Billingsley, C.C., Jacobson, S.N., Crafton, S.M., Crim, A.K., Li, Q., Hade, E.M., . . . O'Malley, D.M. (2015). Evaluation of the hematologic safety of same day versus standard administration (24- to 72-hour delay) of pegfilgrastim in gynecology oncology patients undergoing cytotoxic chemotherapy. International Journal of Gynecological Cancer, 25, 1331–1336. 

To assess the effects of same-day pegfilgrastim administration compared to standard delayed administration among women being treated for gynecologic cancer

Medical records were used for data collection. Women received 6 mg pegfilgrastim on the same day as chemotherapy or within 24–72 hours of chemotherapy administration. Results of absolute neutrophil count (ANC), chemotherapy delay, regimen change related to neutropenia, and incidence of febrile neutropenia (FN) were compared. A 25% difference in risk of these outcomes was established as the noninferiority margin of interest. Sixty-one patients crossed over to the alternate timing of pegfilgrastim during treatment.

• N = 421   
• MEAN AGE = 59.4 years (SD = 12.1)
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Seventy-nine percent had ovarian cancer. The majority had stage III or IV disease.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: United States

• PHASE OF CARE: Active antitumor treatment

• Retrospective cohort comparison, noninferiority

• FN was ANC < 1000/mcl and a single temperature of 101 or sustained temperature of at least 100.4 for over one hour

Grade 3 or 4 neutropenia was observed more often in the same-day administration group (2.6% versus 1.8%, risk ratio [RR] = 1.62, p = 0.05). No significant differences in treatment delays or dose modifications existed within the established margin.

Same-day pegfilgrastim administration was associated with slightly higher grade 3 or 4 neutropenia.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results
• Much smaller number of patients who received same-day pegfilgrastim

This study did not provide sufficient evidence to establish safety and effectiveness of same-day pegfilgrastim administration. The findings suggest that altered timing may be safe in terms of looking at treatment delays related to neutropenia. Prospective studies are needed to determine whether same-day administration is appropriate. This approach can be very helpful for patients who need to travel long distances for treatment and may reduce the number of visits required for treatment.