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

Mark B Faries, Nicola Mozzillo, Mohammed Kashani-Sabet, John F Thompson, Mark C Kelley, Ronald C DeConti, Jeffrey E Lee, James F Huth, Jeffrey Wagner, Angus Dalgleish, Daniel Pertschuk, Christopher Nardo, Stacey Stern, Robert Elashoff, Guy Gammon, Donald L Morton, MMAIT-IV Clinical Trial Group, Mario Santinami

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Abstract

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)3991-4000
Number of pages10
JournalAnnals of Surgical Oncology
Volume24
Issue number13
DOIs
Publication statusPublished - Dec 2017

Keywords

  • Journal Article

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    Faries, M. B., Mozzillo, N., Kashani-Sabet, M., Thompson, J. F., Kelley, M. C., DeConti, R. C., Lee, J. E., Huth, J. F., Wagner, J., Dalgleish, A., Pertschuk, D., Nardo, C., Stern, S., Elashoff, R., Gammon, G., Morton, D. L., MMAIT-IV Clinical Trial Group, & Santinami, M. (2017). Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases. Annals of Surgical Oncology, 24(13), 3991-4000. https://doi.org/10.1245/s10434-017-6072-3