Prospective Observational Study of Febrile Neutropenia (FN) and Pegfilgrastim Primary Prophylaxis in Breast Cancer and Non-Hodgkin's Lymphoma Patients Receiving High (>20%) FN-risk Chemotherapy

NCT02178475 | Completed Results

• 1 other identifier: 20120214
• Study Type: observational
• Target: 943
• Locations: 9 countries
• Sites: 74

Brief Summary

To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (\> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.

Conditions

Chemotherapy-induced Febrile Neutropenia

Keywords

NHL; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Febrile Neutropenia

  Febrile neutropenia (FN) was defined as an absolute neutrophil count (ANC) of \< 0.5 x 10\^9/L, or \< 1.0 x 10\^9/L predicted to fall below 0.5 x 10\^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.

  Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

Secondary Outcomes (16)

• Number of Participants Who Discontinued Pegfilgrastim Prophylaxis

  Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

• Number of Participants Who Discontinued G-CSF Prophylaxis

  Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

• Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis

  Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

• Characteristics of Participants Who Discontinued G-CSF Prophylaxis

  Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

• Number of Cycles With No Pegfilgrastim Prophylaxis

  Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

Study Arms (1)

Chemotherapy + Pegfilgrastim

Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.

Eligibility Criteria

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

Study Population

Patients with NHL or breast cancer who have initiated treatment with a permitted standard-dose chemotherapy regimen that has a high FN risk (\> 20%) per published studies or international guidelines, and who started pegfilgrastim in Cycle 1

You may qualify if:

• Age ≥ 18 years old.
• Any stage NHL or breast cancer and received the first cycle of a new chemotherapy course.
• Received the first cycle of a permitted standard dose chemotherapy regimens with an estimated high (\> 20%) FN risk according to published data or guidelines (dose modifications +/-10% in Cycle 1 are allowable).
• Initiated treatment in Cycle 1 with pegfilgrastim according to the pegfilgrastim summary of product characteristics. (SmPC). Enrolment must occur after the first pegfilgrastim dosing in Cycle 1 and before the second day of Cycle 2.

You may not qualify if:

• Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the national competent authorities for any indication.
• Ongoing or planned concurrent participation in any clinical study where the administration of Colony Stimulating Factor (CSF) is determined by the protocol (clinical trials on an approved drug and observational trials are permitted as long as these do not mandate how neutropenia should be treated).

Sponsors & Collaborators

• Amgen: lead

Study Sites (74)

Research Site

Eggenburg, 3730, Austria

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Graz, 8036, Austria

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Leoben, 8700, Austria

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Schwarzach im Pongau, 5620, Austria

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Vienna, 1030, Austria

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Vienna, 1090, Austria

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Arlon, 6700, Belgium

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Liège, 4000, Belgium

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Pleven, 5800, Bulgaria

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Sofia, 1756, Bulgaria

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Chomutov, 430 12, Czechia

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Hořovice, 268 31, Czechia

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Nový Jičín, 741 01, Czechia

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Pilsen, 304 60, Czechia

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Prague, 100 34, Czechia

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Prague, 128 08, Czechia

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Aix-en-Provence, 13100, France

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Amiens, 80000, France

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Beuvry, 62660, France

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Marseille, 13009, France

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Marseille, 13385, France

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Meaux, 77100, France

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Nancy, 54100, France

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Nîmes, 30029, France

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Orléans, 45067, France

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Perpignan, 66000, France

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Périgueux, 24004, France

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Pierre-Bénite, 69495, France

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Saint-Priest-en-Jarez, 42270, France

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Sarcelles, 95200, France

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Strasbourg, 67000, France

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Bonn, 53111, Germany

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Dresden, 01307, Germany

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Fulda, 36043, Germany

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Hildesheim, 31134, Germany

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Kassel, 34119, Germany

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Stolberg, 52222, Germany

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Troisdorf, 53840, Germany

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Velbert, 42551, Germany

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Westerstede, 26655, Germany

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Athens, 11527, Greece

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Athens, 11528, Greece

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Athens, 12462, Greece

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Chania, 73300, Greece

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Kalamata, 24100, Greece

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Larissa, 41110, Greece

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Nea Kifissia, Athens, 14564, Greece

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Papagou, 11526, Greece

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Piraeus, 18537, Greece

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Thessaloniki, 54622, Greece

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Thessaloniki, 54636, Greece

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Thessaloniki, 54645, Greece

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Thessaloniki, 55236, Greece

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Bialystok, 15-027, Poland

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Gdynia, 81-519, Poland

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Koszalin, 75-581, Poland

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Krakow, 31-501, Poland

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Krakow, 31-531, Poland

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Poznan, 61-485, Poland

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Warsaw, 02-097, Poland

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Warsaw, 02-781, Poland

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Wałbrzych, 58-309, Poland

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Baia Mare, 430031, Romania

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Brăila, 810325, Romania

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Bucharest, 010825, Romania

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Bucharest, 022328, Romania

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Bucharest, 022338, Romania

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Bucharest, 030171, Romania

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Bucharest, 031864, Romania

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Câmpina, 105600, Romania

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Cluj-Napoca, 400124, Romania

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Iași, 700483, Romania

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Oradea, 410469, Romania

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Ploieşti, 100337, Romania

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Related Publications (1)

• Mahtani RL, Belani R, Crawford J, Dale D, DeCosta L, Gawade PL, Huynh C, Lawrence T, Lewis S, MacLaughlin WW, Narang M, Rifkin R. A prospective cohort study to evaluate the incidence of febrile neutropenia in patients receiving pegfilgrastim on-body injector versus other options for prophylaxis of febrile neutropenia: breast cancer subgroup analysis. Support Care Cancer. 2022 Jul;30(7):6135-6144. doi: 10.1007/s00520-022-07025-2. Epub 2022 Apr 14.

  PMID: 35426046 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Chemotherapy-Induced Febrile Neutropenia; Breast Neoplasms

Condition Hierarchy (Ancestors)

Febrile Neutropenia; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The study had planned to enroll equal numbers of subjects with NHL and breast cancer; however, more patients with breast cancer were enrolled.

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: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 30, 2014
• Study Start: July 18, 2014
• Primary Completion: October 28, 2016
• Study Completion: October 28, 2016
• Last Updated: July 23, 2018
• Results First Posted: July 23, 2018

Record last verified: 2017-10

Locations

RO (12); BU (2); BE (2); CZ (6); GR (13); FR (15); DE (9); AU (6); PL (9)