A Study of Neutropenia and Anemia Management in Patients With Solid Tumors Receiving Myelotoxic Chemotherapy

NCT00883181 | Completed Results

• 1 other identifier: 20060445
• Study Type: observational
• Target: 1,370
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Non-Small Cell Lung Cancer; Ovarian Cancer; Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (11)

• Percentage of Participants With Febrile Neutropenia (FN)

  Febrile neutropenia was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm².

  Cycles 1 - 8 (approximately 24 weeks)

• Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia

  FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants in the No G-CSF use group received no G-CSF prophylaxis or treatment at any time during cycles 1 to 8.

  Cycles 1 - 8 (approximately 24 weeks)

• Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia

  FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of Cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.

  Cycles 1 - 8 (approximately 24 weeks)

• Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia

  FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any daily G-CSF (e.g. filgrastim or lenograstim) starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.

  Cycles 1 - 8 (approximately 24 weeks)

• Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia

  FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of pegfilgrastim support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.

  Cycles 1 - 8 (approximately 24 weeks)

• Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia

  FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.

  Cycles 1 - 8 (approximately 24 weeks)

• Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia

  FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any other G-CSF starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.

  Cycles 1 - 8 (approximately 24 weeks)

• Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia

  FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.

  Cycles 1 - 8 (approximately 24 weeks)

• Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia

  FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with pegfilgrastim is defined as participants who started pegfilgrastim treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.

  Cycles 1 - 8 (approximately 24 weeks)

• Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia

  FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any daily G-CSF is defined as participants who started daily G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.

  Cycles 1 - 8 (approximately 24 weeks)

• Percentage of Participants Receiving Treatment With Any Other G-CSF Who Experienced Febrile Neutropenia

  FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of \< 500 cells/mm² or \< 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any other G-CSF is defined as participants who started other G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.

  Cycles 1 - 8 (approximately 24 weeks)

Secondary Outcomes (34)

• Number of Participants Who Received G-CSF During Cycles 1 to 8

  Cycles 1 - 8 (approximately 24 weeks)

• Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim

  Cycles 1 - 8 (approximately 24 weeks)

• Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF

  Cycles 1 - 8 (approximately 24 weeks)

• Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim

  Cycles 1 - 8 (approximately 24 weeks)

• Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF

  Cycles 1 - 8 (approximately 24 weeks)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• 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.

  PMID: 26801413 BACKGROUND

Related Links

• AmgenTrials clinical trials website

Biospecimen

Retention: NONE RETAINED

This is an observational study. No bio-specimens are being collected.

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 17, 2009
• Study Start: November 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: September 1, 2014
• Last Updated: March 15, 2017
• Results First Posted: April 8, 2016

Record last verified: 2017-02