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临床试验/NCT05471427
NCT05471427已完成不适用

Predictive fActors for toleraNce to Taxane Based CHemotherapy In Older adultS Affected by mEtastatic Prostate Cancer, a Prospective Observational Study (ANCHISES)

Azienda Ospedaliero-Universitaria Careggi1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
118
试验地点
1
主要终点
Treatment interruption

研究概览

简要总结

Aiming to explore predictive factors of fitness to taxane chemotherapy in elderly patients, the investigators collected data from a prospective mono-centric database of patients aged >/= 70 years old treated in our department, and explored association between baseline age, G8 score and Charlson comorbidity index with taxane dose reduction, treatment temporary suspension or definitive interruption.

详细描述

Patients included in the analysis were affected by metastatic prostate cancer with >/=70 years old. All patients underwent Taxane treatment starting with standard treatment schedules (75 mg/m2 or 25 mg/m2 every 3 weeks, respectively). Chemotherapy with Docetaxel was scheduled for a total of 6-8 cicles in the mHSPC-mCRPC setting, respectively, and up to 9 cycles for Cabazitaxel treatment.

Indication to taxane chemotherapy was based on treating physician choice. G8 Questionnaires were collected before start and at the end of chemotherapy. Charlson comorbidity index was recorded for all patients before chemotherapy start. Data comprehensive of age, castrate resistant status , type of taxane used , Growth factors use during treatment, previous and following treatment with ARTAs or other taxanes, number of cycles administered, dose reductions , treatment suspension and treatment definitive interruptions unrelated to progressive disease, were collected and reported. Logistic regression was performed to explore the association between outcomes and baseline age, CCI and G8 score. Receiver Operating Characteristic curves analysis was performed to look for the optimal cut-off value for features significantly associated with treatment outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients affected by metastatic prostate cancer
  • >/=70 years old.
  • Patients undergoing Taxane treatment with Docetaxel or Cabazitaxel
  • Exclusion criteria:
  • Patients younger than 70 years old.
  • Patients unsuitable for taxane chemotherapy

排除标准

  • 未提供

结局指标

主要结局

Treatment interruption

时间窗: 10 months

Number of participants with definitive treatment stop unrelated to treatment progression

次要结局

  • Treatment suspension(10 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lorenzo Livi

Full Professor

Azienda Ospedaliero-Universitaria Careggi

研究点 (1)

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