Results From a Large, Multicenter, Retrospective Analysis On Radium223 Use in Metastatic Castration-resistant Prostate Cancer (mCRPC) in the Triveneto Italian Region

Marco Maruzzo, Umberto Basso, Eugenio Borsatti, Laura Evangelista, Filippo Alongi, Orazio Caffo, Francesca Maines, Sara Galuppo, Rocco De Vivo, Fable Zustovich, Dario Palleschi, Andrea Zivi, Teodoro Sava, Mariella Sorarù, Roberto Iacovelli, Maurizio Nicodemo, Susanne Baier, Lucia Fratino, Vittorina Zagonel

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Radium 223 was introduced for metastatic castration-resistant prostate cancer based on the results of a randomized controlled trial showing risk reduction for death and skeletal events. Our aim was to evaluate the outcome of patients receiving radium 223 in a real-world setting.

PATIENTS AND METHODS: We conducted a multicenter retrospective analysis in the Triveneto region of Italy.

RESULTS: One hundred fifty-eight patients received radium 223 in our region. After a median follow-up of 9.5 months, 75 patients died. The median overall survival (OS) was 14.2 months, and the median progression-free survival (PFS) was 6.2 months. Seventy-one (45%) patients achieved progression as best response. Thirty-seven (23%) patients stopped the treatment early because of progression. Eastern Cooperative Oncology Group performance status was prognostic for OS (18.4 vs. 12.3 vs. 7.5 months; 0 vs. 1, P = .0062; 0 vs. 2, P = .0002), whereas previous prostatectomy or docetaxel exposure were not. A neutrophil to lymphocytes ratio ≥ 3 significantly impacted OS (18.1 vs. 9.7 months; P < .001) and slightly impacted PFS (6.6 vs. 5.6 months; P = .05). Patients with a baseline alkaline phosphatase (ALP) value ≥ 220 U/L had worse OS and PFS (24.1 vs. 10.5 months; 7.2 vs. 5.5 months; P < .001). Patients with changes in ALP value achieved better OS (P = .029) and PFS (P = .002). There was no difference according to the line of therapy (0 vs. ≥ 1; P = .490). The main grade 3/4 toxicities were anemia, asthenia, and thrombocytopenia.

CONCLUSION: This large real-world report confirms comparable OS and PFS data when compared with the pivotal study, as well as the predictive role of ALP and neutrophil to lymphocytes ratio. The definition of the optimal position of radium 223 in the treatment of metastatic castration-resistant prostate cancer has still to be defined.

Original languageEnglish
Pages (from-to)e187-e194
JournalClinical Genitourinary Cancer
Volume17
Issue number1
DOIs
Publication statusPublished - Feb 2019

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Castration
Prostatic Neoplasms
Radium
Disease-Free Survival
Survival
Alkaline Phosphatase
docetaxel
Neutrophils
Lymphocytes
Asthenia
Risk Reduction Behavior
Prostatectomy
Thrombocytopenia
Italy
Anemia
Therapeutics
Randomized Controlled Trials

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Results From a Large, Multicenter, Retrospective Analysis On Radium223 Use in Metastatic Castration-resistant Prostate Cancer (mCRPC) in the Triveneto Italian Region. / Maruzzo, Marco; Basso, Umberto; Borsatti, Eugenio; Evangelista, Laura; Alongi, Filippo; Caffo, Orazio; Maines, Francesca; Galuppo, Sara; De Vivo, Rocco; Zustovich, Fable; Palleschi, Dario; Zivi, Andrea; Sava, Teodoro; Sorarù, Mariella; Iacovelli, Roberto; Nicodemo, Maurizio; Baier, Susanne; Fratino, Lucia; Zagonel, Vittorina.

In: Clinical Genitourinary Cancer, Vol. 17, No. 1, 02.2019, p. e187-e194.

Research output: Contribution to journalArticle

Maruzzo, Marco ; Basso, Umberto ; Borsatti, Eugenio ; Evangelista, Laura ; Alongi, Filippo ; Caffo, Orazio ; Maines, Francesca ; Galuppo, Sara ; De Vivo, Rocco ; Zustovich, Fable ; Palleschi, Dario ; Zivi, Andrea ; Sava, Teodoro ; Sorarù, Mariella ; Iacovelli, Roberto ; Nicodemo, Maurizio ; Baier, Susanne ; Fratino, Lucia ; Zagonel, Vittorina. / Results From a Large, Multicenter, Retrospective Analysis On Radium223 Use in Metastatic Castration-resistant Prostate Cancer (mCRPC) in the Triveneto Italian Region. In: Clinical Genitourinary Cancer. 2019 ; Vol. 17, No. 1. pp. e187-e194.
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abstract = "BACKGROUND: Radium 223 was introduced for metastatic castration-resistant prostate cancer based on the results of a randomized controlled trial showing risk reduction for death and skeletal events. Our aim was to evaluate the outcome of patients receiving radium 223 in a real-world setting.PATIENTS AND METHODS: We conducted a multicenter retrospective analysis in the Triveneto region of Italy.RESULTS: One hundred fifty-eight patients received radium 223 in our region. After a median follow-up of 9.5 months, 75 patients died. The median overall survival (OS) was 14.2 months, and the median progression-free survival (PFS) was 6.2 months. Seventy-one (45{\%}) patients achieved progression as best response. Thirty-seven (23{\%}) patients stopped the treatment early because of progression. Eastern Cooperative Oncology Group performance status was prognostic for OS (18.4 vs. 12.3 vs. 7.5 months; 0 vs. 1, P = .0062; 0 vs. 2, P = .0002), whereas previous prostatectomy or docetaxel exposure were not. A neutrophil to lymphocytes ratio ≥ 3 significantly impacted OS (18.1 vs. 9.7 months; P < .001) and slightly impacted PFS (6.6 vs. 5.6 months; P = .05). Patients with a baseline alkaline phosphatase (ALP) value ≥ 220 U/L had worse OS and PFS (24.1 vs. 10.5 months; 7.2 vs. 5.5 months; P < .001). Patients with changes in ALP value achieved better OS (P = .029) and PFS (P = .002). There was no difference according to the line of therapy (0 vs. ≥ 1; P = .490). The main grade 3/4 toxicities were anemia, asthenia, and thrombocytopenia.CONCLUSION: This large real-world report confirms comparable OS and PFS data when compared with the pivotal study, as well as the predictive role of ALP and neutrophil to lymphocytes ratio. The definition of the optimal position of radium 223 in the treatment of metastatic castration-resistant prostate cancer has still to be defined.",
author = "Marco Maruzzo and Umberto Basso and Eugenio Borsatti and Laura Evangelista and Filippo Alongi and Orazio Caffo and Francesca Maines and Sara Galuppo and {De Vivo}, Rocco and Fable Zustovich and Dario Palleschi and Andrea Zivi and Teodoro Sava and Mariella Sorar{\`u} and Roberto Iacovelli and Maurizio Nicodemo and Susanne Baier and Lucia Fratino and Vittorina Zagonel",
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T1 - Results From a Large, Multicenter, Retrospective Analysis On Radium223 Use in Metastatic Castration-resistant Prostate Cancer (mCRPC) in the Triveneto Italian Region

AU - Maruzzo, Marco

AU - Basso, Umberto

AU - Borsatti, Eugenio

AU - Evangelista, Laura

AU - Alongi, Filippo

AU - Caffo, Orazio

AU - Maines, Francesca

AU - Galuppo, Sara

AU - De Vivo, Rocco

AU - Zustovich, Fable

AU - Palleschi, Dario

AU - Zivi, Andrea

AU - Sava, Teodoro

AU - Sorarù, Mariella

AU - Iacovelli, Roberto

AU - Nicodemo, Maurizio

AU - Baier, Susanne

AU - Fratino, Lucia

AU - Zagonel, Vittorina

N1 - Copyright © 2018 Elsevier Inc. All rights reserved.

PY - 2019/2

Y1 - 2019/2

N2 - BACKGROUND: Radium 223 was introduced for metastatic castration-resistant prostate cancer based on the results of a randomized controlled trial showing risk reduction for death and skeletal events. Our aim was to evaluate the outcome of patients receiving radium 223 in a real-world setting.PATIENTS AND METHODS: We conducted a multicenter retrospective analysis in the Triveneto region of Italy.RESULTS: One hundred fifty-eight patients received radium 223 in our region. After a median follow-up of 9.5 months, 75 patients died. The median overall survival (OS) was 14.2 months, and the median progression-free survival (PFS) was 6.2 months. Seventy-one (45%) patients achieved progression as best response. Thirty-seven (23%) patients stopped the treatment early because of progression. Eastern Cooperative Oncology Group performance status was prognostic for OS (18.4 vs. 12.3 vs. 7.5 months; 0 vs. 1, P = .0062; 0 vs. 2, P = .0002), whereas previous prostatectomy or docetaxel exposure were not. A neutrophil to lymphocytes ratio ≥ 3 significantly impacted OS (18.1 vs. 9.7 months; P < .001) and slightly impacted PFS (6.6 vs. 5.6 months; P = .05). Patients with a baseline alkaline phosphatase (ALP) value ≥ 220 U/L had worse OS and PFS (24.1 vs. 10.5 months; 7.2 vs. 5.5 months; P < .001). Patients with changes in ALP value achieved better OS (P = .029) and PFS (P = .002). There was no difference according to the line of therapy (0 vs. ≥ 1; P = .490). The main grade 3/4 toxicities were anemia, asthenia, and thrombocytopenia.CONCLUSION: This large real-world report confirms comparable OS and PFS data when compared with the pivotal study, as well as the predictive role of ALP and neutrophil to lymphocytes ratio. The definition of the optimal position of radium 223 in the treatment of metastatic castration-resistant prostate cancer has still to be defined.

AB - BACKGROUND: Radium 223 was introduced for metastatic castration-resistant prostate cancer based on the results of a randomized controlled trial showing risk reduction for death and skeletal events. Our aim was to evaluate the outcome of patients receiving radium 223 in a real-world setting.PATIENTS AND METHODS: We conducted a multicenter retrospective analysis in the Triveneto region of Italy.RESULTS: One hundred fifty-eight patients received radium 223 in our region. After a median follow-up of 9.5 months, 75 patients died. The median overall survival (OS) was 14.2 months, and the median progression-free survival (PFS) was 6.2 months. Seventy-one (45%) patients achieved progression as best response. Thirty-seven (23%) patients stopped the treatment early because of progression. Eastern Cooperative Oncology Group performance status was prognostic for OS (18.4 vs. 12.3 vs. 7.5 months; 0 vs. 1, P = .0062; 0 vs. 2, P = .0002), whereas previous prostatectomy or docetaxel exposure were not. A neutrophil to lymphocytes ratio ≥ 3 significantly impacted OS (18.1 vs. 9.7 months; P < .001) and slightly impacted PFS (6.6 vs. 5.6 months; P = .05). Patients with a baseline alkaline phosphatase (ALP) value ≥ 220 U/L had worse OS and PFS (24.1 vs. 10.5 months; 7.2 vs. 5.5 months; P < .001). Patients with changes in ALP value achieved better OS (P = .029) and PFS (P = .002). There was no difference according to the line of therapy (0 vs. ≥ 1; P = .490). The main grade 3/4 toxicities were anemia, asthenia, and thrombocytopenia.CONCLUSION: This large real-world report confirms comparable OS and PFS data when compared with the pivotal study, as well as the predictive role of ALP and neutrophil to lymphocytes ratio. The definition of the optimal position of radium 223 in the treatment of metastatic castration-resistant prostate cancer has still to be defined.

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DO - 10.1016/j.clgc.2018.10.013

M3 - Article

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JO - Clinical Genitourinary Cancer

JF - Clinical Genitourinary Cancer

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