223Ra-chloride therapy in men with hormone-refractory prostate cancer and skeletal metastases

Real-world experience

Giuseppe Boni, Sara Mazzarri, Claudia Cianci, Luca Galli, Azzurra Farnesi, Eugenio Borsatti, Roberto Bortolus, Lucia Fratino, Carlo Gobitti, Elda Lamaj, Pietro Ghedini, Elisa Lodi Rizzini, Francesco Massari, Valeria Dionisi, Stefano Fanti, Duccio Volterrani, Fabio Monari

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: Radium-223 (223Ra) chloride, an alpha emitter, has been shown to improve overall survival (OS) and pain control, and to delay skeletal-related events, in patients with castration-resistant prostate cancer (CRPC) and bone metastases. Our retrospective observational study presents the first Italian experience on the efficacy and safety of223Ra therapy in routine clinical practice. Methods: A total of 83 patients with metastatic CRPC were treated with223Ra at 3 Italian centers between August 2013 and August 2016.223Ra-chloride (55 kBq/kg) was administered every 4 weeks for a total of 6 cycles. Primary endpoints were OS and progression-free survival (PFS). Secondary endpoints included toxicity, pain evaluation using numeric rating scale (NRS), symptomatic skeletal-related events and biomarkers response. Results: Patients had a median age of 75 (range 53–89) years. The majority of men showed a Gleason score of 7, 8, or 9. Forty-one patients completed 6 treatment cycles; 33 stopped treatment before completing 6 cycles. Nine were still receiving therapy at the time of data collection. At the end of therapy, NRS pain scores significantly improved (p <.000001). OS was a mean of 10.1 months, while median OS had not been attained. According to Kaplan-Meier estimation, OS and PFS were 17.5 and 7.7 months, respectively. There was a significant correlation between OS and PFS with the number of223Ra cycles; patients receiving all 6 cycles experienced the major benefit from the therapy.223Ra was well-tolerated. Conclusions:223Ra alpha therapy is an important therapeutic option for men with CRPC and symptomatic skeletal metastases.

Original languageEnglish
Pages (from-to)128-136
Number of pages9
JournalTumori
Volume104
Issue number2
DOIs
Publication statusPublished - Jan 1 2018

Fingerprint

Chlorides
Prostatic Neoplasms
Hormones
Neoplasm Metastasis
Survival
Castration
Disease-Free Survival
Pain
Therapeutics
Radium
Bone Neoplasms
Neoplasm Grading
Observational Studies
Retrospective Studies
Biomarkers
Safety

Keywords

  • Brachytherapy
  • Hormone-refractory prostate cancer
  • Neoplasm metastasis
  • Radium
  • prostate cancer

ASJC Scopus subject areas

  • Medicine(all)

Cite this

223Ra-chloride therapy in men with hormone-refractory prostate cancer and skeletal metastases : Real-world experience. / Boni, Giuseppe; Mazzarri, Sara; Cianci, Claudia; Galli, Luca; Farnesi, Azzurra; Borsatti, Eugenio; Bortolus, Roberto; Fratino, Lucia; Gobitti, Carlo; Lamaj, Elda; Ghedini, Pietro; Rizzini, Elisa Lodi; Massari, Francesco; Dionisi, Valeria; Fanti, Stefano; Volterrani, Duccio; Monari, Fabio.

In: Tumori, Vol. 104, No. 2, 01.01.2018, p. 128-136.

Research output: Contribution to journalArticle

Boni, G, Mazzarri, S, Cianci, C, Galli, L, Farnesi, A, Borsatti, E, Bortolus, R, Fratino, L, Gobitti, C, Lamaj, E, Ghedini, P, Rizzini, EL, Massari, F, Dionisi, V, Fanti, S, Volterrani, D & Monari, F 2018, '223Ra-chloride therapy in men with hormone-refractory prostate cancer and skeletal metastases: Real-world experience', Tumori, vol. 104, no. 2, pp. 128-136. https://doi.org/10.1177/0300891618765571
Boni, Giuseppe ; Mazzarri, Sara ; Cianci, Claudia ; Galli, Luca ; Farnesi, Azzurra ; Borsatti, Eugenio ; Bortolus, Roberto ; Fratino, Lucia ; Gobitti, Carlo ; Lamaj, Elda ; Ghedini, Pietro ; Rizzini, Elisa Lodi ; Massari, Francesco ; Dionisi, Valeria ; Fanti, Stefano ; Volterrani, Duccio ; Monari, Fabio. / 223Ra-chloride therapy in men with hormone-refractory prostate cancer and skeletal metastases : Real-world experience. In: Tumori. 2018 ; Vol. 104, No. 2. pp. 128-136.
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abstract = "Background: Radium-223 (223Ra) chloride, an alpha emitter, has been shown to improve overall survival (OS) and pain control, and to delay skeletal-related events, in patients with castration-resistant prostate cancer (CRPC) and bone metastases. Our retrospective observational study presents the first Italian experience on the efficacy and safety of223Ra therapy in routine clinical practice. Methods: A total of 83 patients with metastatic CRPC were treated with223Ra at 3 Italian centers between August 2013 and August 2016.223Ra-chloride (55 kBq/kg) was administered every 4 weeks for a total of 6 cycles. Primary endpoints were OS and progression-free survival (PFS). Secondary endpoints included toxicity, pain evaluation using numeric rating scale (NRS), symptomatic skeletal-related events and biomarkers response. Results: Patients had a median age of 75 (range 53–89) years. The majority of men showed a Gleason score of 7, 8, or 9. Forty-one patients completed 6 treatment cycles; 33 stopped treatment before completing 6 cycles. Nine were still receiving therapy at the time of data collection. At the end of therapy, NRS pain scores significantly improved (p <.000001). OS was a mean of 10.1 months, while median OS had not been attained. According to Kaplan-Meier estimation, OS and PFS were 17.5 and 7.7 months, respectively. There was a significant correlation between OS and PFS with the number of223Ra cycles; patients receiving all 6 cycles experienced the major benefit from the therapy.223Ra was well-tolerated. Conclusions:223Ra alpha therapy is an important therapeutic option for men with CRPC and symptomatic skeletal metastases.",
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author = "Giuseppe Boni and Sara Mazzarri and Claudia Cianci and Luca Galli and Azzurra Farnesi and Eugenio Borsatti and Roberto Bortolus and Lucia Fratino and Carlo Gobitti and Elda Lamaj and Pietro Ghedini and Rizzini, {Elisa Lodi} and Francesco Massari and Valeria Dionisi and Stefano Fanti and Duccio Volterrani and Fabio Monari",
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T1 - 223Ra-chloride therapy in men with hormone-refractory prostate cancer and skeletal metastases

T2 - Real-world experience

AU - Boni, Giuseppe

AU - Mazzarri, Sara

AU - Cianci, Claudia

AU - Galli, Luca

AU - Farnesi, Azzurra

AU - Borsatti, Eugenio

AU - Bortolus, Roberto

AU - Fratino, Lucia

AU - Gobitti, Carlo

AU - Lamaj, Elda

AU - Ghedini, Pietro

AU - Rizzini, Elisa Lodi

AU - Massari, Francesco

AU - Dionisi, Valeria

AU - Fanti, Stefano

AU - Volterrani, Duccio

AU - Monari, Fabio

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Background: Radium-223 (223Ra) chloride, an alpha emitter, has been shown to improve overall survival (OS) and pain control, and to delay skeletal-related events, in patients with castration-resistant prostate cancer (CRPC) and bone metastases. Our retrospective observational study presents the first Italian experience on the efficacy and safety of223Ra therapy in routine clinical practice. Methods: A total of 83 patients with metastatic CRPC were treated with223Ra at 3 Italian centers between August 2013 and August 2016.223Ra-chloride (55 kBq/kg) was administered every 4 weeks for a total of 6 cycles. Primary endpoints were OS and progression-free survival (PFS). Secondary endpoints included toxicity, pain evaluation using numeric rating scale (NRS), symptomatic skeletal-related events and biomarkers response. Results: Patients had a median age of 75 (range 53–89) years. The majority of men showed a Gleason score of 7, 8, or 9. Forty-one patients completed 6 treatment cycles; 33 stopped treatment before completing 6 cycles. Nine were still receiving therapy at the time of data collection. At the end of therapy, NRS pain scores significantly improved (p <.000001). OS was a mean of 10.1 months, while median OS had not been attained. According to Kaplan-Meier estimation, OS and PFS were 17.5 and 7.7 months, respectively. There was a significant correlation between OS and PFS with the number of223Ra cycles; patients receiving all 6 cycles experienced the major benefit from the therapy.223Ra was well-tolerated. Conclusions:223Ra alpha therapy is an important therapeutic option for men with CRPC and symptomatic skeletal metastases.

AB - Background: Radium-223 (223Ra) chloride, an alpha emitter, has been shown to improve overall survival (OS) and pain control, and to delay skeletal-related events, in patients with castration-resistant prostate cancer (CRPC) and bone metastases. Our retrospective observational study presents the first Italian experience on the efficacy and safety of223Ra therapy in routine clinical practice. Methods: A total of 83 patients with metastatic CRPC were treated with223Ra at 3 Italian centers between August 2013 and August 2016.223Ra-chloride (55 kBq/kg) was administered every 4 weeks for a total of 6 cycles. Primary endpoints were OS and progression-free survival (PFS). Secondary endpoints included toxicity, pain evaluation using numeric rating scale (NRS), symptomatic skeletal-related events and biomarkers response. Results: Patients had a median age of 75 (range 53–89) years. The majority of men showed a Gleason score of 7, 8, or 9. Forty-one patients completed 6 treatment cycles; 33 stopped treatment before completing 6 cycles. Nine were still receiving therapy at the time of data collection. At the end of therapy, NRS pain scores significantly improved (p <.000001). OS was a mean of 10.1 months, while median OS had not been attained. According to Kaplan-Meier estimation, OS and PFS were 17.5 and 7.7 months, respectively. There was a significant correlation between OS and PFS with the number of223Ra cycles; patients receiving all 6 cycles experienced the major benefit from the therapy.223Ra was well-tolerated. Conclusions:223Ra alpha therapy is an important therapeutic option for men with CRPC and symptomatic skeletal metastases.

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