Nuklearmedizin 2021; 60(02): 133
DOI: 10.1055/s-0041-1726706
Leuchtturm
Bildgebung und Therapie

Clinical outcomes and patient (pt) profiles in REASSURE: an observational study of radium-223 (Ra-223) in metastatic castration-resistant prostate cancer (mCRPC)

K Miller
1   Charité, Urologie, Berlin
,
C Higano
2   Department of Medicine, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, Washington, USA
,
F Saad
3   University of Montreal Hospital Center, Montreal, Quebec, Canada
,
O Sartor
4   Tulane Cancer Center, Tulane University School of Medicine, New Orleans, Louisiana, USA
,
P Conti
5   Molecular Imaging Center, Keck School of Medicine of USC, Los Angeles, California, USA
,
D George
6   Departments of Medicine and Surgery, Duke Cancer Institute, Duke University, Durham, North Carolina, USA
,
CN Sternberg
7   Weill Cornell Department of Medicine, New York-Presbyterian Hospital, New York, New York, USA
,
N Shore
8   Carolina Urologic Research Center, Myrtle Beach, South Carolina, USA
,
JP Sade
9   Instituto Alexander Fleming, Buenos Aires, Argentina
,
J Bellmunt
10   Dana-Farber Cancer Institute, Boston, Massachusetts, USA
,
M Smith
11   Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA
,
C Logothetis
12   MD Anderson Cancer Center, Houston, Texas, USA
,
F Verholen
13   Bayer HealthCare Pharmaceuticals, Whippany, New Jersey, USA
,
J Kalinovsky
14   Bayer Consumer Care AG, Basel, Switzerland
,
I Bayh
13   Bayer HealthCare Pharmaceuticals, Whippany, New Jersey, USA
,
B Tombal
15   Division of Urology, IREC, Cliniques Universitaires Saint Luc, UCLouvain, Brussels, Belgium
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Ziel/Aim Ra-223 is a targeted alpha therapy that showed a survival advantage and favorable safety profile in the phase 3 ALSYMPCA trial in pts with mCRPC. REASSURE is evaluating the long-term safety of Ra-223 in routine clinical practice in pts with mCRPC over a 7-year follow-up period.

Methodik/Methods In this global, prospective, single-arm, observational study, the second prespecified interim analysis (data cut-off March 2019) evaluated safety and clinical outcomes of Ra-223 in pts with mCRPC. Primary outcome measures were incidence of second primary malignancies (SPM), bone marrow suppression and short- and long-term safety in pts who had ≥1 Ra-223 dose. Secondary outcomes included overall survival (OS).

Ergebnisse/Results For 1465 pts in the safety analysis, median follow up was 11.5 months. Median PSA (n = 1053), ALP (n = 1048), and LDH (n = 555) levels at baseline were 59 ng/mL, 135 U/L, and 269 U/L, respectively. 81 % of pts had bone metastases only at baseline; 19 % of pts had other metastatic sites, mostly in the lymph nodes. 19 % of pts had 20 lesions but not a superscan, and 6 % had a superscan. 45 %, 38 %, 37 %, 9 %, and 8 % of pts received prior abiraterone, docetaxel, enzalutamide, cabazitaxel, or sipuleucel-T as prior therapies, respectively. Median number of Ra-223 doses received was 6; 67 % of pts had ≥5 doses. SPM occurred in 1 % of pts. The most common treatment-emergent drug-related adverse event (AE) of any grade was diarrhea (11 %). 10 % of pts had a bone-associated event, 5 % had fractures, and 15 % had a hematological AE. Median OS was 15.6 months (95 % CI 14.6–16.5).

Schlussfolgerungen/Conclusions In REASSURE, there was a low incidence of SPM, bone fractures, and bone marrow suppression after Ra-223 treatment, with no new AEs identified. This study confirms that in routine clinical practice, Ra-223 AE rates were low, and pts generally received ≥5 doses.



Publication History

Article published online:
08 April 2021

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