Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases

Mark Faries, Nicola Mozzillo, Mohammed Kashani-Sabet, John F. Thompson, Mark C. Kelley, Ronald C. DeConti, Jeffrey Lee, James F. Huth, Jeffrey Wagner, Angus Dalgleish, Daniel Pertschuk, Christopher Nardo, Stacey Stern, Robert Elashoff, Guy Gammon, Donald L. Morton, John F. Thompson, Mark Smithers, Michael Hughes, Brendon J. CoventryJeremy Shapiro, Grant McArthur, Antonio Buzaid, Wilson Miller, Dirk Schadendorf, Claus Garbe, Martin Kaatz, Ralf Uwe Peter, Patrick Terheyden, Angus Dalgleish, Paul Redmond, Schlomo Schneebaum, Alessandro Testori, Mario Santinami, Harald J. Hoekstra, Michael McCrystal, Reinhard Dummer, Mohammed Kashani-Sabet, Mark C. Kelley, Ronald DeConti, Jeffrey Lee, James F. Huth, Mark Faries, Jeffrey Wagner, Evan Hersh, Clay Anderson, Kelly McMasters, Lynn Schuchter, Constantine P. Karakousis, Mmait-Iv Clinical Trial Group

Research output: Contribution to journalArticlepeer-review


Background: This phase III study was undertaken to evaluate the efficacy of an allogeneic whole-cell vaccine (Canvaxin™) plus bacillus Calmette-Guerin (BCG) after complete resection of stage IV melanoma. Methods: After complete resection of ≤5 distant metastases, patients were randomly assigned to BCG+Canvaxin (BCG/Cv) or BCG+placebo (BCG/Pl). The primary endpoint was overall survival (OS); secondary endpoints were disease-free survival (DFS), and immune response measured by skin test (ClinicalTrials.gov identifier: NCT00052156). Results: Beginning in May 1998, 496 patients were randomized. In April 2005, the Data Safety Monitoring Board recommended stopping enrollment due to a low probability of efficacy. At that time, median OS and 5-year OS rate were 38.6 months and 44.9%, respectively, for BCG/Pl versus 31.4 months and 39.6% in the BCG/Cv group (hazard ratio (HR), 1.18; p = 0.250). Follow-up was extended at several trial sites through March 2010. Median OS and 5-year and 10-year survival was 39.1 months, 43.3 and 33.3%, respectively, for BCG/Pl versus 34.9 months, 42.5 and 36.4%, in the BCG/Cv group (HR 1.053; p = 0.696). Median DFS, 5- and 10-year DFS were 7.6 months, 23.8 and 21.7%, respectively, for BCG/Pl versus 8.5 months, 30.0%, and 30.0%, respectively, for the BCG/Cv group (HR 0.882; p = 0.260). Positive DTH skin testing correlated with increased survival. Discussion: In this, the largest study of postsurgical adjuvant therapy for stage IV melanoma reported to date, BCG/Cv did not improve outcomes over BCG/placebo. Favorable long-term survival among study patients suggests that metastasectomy should be considered for selected patients with stage IV melanoma.

Original languageEnglish
Pages (from-to)1-10
Number of pages10
JournalAnnals of Surgical Oncology
Publication statusPublished - Dec 2017

ASJC Scopus subject areas

  • Surgery
  • Oncology


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