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

被引:107
作者
Faries, Mark B. [1 ]
Mozzillo, Nicola [2 ]
Kashani-Sabet, Mohammed [3 ]
Thompson, John F. [4 ]
Kelley, Mark C. [5 ]
DeConti, Ronald C. [6 ]
Lee, Jeffrey E. [7 ]
Huth, James F. [8 ]
Wagner, Jeffrey [9 ]
Dalgleish, Angus [10 ]
Pertschuk, Daniel [11 ]
Nardo, Christopher [11 ]
Stern, Stacey [1 ]
Elashoff, Robert [12 ]
Gammon, Guy [11 ]
Morton, Donald L. [1 ]
机构
[1] John Wayne Canc Inst, Santa Monica, CA 90404 USA
[2] Ist Nazl Tumori Napoli, Naples, Italy
[3] Univ Calif San Francisco, Mt Zion Med Ctr, San Francisco, CA USA
[4] Royal Prince Alfred Hosp, Sydney, NSW, Australia
[5] Vanderbilt Univ, 221 Kirkland Hall, Nashville, TN 37235 USA
[6] H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL USA
[7] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA
[8] Univ Texas Dallas, Southwestern Med Ctr Dallas, Dallas, TX USA
[9] Wagner & Associates, Indianapolis, IN USA
[10] St George Hosp, Med Sch, London, England
[11] CancerVax Corp, Carlsbad, CA USA
[12] UCLA Life Sci, Biomath, Los Angeles, CA USA
基金
美国国家卫生研究院;
关键词
CALMETTE-GUERIN BCG; STAGE IV MELANOMA; ACTIVE SPECIFIC IMMUNOTHERAPY; MALIGNANT-MELANOMA; TRIAL; RESPONSES; VACCINIA; THERAPY; SURGERY;
D O I
10.1245/s10434-017-6072-3
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
This phase III study was undertaken to evaluate the efficacy of an allogeneic whole-cell vaccine (Canvaxin (TM)) plus bacillus Calmette-Guerin (BCG) after complete resection of stage IV melanoma. 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). 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. 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.
引用
收藏
页码:3991 / 4000
页数:10
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