Anemia, Neoplasms Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 1060 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Secondary | Mean Starting Dose of NeoRecormon® Injection | Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks). | Baseline | No |
| Secondary | Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks | Baseline | No | |
| Secondary | 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 | No |
| Secondary | Percentage of Participants With Subcutaneous (SC) Route of Administration | Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48 | No | |
| Secondary | Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU | Baseline up to Week 28 | No | |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment | Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28 | No | |
| Secondary | 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 | No | |
| Secondary | Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL | Baseline up to Week 28 | No | |
| Secondary | 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 | No |
| Secondary | Percentage of Participants With Vitamins Prescription | Week 4 to 6, Week 12 to 16, Week 24 to 48 | No |