TriangleNCT01459653 · REGISTRY CONDITION SEARCH
Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- Not reported
- Status at capture
- COMPLETED
- Registry last update
- 2016-01-11
This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for primary or secondary FN prophylaxis to better describe the patient population at risk for FN and treated prophylactically in physician's best clinical judgement with filgrastim biosimilar (EP2006), to describe prophylaxis patterns involving filgrastim biosimilar (EP2006), and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and experience break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which prophylaxis of FN is in congruence with guideline recommendations.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Chemotherapy Toxicity (%FN Risk)
Cancer Treatment Type - Ever Received During Study
Fever and Infections Ever During the Study
Clinical Events Ever During Study (Frequency Threshold: 5%)
Type of EP2006 Prophylaxis
Type of EP2006 Prophylaxis by Gender
Type of EP 2006 Prophylaxis by Age Group
Type of EP 2006 Prophylaxis by Tumor Type
Concomitant Antibiotic Prophylaxis
EP2006 Dose (All Cycles)
EP2006 Dose (Enrollment Cycle)
EP2006 Dose (Cycle 1)
EP2006 Dose (Cycle 2)
EP2006 Dose (Cycle 3)
EP2006 Dose (Cycle 4)
EP2006 Dose (Cycle 5)
EP2006 Dose (Cycle 6)
EP2006 Dose by Patient Weight: Cycle Level
EP2006 Dose by Tumor Type: Cycle Level
Patient Weight by Tumor Type (Solid Tumor vs. Hematological Tumor)
EP2006 Dose by Chemotherapy Toxicity: Cycle Level
EP2006 Day of Initiation: All Cycles
EP2006 Day of Initiation: Cycle 1
EP2006 Day of Initiation: Cycle 2
EP2006 Day of Initiation: Cycle 3
EP2006 Day of Initiation: Cycle 4
EP2006 Day of Initiation: Cycle 5
EP2006 Day of Initiation: Cycle 6
EP2006 Day of Initiation by Tumor Type (Solid Tumor vs. Hematological Tumor): Cycle Level
EP2006 Day of Initiation by Prophylaxis Type: Cycle Level
EP2006 Day of Initiation by Chemotherapy Toxicity: Cycle Level
EP2006 Treatment Duration in Any Cycle
EP2006 Treatment Duration in Cycle 1
EP2006 Treatment Duration in Cycle 2
EP2006 Treatment Duration in Cycle 3
EP2006 Treatment Duration in Cycle 4
EP2006 Treatment Duration in Cycle 5
EP2006 Treatment Duration in Cycle 6
EP2006 Duration by Tumor Type: Cycle Level
EP2006 Duration by Prophylaxis Type: Cycle Level
EP2006 Duration by Chemotherapy Toxicity: Cycle Level
Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline
Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10-20% at Baseline
Cohort Identification
Characteristics of Clusters: Hemoglobin Study Start
Patient Risk Score (PRS) for All Patients
Patient Risk Score (PRS) for Patients Receiving Chemotherapy With 10-20% FN Risk by Tumor Type
Percentage of Patients With Each Prophylaxis Decision by Chemotherapy-associated FN Risk
Percentage of Patients With Each Chemotherapy Risk Score (CRS) Result by Tumor Type
EP2006 Day of Initiation Relative to Guidelines by Cancer Type
GCSF Initiation Score (GIS)
GCSF Persistence Score (GPS)
GCSF Congruence Score (GCS)
Absolute Neutrophil Count (ANC) at EP2006 Initiation
Absolute Neutrophil Count (ANC) Across All Cycles
Number of Patients With CIN/FN Episodes: Patient Level
CIN/FN Episodes: Cycle Level
Incidence of Outcomes by Chemotherapy Risk: Patient Level
Incidence of CIN/FN-related Chemotherapy Disturbance by EP2006 Prophylaxis Type: Patient Level
Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level
Incidence of CIN Grade 4 Episodes by EP2006 Dose: Patient Level
Incidence of Outcomes by Mean GIS: Patient Level
Incidence of Outcomes: Cycles Level
Incidence of Outcomes by Day of Study Drug Initiation: Cycle Level
Incidence of Outcomes by Study Drug Duration: Cycle Level
Number of Patients by Cause of Death
Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or FN
Number of Participants With All-cause Mortality by CIN/FN-related Chemotherapy Disturbance
Number of Participants With Cancer-related Mortality by Any/no Grade 4 CIN or FN
Number of Participants With Cancer-related Mortality by Any CIN/FN-related Chemotherapy Disturbance
Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Prophylaxis Type
Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Treatment Decision
Predictors of Absolute Neutrophil Count
Patient/Center-level Covariance Parameter Estimates of Absolute Neutrophil Count
Characteristics of Clusters: ECOG Performance Status
Characteristics of Clusters: Cancer Stage
Characteristics of Clusters: History of Antibiotic Use for CIN
Characteristics of Clusters: Liver, Renal and/or Cardiovascular Disease
Modeling Grade 4 CIN Episode: Cycle Level
Modeling Grade 4 CIN Episode: Patient Level
Modeling FN Episode: Cycle Level
Modeling FN Episode: Patient Level
Modeling CIN/FN-related Hospitalization: Cycle Level
Modeling CIN/FN-related Hospitalization: Patient Level
Modeling CIN/FN-related Chemotherapy Disturbance: Cycle Level
Modeling CIN/FN-related Chemotherapy Disturbance: Patient Level (Patient-level Predictors)
Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Cycle Level
Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Patient Level
Patient-level Predictors for All-cause Mortality
EP2006 Day of Initiation: Cycle Distribution
EP2006 Cycles by Treatment Duration
Incidence of Outcomes
Patient-level Predictor for Cancer-related Mortality
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Male or female adults (age \> / = 18 years) * Diagnosed with one of the following types and stages of tumors: stage III or IV breast cancer; stage III or IV ovarian cancer; stage III or IV bladder cancer; stage III or IV lung cancer; metastatic prostate cancer; stage III or IV diffuse large B-cell lymphoma; multiple myeloma. * Planned to receive primary prophylaxis with filgrastim biosimilar (EP2006) at the first cycle of chemotherapy (regardless of line of chemotherapy); or receiving secondary prophylaxis with filgrastim biosimilar (EP2006) irrespective of chemotherapy cycle. * Treated with commercially available filgrastim biosimilar per physician's best clinical judgment and per current European filgrastim biosimilar (EP2006) label. * Female patients must be either post-menopausal for one year or surgically sterile or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Oral contraceptive use is allowed. * Informed written consent to participate in the study by patients or their legal guardian. Exclusion Criteria: * Patients with myeloid malignancies, with the exception of multiple myeloma. * Sensitivity to filgrastim biosimilar or any other CSF. * Hypersensitivity to E. coli-derived proteins. * Radiotherapy to ≥ 20% of total body bone. * Infection within two weeks of starting current line of chemotherapy. * Patients with several medical condition(s) that in view of the investigator prohibits participation in the study. * Patients with willfully negligent nonadherence to their cancer treatment. * Use of any investigational agent in the 30 days prior to enrollment. * Women of childbearing potential not using the contraception method(s) described above. * Women who are breastfeeding.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sampling Method
- NON_PROBABILITY_SAMPLE
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
- study Population
- Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar (EP2006) for primary or secondary prophylaxis for febrile neutropenia.
Treatment arms and interventions
- arm Groups
- description
- Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
- label
- Only 1 group
Study design
- observational Model
- CASE_ONLY
- time Perspective
- PROSPECTIVE
Enrollment
- count
- 1496
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. Chemotherapy regimens were classified for FN risk (\<10% risk, 10-20% risk or \>20% risk) according to the published rates in the EORTC Guidelines under consideration of agent(s) and schedules. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;
- measure
- Chemotherapy Toxicity (%FN Risk)
- time Frame
- Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
- description
- Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;
- measure
- Cancer Treatment Type - Ever Received During Study
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- description
- Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;
- measure
- Fever and Infections Ever During the Study
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- description
- Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia
- measure
- Clinical Events Ever During Study (Frequency Threshold: 5%)
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- description
- Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
- measure
- Type of EP2006 Prophylaxis
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- description
- Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
- measure
- Type of EP2006 Prophylaxis by Gender
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- description
- Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
- measure
- Type of EP 2006 Prophylaxis by Age Group
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- description
- Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
- measure
- Type of EP 2006 Prophylaxis by Tumor Type
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- description
- Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
- measure
- Concomitant Antibiotic Prophylaxis
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- description
- Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
- measure
- EP2006 Dose (All Cycles)
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- description
- Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
- measure
- EP2006 Dose (Enrollment Cycle)
- time Frame
- Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
- description
- Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
- measure
- EP2006 Dose (Cycle 1)
- time Frame
- Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
- secondary Outcomes
- description
- Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the "high risk group" comprised of only 3.0% of the evaluable sample. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia
- measure
- Cohort Identification
- time Frame
- Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
- description
- Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.
- measure
- Characteristics of Clusters: Hemoglobin Study Start
- time Frame
- Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
- description
- Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. ECOG score is a severity scale from 0 to 5 (highest) to grade toxicity and is defined as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=lethal. ECOG is described in more detail by Oken et al, Am J Clin Oncol (CCT) 5:649-655, 1982. FN=Febrile Neutropenia; ECOG: European Cooperative Oncology Group
- measure
- Characteristics of Clusters: ECOG Performance Status
- time Frame
- Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
- description
- Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. FN=Febrile Neutropenia
- measure
- Characteristics of Clusters: Cancer Stage
- time Frame
- Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
- description
- Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. CIN=Chemotherapy Induced Neutropenia; FN=Febrile Neutropenia
- measure
- Characteristics of Clusters: History of Antibiotic Use for CIN
- time Frame
- Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
- description
- Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. FN=Febrile Neutropenia
- measure
- Characteristics of Clusters: Liver, Renal and/or Cardiovascular Disease
- time Frame
- Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
- description
- Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006 Only results with a p-value of \<0.05 are added as statistical analyses appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score
- measure
- Modeling Grade 4 CIN Episode: Cycle Level
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- description
- Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006 Only results with a p-value of \<0.05 are shown in the statistical appendices. H/o=History of; CI=confidence interval; CIN=chemotherapy-induced neutropenia
- measure
- Modeling Grade 4 CIN Episode: Patient Level
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- description
- Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of \<0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group
- measure
- Modeling FN Episode: Cycle Level
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- description
- Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006 Only results with a p-value of \<0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
- measure
- Modeling FN Episode: Patient Level
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- description
- Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of \<0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group.
- measure
- Modeling CIN/FN-related Hospitalization: Cycle Level
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- description
- Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of \<0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group.
- measure
- Modeling CIN/FN-related Hospitalization: Patient Level
- time Frame
- All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
Full study description
- brief Summary
- This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for primary or secondary FN prophylaxis to better describe the patient population at risk for FN and treated prophylactically in physician's best clinical judgement with filgrastim biosimilar (EP2006), to describe prophylaxis patterns involving filgrastim biosimilar (EP2006), and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and experience break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which prophylaxis of FN is in congruence with guideline recommendations.
Source references
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice