CompletedNot Applicable

Descriptive Analysis of G-CSF Use in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated

57,725 participantsStarted 2008-01

Plain-language summary

Purpose: With the existing recombinant human granulocyte colony-stimulating factors (G-CSFs) patents expiring and the FDA approval of new biosimilar and innovator biologics, patients being treated with Grade III and IV myelosuppressive chemotherapy regimens will have additional therapeutic options. This observational study will describe the patient characteristics of new users of G-CSFs. It will describe in the treatment cohorts a primary outcome of hospitalizations for febrile neutropenia. The BBCIC will use the findings from this descriptive analysis to design a comparative study evaluating the real-world effectiveness and safety of biosimilar and innovator G-CSFs.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Individuals with baseline period of 183 days with continuous medical and pharmacy coverage preceding the first prescription fill for G-CSF * Breast or lung cancer patients receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF. Exclusion Criteria: During baseline 365 days, any patient with a claim for (or with) * Chemotherapy drug. * Skilled nursing facility (SNF) or hospice care * Diagnosis for a secondary breast cancer diagnosis * A second cancer diagnosis (i.e., not breast, lung, lymphoma) * Bone marrow or stem cell transplant * Radiotherapy * Chemo cycle \>First: (exclude any chemotherapy cycles post the index G-CSF date) * HIV/AIDS * Hepatic disease * Other non-oncology related neutropenia

What they're measuring

Hospitalizations for severe neutropenia

Timeframe: Anticipated completion February 2017

Trial details

NCT IDNCT02921191

SponsorBiologics & Biosimilars Collective Intelligence Consortium

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-09