Pain Outcomes in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with 223 Ra: PARABO, a Prospective, Noninterventional Study.

Autor: Palmedo H; Institute of Radiology and Nuclear Medicine Kaiser Passage and PET/CT Centre, Johanniter Hospital, Bonn, Germany; holger.palmedo@gmx.de., Ahmadzadehfar H; Klinikum Westfalen and MVZ Prof. Uhlenbrock and Partner, Dortmund, Germany., Eschmann S; Marienhospital Stuttgart, Stuttgart, Germany., Niesen A; Diakovere Henriettenstift, Hannover, Germany., Schönberger J; Klinikum Weiden, Weiden, Germany., Barsegian V; Helios Kliniken Schwerin, Schwerin, Germany., Liepe K; Department of Nuclear Medicine, Klinikum Frankfurt (Oder) GmbH, Frankfurt, Germany., Mottaghy FM; Department of Nuclear Medicine, University Hospital RWTH Aachen University, Aachen, Germany, and Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, The Netherlands., Guan R; Bayer HealthCare Pharmaceuticals, Whippany, New Jersey., Pinkert J; Bayer AG, Berlin, Germany; and., Sandström P; Bayer HealthCare Pharmaceuticals, Whippany, New Jersey., Herrmann K; Department of Nuclear Medicine, University of Duisburg-Essen, and German Cancer Consortium-University Hospital Essen, Essen, Germany.
Jazyk: angličtina
Zdroj: Journal of nuclear medicine : official publication, Society of Nuclear Medicine [J Nucl Med] 2023 Sep; Vol. 64 (9), pp. 1392-1398. Date of Electronic Publication: 2023 Jun 29.
DOI: 10.2967/jnumed.123.265557
Abstrakt: 223 Ra, a targeted α-therapy, is approved for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have bone metastases. In the phase 3 ALSYMPCA study, 223 Ra prolonged survival and improved quality of life versus placebo. Our real-world study, PARABO, investigated pain and bone pain-related quality of life in patients with mCRPC and symptomatic bone metastases receiving 223 Ra in clinical practice. Methods: PARABO was a prospective, observational, noninterventional single-arm study conducted in nuclear medicine centers across Germany (NCT02398526). The primary endpoint was a clinically meaningful pain response (≥2-point improvement from baseline for the worst-pain item score in the Brief Pain Inventory-Short Form). Results: The analysis included 354 patients, who received a median of 6 223 Ra injections (range, 1-6). Sixty-seven percent (236/354) received 5-6 injections, and 33% (118/354) received 1-4 injections. Of 216 patients with a baseline worst-pain score of more than 1, 59% (128) had a clinically meaningful pain response during treatment. Corresponding rates were 67% (range, 98/146) with 5-6 223 Ra injections versus 43% (range, 30/70) with 1-4 injections, 60% (range, 60/100) in patients with no more than 20 lesions versus 59% (range, 65/111) in those with more than 20 lesions, and 65% (range, 69/106) in patients without prior or concomitant opioid use versus 54% (range, 59/110) in those with prior or concomitant opioid use. Mean subscale scores (pain severity and pain interference) on the Brief Pain Inventory-Short Form improved during treatment. Conclusion: 223 Ra reduced pain in patients with mCRPC and symptomatic bone metastases, particularly in patients who received 5-6 injections. The extent of metastatic disease did not impact pain response.
(© 2023 by the Society of Nuclear Medicine and Molecular Imaging.)
Databáze: MEDLINE