Quality of life after sipuleucel-T therapy: results from a randomized, double-blind study in patients with androgen-dependent prostate cancer.

Abstract

OBJECTIVE:

To collect and analyze quality-of-life (QOL) data from PROvenge Treatment and Early Cancer Treatment trial (PROTECT, NCT00779402), a phase III, randomized controlled trial of sipuleucel-T in patients with asymptomatic androgen-dependent prostate cancer.

METHODS:

Patients experiencing prostate-specific antigen relapse after radical prostatectomy entered a 3- to 4-month run-in phase of androgen-deprivation therapy (ADT), followed by 2:1 randomization to sipuleucel-T or control. QOL was assessed throughout the run-in and 26-week post-randomization phases using the Brief Fatigue Inventory (BFI), Linear Analog Self-Assessment (LASA) scale, Global Rating of Change (GRoC) scale, and an elicited symptoms list.

RESULTS:

One hundred seventy-six patients were randomized into 2 groups, the sipuleucel-T group (n = 117) or the control group (n = 59). The sample provided 80% power to detect a difference in fatigue interference score between treatment arms of 0.9 points. QOL declined predictably during ADT. At week 26, 26.2% of sipuleucel-T-treated patients and 21.6% of control-treated patients (P = .68) reported fatigue in the previous week, and the mean score for fatigue interference in the past 24 hours was 0.9 for both arms (P = .88). Results were comparable for usual fatigue (P = .91) and worst fatigue (P >.99). Mean LASA scores decreased in both groups (P = .26). The proportion of patients reporting better overall QOL on GRoC was similar (P = .62).

CONCLUSION:

There is no clinically significant negative impact on QOL after sipuleucel-T treatment compared with control after a period of ADT in patients with asymptomatic androgen-dependent prostate cancer.

• Authors: Tomasz M Beer, Paul F Schellhammer, John M Corman, L Michael Glodé, Simon J Hall, James B Whitmore, Mark W Frohlich, David F Penson
• Journal: Urology (Urology) Vol. 82 Issue 2 Pg. 410-5 (Aug 2013) ISSN: 1527-9995 [Electronic] United States
• PMID: 23896100 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 Elsevier Inc. All rights reserved.

Chemical References

• Androgen Antagonists
• Cancer Vaccines
• Tissue Extracts
• Gonadotropin-Releasing Hormone
• sipuleucel-T

Topics

• Aged
• Androgen Antagonists (administration & dosage, adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Cancer Vaccines (administration & dosage)
• Double-Blind Method
• Fatigue (chemically induced)
• Gonadotropin-Releasing Hormone (administration & dosage, adverse effects, analogs & derivatives)
• Hot Flashes (chemically induced)
• Humans
• Male
• Middle Aged
• Prostatic Neoplasms (complications, drug therapy)
• Quality of Life
• Sexual Dysfunction, Physiological (chemically induced)
• Surveys and Questionnaires
• Sweating (drug effects)
• Tissue Extracts (administration & dosage)