Quality of Life After Sipuleucel-T Therapy: Results From a Randomized, Double-blind Study in Patients With Androgen-dependent Prostate Cancer - 28/07/13
, Paul F. Schellhammer b, John M. Corman c, L. Michael Glodé d, Simon J. Hall e, f, James B. Whitmore g, Mark W. Frohlich g, David F. Penson hAbstract |
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.
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| Financial Disclosure: Tomasz M. Beer has received financial compensation from Dendreon Corporation (consultancy); James B. Whitmore and Mark W. Frohlich are employees of Dendreon Corporation; L. Michael Glodé has received financial compensation from Johnson & Johnson and Exelixis (consultancy), and from Aurora Oncology (owner), and is an owner of Gonex, Inc.; Simon J. Hall has received financial compensation from Dendreon Corporation (consultancy); Paul F. Schellhammer has received financial compensation from Dendreon Corporation (meeting participation and lectures) and from Amgen and Janssen (meeting participation); the remaining authors declare that they have no relevant financial interests. |
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| Funding Support: Financial and material support for this research and the manuscript was provided by Dendreon Corporation. |
Vol 82 - N° 2
P. 410-415 - août 2013 Retour au numéro
Article précédent
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