An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST)

NCT01168349 | Completed Results

• 1 other identifier: ML22733
• Study Type: observational
• Target: 1,060
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia, Neoplasms

Outcome Measures

Primary Outcomes (20)

• Percentage of Participants With Early Treatment Response: 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.

  Day 28 to 42

• Percentage of Participants With Early Treatment Response: 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.

  Day 21 to 42

• Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion

  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.

  Baseline up to Week 28

• Mean Number of RBC Transfusions

  Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion.

  Baseline up to Week 28

• Mean Number of RBC Units

  Mean number of units was based on the number of participants with at least 1 RBC transfusion.

  Baseline up to Week 28

• Time to First RBC Transfusions

  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.

  Baseline up to Week 28

• Karnofsky Performance Status (KPS): 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.

  Baseline

• KPS: 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.

  Week 4 to 6

• KPS: 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.

  Week 12 to 16

• KPS: 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.

  Week 24 to 28

• Percentage of Participants With Professional Activity: 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.

  Baseline

• Percentage of Participants With At Least 1 Sick Leave

  Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).

  Week 4 Up to Week 28

• Mean Number of Days of Sick Leave

  Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).

  Week 4 Up to Week 28

• Self-Reported Questionnaire: Percentage of Participants With Current Employment at 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.

  Baseline

• Self-Reported Questionnaire: Percentage of Participants With Current Employment at 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.

  Week 4 to 6

• Self-Reported Questionnaire: Percentage of Participants With Current Employment at 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.

  Week 12 to 16

• Self-Reported Questionnaire: Percentage of Participants With Current Employment at 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.

  Week 24 to 28

• Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at 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).

  Baseline, Week 4 to 6

• Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at 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).

  Baseline, Week 12 to 16

• Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at 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).

  Baseline, Week 24 to 28

Secondary Outcomes (12)

• 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

Study Arms (1)

Cohort

Drug: epoetin beta [NeoRecormon]

Interventions

epoetin beta [NeoRecormon] DRUG

As prescribed by physician

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Anemic cancer patients receiving NeoRecormon (epoetin beta)

You may qualify if:

• Adult patients, \>/=18 years of age
• Patients receiving myelosuppressive chemotherapy for a solid tumor, a hematological malignancy or an autograft for hematological malignancy
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Neuilly-sur-Seine, 92521, France

Location

MeSH Terms

Conditions

Anemia; Neoplasms

Interventions

epoetin beta

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 23, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 2, 2015
• Results First Posted: October 2, 2015

Record last verified: 2015-09

Locations

FR (1)