[Exploratory Analysis Results from Post-marketing Surveillance Study of Radium-223 in Japanese Patients with Castration-resistant Prostate Cancer and Bone Metastases: Subgroup Analysis by Age].
Kaku Igaku
; 58(1): 91-101, 2021.
Article
em Ja
| MEDLINE
| ID: mdl-34645727
ABSTRACT
OBJECTIVE:
To perform an exploratory analysis on the safety and effectiveness of radium-223 (Ra-223) by patient baseline age, using the results of a post-marketing surveillance study of Ra-223 in castration-resistant prostate cancer patients with bone metastasis in Japan.METHOD:
The safety analysis population of 296 patients was stratified into two groups based on age (<75 and ≥ 75 years-old [yo]), and their characteristics, drugrelated treatment-emergent adverse events (TEAEs), and clinical laboratory values were evaluated. Additionally, these endpoints were evaluated in patients aged ≥ 80 yo.RESULTS:
There were 148 patients in each of the <75-yo and ≥ 75-yo age groups, and 69 patients in the ≥ 80-yo age group. The characteristics of patients in the <75-yo group were suggestive of more aggressive disease at diagnosis of prostate cancer and a greater proportion of patients had prior chemotherapy compared with patients in the ≥ 75-yo age group. The incidences of overall drugrelated TEAEs and drug-related hematological TEAEs were slightly higher in the <75-yo age group; however, there was little difference in the incidences of drug-related TEAEs leading to drug discontinuation (1.4-4.1%) between patient groups. Changes in total alkaline phosphatase and prostate-specific antigen values were similar in all groups.CONCLUSIONS:
Ra-223 therapy seemed tolerable regardless of age in real-world practice in Japan. Especially, there were no new safety concerns of Ra-223 in elderly patients.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias Ósseas
/
Rádio (Elemento)
/
Neoplasias de Próstata Resistentes à Castração
Tipo de estudo:
Screening_studies
Limite:
Aged
/
Humans
/
Male
País/Região como assunto:
Asia
Idioma:
Ja
Revista:
Kaku Igaku
Ano de publicação:
2021
Tipo de documento:
Article