The Contemporary Use of Radium-223 in Metastatic Castration-resistant Prostate Cancer

Heinrich, Daniel; Bektic, Jasmin; Bergman, Andries M.; Caffo, Orazio; Cathomas, Richard; N., Kim; Daugaard, Gedske; Keizman, Daniel; Kindblom, Jon; Kramer, Gero; Olmos, David; Omlin, Aurelius; Sridhar, Srikala S.; Tucci, Marco; Oort, Inge M. van; Nilsson, Sten

doi:10.1016/j.clgc.2017.08.020

Cited by 31 publications

(21 citation statements)

References 56 publications

(66 reference statements)

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“…Some physicians consider that it is important for management of the disease that the opportunity is provided to administer as many of the available life-prolonging therapies as possible. Therefore, it may be the case that radium-223 might be better placed early in the disease course during initial lines of treatment, but must be placed prior to the onset of visceral disease (lung, liver, or other organ metastases) [ 20 ].…”

Section: Discussionmentioning

confidence: 99%

Interim analysis of the REASSURE (Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation) study: patient characteristics and safety according to prior use of chemotherapy in routine clinical practice

Dizdarevic

Petersen

Essler

et al. 2019

Eur J Nucl Med Mol Imaging

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Purpose REASSURE is a global, prospective, non-interventional study to assess long-term safety of radium-223 in patients with bone metastatic castration-resistant prostate cancer. Here we report an interim analysis of patients according to previous use of chemotherapy. Methods Radium-223 was administered in routine clinical practice. Interim safety analysis was planned after enrolment of the first 600 patients. Patient characteristics and safety data by previous administration of chemotherapy (docetaxel and/or cabazitaxel) were investigated. Results This interim analysis included 583 patients. Median duration of observation was 7 months (range, 0–20). Nineteen patients treated with concomitant chemotherapy were excluded, 564 (97%) were eligible for exploratory analysis according to prior use of chemotherapy; 190 (34%) had previously received and completed chemotherapy, and 374 (66%) had not. In the prior versus no prior chemotherapy group, a higher proportion of patients had an Eastern Cooperative Oncology Group performance status of ≥2 (22% vs 11%) and > 20 metastatic lesions (26% vs 15%), median alkaline phosphatase (162.0 vs 115.0 U/L) and prostate-specific antigen (132.0 vs 40.2 ng/mL) levels were higher, and a lower proportion completed 6 radium-223 injections (45% vs 63%). Drug-related treatment-emergent adverse events (TEAEs) occurred in 63 and 48%, and haematological drug-related TEAEs in 21 and 9% of patients who had or had not previously received chemotherapy. Four drug-related deaths were reported, all in the prior chemotherapy group. Conclusions The short-term safety profile of radium-223 in routine clinical practice was comparable to other clinical studies, irrespective of prior chemotherapy use. Haematological TEAEs occurred more frequently in the prior chemotherapy group, presumably due to decreased bone marrow function as a consequence of more advanced disease and prior exposure to cytotoxic therapy. Patients who had not previously received chemotherapy appeared to have a lower burden of disease at baseline, and a lower proportion discontinued radium-223 treatment. Electronic supplementary material The online version of this article (10.1007/s00259-019-4261-y) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Interim analysis of the REASSURE (Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation) study: patient characteristics and safety according to prior use of chemotherapy in routine clinical practice

Dizdarevic

Petersen

Essler

et al. 2019

Eur J Nucl Med Mol Imaging

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“…It is accumulated in osteoblastic activity spots. Elimination occurs in the gastrointestinal (GI) tract [89]. Radiobiological effect is associated with direct damage of tumor DNA by alpha particles.…”

Section: Radium-223mentioning

confidence: 99%

“…Radiobiological effect is associated with direct damage of tumor DNA by alpha particles. Alpha particles produce ionization around the decay site [89]. The ALSYMPCA randomized phase III trial compared radium-223 versus placebo.…”

Section: Radium-223mentioning

confidence: 99%

Previous, Current, and Future Pharmacotherapy and Diagnosis of Prostate Cancer—A Comprehensive Review

et al. 2019

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Prostate cancer (PCa) is one of the most common cancers in men that usually develops slowly. Since diagnostic methods improved in the last decade and are highly precise, more cancers are diagnosed at an early stage. Active surveillance or watchful waiting are appealing approaches for men diagnosed with low-risk prostate cancer, and they are an antidote to the overtreatment problem and unnecessary biopsies. However, treatment depends on individual circumstances of a patient. Older hormonal therapies based on first generation antiandrogens and steroids were widely used in metastatic castration-resistant prostate cancer (mCRPC) patients prior to the implementation of docetaxel. Nowadays, accordingly to randomized clinical trials, abiraterone, enzalutamide, apalutamide. and docetaxel became first line agents administrated in the treatment of mCRPC. Furthermore, radium-223 is an optional therapy for bone-only metastasis patients. Sipuleucel-T demonstrated an overall survival benefit. However, other novel immunotherapeutics showed limitations in monotherapy. Possible combinations of new vaccines or immune checkpoint blockers with enzalutamide, abiraterone, radium-223, or docetaxel are the subject of ongoing rivalry regarding optimal therapy of prostate cancer.

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“…These are thorium-227 ( 227 Th), actinium-225 ( 225 Ac), and radium-223 ( 223 Ra). [5][6][7] Including also nuclides with shorter half-lives, bismuth-213 ( 213 Bi) and the lead-212/ bismuth-212 ( 212 Pb/ 212 Bi) system can be added as potential choices. 8,9 All these nuclides have been used in clinical settings but Ra[ 223 Ra]-dichloride (Ra[ 223 Ra]Cl 2 ; Xofigo Ò ) is the only clinically approved a-emitting radionuclide.…”

Section: Introductionmentioning

confidence: 99%

Realizing Clinical Trials with Astatine-211: The Chemistry Infrastructure

Lindegren

Albertsson

Bäck

et al. 2020

Cancer Biotherapy and Radiopharmaceuticals

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Despite the consensus around the clinical potential of the a-emitting radionuclide astatine-211 (211 At), there are only a limited number of research facilities that work with this nuclide. There are three main reasons for this: (1) Scarce availability of the nuclide. Despite a relatively large number of globally existing cyclotrons capable of producing 211 At, few cyclotron facilities produce the nuclide on a regular basis. (2) Lack of a chemical infrastructure, that is, isolation of 211 At from irradiated targets and the subsequent synthesis of an astatinated product. At present, the research groups that work with 211 At depend on custom systems for recovering 211 At from the irradiated targets. Setting up and implementing such custom units require long lead times to provide a proper working system. (3) The chemistry of 211 At. Compared with radiometals there are no well-established and generally accepted synthesis methods for forming sufficiently stable bonds between 211 At and the tumor-specific vector to allow for systemic applications. Herein we present an overview of the infrastructure of producing 211 At radiopharmaceuticals, from target to radiolabeled product including chemical strategies to overcome hurdles for advancement into clinical trials with 211 At.

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The Contemporary Use of Radium-223 in Metastatic Castration-resistant Prostate Cancer

Cited by 31 publications

References 56 publications

Interim analysis of the REASSURE (Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation) study: patient characteristics and safety according to prior use of chemotherapy in routine clinical practice

Interim analysis of the REASSURE (Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation) study: patient characteristics and safety according to prior use of chemotherapy in routine clinical practice

Previous, Current, and Future Pharmacotherapy and Diagnosis of Prostate Cancer—A Comprehensive Review

Realizing Clinical Trials with Astatine-211: The Chemistry Infrastructure

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