Clinical trial NCT00883181: A Study of Neutropenia and Anemia Management in Patients With Solid Tumors Receiving Myelotoxic Chemotherapy
Official title: A Prospective Observational Study of Neutropenia and Anemia Management in Subjects With Solid Tumors Receiving Myelotoxic Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Non-Small Cell Lung Cancer
Ovarian Cancer
Small Cell Lung Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-04-17
Enrollment: 1370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sites were selected based on where medical data of interest were routinely and completely collected. To avoid geographical bias, sites represented various types of treating centers within each country and sites were encouraged to provide data on patients within all tumor types.

Brief summary: The primary objective was to describe the incidence of febrile neutropenia based on granulocyte-colony stimulating factor (G-CSF) use (primary, secondary, treatment, or no usage) in patients receiving myelotoxic chemotherapy.

Detailed description: This is a multi-center international observational study of patients receiving myelotoxic regimens, with an investigator assessed risk of febrile neutropenia ≥ 20%, for the treatment of solid tumors (breast, ovarian and lung).

This is an observational study in which patient risk factors were qualitatively (but not quantitatively) assessed, and adherence to G-CSF primary prophylaxis was at the discretion of physicians and not mandated by the protocol.

Eligibility criteria: Inclusion Criteria:

* Subjects greater than or equal to 18 years old with breast, ovarian or lung cancer receiving chemotherapy in any schedule, e.g. dose dense or standard chemotherapy.
* These subjects must have an Investigator assessed risk of febrile neutropenia (FN) ≥20% (based on 2006 European Organisation for Research and Treatment of Cancer (EORTC) G-CSF Guidelines

Exclusion Criteria:

- Subjects with concurrent administration of radiotherapy are not eligible (previous radiotherapy is permitted if terminated at least 2 weeks prior to commencing applicable chemotherapy in this study).

Primary outcomes:
measure: Percentage of Participants With Febrile Neutropenia (FN)
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Percentage of Participants Receiving Treatment With Any Other G-CSF Who Experienced Febrile Neutropenia
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
Secondary outcomes:
measure: Number of Participants Who Received G-CSF During Cycles 1 to 8
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Number of Days of Treatment in Participants Receiving Treatment With Pegfilgrastim
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8
timeFrame: Cycles 2 - 8 (approximately 21 weeks)
measure: Percentage of Cycles With Chemotherapy Dose Delays
timeFrame: Cycles 2 - 8 (approximately 21 days)
measure: Percentage of Participants With Chemotherapy Dose Reductions
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Percentage of Cycles With Chemotherapy Dose Reductions
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8
timeFrame: Cycles 2 - 8 (approximately 21 weeks)
measure: Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Number of Participants With Unplanned Hospitalizations
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Investigator Assessed Clinical Response at End of Treatment
timeFrame: End of treatment (approximately 24 weeks)
measure: Number of Participants With Hematological Toxicities
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Time to Disease Progression
timeFrame: From cycle 1, day 1 until end of the long-term follow-up; median time on follow-up from cycle 1, day 1 was 52 months.
measure: Duration of Treatment With Erythropoiesis-stimulating Agents (ESAs)
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Reason for Treatment With Erythropoiesis-stimulating Agents
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Number of Clinical Visits in Cycles 1-8 by ESA Use
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Percentage of Participants Who Received ESAs and Required a Red Blood Cell (RBC) Transfusion After 5 Weeks of ESA Treatment
timeFrame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
measure: Change in Hemoglobin During ESA Treatment Phase
timeFrame: Initiation of ESA treatment (last assessment on or prior to ESA day 1) and at end of ESA treatment; median duration of ESA treatment was 4 weeks, maximum was 23 weeks.
measure: Percentage of Participants Who Received ESAs and Achieved Hematopoietic Response
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 9 g/dL After 5 Weeks ESA Treatment
timeFrame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
measure: Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 10 g/dL After 5 Weeks ESA Treatment
timeFrame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
measure: Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 11 g/dL After 5 Weeks ESA Treatment
timeFrame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
measure: Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 12 g/dL After 5 Weeks ESA Treatment
timeFrame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
measure: Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL After 5 Weeks ESA Treatment
timeFrame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
measure: Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 12 to 13 g/dL After 5 Weeks ESA Treatment
timeFrame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
measure: Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL 9 Weeks After Initiation of ESA Treatment
timeFrame: 9 weeks post initiation of ESA treatment
measure: Number of Participants With Systemic Transfusions in Cycles 1 to 8
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
measure: Number of Transfusions Per Participant in Cycles 1 to 8
timeFrame: Cycles 1 - 8 (approximately 24 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Maenpaa J, Varthalitis I, Erdkamp F, Trojan A, Krzemieniecki K, Lindman H, Bendall K, Vogl FD, Verma S. The use of granulocyte colony stimulating factor (G-CSF) and management of chemotherapy delivery during adjuvant treatment for early-stage breast cancer--further observations from the IMPACT solid study. Breast. 2016 Feb;25:27-33. doi: 10.1016/j.breast.2015.11.007. Epub 2015 Dec 20.