean change from baseline at Months 1, 2, 3, and 4-6 for the “fatigue” aspect of the EORTC QLQ-C30
2.55 [0.23-4.86]
31%
0.71 [0.20-1.22]
Time (Months)
1.68 [-0.55-3.91]
46%
0.025 Month 1
-0.70 [-1.30 to –0.10] p Value 0.023 Month 1
Perceived cognitive abilities (+)
52%
0.76 [0.25-1.26]
D. BFI-SF Significant differences favoring AAP over ENZ were seen for mean change from baseline for “fatigue right now” at Months 1, 2, and 3
4.25 [0.55-7.95] 7.13 [2.40-11.86] 7.79 [1.21-14.37] 2.25 [-2.41-6.90]
Diff. [95% CI]
3.
0% Odds ratio (95% CI)
0.0002
0.58 [0.00-1.17]
55% 40%
0.0002
N Mean change from BL
0.95 [0.30-1.60]
No change/ improvment
79 82 0.141 -0.412
-1.0
0.71 [0.20-1.22]
80%
70 72 0.242 -7.042
-0.5
0.76 [0.25-1.26]
Worsening
88 90 0.958 -4.682
0
Comments from others (+)
54%
59 63 0.169 -0.796
Time (Months)
0.5
2.
40% 56%
Worse Better
10% 16%
4.22 [1.51-6.93]
69%
p Value
1.0
5.44 [2.50-8.37]
47%
0.003 Month 4-6
E. BFI-SF Significant differences favoring AAP over ENZ were seen for mean change from baseline for “usual level of fatigue” at Months 1, 2, 3, and a trend at 4-6 months
4.73 [2.25-7.22]
100%
< 0.001 Month 3
Time (Months)
3.25 [1.09-5.40]
11. Appetite loss
< 0.001 Month 2
-10
Perceived cognitive impairments (+)
Figure 1. Patients With ≥ 1 Episode of CMW During the First 6 Months of Treatment
0.003 Month 1
Diff. [95% CI]
-5
1.
Percentage of Patients Who Experienced at Least 1 CMW in First 6 Months • A significantly lower proportion of patients receiving AAP versus ENZ experienced at least 1 CMW in cognition and fatigue during the first 6 months of treatment (Figure 1).
4.22 [1.51-6.93]
0
77%
LDH, lactate dehydrogenase; ALP, alkaline phosphatase; PSA, prostate-specific antigen.
Completion Rate • Although completion rates reduced from baseline (91%-99%) to Month 3 (52%-59%), they were maintained above 65% for all PROs during Months 4-6 (AAP, 69%-74%; ENZ, 67%-75%). • Within the first 6 months, 47 patients (AAP, n = 21; ENZ, n = 26) discontinued treatment and of these, 19 patients (AAP, n = 9; ENZ, n = 10) switched from one treatment to the other. – Reasons for discontinuations (AAP, ENZ) were toxicity (n = 4, n = 8), PSA progression (n = 6, n = 4), clinical progression (n = 2, n = 1), radiologic progression (n = 5, n = 6), death (n = 2, n = 1), other (n = 2, n = 5), and missing (n = 1, ENZ only). – Reasons for switching were toxicity (n = 4), PSA progression (n = 2), clinical progression, radiologic progression, other (each n = 1) for AAP, and toxicity (n = 6) and other (n = 4) for ENZ.
5.44 [2.50-8.37]
71 72 0.127 -0.582
1.5
p Value
79%
20%
29%
27%
8%
Difference (worsening AAP ENZ Month 1 vs no change 0.19 or improvement) (95% CI) (0.08-0.46) p Value
4.73 [2.25-7.22]
87 91 0.256 -0.493
40%
20%
102 (96.2) 4 (3.8)
3.25 [1.09-5.40]
N Mean change from BL
C. QLQ-C30 For cognitive functioning (which was evaluated as one aspect of QoL using the EORTC QLQ-C30), significant differences favoring AAP over ENZ were seen for mean change from baseline at Months 1, 2, and 3, and a trend at 4-6 months
Diff. [95% CI]
79%
0.597
0%
79 83 0.845 -3.352
Time (Months)
N Mean change from BL
53% 74%
0.472
58 64 1.350 -3.575
80%
60%
0.851
87 (82.1) 19 (17.9)
101 (96.2) 4 (3.8)
6%
B 100%
54%
89 (84.0) 1 (0.9) 16 (15.1)
90 (85.7) 15 (14.3)
Sedatives at baseline, n (%) No Yes
0.352
93 (87.7) 13 (12.3)
90 (85.7) 0 (0) 15 (14.3)
A 100% 18% 15%
92 (86.8) 11 (10.4) 3 (2.8)
93 (88.6) 12 (11.4)
Anemia, n (%) Grade ≤ 2 Grade ≥ 3 Missing
0.605
Figure 2. Percent CMW of Perceived Cognitive Impairments (A) and Comments From Others (B) at Months 1, 2, 3, and 4-6
p Value
72 71 0.941 -3.997
PRO Score
213.0 (130.0-1207.0)
-0.5
PRO Score
0.980
Diff. [95% CI]
87 91 1.444 -1.998
Better Worse
76.0 (44.0-92.0)
0
-1.0
N Mean change from BL
PRO Score
76.0 (53.0-96.0)
-2
Better Worse
Study Design • AQUARiUS is an ongoing 2-arm, prospective, observational, nonrandomized, multicenter, phase 4 study conducted in Denmark, France, and the United Kingdom (NCT02813408). • Eligibility criteria include age ≥ 18 years, histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate, documented metastatic disease, and documented castration resistance with progression of prostate cancer on surgical or chemical androgen deprivation therapy. • Exclusion criteria include prior chemotherapy to treat mCRPC and prior chemotherapy to treat metastatic hormone-sensitive prostate cancer in the previous 12 months. • Study physicians were urology and/or oncology specialists who routinely treat patients with mCRPC; to minimize recruitment bias, all of their eligible patients were invited to participate in the study. • The decision to treat patients with AAP or ENZ preceded study enrollment and was per routine clinical practice. • A sample size of 211 patients is required to detect a difference of ≥ 0.5 standard deviation between the 2 treatment groups, with 85% power at the 5% level of significance with a follow-up of ≤ 12 months. Data Collection and Analysis • This analysis focuses on PROs from all 211 patients with 6 months’ follow-up (cutoff 09 November 2017). • PROs on cognitive function, fatigue, pain, and HRQoL were collected prospectively over 12 months using the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), Brief Fatigue Inventory-Short Form (BFI-SF), Brief Pain Inventory-Short Form (BPI-SF), and European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30) at baseline and during a patient’s routine visits to the clinic. – Medical records were used to capture data on prostate cancer diagnosis and history, baseline patient demographics and clinical characteristics, and current treatment regimens. • Three analyses were performed to compare the treatment groups: – The percentage of patients who experienced at least 1 clinically meaningful worsening (CMW) in PROs over the whole 6-month period was analyzed using multivariate logistic models. A clinically meaningful change in status was defined as a difference from baseline greater than the minimal important difference (0.5 times the standard deviation of the baseline PRO of all patients). – The mean change from baseline in PRO score over time was analyzed using multivariate repeated measures linear models. – The percentage of patients with CMW over time was analyzed using multivariate repeated measures logistic regression models. • All 3 analyses were adjusted for baseline characteristics. • Analyses were based on the intent-to-treat population. Per-protocol and censoring analyses were conducted as a sensitivity analysis. • Data at Months 1, 2, and 3 and Months 4-6 were used for the analyses over time points. – Months refer to 28-day treatment cycles; monthly intervals were defined as 28 days, 56 days, or 84 days, ±14, for Months 1, 2, and 3, respectively, and Day 98 to Day 181 for Months 4-6. – For Months 1, 2, and 3, centered PRO data were used when multiple assessments were performed; for the period of Months 4-6, the assessment closest to Month 6 was used. • For the analysis of the percentage of patients who experienced at least 1 CMW in the first 6 months, all collected PROs were used.
LDH at baseline, median IU/L (range)
p Value
0
0.5
-1.5
PRO Score
METHODS
Age, median years (range)
ENZ (n = 106)
2
PRO Score
• AQUARiUS is an ongoing, observational, 2-arm study that aims to explore whether there are differences in PROs (cognitive function, fatigue, pain, and HRQoL) and MRU between chemotherapy-naïve patients with mCRPC newly initiated on ENZ or AAP in the real-world setting. • Initial 3-month data suggested more favorable outcomes in cognition and fatigue for patients treated with AAP versus ENZ.3 • Here we report data from the full patient cohort, with analyses up to 6-month follow-up.
AAP (n = 105)
B. FACT-Cog Significant differences favoring AAP over ENZ were seen for mean change from baseline for comments from others at Months 1, 2, 3, and 4-6
-4
Worse Better
STUDY OBJECTIVES
Table 1. Baseline Characteristics
Mean Change From Baseline in PRO Scores Over Time • PRO scales with consistent significant differences (p < 0.05 for ≥ 3 consecutive time points) in change from baseline scores were (Figures 3 and 4): – FACT-Cog: “perceived cognitive impairments” and “comments from others”; – BFI-SF: “fatigue right now,” “usual level of fatigue,” and “worst level of fatigue”; – EORTC QLQ-C30: “cognitive functioning” and “fatigue.” • All of the above favored AAP over ENZ (Figures 3 and 4). • Where significant differences for these scales were not maintained through the full 6-month period, nonsignificant trends in favor of AAP were observed (Figures 2 and 3).
A. FACT-Cog Significant differences favoring AAP over ENZ were seen for mean change from baseline for perceived cognitive impairments at Months 1, 2, 3, and 4-6
Better Worse
• Abiraterone acetate plus prednisone (AAP) and enzalutamide (ENZ) have been shown to increase survival of patients with metastatic castration-resistant prostate cancer (mCRPC) without prior chemotherapy compared with placebo plus prednisone or placebo alone.1,2 • However, data on the effect of AAP and ENZ on patient-reported outcomes (PROs), such as cognitive function, fatigue, pain and health-related quality of life (HRQoL), and medical resource use (MRU), are limited.
Patients • All 211 patients were included in this analysis. – 105 patients received AAP. – 106 patients received ENZ. • Baseline characteristics were well balanced between AAP- and ENZ-treated patients; there were no significant differences between the 2 treatment cohorts (Table 1).
Cognitive Functioning • Patients treated with ENZ had a significantly higher risk of experiencing CMW in perceived cognitive impairments (Figure 2A) and comments from others (Figure 2B) compared with those treated with AAP at Months 1, 2, 3, and 4-6 (except comments from others Months 4-6, p = 0.188 [not significant]).
Figure 4. Mean Change From Baseline in PRO for Cognitive Functioning (A-C) and Fatigue (D-G)
Better Worse
BACKGROUND
RESULTS
CMW Over Time
Time (Months)
BL, baseline. Interpretation of the PRO items: for FACT-Cog, higher scores are favorable; for EORTC QLQ-C30 functional scales and global health status/QoL, higher scores are favorable, for EORTC QLQ-C30 symptom scales, lower scores are favorable; for BPI-SF and BFI-SF, lower scores are favorable.
DISCUSSION • The findings from this analysis of the AQUARiUS study demonstrate that a lower proportion of patients treated with AAP versus ENZ experienced CMW in cognitive outcomes (“perceived cognitive impairments” and “comments from others”) and fatigue outcomes (“fatigue right now,” “usual level of fatigue,” and “fatigue”) over the first 6 months of treatment. • This was supported by the results for difference in mean change from baseline analysis for cognitive end points (“perceived cognitive impairment” and “comments from others”) and fatigue end points (“fatigue right now,” “usual level of fatigue,” and “worst level of fatigue”) based on FACT-Cog and BFI-SF questionnaires, respectively.
5. K halaf DJ, et al. Assessment of quality of life (QOL), cognitive function and depression in a randomized phase II study of abiraterone acetate (ABI) plus prednisone (P) vs enzalutamide (ENZA) for metastatic castrate-resistant prostate cancer (mCRPC). J Clin Oncol. 2017;35:(suppl; abstr 5036).
Conflicts of Interest Antoine Thiery-Vuillemin reports grants and nonfinancial support from Janssen, personal fees from Astellas, grants from Janssen and Sanofi, and grants and personal fees from Ipsen, Roche, BMS, and Pfizer. Mads Hvid Poulsen has nothing to disclose. Louis-Marie Dourthe has nothing to disclose. Redas Trepiakas reports personal fees from Janssen-Cilag Astellas. Edouard Lagneau has nothing to disclose. Elias Pintus reports personal fees from Astellas, BMS, and Clovis Oncology, and nonfinancial support from Astellas, Clovis Oncology, and Janssen. Dominique Beal-Ardisson has nothing to disclose. Alison Birtle has received personal fees from Janssen, Sanofi Aventis, Astellas, and Roche. Guillaume Ploussard serves on advisory boards and has received honoraria from Astellas and Janssen. Hervé Besson and Paul Robinson are employees of Janssen Pharmaceutica N.V., and hold stock in Johnson & Johnson. Martin Lukac is an employee of PAREXEL International Czech Republic s.r.o, on behalf of Janssen Pharmaceutica N.V., Beerse, Belgium. Alison Reid has received personal fees from Janssen.
Acknowledgements The authors would like to acknowledge the dedicated efforts of the investigational sites that contributed to the study, and the patients who allowed collection of their data. This study is funded by Janssen EMEA. Writing assistance was provided by PAREXEL and was funded by Janssen EMEA. The authors also acknowledge Nathalie Allietta, Laurent Antoni, Marieke Buitenhuis, Lindsay Dearden, Martin Kluska, Emma Lee, Florence Lefresne, Geneviève Pissart, Suzy Van Sanden, and Divyagiri Seshagiri, employees of Janssen EMEA, who contributed to the study and analysis. Poster presented at the 2018 ASCO Annual Meeting, June 1-5, 2018, Chicago, IL.
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