Prevalence of pain and analgesic use in men with metastatic prostate cancer using a patient-reported outcome measure.
OBJECTIVE
Contemporary tumor-directed therapies for metastatic castration-resistant prostate cancer (mCRPC) are approved to prolong life, but their effects on symptoms such as pain are less well understood as a result of the lack of analytically valid assessments of pain prevalence and severity, clinically meaningful definitions of therapeutic benefit, and methodologic standards of trial conduct. This study establishes pain characteristics in the mCRPC population using a PRO measure.


METHODS
Patients with prostate cancer participated in an anonymous survey at five US comprehensive cancer centers in the Prostate Cancer Clinical Trials Consortium that incorporated the Brief Pain Inventory (BPI), analgesic use, and interference with daily activities. Prevalence and severity of cancer-related pain and analgesic use were tabulated according to castration-resistant status and exposure to docetaxel chemotherapy.


RESULTS
Four hundred sixty-one patients with prostate cancer participated, of whom 147 had mCRPC involving bone (61% [89 of 147] docetaxel exposed, 39% [58 of 147] docetaxel naive). Pain of any level was more common among docetaxel-exposed versus docetaxel-naive patients with mCRPC (70% [62 of 89] v 38% [22 of 58], respectively; P<.001). BPI score≥4 was reported by 38% (34 of 89) of docetaxel-pretreated and 24% (14 of 58) of docetaxel-naive patients with mCRPC; 40% of these patients with pain intensity≥4 reported no current narcotic analgesic.


CONCLUSIONS
Pain prevalence and severity were higher in patients with prior docetaxel exposure. Analgesics were underutilized. These results provide a method for estimating accruals along the disease continuum, and for enabling design of trials appropriately powered to assess pain.
Memorial Sloan-Kettering Cancer Center, New York; Weill Cornell Medical College, New York, NY; Knight Cancer Institute, Oregon Health & Science University, Portland, OR; Duke University Medical Center, Durham; Cancer Outcomes Research Program, University of North Carolina, Chapel Hill, NC; Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore; US Food and Drug Administration, Silver Spring, MD; and University of Texas MD Anderson Cancer Center, Houston, TX.
Karen A
KA
Autio
Antonia V
AV
Bennett
Xiaoyu
X
Jia
Michael
M
Fruscione
Tomasz M
TM
Beer
Daniel J
DJ
George
Michael A
MA
Carducci
Christopher J
CJ
Logothetis
Robert C
RC
Kane
Laura
L
Sit
Lauren
L
Rogak
Michael J
MJ
Morris
Howard I
HI
Scher
Ethan M
EM
Basch
D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000556:secondary; D000077143:Docetaxel; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000453:epidemiology; D063868:Patient Outcome Assessment; D015995:Prevalence; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D057566:Self Report; D043823:Taxoids / Q000627:therapeutic use
D000700:Analgesics; D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel