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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.
To most effectively interpret results from this descriptive analysis it is important to consider that this protocol was not designed to support a hypothesis. This information is being provided to the public in the interest of transparency and for demonstrating the BBCIC's Distributed Research Network's (DRN) ability to define exposures, outcomes, covariates and confounders. When published, the report will caution that the protocol does not support any ability to compare safety or effectiveness but instead is to be used only to explore the feasibility of future, more detailed comparative analyses and to better understand the capabilities of the BBCIC project. Further, the report will caution that information from this protocol should not affect use of the medical products described in any way and the fact that the BBCIC is performing this descriptive analysis in no way suggests there is a safety or effectiveness issue with any of the products described.
Observational Model: Cohort, Time Perspective: Retrospective
filgrastim, TBO-filgrastim or pegfilgrastim
Enrolling by invitation
Biologics & Biosimilars Collective Intelligence Consortium
Published on BioPortfolio: 2016-10-03T23:38:21-0400
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To compare the efficacy and safety of Day 2 (D2) once a cycle pegfilgrastim with Intermittent Every Other Days of 5 Shot (D3-11) filgrastim in early breast cancer patients treated with adj...
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimu...
The purpose of this study is to determine if a single dose of pegfilgrastim is able to reduce the time of severe neutropenia in patients receiving induction and consolidation myelosuppress...
Comparing granulocyte colony-stimulating factor filgrastim and pegfilgrastim to its biosimilars in terms of efficacy and safety: A meta-analysis of randomised clinical trials in breast cancer patients.
Granulocyte colony-stimulating factors (G-CSFs) are widely used to prevent neutropenia in cancer patients undergoing myelosuppressive chemotherapy. Several biosimilar medicines of G-CSF are now availa...
We report a case of Burkitt lymphoma with largely extranodal disease localizations at staging. Chemotherapy was given, thus obtaining a complete metabolic response in all previous disease sites as sho...
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This randomized, open-label, active-controlled study investigated the safety and efficacy of three doses of Rolontis (eflapegrastim), a novel, long-acting myeloid growth factor, versus pegfilgrastim i...
Administration of Filgrastim (rhG-CSF) (Neupogen®) in healthy donors to mobilize hematopoietic stem cells (HSC) is a widespread practice in adults. Application of peripheral blood stem cell (PBSC) co...
Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
A hematopoietic growth factor which promotes proliferation and maturation of neutrophil granulocytes. Clinically it is effective in decreasing the incidence of febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive therapy or in reducing the duration of neutropenia and neutropenia-related clinical sequelae in patients with non-myeloid malignancies undergoing myeloblastive chemotherapy followed by BMT. It has also been used in AIDS patients with CMV retinitis being treated with GANCICLOVIR. (Gelman CR, Rumack BH & Hess AJ (eds): DRUGDEX(R) System. MICROMEDEX, Inc., Englewood, Colorado (Edition expires 11/30/95))
A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)
A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.
Recombinant DNA is the formation of a novel DNA sequence by the formation of two DNA strands. These are taken from two different organisms. These recombinant DNA molecules can be made with recombinant DNA technology. The procedure is to cut the DNA of ...
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...
Biosimilars or Follow-on biologics are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Products that ar...