{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T11:46:22Z","timestamp":1790768782807,"version":"4.1.0"},"reference-count":18,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"34","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2015,12,1]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> We conducted a double-blind, placebo-controlled trial to evaluate the effect of granulocyte-macrophage colony-stimulating factor (GM-CSF) and peptide vaccination (PV) on relapse-free survival (RFS) and overall survival (OS) in patients with resected high-risk melanoma. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> Patients with completely resected stage IV or high-risk stage III melanoma were grouped by human leukocyte antigen (HLA) -A2 status. HLA-A2\u2013positive patients were randomly assigned to receive GM-CSF, PV, both, or placebo; HLA-A2\u2013negative patients, GM-CSF or placebo. Treatment lasted for 1 year or until recurrence. Efficacy analyses were conducted in the intent-to-treat population. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> A total of 815 patients were enrolled. There were no significant improvements in OS (stratified log-rank P = .528; hazard ratio, 0.94; 95% repeated CI, 0.77 to 1.15) or RFS (P = .131; hazard ratio, 0.88; 95% CI, 0.74 to 1.04) in the patients assigned to GM-CSF (n = 408) versus those assigned to placebo (n = 407). The median OS times with GM-CSF versus placebo treatments were 69.6 months (95% CI, 53.4 to 83.5 months) versus 59.3 months (95% CI, 44.4 to 77.3 months); the 5-year OS probability rates were 52.3% (95% CI, 47.3% to 57.1%) versus 49.4% (95% CI, 44.3% to 54.3%), respectively. The median RFS times with GM-CSF versus placebo were 11.4 months (95% CI, 9.4 to 14.8 months) versus 8.8 months (95% CI, 7.5 to 11.2 months); the 5-year RFS probability rates were 31.2% (95% CI, 26.7% to 35.9%) versus 27.0% (95% CI, 22.7% to 31.5%), respectively. Exploratory analyses showed a trend toward improved OS in GM-CSF\u2013treated patients with resected visceral metastases. When survival in HLA-A2\u2013positive patients who received PV versus placebo was compared, RFS and OS were not significantly different. Treatment-related grade 3 or greater adverse events were similar between GM-CSF and placebo groups. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Neither adjuvant GM-CSF nor PV significantly improved RFS or OS in patients with high-risk resected melanoma. Exploratory analyses suggest that GM-CSF may be beneficial in patients with resected visceral metastases; this observation requires prospective validation. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2015.62.0500","type":"journal-article","created":{"date-parts":[[2015,9,9]],"date-time":"2015-09-09T02:29:51Z","timestamp":1441765791000},"page":"4066-4076","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":120,"title":["Randomized, Placebo-Controlled, Phase III Trial of Yeast-Derived Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With No Evidence of Disease After Complete Surgical Resection of Locally Advanced and\/or Stage IV Melanoma: A Trial of the Eastern Cooperative Oncology Group\u2013American College of Radiology Imaging Network Cancer Research Group (E4697)"],"prefix":"10.1200","volume":"33","author":[{"given":"David H.","family":"Lawson","sequence":"first","affiliation":[{"name":"David H. Lawson, Winship Cancer Institute of Emory University, Atlanta, GA; Sandra Lee and Fengmin Zhao, Dana-Farber Cancer Institute; Michael B. Atkins, Beth Israel Deaconess Medical Center, Boston, MA; Ahmad A. Tarhini, Theresa L. Whiteside, Lisa H. Butterfield, and John M. Kirkwood, University of Pittsburgh Medical Center, Pittsburgh, PA; Kim A. Margolin, Seattle Cancer Care Alliance, Seattle, WA; Marc S. Ernstoff, Dartmouth-Hitchcock Medical Center, Lebanon, NH; and Gary I. Cohen, Greater Baltimore..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Lee","sequence":"additional","affiliation":[{"name":"David H. Lawson, Winship Cancer Institute of Emory University, Atlanta, GA; Sandra Lee and Fengmin Zhao, Dana-Farber Cancer Institute; Michael B. Atkins, Beth Israel Deaconess Medical Center, Boston, MA; Ahmad A. Tarhini, Theresa L. Whiteside, Lisa H. Butterfield, and John M. Kirkwood, University of Pittsburgh Medical Center, Pittsburgh, PA; Kim A. Margolin, Seattle Cancer Care Alliance, Seattle, WA; Marc S. Ernstoff, Dartmouth-Hitchcock Medical Center, Lebanon, NH; and Gary I. Cohen, Greater Baltimore..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fengmin","family":"Zhao","sequence":"additional","affiliation":[{"name":"David H. Lawson, Winship Cancer Institute of Emory University, Atlanta, GA; Sandra Lee and Fengmin Zhao, Dana-Farber Cancer Institute; Michael B. Atkins, Beth Israel Deaconess Medical Center, Boston, MA; Ahmad A. Tarhini, Theresa L. Whiteside, Lisa H. Butterfield, and John M. Kirkwood, University of Pittsburgh Medical Center, Pittsburgh, PA; Kim A. Margolin, Seattle Cancer Care Alliance, Seattle, WA; Marc S. Ernstoff, Dartmouth-Hitchcock Medical Center, Lebanon, NH; and Gary I. Cohen, Greater Baltimore..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmad A.","family":"Tarhini","sequence":"additional","affiliation":[{"name":"David H. Lawson, Winship Cancer Institute of Emory University, Atlanta, GA; Sandra Lee and Fengmin Zhao, Dana-Farber Cancer Institute; Michael B. Atkins, Beth Israel Deaconess Medical Center, Boston, MA; Ahmad A. Tarhini, Theresa L. Whiteside, Lisa H. Butterfield, and John M. Kirkwood, University of Pittsburgh Medical Center, Pittsburgh, PA; Kim A. Margolin, Seattle Cancer Care Alliance, Seattle, WA; Marc S. Ernstoff, Dartmouth-Hitchcock Medical Center, Lebanon, NH; and Gary I. Cohen, Greater Baltimore..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim A.","family":"Margolin","sequence":"additional","affiliation":[{"name":"David H. Lawson, Winship Cancer Institute of Emory University, Atlanta, GA; Sandra Lee and Fengmin Zhao, Dana-Farber Cancer Institute; Michael B. Atkins, Beth Israel Deaconess Medical Center, Boston, MA; Ahmad A. Tarhini, Theresa L. Whiteside, Lisa H. Butterfield, and John M. Kirkwood, University of Pittsburgh Medical Center, Pittsburgh, PA; Kim A. Margolin, Seattle Cancer Care Alliance, Seattle, WA; Marc S. Ernstoff, Dartmouth-Hitchcock Medical Center, Lebanon, NH; and Gary I. Cohen, Greater Baltimore..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc S.","family":"Ernstoff","sequence":"additional","affiliation":[{"name":"David H. Lawson, Winship Cancer Institute of Emory University, Atlanta, GA; Sandra Lee and Fengmin Zhao, Dana-Farber Cancer Institute; Michael B. Atkins, Beth Israel Deaconess Medical Center, Boston, MA; Ahmad A. Tarhini, Theresa L. Whiteside, Lisa H. Butterfield, and John M. Kirkwood, University of Pittsburgh Medical Center, Pittsburgh, PA; Kim A. Margolin, Seattle Cancer Care Alliance, Seattle, WA; Marc S. Ernstoff, Dartmouth-Hitchcock Medical Center, Lebanon, NH; and Gary I. Cohen, Greater Baltimore..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael B.","family":"Atkins","sequence":"additional","affiliation":[{"name":"David H. Lawson, Winship Cancer Institute of Emory University, Atlanta, GA; Sandra Lee and Fengmin Zhao, Dana-Farber Cancer Institute; Michael B. Atkins, Beth Israel Deaconess Medical Center, Boston, MA; Ahmad A. Tarhini, Theresa L. Whiteside, Lisa H. Butterfield, and John M. Kirkwood, University of Pittsburgh Medical Center, Pittsburgh, PA; Kim A. Margolin, Seattle Cancer Care Alliance, Seattle, WA; Marc S. Ernstoff, Dartmouth-Hitchcock Medical Center, Lebanon, NH; and Gary I. Cohen, Greater Baltimore..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary I.","family":"Cohen","sequence":"additional","affiliation":[{"name":"David H. Lawson, Winship Cancer Institute of Emory University, Atlanta, GA; Sandra Lee and Fengmin Zhao, Dana-Farber Cancer Institute; Michael B. Atkins, Beth Israel Deaconess Medical Center, Boston, MA; Ahmad A. Tarhini, Theresa L. Whiteside, Lisa H. Butterfield, and John M. Kirkwood, University of Pittsburgh Medical Center, Pittsburgh, PA; Kim A. 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