Clinical trial NCT01168349: An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST)
Official title: Pharmaco-epidemiological Observational Study of the Clinical Benefit of NeoRecormon® in Cancer Patients With Anemia, According to Early Response to Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia, Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-07-23
Enrollment: 1060
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Anemic cancer patients receiving NeoRecormon (epoetin beta)

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Early Treatment Response: Day 28 to 42
timeFrame: Day 28 to 42
measure: Percentage of Participants With Early Treatment Response: Day 21 to 42
timeFrame: Day 21 to 42
measure: Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion
timeFrame: Baseline up to Week 28
measure: Mean Number of RBC Transfusions
timeFrame: Baseline up to Week 28
measure: Mean Number of RBC Units
timeFrame: Baseline up to Week 28
measure: Time to First RBC Transfusions
timeFrame: Baseline up to Week 28
measure: Karnofsky Performance Status (KPS): Baseline
timeFrame: Baseline
measure: KPS: Week 4 to 6
timeFrame: Week 4 to 6
measure: KPS: Week 12 to 16
timeFrame: Week 12 to 16
measure: KPS: Week 24 to 28
timeFrame: Week 24 to 28
measure: Percentage of Participants With Professional Activity: Baseline
timeFrame: Baseline
measure: Percentage of Participants With At Least 1 Sick Leave
timeFrame: Week 4 Up to Week 28
measure: Mean Number of Days of Sick Leave
timeFrame: Week 4 Up to Week 28
measure: Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline
timeFrame: Baseline
measure: Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6
timeFrame: Week 4 to 6
measure: Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16
timeFrame: Week 12 to 16
measure: Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28
timeFrame: Week 24 to 28
measure: Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6
timeFrame: Baseline, Week 4 to 6
measure: Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16
timeFrame: Baseline, Week 12 to 16
measure: Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28
timeFrame: Baseline, Week 24 to 28
Secondary outcomes:
measure: Mean Starting Dose of NeoRecormon® Injection
timeFrame: Baseline
measure: Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks
timeFrame: Baseline
measure: Percentage of Participants With Pre-specified Dose and Frequency of Injections
timeFrame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48
measure: Percentage of Participants With Subcutaneous (SC) Route of Administration
timeFrame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48
measure: Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU
timeFrame: Baseline up to Week 28
measure: Percentage of Participants With Modifications of NeoRecormon® Regimen
timeFrame: Baseline up to Week 28
measure: Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment
timeFrame: Baseline up to Week 28
measure: Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment
timeFrame: Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28
measure: Relative Percent Change in Hb Concentration From Baseline Over the Study Period
timeFrame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28
measure: Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL
timeFrame: Baseline up to Week 28
measure: Percentage of Participants With Adequate Iron Status
timeFrame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48
measure: Percentage of Participants With Vitamins Prescription
timeFrame: Week 4 to 6, Week 12 to 16, Week 24 to 48
Other outcomes:
Locations:
city: Neuilly-sur-seine
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: