Serum TA90 antigen-antibody complex as a surrogate marker for the efficacy of a polyvalent allogeneic whole-cell vaccine (CancerVax) in melanoma.

Abstract

INTRODUCTION:

TA90 is a tumor-associated 90-kD glycoprotein antigen expressed on most melanoma cells, including those of CancerVax, a polyvalent allogeneic whole-cell vaccine. Previous studies have shown that a TA90 antigen-antibody immune complex (IC) in the serum of patients with melanoma is a marker of subclinical tumor burden and a strong prognostic factor. We hypothesized that the induction of TA90-IC during postoperative adjuvant CancerVax therapy might indicate vaccine-mediated immune destruction of subclinical melanoma cells with release of TA90, and thereby serve as a surrogate marker of vaccine efficacy.

METHODS:

From 1993 to 1997, 219 melanoma patients were enrolled in a prospective phase II trial of CancerVax plus bacille Calmette-Guerin (BCG) after complete tumor resection. Coded serum samples were prospectively collected and analyzed for TA90-IC before and 2, 4, 8, 12, and 16 weeks after initiation of CancerVax therapy. TA90-IC seroconverters were those patients whose negative TA90-IC values (< .410) became positive (> or = .410) after initiation of CancerVax treatment.

RESULTS:

Before CancerVax therapy, 51 patients had positive TA90-IC values and 168 patients had negative TA90-IC values. During CancerVax treatment, all 51 positive patients remained positive, 79 (47%) negative patients seroconverted to positive, and 89 (53%) negative patients remained negative. Seroconverters had higher 2-year rates of disease-free survival (59% vs. 32%; P < .006) and overall survival (78% vs. 63%; P < .02) than did patients whose TA90-IC values remained positive.

CONCLUSIONS:

CancerVax induces TA90-IC in melanoma patients with subclinical disease. TA90-IC seroconverted patients have significantly improved disease-free and overall survival compared with TA90-IC positive patients. TA90-IC is an important prognostic factor that can serve as a surrogate marker for the clinical efficacy of CancerVax.

• Authors: G J Tsioulias, R K Gupta, G Tisman, E C Hsueh, R Essner, L A Wanek, D L Morton
• Journal: Annals of surgical oncology (Ann Surg Oncol) Vol. 8 Issue 3 Pg. 198-203 (Apr 2001) ISSN: 1068-9265 [Print] United States
• PMID: 11314934 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antigens, Neoplasm
• Biomarkers, Tumor
• Cancer Vaccines
• TA90 immune complex

Topics

• Adult
• Aged
• Antigens, Neoplasm (metabolism)
• Biomarkers, Tumor (metabolism)
• California (epidemiology)
• Cancer Vaccines
• Disease-Free Survival
• Female
• Humans
• Male
• Melanoma (diagnosis, mortality, therapy)
• Middle Aged
• Prognosis
• Prospective Studies
• Survival Rate