Park, K.H., Sohn, J.H., Lee, S., Park, J.H., Kang, S.Y., Kim, H.Y., . . . Seo, J.H. (2013). A randomized, multi-center, open-label, phase II study of once-per-cycle DA-3031, a biosimilar pegylated G-CSF, compared with daily filgrastim in patients receiving TAC chemotherapy for early-stage breast cancer. Investigational New Drugs, 31, 1300–1306.

DOI Link

Study Purpose

To evaluate the safety and efficacy of once-per-cycle DA-3031 in patients receiving chemotherapy for breast cancer

Intervention Characteristics/Basic Study Process

Patients were randomized to daily injections of filgrastim 100 mcg/m2beginning 24 hours after chemotherapy until absolute neutrophil count (ANC) was 5x109 after nadir or up to 10 days, or to one of two doses of pegfilgrastim (3.6 mg or 6 mg). The primary endpoint was duration of grade 4 neutropenia.

Sample Characteristics

  • N = 61
  • MEAN AGE = 44.9 years
  • AGE RANGE = 29–67 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All had breast cancer and were receiving chemotherapy consisting of doxorubicin, cyclophosphamide, and docetaxel. Chemotherapy was given every three weeks for up to six cycles.

Setting

  • SITE: Multi-site 
  • SETTING TYPE: Outpatient 
  • LOCATION: South Korea

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Randomized, open-label, phase II

Measurement Instruments/Methods

  • National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.01)

Results

No significant differences were seen among groups in ANC nadirs or time to recovery. Overall incidence of febrile neutropenia was 9.8%, with no significant differences between groups. The most common adverse event was musculoskeletal pain, with no significant differences between groups, although pain was slightly higher in the 6 mg pegfilgrastim group.

Conclusions

Single-dose pegfilgrastim had similar efficacy and side effects to daily filgrastim.

Limitations

  • Small sample (less than 100)
  • Risk of bias (no blinding)

 

Nursing Implications

Daily dosing of filgrastim had essentially the same efficacy and side effects as once-per-cycle pegfilgrastim. Severity of musculoskeletal pain appeared to be slightly higher with the higher dose of pegfilgrastim. Reducing the need for daily injections may be an important consideration for some patients and has been shown to have essentially the same effects. Higher doses may be associated with increased musculoskeletal pain. Although not statistically significant, this can be an important consideration to promote patient quality of care.