Trifilio, S., Zhou, Z., Galvin, J., Fong, J.L., Monreal, J., & Mehta, J. (2015). Filgrastim versus TBO-filgrastim to reduce the duration of neutropenia after autologous hematopoietic stem cell transplantation: TBO, or not TBO, that is the question. Clinical Transplantation, 29, 1128–1132. 

To determine the safety and effectiveness of TBO-filgrastim and filgrastim alone to reduce the duration of neutropenia in recipients of autologous transplantation with multiple myeloma receiving melphalan 200 mg/m²

Two groups with the same diagnosis received filgrastim alone from June 2013 to April 15, 2014, and TBO-filgrastim from April 16, 2016, to February 15, 2015, were analyzed. Three weeks before autologous transplantation, most patients underwent a mobilization process with chemotherapy regimens, including cytoxan, doxorubicin, vincristine, and dexamethasone, and few patients (less than 20%) were mobilized with TBO-filgrastim or filgrastim alone with or without plerixafor. In the conditioning period of transplantation, all patients received melphalan 200 mg/m² on day 1, followed by stem cells on day 0. Five days after transplantation infusion, patients who weighed less than 80 kg were treated with 300 microgram daily and patients weighing more than 80 kg received 480 microgram daily subcutaenous injections of TBO-filgrastim or filgrastim, which was discontinued when the absolute neutrophil count reached more than 1 x 10(9)/L. Patients were also covered with antimicrobial prophylaxis, that is, acyclovir, fluconazole, and ciprofloxacin, given on day 1, and cefepime was started with the first spike of temperature. Those with viral infections and gram-positive organisms associated with colonization were excluded from the study.

• N = 182   
• AGE = 39–71 years
• MALES: 96%, FEMALES: 4%
• CURRENT TREATMENT: Chemotherapy, other
• KEY DISEASE CHARACTERISTICS: Multiple myeloma
• OTHER KEY SAMPLE CHARACTERISTICS: Demographics

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Northwestern Memorial Hospital, Chicago, IL

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care

Retrospective cohort study

Hospital database

Significant difference seen in the post-transplantation infection complication with the use of TBO-filgrastim–treated patients (21%) versus filgrastim-treated patients (8%), respectively (p < 0.0185). No significant change was noticed in the stem cell transplantation time.

As per the findings with the use of both TBO-filgrastim and filgrastim, engraftment time was more or less the same, but, in terms of the occurrence of infection, more incidences were noticed in TBO-filgrastim group than the filgrastim group. Moreover, other highlighted views were the cost of the two medications, as TBO-filgrastim is less expensive than filgrastim and has received FDA approval only in one out of six settings.

• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Risk of bias (sample characteristics)
• Selective outcomes reporting
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Differences in conditioning regimes, growth factor doses, and institution-specific clinical practices

Overall, the study was very limited to the disease and treatment protocols. More focus was on the use of cost-saving medication, which is a decent thought, but in terms of FDA approval, those medications should bring in the market that is already approved by authority and can be implemented sooner to achieve a good quality care.