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The Oncologist, Vol. 12, No. 12, 1416-1424, December 2007; doi:10.1634/theoncologist.12-12-1416
© 2007 AlphaMed Press

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Geriatric Oncology

Elderly Cancer Patients Receiving Chemotherapy Benefit from First-Cycle Pegfilgrastim

Lodovico Balduccia,d, Hafez Al-Halawanib, Veena Charuc, Jennifer Tamd, Seta Shahine, Lyndah Dreilinge, William B. Ershlerd,f

aH. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA; bCabrini Center for Cancer Care at Christus St. Frances Cabrini Hospital, Alexandria, Louisiana, USA; cPacific Cancer Medical Center, Anaheim, California, USA; dGeriatric Oncology Consortium (GOC), Baltimore, Maryland, USA; eAmgen Inc., Thousand Oaks, California, USA; fClinical Research Branch, National Institute on Aging, and Institute for Advanced Studies in Aging, Washington, District of Columbia, USA

Key Words. Elderly • Neutropenia • Chemotherapy • Cancer

Correspondence: Lodovico Balducci, M.D., H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, Florida 33612, USA. Telephone: 813-979-3822; Fax: 813-972-8359; e-mail: Balducci{at}moffitt.usf.edu

Disclosure: This study was sponsored by Amgen Inc., Thousand Oaks, CA. L.B., H.Al-H., V.C., and W.B.E. have received research support from Amgen Inc., and have acted as consultants on advisory boards for Amgen Inc. L.B. and W.B.E. have served on a speakers bureau for Amgen Inc. L.D. and S.S. are employees of and stockholders of Amgen Inc. V.C. holds stock in Amgen Inc. No other potential conflicts of interest were reported by the authors, planners, reviewers, or staff managers of this article.

Background. There is a misconception that elderly cancer patients cannot tolerate standard doses of chemotherapy because of the frequency and severity of myelosuppressive complications. The reactive use of colony-stimulating factors (i.e., in response to severe neutropenia) commonly observed in this setting contributes to the frequency and severity of these complications. This study evaluated the incidence of febrile neutropenia and related events in elderly cancer patients receiving pegfilgrastim beginning with cycle 1 (proactive) in comparison with pegfilgrastim initiated after cycle 1 at the physician's discretion (reactive).

Methods. Patients (≥65 years of age) with either solid tumors or non-Hodgkin's lymphoma (NHL) were randomly assigned to receive pegfilgrastim either proactively or reactively. The primary endpoint was the proportion of patients experiencing febrile neutropenia.

Results. There were 852 patients enrolled (median age, 72 years). Proactive pegfilgrastim use resulted in a significantly lower incidence of febrile neutropenia for both solid tumor and NHL patients compared with reactive use. Proactive pegfilgrastim use also led to fewer hospitalizations resulting from neutropenia and febrile neutropenia by approximately 50%. Antibiotic use was lower for solid tumor patients receiving proactive pegfilgrastim and equivalent in the two NHL groups.

Conclusions. This is the largest, randomized, prospective trial evaluating growth factor support in typical elderly cancer patients. Proactive pegfilgrastim use effectively produced a lower incidence of febrile neutropenia and related events in elderly patients with either solid tumors or NHL receiving an array of mild to moderately neutropenic chemotherapy regimens. Pegfilgrastim should be used proactively in elderly cancer patients to support the optimal delivery of standard chemotherapy.




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