Pharmaco-epidemiological Observational Study of the Clinical Benefit of NeoRecormon® in Cancer Patients With Anemia, According to Early Response to Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,060
- 主要终点
- Percentage of Participants With Early Treatment Response: Day 28 to 42
研究概览
简要总结
This observational study will evaluate the clinical benefit of NeoRecormon (epoetin beta) in daily routine practice in cancer patients with anemia. Data will be collected from patients who are receiving chemotherapy for a solid tumor or hematological malignancy. Patients will be followed for 28 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/=18 years of age
- •Patients receiving myelosuppressive chemotherapy for a solid tumor, a hematological malignancy or an autograft for hematological malignancy
- •Patients for whom treatment with epoetin beta is started at the inclusion visit
- •Life expectancy >/=6 months according to the physician
- •Patients accepting and able to complete a French written questionnaire about his/her professional and social activities at each visit
排除标准
- •Patients who received erythropoiesis-stimulating agents treatment, or red blood cell transfusion within 4 weeks before enrollment
- •Participation in a clinical trial in onco-hematology
- •Patients with myelodysplasia
- •Patients with more than one active malignancy at the time of enrollment
研究组 & 干预措施
Cohort
干预措施: epoetin beta [NeoRecormon] (Drug)
结局指标
主要结局
Percentage of Participants With Early Treatment Response: Day 28 to 42
时间窗: Day 28 to 42
Early treatment response was defined as an increase of Hemoglobin (Hb) concentration of at least 1 gram/deciliter (g/dL), 4 to 6 weeks after treatment initiation.
Percentage of Participants With Early Treatment Response: Day 21 to 42
时间窗: Day 21 to 42
Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion
时间窗: Baseline up to Week 28
Participants with at least 1 RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
Mean Number of RBC Transfusions
时间窗: Baseline up to Week 28
Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion.
Mean Number of RBC Units
时间窗: Baseline up to Week 28
Mean number of units was based on the number of participants with at least 1 RBC transfusion.
Karnofsky Performance Status (KPS): Baseline
时间窗: Baseline
KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
KPS: Week 4 to 6
时间窗: Week 4 to 6
KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
Percentage of Participants With At Least 1 Sick Leave
时间窗: Week 4 Up to Week 28
Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).
Mean Number of Days of Sick Leave
时间窗: Week 4 Up to Week 28
Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline
时间窗: Baseline
Self-administered questionnaire, work productivity and activity impairment (WPAI) questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6
时间窗: Week 4 to 6
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16
时间窗: Week 12 to 16
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6
时间窗: Baseline, Week 4 to 6
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).
Time to First RBC Transfusions
时间窗: Baseline up to Week 28
Time to first RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. Kaplan-Meier estimate was used.
KPS: Week 12 to 16
时间窗: Week 12 to 16
KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
KPS: Week 24 to 28
时间窗: Week 24 to 28
KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
Percentage of Participants With Professional Activity: Baseline
时间窗: Baseline
Percentage of participants with professional activity was assessed based on the number of participants with early response or not at Day 21 to 42. Professional activity was categorized as active; disability; no occupation; retired; sick leave; student, training; and unemployment.
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28
时间窗: Week 24 to 28
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16
时间窗: Baseline, Week 12 to 16
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28
时间窗: Baseline, Week 24 to 28
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).
次要结局
- Mean Starting Dose of NeoRecormon® Injection(Baseline)
- Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks(Baseline)
- Percentage of Participants With Pre-specified Dose and Frequency of Injections(Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48)
- Percentage of Participants With Subcutaneous (SC) Route of Administration(Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48)
- Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU(Baseline up to Week 28)
- Percentage of Participants With Modifications of NeoRecormon® Regimen(Baseline up to Week 28)
- Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment(Baseline up to Week 28)
- Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment(Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28)
- Relative Percent Change in Hb Concentration From Baseline Over the Study Period(Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28)
- Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL(Baseline up to Week 28)
- Percentage of Participants With Adequate Iron Status(Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48)
- Percentage of Participants With Vitamins Prescription(Week 4 to 6, Week 12 to 16, Week 24 to 48)