A large study of the older cancer patient in the community setting: Initial report of a randomized controlled trial using pegfilgrastim to reduce neutropenic complications

2005 
8111 Background: There is a paucity of randomized controlled studies in older pts despite that most new cancer diagnoses occur in people ≥ 65 yrs. The increased risks of the older population, which mandate an individualized treatment approach, are obstacles to study accrual. The Geriatric Oncology Consortium (GOC), which includes a cooperative group of community practices, was established to facilitate the study of older cancer pts, thereby reducing the data gap in older pts. This study documents the feasibility of conducting community clinical trials in older pts and addresses age-related increased risk of neutropenia and its complications that may prevent optimal treatment of this special population. Methods: This is a large, prospective, open-label trial in pts ≥ 65 yrs scheduled to receive chemotherapy (CT) Q21 days for lung, breast, or ovarian cancer (solid tumor stratum), or NHL. Pts were randomized to either pegfilgrastim (Neulasta) in first and subsequent cycles, or, no pegfilgrastim in cycle 1 wi...
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