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

Publication ,  Journal Article
Faries, MB; Mozzillo, N; Kashani-Sabet, M; Thompson, JF; Kelley, MC; DeConti, RC; Lee, JE; Huth, JF; Wagner, J; Dalgleish, A; Pertschuk, D ...
Published in: Ann Surg Oncol
December 2017

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.

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Published In

Ann Surg Oncol

DOI

EISSN

1534-4681

Publication Date

December 2017

Volume

24

Issue

13

Start / End Page

3991 / 4000

Location

United States

Related Subject Headings

  • Survival Rate
  • Skin Neoplasms
  • Prognosis
  • Oncology & Carcinogenesis
  • Middle Aged
  • Melanoma
  • Male
  • Immunotherapy
  • Humans
  • Follow-Up Studies
 

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Faries, M. B., Mozzillo, N., Kashani-Sabet, M., Thompson, J. F., Kelley, M. C., DeConti, R. C., … MMAIT-IV Clinical Trial Group, . (2017). Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases. Ann Surg Oncol, 24(13), 3991–4000. https://doi.org/10.1245/s10434-017-6072-3
Faries, Mark B., Nicola Mozzillo, Mohammed Kashani-Sabet, John F. Thompson, Mark C. Kelley, Ronald C. DeConti, Jeffrey E. Lee, et al. “Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases.Ann Surg Oncol 24, no. 13 (December 2017): 3991–4000. https://doi.org/10.1245/s10434-017-6072-3.
Faries MB, Mozzillo N, Kashani-Sabet M, Thompson JF, Kelley MC, DeConti RC, et al. Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases. Ann Surg Oncol. 2017 Dec;24(13):3991–4000.
Faries, Mark B., et al. “Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases.Ann Surg Oncol, vol. 24, no. 13, Dec. 2017, pp. 3991–4000. Pubmed, doi:10.1245/s10434-017-6072-3.
Faries MB, Mozzillo N, Kashani-Sabet M, Thompson JF, Kelley MC, DeConti RC, Lee JE, Huth JF, Wagner J, Dalgleish A, Pertschuk D, Nardo C, Stern S, Elashoff R, Gammon G, Morton DL, MMAIT-IV Clinical Trial Group. Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases. Ann Surg Oncol. 2017 Dec;24(13):3991–4000.
Journal cover image

Published In

Ann Surg Oncol

DOI

EISSN

1534-4681

Publication Date

December 2017

Volume

24

Issue

13

Start / End Page

3991 / 4000

Location

United States

Related Subject Headings

  • Survival Rate
  • Skin Neoplasms
  • Prognosis
  • Oncology & Carcinogenesis
  • Middle Aged
  • Melanoma
  • Male
  • Immunotherapy
  • Humans
  • Follow-Up Studies