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
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
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
Fatigue right now
Usual level of fatigue
aAAP vs ENZ.