Adjuvant GM-CSF therapy for patients with resected stage III/IV melanoma: A retrospective review of a single-center experience.

8596 Background: Published phase II clinical data suggest a survival advantage of adjuvant GM-CSF (250 mcg/day x14 days every 28 days) therapy in patients with resected advanced stage III/IV melanoma (Spitler et al, JCO, 18:1614, 2000). Preliminary reports of a randomized phase III clinical trial (E4697) of adjuvant GM-CSF with/without a peptide vaccine in the same patient population do not suggest a statistically significant survival benefit of GM-CSF over placebo. Thus, we sought to retrospectively review our clinical experience with adjuvant GM-CSF therapy administered on a compassionate use protocol to patients with resected advanced stage III/IV melanoma. Methods: Following IRB approval we abstracted medical records of patients with resected advanced stage III/IV melanoma treated at our institution since 2000. Nearly 1000 patients with resected advanced stage III/IV melanoma were identified, some of whom were treated with adjuvant GM-CSF on a compassionate use protocol following complete surgical res...