PMID- 32116138
OWN - NLM
STAT- MEDLINE
DCOM- 20201102
LR  - 20220417
IS  - 2038-2529 (Electronic)
IS  - 0300-8916 (Linking)
VI  - 106
IP  - 5
DP  - 2020 Oct
TI  - Safety and activity of radium-223 in metastatic castration-resistant prostate 
      cancer: the experience of Istituto Nazionale dei Tumori.
PG  - 406-412
LID - 10.1177/0300891620905646 [doi]
AB  - INTRODUCTION: Therapeutic decision-making in metastatic castration-resistant 
      prostate cancer (mCRPC) represents an open challenge. Radium-223 is approved for 
      patients with symptomatic bone metastases, no visceral involvement, progressing 
      after at least 2 lines of systemic therapy, or ineligible for any other systemic 
      treatment. METHODS: We performed a retrospective, observational study on patients 
      with mCRPC treated with radium-223 at our institution outside of clinical trials, 
      to assess the safety and activity in a real-world population. Data regarding 
      baseline patient/disease characteristics and treatment outcomes (number of 
      cycles, treatment-related adverse events [AEs], cause of discontinuation, and 
      best response) were collected. RESULTS: Overall, 41 patients were treated from 
      September 2015 to September 2018. Median age was 73 years; baseline Eastern 
      Cooperative Oncology Group Performance Status (ECOG PS) was 0, 1, or 2 in 15%, 
      80%, and 5% of cases, respectively; and 3%, 41%, 44%, and 12% of patients had <6, 
      6-20, >20, and superscan bone lesions, respectively. A median number of 5 cycles 
      (interquartile range 3-6) with median dose 19.52 MBq (interquartile range 
      12.87-24.83) was received. Treatment schedule was completed in 49% of cases; 
      discontinuations due to AEs, disease-related death, or disease progression 
      occurred in 24%, 33%, and 43% of patients, respectively. Any-grade AEs occurred 
      in 73% and grade 3/4 treatment-related AEs occurred in 29% of patients, mainly 
      anemia, decreased platelet count, and fatigue. No skeletal-related events or 
      treatment-related deaths were recorded. After treatment, 66%, 2%, and 32% of 
      patients had a stable, improved, or deteriorated ECOG PS versus baseline, 
      respectively, and 24%, 61%, and 15% reported a stable, improved, or worsened pain 
      symptom control. Post-treatment versus baseline alkaline phosphatase was reduced 
      or stable in 46% and increased in 54% of patients, whereas prostate-specific 
      antigen was decreased or stable in 83% and increased in 17% of patients. 
      CONCLUSIONS: Our study provides clinically useful real-world data on radium-223, 
      highlighting the importance of multidisciplinary patient management to guarantee 
      the best continuum of care for patients with mCRPC.
FAU - Raimondi, Alessandra
AU  - Raimondi A
AD  - Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      Milan, Italy.
FAU - Sepe, Pierangela
AU  - Sepe P
AD  - Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      Milan, Italy.
FAU - Claps, Melanie
AU  - Claps M
AD  - Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      Milan, Italy.
FAU - Maccauro, Marco
AU  - Maccauro M
AD  - Department of Nuclear Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      Milan, Italy.
FAU - Aliberti, Gianluca
AU  - Aliberti G
AD  - Department of Nuclear Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      Milan, Italy.
FAU - Pagani, Filippo
AU  - Pagani F
AD  - Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      Milan, Italy.
FAU - Apollonio, Giulia
AU  - Apollonio G
AD  - Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      Milan, Italy.
FAU - Randon, Giovanni
AU  - Randon G
AD  - Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      Milan, Italy.
FAU - Peverelli, Giorgia
AU  - Peverelli G
AD  - Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      Milan, Italy.
FAU - Seregni, Ettore
AU  - Seregni E
AD  - Department of Nuclear Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      Milan, Italy.
FAU - Verzoni, Elena
AU  - Verzoni E
AD  - Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      Milan, Italy.
FAU - Procopio, Giuseppe
AU  - Procopio G
AUID- ORCID: 0000-0002-2498-402X
AD  - Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 
      Milan, Italy.
LA  - eng
PT  - Journal Article
DEP - 20200302
PL  - United States
TA  - Tumori
JT  - Tumori
JID - 0111356
RN  - 0 (Radioisotopes)
RN  - 8BR2SOL3L1 (Radium-223)
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
RN  - W90AYD6R3Q (Radium)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Prostate-Specific Antigen/blood
MH  - Prostatic Neoplasms, 
      Castration-Resistant/blood/epidemiology/pathology/*radiotherapy
MH  - Radioisotopes/adverse effects/*therapeutic use
MH  - Radium/adverse effects/*therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Radium-223
OT  - bone metastases
OT  - castration resistance
OT  - prostate cancer
EDAT- 2020/03/03 06:00
MHDA- 2020/11/03 06:00
CRDT- 2020/03/03 06:00
PHST- 2020/03/03 06:00 [pubmed]
PHST- 2020/11/03 06:00 [medline]
PHST- 2020/03/03 06:00 [entrez]
AID - 10.1177/0300891620905646 [doi]
PST - ppublish
SO  - Tumori. 2020 Oct;106(5):406-412. doi: 10.1177/0300891620905646. Epub 2020 Mar 2.