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2018 ASCO Annual Meeting!

Session: Genitourinary (Prostate) Cancer

Type: Poster Session

Time: Saturday June 2, 1:15 PM to 4:45 PM

Location: Hall A

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).


Genitourinary (Prostate) Cancer

2018 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Session (Board #285)

J Clin Oncol 36, 2018 (suppl; abstr 5058)

Author(s): Antoine Thiery Vuillemin, Mads Hvid Poulsen, Louis-Marie Dourthe, Redas Trepiakas, Edouard Lagneau, Elias Pasquale Pintus, Dominique Beal-Ardisson, Alison Jane Birtle, Guillaume Ploussard, Hervé Besson, Martin Lukac, Paul Robinson, Alison Helen Reid; Medical Oncology Unit, CHU Minjoz, Besançon, France; Odense Hospital, Odense C, DK; Clinique Sainte-Anne, Strasbourg, France; Næstved Hospital, Zeeland, Denmark; Institut de Cancérologie de Bourgogne, Côte-D'or, France; Frimley Health NHS Foundation Trust, Wexham Park Hospital, Berkshire, GB; Département d'Oncologie Médicale, Hôpital Privé Jean Mermoz, Lyon, France; Rosemere Cancer Centre, Royal Preston Hospital, Preston, United Kingdom; Clinique Saint Jean Languedoc, Toulouse, France; Janssen Pharmaceutica NV, Beerse, Belgium; PAREXEL International Czech Republic s.r.o, on behalf of Janssen Pharmaceutica NV, Beerse, Belgium; Janssen Cilag, High Wycombe, United Kingdom; Royal Marsden Hospital, Surrey, United Kingdom

Abstract Disclosures


Background: AQUARiUS is an ongoing study of PROs and medical resource use in chemotherapy-naïve pts with mCRPC newly initiated on AAP or ENZ in a real-world setting. Initial 3-month (mo) subset analyses suggested favorable outcomes for AAP vs ENZ in cognition and fatigue. We report 6-mo results. Methods: AQUARiUS prospectively collects PROs on quality of life, cognition, fatigue, and pain using EORTC QLQ-C30, FACT-Cog, BFI-SF, and BPI-SF questionnaires, over 12 mos. PROs were collected at baseline (BL) and during visits based on real-world practice schedules. Incidence of clinically meaningful worsening (CMW) and change from BL scores were determined, adjusting for BL characteristics. Results: All 211 pts were analyzed (AAP, n = 105; ENZ, n = 106). BL characteristics were well balanced (no significant differences). A significantly lower proportion of pts on AAP vs ENZ experienced CMW for cognition and fatigue during the first 6 mos of treatment (TABLE). Clinical trial information: NCT02813408 PRO scales with consistent significant differences (p< 0.05 for ≥ 3 consecutive time points) in change from BL scores were “perceived cognitive impairments” and “comments from others” (FACT-Cog); “fatigue right now,”“usual level of fatigue,” and “worst level of fatigue” (BFI-SF); and “cognitive functioning” and “fatigue” (EORTC QLQ-C30); all favored AAP over ENZ. Where significant differences for these scales were not maintained through the full 6-mo period, nonsignificant trends in favor of AAP were observed. Conclusions: These 6-mo results continue to suggest that AAP provides favorable outcomes vs ENZ for certain measures of cognition and fatigue in pts with mCRPC.

Pts with ≥ 1 episode of CMW during first 6 mos of treatment
AAP, %ENZ, %Odds ratioa (95% CI)p
Perceived cognitive impairments
Comments from others
27560.27 (0.13-0.56)0.0004
20390.38 (0.17-0.85)0.0191
Fatigue right now
Usual level of fatigue
42550.46 (0.22-0.95)0.0365
40550.42 (0.20-0.86)0.0174
Appetite loss
31530.36 (0.18-0.73)0.0047
20460.28 (0.13-0.61)0.0013

aAAP vs ENZ.

Other Abstracts in this Sub-Category:


1. The PROPHECY trial: Multicenter prospective trial of circulating tumor cell (CTC) AR-V7 detection in men with mCRPC receiving abiraterone (A) or enzalutamide (E).

Meeting: 2018 ASCO Annual Meeting Abstract No: 5004 First Author: Andrew J. Armstrong
Category: Genitourinary (Prostate) Cancer - Biomarkers/Epidemiology/Outcomes


2. Expression of immune checkpoints (ICs) on circulating tumor cells (CTCs) in men with metastatic prostate cancer (mPC).

Meeting: 2018 ASCO Annual Meeting Abstract No: 5059 First Author: Tian Zhang
Category: Genitourinary (Prostate) Cancer - Biomarkers/Epidemiology/Outcomes


3. The association of BRCA1 and BRCA2 mutations on prostate cancer risk, frequency, and mortality: Systematic review and meta-analysis.

Meeting: 2018 ASCO Annual Meeting Abstract No: 5060 First Author: Mok Oh
Category: Genitourinary (Prostate) Cancer - Biomarkers/Epidemiology/Outcomes