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Effect of primary prophylactic G-CSF use on systemic therapy administration for elderly breast cancer patients

  • Epidemiology
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Abstract

Effective systemic therapy is vital for successful breast cancer treatment, but early onset toxicities like neutropenia hinder systemic therapy administration, especially in the elderly. Primary prophylactic use of granulocyte-colony stimulating factors (G-CSF) helps prevent neutropenia, and according to some clinical trials, facilitates chemotherapy completion. Nevertheless, evidence supporting the effectiveness of primary prophylactic G-CSF in the elderly is limited. Thus, the ASCO recommendations for primary prophylactic G-CSF use in the elderly are not explicit. This retrospective observational study examined the association between primary prophylactic G-CSF administration at the start of first course chemotherapy with adequate first course chemotherapy and radiation therapy administration in elderly breast cancer patients. The study analyzes newly diagnosed breast cancer patients receiving chemotherapy present in the SEER-Medicare data from 1994 to 2003. To account for the non-random nature of the observational data, a non-parametric matching technique was used to pre-process the data before estimating the effect of primary prophylactic G-CSF on adequate chemotherapy and radiation therapy administration. Adequate chemotherapy was defined as administration of six or more cycles during the first course. Primary prophylactic G-CSF administered at the start of the first course chemotherapy was associated with a statistically significant increase in the probability of administration of six or more first course chemotherapy cycles by 29% [95% CI 7.7–50.6%] and any radiation therapy administration by 42% [95% CI 25.2–58.4%]. Primary prophylactic G-CSF use with the first course of chemotherapy is associated with improved chemotherapy completion rates and radiation therapy. These findings emphasize the clinical value of primary prophylactic G-CSF use for systemic therapy completion, and have implications for ASCO guidelines and medicare coverage policies.

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Acknowledgments

This study used the linked SEER-medicare database. The interpretation and reporting of these data are the sole responsibility of the authors. The authors acknowledge the efforts of the Applied Research Program, NCI; the Office of Research, Development and Information, CMS; Information Management Services (IMS), Inc.; and the surveillance, epidemiology, and end results (SEER) Program tumor registries in the creation of the SEER-medicare database. We sincerely appreciate the support provided by Paul Godley for his interest in this topic and providing us with data access and useful advice. We also, appreciate George Pink and Morris Weinberger for their expert opinions and advice as part of the first author’s Doctoral Thesis Committee.

Conflict of interest

This study was not funded by any drug company or organization with stakes or financial incentives associated with the drugs analyzed in this study. The first author was a graduate student at the time of the study and was partly supported by a research assistant position at UNC-Chapel Hill from a Department of Defense grant for a prostate cancer study unrelated to the study presented in this article. This study was completed as part of the first author’s Ph.D. dissertation. One of the authors, Dr. Gary Lyman, is a principal investigator on a research grant to Duke University from Amgen, Inc for work completely unrelated with this study or the dissertation. Dr. Lyman is one of the most experienced clinical investigators in this field and thus provided expert advice as a member of the dissertation committee. The results presented in this publication were presented, in part, at the 2010 Annual Research Meeting of Academy Health in Boston, MA.

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Authors and Affiliations

  1. Department of Clinical Sciences and Administration, University of Houston, College of Pharmacy, 1441 Moursund St., Room 436, Houston, TX, 77030, USA

    Suja S. Rajan

  2. Department of Health Policy and Management, University of North Carolina, 1104c Mcgavran-Greenberg Hall, 135 Dauer Drive, Campus Box 7411, Chapel Hill, NC, 27599-7411, USA

    Sally C. Stearns

  3. Duke University School of Medicine and Duke Comprehensive Cancer Center, Duke Center for Clinical Health Policy Research, 2424 Erwin Road, Suite 205, Durham, NC, 27705, USA

    Gary H. Lyman

  4. Department of Health Policy and Management, University of North Carolina, 1102A McGavran-Greenberg Hall, 135 Dauer Drive, Campus Box 7411, Chapel Hill, NC, 27599-7411, USA

    William R. Carpenter

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Correspondence to Suja S. Rajan.

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Rajan, S.S., Stearns, S.C., Lyman, G.H. et al. Effect of primary prophylactic G-CSF use on systemic therapy administration for elderly breast cancer patients. Breast Cancer Res Treat 130, 255–266 (2011). https://doi.org/10.1007/s10549-011-1553-8

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