Balducci, L., Al-Halawani, H., Charu, V., Tam, J., Shahin, S., Dreiling, L., & Ershler, W.B. (2007). Elderly cancer patients receiving chemotherapy benefit from first-cycle pegfilgrastim. Oncologist, 12, 1416–1424.

The purpose of the study was to compare the proportion of elderly patients with febrile neutropenia while receiving pegfilgrastim from the first cycle of chemotherapy (proactive) with the proportion with febrile neutropenia using the current practice of receiving pegfilgrastim after observed severe neutropenia or neutropenia-related events.

Patients randomized to either proactive pegfilgrastim (subcutaneous injection 6 mg one time per cycle 24 hours after chemotherapy completion staring with cycle one) or secondary prophylaxis with pegfilgrastim (subcutaneous injection 6 mg one time per cycle 24 hours after chemotherapy completion starting after cycle one) at physician’s discretion.

• 852 total patients
• Patients were age 65 or older
• 64.3% were female, 35.7% were male
• Cancers of the lung, breast, ovary, or non-Hodgkin lymphoma
• Patients with with a life expectancy of three months or longer
• ECOG performance status score of 2 or lower

Multiple outpatient settings in community cancer center across the United States.

• The phase of care was active treatment
• Application was elderly care

Phase IV, open-label, randomized, controlled trial.

• Febrile neutropenia
• Grade 3 or grade 4 neutropenia
• Chemotherapy regimen
• Solid tumor type
• Pegfilgrastim administered
• Dose delay, dose reduction, hospitalization, and antibiotic use
   

For the reduction of febrile neutropenia, pegfilgrastim in all chemotherapy cycles was statistically significantly better than use of pegfilgrastim at the physician’s discretion for both solid tumors (p = 0.001) and non-Hodgkin lymphoma (p = 0.004). Pegfilgrastim throughout cycles showed better results than physician discretion for fewer events of grade 3 or 4 neutropenia, hospitalizations and antibiotic use for both solid tumor and non-Hodgkin groups, and for less dose delay and dose reduction in the solid tumor group.

The most common adverse events related to pegfilgrastim was arthralgia.
 

Pegfilgratim use in older adults undergoing chemotherapy appears safe and effective with use starting in the first cycle for the reduction of neutropenia, febrile neutropenia, grade 3 or 4 neutropenia, hospitalizations, and antibiotic use.

The study was not blinded. Fewer patients with non-Hodgkin lymphoma were able to be randomized to the discretion arm since physicians often wanted pegfilgrastim started early in these patients due to known neutropenic outcomes. It also was unclear as to the amount of pegfilgrastim delivered in the physician discretion arm.

The administration of pegfilgrastim starting with the first cycle of chemotherapy may reduce neutropenic events and related complications in older adults with cancer. Nurses can be at the forefront of advocating for this therapy, administering it, and monitoring patients for effective outcomes and/or adverse events.