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

Autor: Faries MB; John Wayne Cancer Institute, Santa Monica, CA, USA. mfaries@theangelesclinic.org., Mozzillo N; Istituto Nazionale dei Tumori de Napoli, Naples, Italy., Kashani-Sabet M; Mt. Zion Medical Center, University of California, San Francisco, San Francisco, CA, USA., Thompson JF; Royal Prince Alfred Hospital, Sydney, Australia., Kelley MC; Vanderbilt University, Nashville, TN, USA., DeConti RC; H. Lee Moffitt Cancer Center, Tampa, FL, USA., Lee JE; MD Anderson Cancer Center, Houston, TX, USA., Huth JF; Southwestern Medical Center at Dallas, University of Texas, Dallas, TX, USA., Wagner J; Wagner & Associates, Indianapolis, IN, USA., Dalgleish A; St. George's Hospital Medical School, London, Great Britain., Pertschuk D; CancerVax Corp, Carlsbad, CA, USA., Nardo C; CancerVax Corp, Carlsbad, CA, USA., Stern S; John Wayne Cancer Institute, Santa Monica, CA, USA., Elashoff R; UCLA Life Sciences, Biomathematics, Los Angeles, CA, USA., Gammon G; CancerVax Corp, Carlsbad, CA, USA., Morton DL; John Wayne Cancer Institute, Santa Monica, CA, USA.
Jazyk: angličtina
Zdroj: Annals of surgical oncology [Ann Surg Oncol] 2017 Dec; Vol. 24 (13), pp. 3991-4000. Date of Electronic Publication: 2017 Oct 10.
DOI: 10.1245/s10434-017-6072-3
Abstrakt: 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.
Databáze: MEDLINE
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