TY - JOUR
T1 - Integrated analysis of pain, health-related quality of life, and analgesic use in patients with metastatic castration-resistant prostate cancer treated with Radium-223
AU - Badrising, Sushil K
AU - Louhanepessy, Rebecca D
AU - van der Noort, Vincent
AU - Kieffer, Jacobien
AU - Coenen, Jules L L M
AU - Hamberg, Paul
AU - Beeker, Aart
AU - Wagenaar, Nils
AU - Lam, Marnix
AU - Celik, Filiz
AU - Loosveld, Olaf J L
AU - Oostdijk, Ad
AU - Zuetenhorst, Hanneke
AU - de Feijter, Jeantine M
AU - Dezentjé, Vincent O
AU - Ras-van Spijk, Suzan
AU - Vegt, Erik
AU - Haanen, John B
AU - van de Poll-Franse, Lonneke V
AU - Zwart, Wilbert
AU - Bergman, Andries M
N1 - Funding Information:
A.M.B. participated in Advisory Boards of Janssen Pharma, Bayer, Sanofi and Astellas, received speaking fees from Jansen Pharma, Bayer and Astellas, and received research grants from Sanofi and Astellas. J.M.F. participated in advisory boards of Janssen Pharma, Merck, and Pfizer. J.B.H. has provided consultation, attended advisory boards, and/or provided lectures for AIMM, Amgen, BioNTech, BMS, GSK, Ipsen, Merck Serono, Molecular Partners, MSD, Novartis, Pfizer, Roche/Genentech, Sanofi, Seattle Genetics, and Third Rock ventures. He is on the scientific advisory boards of IMM, BioNTech US, Gadeta, Immunocore, T-Knife and Neogene Therapeutics. He received grant support from Amgen, BioNTech US, BMS, MSD, and Novartis. He also has stock options in Neogene Therapeutics. All the remaining authors declare no competing interests.
Funding Information:
This work was supported by a grant from Bayer BV, Mijdrecht, The Netherlands.
Funding Information:
In addition to the authors, the following investigators contributed to this study (in alphabetical order): F. vd Berkmortel, H.J. Bloemendal, W. vd Deure-Gielisse, N. Hagen, H.H. Helgason, C.J. Hoekstra, D. Houtsma, B. de Keizer, J.M.H. de Klerk, K.P. Koopmans, B. Kuenen, M. Los, L. Prompers, T.A. Roeleveld, W. Schreurs, T. Smilde, W. Vogel, T. van Voorthuizen, and D.N.J Wyndaele. We also thank the members of the Dutch Uro-Oncology Study group (DUOS15102).
Publisher Copyright:
© 2021, The Author(s).
PY - 2022/2
Y1 - 2022/2
N2 - BACKGROUND: Radium-223 (Ra-223), an alpha-emitting radiopharmaceutical, established an improved overall survival and health-related quality of life (HRQoL) in symptomatic metastatic castration-resistant prostate cancer (mCRPC) patients. However, effects on pain were not specifically evaluated. Here we assess integrated HRQoL, pain, and opioid use in a contemporary, more extensively pretreated, symptomatic and asymptomatic mCRPC population.METHODS: mCRPC patients scheduled for Ra-223 treatment were included and analyzed for HRQoL, pain, and opioid use, using Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Brief Pain Inventory-Short Form (BPI-SF) questionnaires and recording of opioid use and dosage, respectively. Primary outcome measure was the percentage of patients experiencing a complete pain response (score of 0 on the BPI-SF Worst pain item and no increase in daily use of analgesics). A complete or partial pain response (better BPI-SF score and decrease in opioid use) and a better or no change in HRQoL was evaluated as an integrated overall clinical response (IOCR). Secondary endpoints included the time to pain progression (TPP) and Total FACT-P deterioration (TTFD), defined as time from first Ra-223 treatment to clinical meaningful increase in BPI-SF Worst pain item score and Total FACT-P score, respectively.RESULTS: This registry included 300 patients, of whom 105 (35%) were evaluable for FACT-P and BPI-SF during Ra-223 treatment. Forty-five (43%) patients had pain at baseline (PAB) (BPI-SF Worst pain score 5-10 points) and 60 (57%) had no pain at baseline (no-PAB) (BPI-SF Worst pain score 0-4 points). Complete pain response was achieved in 31.4% of the patients, while 58% had an IOCR. The median TTP and TTFD were 5.6 and 5.7 months, respectively, while the difference between PAB and no-PAB patients was not significant.CONCLUSIONS: In contemporary, extensively pretreated mCRPC patients, Ra-223 treatment induced complete pain responses while integrated analysis of HRQoL, pain response, and opioid use demonstrated that the majority of patients derive clinical benefit.
AB - BACKGROUND: Radium-223 (Ra-223), an alpha-emitting radiopharmaceutical, established an improved overall survival and health-related quality of life (HRQoL) in symptomatic metastatic castration-resistant prostate cancer (mCRPC) patients. However, effects on pain were not specifically evaluated. Here we assess integrated HRQoL, pain, and opioid use in a contemporary, more extensively pretreated, symptomatic and asymptomatic mCRPC population.METHODS: mCRPC patients scheduled for Ra-223 treatment were included and analyzed for HRQoL, pain, and opioid use, using Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Brief Pain Inventory-Short Form (BPI-SF) questionnaires and recording of opioid use and dosage, respectively. Primary outcome measure was the percentage of patients experiencing a complete pain response (score of 0 on the BPI-SF Worst pain item and no increase in daily use of analgesics). A complete or partial pain response (better BPI-SF score and decrease in opioid use) and a better or no change in HRQoL was evaluated as an integrated overall clinical response (IOCR). Secondary endpoints included the time to pain progression (TPP) and Total FACT-P deterioration (TTFD), defined as time from first Ra-223 treatment to clinical meaningful increase in BPI-SF Worst pain item score and Total FACT-P score, respectively.RESULTS: This registry included 300 patients, of whom 105 (35%) were evaluable for FACT-P and BPI-SF during Ra-223 treatment. Forty-five (43%) patients had pain at baseline (PAB) (BPI-SF Worst pain score 5-10 points) and 60 (57%) had no pain at baseline (no-PAB) (BPI-SF Worst pain score 0-4 points). Complete pain response was achieved in 31.4% of the patients, while 58% had an IOCR. The median TTP and TTFD were 5.6 and 5.7 months, respectively, while the difference between PAB and no-PAB patients was not significant.CONCLUSIONS: In contemporary, extensively pretreated mCRPC patients, Ra-223 treatment induced complete pain responses while integrated analysis of HRQoL, pain response, and opioid use demonstrated that the majority of patients derive clinical benefit.
UR - http://www.scopus.com/inward/record.url?scp=85113814855&partnerID=8YFLogxK
U2 - 10.1038/s41391-021-00412-6
DO - 10.1038/s41391-021-00412-6
M3 - Article
C2 - 34446849
SN - 1365-7852
VL - 25
SP - 248
EP - 255
JO - Prostate cancer and prostatic diseases
JF - Prostate cancer and prostatic diseases
IS - 2
ER -