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. 2010 May;6(3):133-40.
doi: 10.1200/JOP.091094.

Pegfilgrastim on the Same Day Versus Next Day of Chemotherapy in Patients With Breast Cancer, Non-Small-Cell Lung Cancer, Ovarian Cancer, and Non-Hodgkin's Lymphoma: Results of Four Multicenter, Double-Blind, Randomized Phase II Studies

Howard A Burris  1 , Chandra P Belani, Peter A Kaufman, Alan N Gordon, Lee S Schwartzberg, Warren S Paroly, Seta Shahin, Lyndah Dreiling, Alan Saven
Affiliations

Pegfilgrastim on the Same Day Versus Next Day of Chemotherapy in Patients With Breast Cancer, Non-Small-Cell Lung Cancer, Ovarian Cancer, and Non-Hodgkin's Lymphoma: Results of Four Multicenter, Double-Blind, Randomized Phase II Studies

Howard A Burris et al. J Oncol Pract. 2010 May.

Abstract

Purpose: To compare data on severe (grade 4) neutropenia duration and febrile neutropenia incidence in patients receiving chemotherapy with pegfilgrastim administered the same day or 24 hours after chemotherapy.

Patients and methods: These were similar, randomized, double-blind phase II noninferiority studies of patients with lymphoma or non-small-cell lung (NSCLC), breast, or ovarian cancer. Each study was analyzed separately. The primary end point in each study was cycle-1 severe neutropenia duration. Approximately 90 patients per study were to be randomly assigned at a ratio of 1:1 to receive pegfilgrastim 6 mg once per cycle on the day of chemotherapy or the day after (with placebo on the alternate day).

Results: In four studies, 272 patients received chemotherapy and one or more doses of pegfilgrastim (133 same day, 139 next day). Three studies (breast, lymphoma, NSCLC) enrolled an adequate number of patients for analysis. However, in the NSCLC study, the neutropenic rate was lower than expected (only two patients per arm experienced grade 4 neutropenia). In the breast cancer study, the mean cycle-1 severe neutropenia duration was 1.2 days (95% confidence limit [CL], 0.7 to 1.6) longer in the same-day compared with the next-day group (mean, 2.6 v 1.4 days). In the lymphoma study, the mean cycle-1 severe neutropenia duration was 0.9 days (95% CL, 0.3 to 1.4) longer in the same-day compared with the next-day group (mean, 2.1 v 1.2 days). In the breast and lymphoma studies, the absolute neutrophil count profile for same-day patients was earlier, deeper, and longer compared with that for next-day patients, although the results indicate that same-day administration was statistically noninferior to next-day administration according to neutropenia duration.

Conclusion: For patients receiving pegfilgrastim with chemotherapy, pegfilgrastim administered 24 hours after chemotherapy completion is recommended.

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Figures

Figure 1.
Figure 1.
Median daily absolute neutrophil count (ANC) in cycle 1 by study: (A) breast cancer, (B) non-Hodgkin's lymphoma, (C) non–small-cell lung cancer, (D) ovarian cancer. Horizontal reference line at ANC = 0.5 × 109/L. Bars indicate interquartile range.
Figure 2.
Figure 2.
Day 1 mean absolute neutrophil counts (ANCs) and platelet counts for the (A) breast cancer and (B) non-Hodgkin's lymphoma studies. Error bars represent standard deviation.
See this image and copyright information in PMC

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