2530 Baseline characteristics, number of radium-223 (Ra-223) injections, and overall survival (OS) in US Expanded Access Program (EAP) and ALSYMPCA

Coleman, R.; Morris, M.; Nilsson, Staffan; Shore, Neal D.; Sweeney, Christopher; Vogelzang, Nicholas J.; Petrenciuc, Oana; Gratt, Jeremy; Parker, C.

doi:10.1016/s0959-8049(16)31349-1

Cited by 20 publications

(11 citation statements)

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“…Median OS appeared to be prolonged with 5–6 versus 1–4 radium‐223 injections (median not reached vs. 7.5 months, respectively). In similar analyses of ALSYMPCA and international EAP patients, 5–6 versus 1–4 study‐drug injections was also associated with prolonged OS . In all three studies, there appeared to be an association between number of radium‐223 injections and OS, with 5–6 injections associated with prolonged survival; however, because number of injections and OS are postbaseline factors, these results could be confounded by patient baseline characteristics.…”

Section: Discussionmentioning

confidence: 83%

Radium-223 Safety, Efficacy, and Concurrent Use with Abiraterone or Enzalutamide: First U.S. Experience from an Expanded Access Program

et al. 2017

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In this phase II U.S. expanded access program, radium-223 was well tolerated, with a median overall survival of 17 months in metastatic castration-resistant prostate cancer patients. In post hoc analyses, radium-223 was safe regardless of concurrent abiraterone or enzalutamide, and median overall survival appeared longer when radium-223 was used earlier in patients with less prior treatment. Patients with more advanced disease were less likely to benefit from radium-223. Clinicians should consider baseline clinical characteristics and therapy sequence to provide the greatest clinical value to patients.

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Section: Discussionmentioning

confidence: 83%

Radium-223 Safety, Efficacy, and Concurrent Use with Abiraterone or Enzalutamide: First U.S. Experience from an Expanded Access Program

et al. 2017

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“…An analysis of the open-label, single-arm, phase 3b, international expanded access program for patients with bone-predominant mCRPC found that median OS was greater in patients who received 5–6 injections vs those who received 1–4 injections [ 65 ]. Similarly, an OS advantage for patients who received 5–6 injections vs those who received 1–4 injections was seen in post hoc subgroup analyses of the US expanded access program and ALSYMPCA [ 66 ]. This suggests that 5 or 6 cycles of treatment might be more effective than fewer cycles, although this was not a randomized comparison.…”

Section: Resultsmentioning

confidence: 96%

Current approaches to incorporation of radium-223 in clinical practice

Parker

Heidenreich

Nilsson

et al. 2018

Prostate Cancer Prostatic Dis

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BackgroundTreatment options for metastatic castration-resistant prostate cancer (mCRPC) have expanded in recent years and include cytotoxic agents (e.g., docetaxel and cabazitaxel), immunotherapy (e.g., sipuleucel-T), oral hormonal therapies targeting the androgen receptor axis (e.g., enzalutamide and abiraterone), and targeted alpha therapy (e.g., radium-223 dichloride (radium-223)). Although treatment guidelines have been updated to reflect the availability of new agents, it is not easy to apply them in daily clinical practice because recommendations vary depending on patient comorbidities and disease characteristics. Furthermore, therapeutic accessibility, clinical judgment, and experience affect the selection of treatment options.MethodsIn this review, we provide practical guidance for the integration of radium-223 into the management of patients with mCRPC based on our collective clinical experience, as well as the available clinical trial data.ResultsRadium-223 is a targeted alpha therapy; as a bone-seeking calcium mimetic, it accumulates in hydroxyapatite areas surrounding tumor lesions and selectively binds to the areas of increased bone turnover. Radium-223 prolongs overall survival and delays time to the first symptomatic skeletal events in men with mCRPC, and is indicated for the treatment of patients with CRPC, symptomatic bone metastases, and no known visceral metastases. We review its clinical efficacy and safety, practical guidance on identifying the appropriate patient, and recommendations for how best to educate and inform prospective patients regarding their treatment decision making. In addition, we review recent evidence for sequential and combination therapies with radium-223, provide our experiences with these treatment approaches, and discuss their implications for the future treatment of patients with mCRPC.ConclusionsBased on our clinical experience, radium-223 should be considered relatively early in the treatment course in patients with mCRPC with bone metastases. Coordination of care among multidisciplinary team members, patients, and caregivers is essential for optimizing safe and effective treatment with all CRPC therapies.

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“…A interdisciplinary approach facilitates identification of patients who are suitable for 223Ra treatment. It has been established that the effectiveness of the treatment on survival is obtained after at least five administrations of 223Ra (15). For this reason, in this study, complete treatment for patients was defined as 5-6 cycles.…”

Section: Discussionmentioning

confidence: 99%

Overall survival prediction in metastatic castration-resistant prostate cancer treated with radium-223

et al. 2020

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Objective: Radium-223(223Ra) is indicated for patients (p) with metastatic castration resistant prostate cancer (mCRCP). Objectives: The aim of this study was to evaluate the role of baseline clinical variables associated with overall survival (OS) and toxicity of 223Ra. Its purpose was to identify the factors that can predict a better response to treatment and provide information regarding the most appropriate time for the application of 223Ra. Materials and Methods: Prospective study in 40p with mCRPC treated with 223Ra. End points were OS, progression-free survival and time to progression. The follow-up parameters were: doses received, hemoglobin (Hb), absolute neutrophil count (ANC), platelet count (PC), prostate specific antigen (PSA), alkaline phosphatase (ALP), Visual Analogue Scale for pain, Eastern Cooperative Oncology Group (ECOG) and WHO's Cancer Pain Ladder. The use of other treatments was also evaluated. Results: Median OS was 17.1 months(mo) (CI95%6.5-27.7); 26/40p received complete treatment of 223Ra, without reaching a median OS and 14p received incomplete treatment with a median OS 13.6mo(CI95%1.6-25.6). Median follow-up was 11.2mo (range:1.3-45.2). The univariate analysis showed that factors as VAS, ECOG, Hb and ALP values were independently associated with OS. First line treatment with 223Ra was started in 11/40p, while 19p had been heavily pre-treated and 13p received concomitant treatment. Conclusions: 223Ra therapy require an adequate selection of patients to obtain the greatest clinical benefit. Low basal Hb, hight basal ALP, bone marrow involvement and an altered ECOG were the main factors that decreased OS in our patients. 223Ra should be considered relatively early in the course of treatment.

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2530 Baseline characteristics, number of radium-223 (Ra-223) injections, and overall survival (OS) in US Expanded Access Program (EAP) and ALSYMPCA

Cited by 20 publications

References 0 publications

Radium-223 Safety, Efficacy, and Concurrent Use with Abiraterone or Enzalutamide: First U.S. Experience from an Expanded Access Program

Radium-223 Safety, Efficacy, and Concurrent Use with Abiraterone or Enzalutamide: First U.S. Experience from an Expanded Access Program

Current approaches to incorporation of radium-223 in clinical practice

Overall survival prediction in metastatic castration-resistant prostate cancer treated with radium-223

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