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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01168349
First received: July 21, 2010
Last updated: September 1, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention
Anemia, Neoplasms
Drug: epoetin beta [NeoRecormon]

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmaco-epidemiological Observational Study of the Clinical Benefit of NeoRecormon® in Cancer Patients With Anemia, According to Early Response to Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Early Treatment Response: Day 28 to 42 [ Time Frame: Day 28 to 42 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 21 to 42 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: No ]
    Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion.

  • Mean Number of RBC Units [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: No ]
    Mean number of units was based on the number of participants with at least 1 RBC transfusion.

  • Time to First RBC Transfusions [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: No ]
    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.

  • Karnofsky Performance Status (KPS): Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 4 to 6 ] [ Designated as safety issue: No ]
    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 12 to 16 [ Time Frame: Week 12 to 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 24 to 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With At Least 1 Sick Leave [ Time Frame: Week 4 Up to Week 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 4 Up to Week 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 4 to 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 12 to 16 ] [ Designated as safety issue: No ]
    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 24 to 28 [ Time Frame: Week 24 to 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 4 to 6 ] [ Designated as safety issue: No ]
    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 12 to 16 [ Time Frame: Baseline, Week 12 to 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 24 to 28 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Mean Starting Dose of NeoRecormon® Injection [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks).

  • Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Percentage of Participants With Pre-specified Dose and Frequency of Injections [ Time Frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Subcutaneous (SC) Route of Administration [ Time Frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48 ] [ Designated as safety issue: No ]
  • Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Modifications of NeoRecormon® Regimen [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: No ]
    Percentage of participants with at least 1 temporary discontinuation was reported.

  • Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment [ Time Frame: Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28 ] [ Designated as safety issue: No ]
  • Relative Percent Change in Hb Concentration From Baseline Over the Study Period [ Time Frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Adequate Iron Status [ Time Frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48 ] [ Designated as safety issue: No ]
    Criteria for adequate iron status included serum ferritin greater than (>) 100 micrograms/liter (µg/L) and transferrin saturation (TSAT)> 20%.

  • Percentage of Participants With Vitamins Prescription [ Time Frame: Week 4 to 6, Week 12 to 16, Week 24 to 48 ] [ Designated as safety issue: No ]

Enrollment: 1060
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort Drug: epoetin beta [NeoRecormon]
As prescribed by physician

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Anemic cancer patients receiving NeoRecormon (epoetin beta)
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168349

Locations
France
Neuilly-sur-seine, France, 92521
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01168349     History of Changes
Other Study ID Numbers: ML22733 
Study First Received: July 21, 2010
Results First Received: July 23, 2015
Last Updated: September 1, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 26, 2016