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Quality of life (QOL) analysis from E3805, chemohormonal androgen ablation randomized trial (CHAARTED) in prostate cancer (PrCa).
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
|Difference between Arm A and Arm B2||Estimate||SE||p-value|
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
Abstracts by Linda J. Patrick-Miller:
Interest in and outcomes with return of individual genetic research results for inherited susceptibility to breast cancer.Meeting: 2015 ASCO Annual Meeting | Abstract No: e12503
- Meeting: 2013 ASCO Annual Meeting | Abstract No: 1538