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

Pharmaco-epidemiological Observational Study of the Clinical Benefit of NeoRecormon® in Cancer Patients With Anemia, According to Early Response to Treatment

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.

Study Overview

• Status: Completed
• Conditions: Anemia, Neoplasms
• Intervention / Treatment: Drug: epoetin beta [NeoRecormon]

• Study Type: Observational
• Enrollment (Actual): 1060

Contacts and Locations

Study Locations

• France
  • Neuilly-sur-seine, France, 92521

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Anemic cancer patients receiving NeoRecormon (epoetin beta)

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort	Drug: epoetin beta [NeoRecormon]; As prescribed by physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Starting Dose of NeoRecormon® Injection	Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks).	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	Pre-specified doses and frequency included; 20000 IU/week - Once a week (qw), 30000 IU/week -qw, 30000 IU/week - Twice a week (tw), 30000 IU/week - Once every 2 weeks (q2w), 40000 IU/week - qw, 60000 IU/week - qw, and other. Missing data were not reported.	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	All modifications were based on the change in frequency, route of administration or dose depending on the need for treatment adjustments according to Hb concentration. Percentage of participants with at least 1 modification in NeoRecormon® regimen was reported.	Baseline up to Week 28
Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment	Percentage of participants with at least 1 temporary discontinuation was reported.	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	Criteria for adequate iron status included serum ferritin greater than (>) 100 micrograms/liter (µg/L) and transferrin saturation (TSAT)> 20%.	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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: July 21, 2010
• First Submitted That Met QC Criteria: July 22, 2010
• First Posted (Estimate): July 23, 2010

Study Record Updates

• Last Update Posted (Estimate): October 2, 2015
• Last Update Submitted That Met QC Criteria: September 1, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML22733