N/A
Completed N=1,055
An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST)
Anemia, Neoplasms
Source: ClinicalTrials.gov NCT01168349 ↗
Enrolled (actual)
1,055
Serious AEs
1.0%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Participants With Early Treatment Response: Day 28 to 42 — 52.4; 56.5; 53.8 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Early Treatment Response: Day 28 to 42 |
52.4; 56.5; 53.8 | — |
| PRIMARY Percentage of Participants With Early Treatment Response: Day 21 to 42 |
52.4; 55.7; 53.5 | — |
| PRIMARY Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion |
17.2; 31.4; 23.8 | — |
| PRIMARY Mean Number of RBC Transfusions |
1.7; 2.1; 2.0 | — |
| PRIMARY Mean Number of RBC Units |
3.4; 4.3; 4.0 | — |
| PRIMARY Time to First RBC Transfusions |
NA; NA | <0.0001 sig |
| PRIMARY Karnofsky Performance Status (KPS): Baseline |
78.5; 78.6; 78.6 | — |
| PRIMARY KPS: Week 4 to 6 |
81.2; 76.7; 79.2 | — |
| PRIMARY KPS: Week 12 to 16 |
78.4; 74.7; 76.7 | — |
| PRIMARY KPS: Week 24 to 28 |
79.7; 75.6; 77.8 | — |
| PRIMARY Percentage of Participants With Professional Activity: Baseline |
4.1; 3.0; 3.6; 2.6; 3.3; 2.9 | — |
| PRIMARY Percentage of Participants With At Least 1 Sick Leave |
59.2; 74.4; 66.3 | — |
| PRIMARY Mean Number of Days of Sick Leave |
89.4; 93.3; 91.5 | — |
| PRIMARY Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline |
6.8; 8.1; 7.4 | — |
| PRIMARY Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6 |
5.8; 6.2; 6.0 | — |
| PRIMARY Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16 |
4.3; 4.3; 4.3 | — |
| PRIMARY Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28 |
4.9; 4.1; 4.5 | — |
| PRIMARY Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6 |
6.2; 6.2; 6.2; -1.1; -0.8; -0.9 | — |
| PRIMARY Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16 |
6.1; 5.9; 6.0; -1.5; -1.3; -1.4 | — |
| PRIMARY Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28 |
5.9; 5.7; 5.8; -1.5; -1.4; -1.5 | — |
| SECONDARY Mean Starting Dose of NeoRecormon® Injection |
471.2; 447.3; 463.9 | — |
| SECONDARY Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks |
69.9; 67.6; 69.2 | — |
| SECONDARY Percentage of Participants With Pre-specified Dose and Frequency of Injections |
97.8; 93.7; 96.5; 1.2; 3.7; 2.0 | — |
| SECONDARY Percentage of Participants With Subcutaneous (SC) Route of Administration |
98.7; 100.0; 99.1; 98.8; 100.0; 99.2 | — |
| SECONDARY Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU |
86.2; 82.7; 85.1 | — |
| SECONDARY Percentage of Participants With Modifications of NeoRecormon® Regimen |
7.2; 12.0; 8.7 | — |
| SECONDARY Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment |
8.1; 10.3; 8.8 | — |
| SECONDARY Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment |
19.9; 8.5; 16.3; 54.6; 37.1; 49.0 | — |
| SECONDARY Relative Percent Change in Hb Concentration From Baseline Over the Study Period |
11.3; 13.0; 11.9; 15.6; 18.6; 16.6 | — |
| SECONDARY Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL |
36.0; 18.5; 30.3 | — |
| SECONDARY Percentage of Participants With Adequate Iron Status |
37.9; 47.7; 43.1; 22.6; 16.7; 20.4 | — |
| SECONDARY Percentage of Participants With Vitamins Prescription |
12.4; 1.6; 0.7; 4.1; 3.2; 9.8 | — |
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
Data sourced from ClinicalTrials.gov (NCT01168349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.