158431-172

Quality of life (QOL) analysis from E3805, chemohormonal androgen ablation randomized trial (CHAARTED) in prostate cancer (PrCa).

Category: 
Genitourinary Cancer
Session Type and Session Title: 
Poster Session A: Prostate Cancer
Abstract Number: 

286

Poster Board Number: 
Poster Session A Board #M13
Citation: 
J Clin Oncol 34, 2016 (suppl 2S; abstr 286)
Author(s): 
Linda J. Patrick-Miller, Yu-Hui Chen, Michael Anthony Carducci, David Cella, Robert S. DiPaola, Benjamin Adam Gartrell, David Frazier Jarrard, Glenn Liu, Alicia Katherine Morgans, Yu-Ning Wong, Christopher Sweeney; The University of Chicago Medical Center, Chicago, IL; Dana-Farber Cancer Institute, Brookline, MA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD; Northwestern University, Chicago, IL; Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Montefiore Medical Center, Bronx, NY; University of Wisconsin Hosp and Clinics, Madison, WI; University of Wisconsin Carbone Cancer Center, Madison, WI; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA; Dana-Farber Cancer Institute, Boston, MA

Abstract Disclosures

Abstract: 

Background: Docetaxel concurrent with androgen deprivation (ADT) for metastatic hormone sensitive prostate cancer (mHSPC) improves overall survival over ADT alone. However, docetaxel as a cytotoxic has an adverse event profile that can diminish QOL. Methods: Patients were randomized to ADT plus 6 cycles of docetaxel every 3 weeks (Arm A, N = 397) or ADT alone (Arm B, N = 393). Validated QOL instruments for PrCa and docetaxel including Functional Assessment of Cancer Therapy (FACT)–Prostate were administered at baseline and 3, 6, 9 and 12 months (mos.) after randomization. Paired t-tests were used to examine QOL changes over time. A mixed effect model compared QOL between arms at each time point (Table). Results: 790 patients were randomized and QOL completed for Arm A and B (91% and 88%, baseline; 87% and 80%, 3 mos.; and 70% and 67%, 12 mos.). Patients in Arm A (ADT + docetaxel) reported -2.7 [Standard Error (SE) 0.9] decline in FACT-P at 3 mos. (p = 0.003), but did not differ significantly from baseline at 12 mos. (-0.7, SE 1.1). In contrast, patients in Arm B (ADT alone), did not differ significantly at 3 mos. [-1.1 (SE: 1.0)], but reported a significant decline [-4.2 (SE: 1.1); p = 0.0001] from baseline to 12 mos. FACT-P scores differed significantly between Arm A and B at 3 mos. (p = 0.02) and 12 mos. (0.04), with Arm A lower at 3 mos. and higher at 12 mos. Conclusions: Docetaxel is associated with decreased QOL on treatment (at 3 mos.) not seen with ADT alone. However, 12 mos. QOL was better for the patients who had docetaxel versus ADT alone, returning to baseline. This suggests that docetaxel + ADT does not confer long-term negative impact on QOL for mHSPC. Clinical trial information: NCT00309985

Mixed effects model1for FACT-P total score.

Difference between Arm A and Arm B2EstimateSEp-value
Baseline-1.001.280.43
3 months-3.091.320.02
6 months0.851.340.52
9 months0.271.370.84
12 months2.831.390.04

1. Adjusted for age ( ≤ 59 vs. 60-69 v. ≥ 70 disease extent (high v. low), local therapy (Y/N), ECOG PS (0 v. ½), baseline physical well-being ( ≤ 20 v. 20 < PWB ≤ 25 v. > 25) and baseline pain score (0/1 v. 2/3 vs. ≥ 4) 2. Arm A score - Arm B score *Sanofi provided drug and grant financial support