title: CA125 velocity at relapse is a highly significant predictor of survival post relapse: results of a 5-year follow-up survey to a randomized placebo-controlled study of maintenance oregovomab immunotherapy in advanced ovarian cancer.
abstract: This report presents final survival survey results from a previously reported study using oregovomab immunotherapy in patients with advanced ovarian epithelial cancer. Follow-up surveys to 5 years from randomization were collected for the cohort of stage III/IV ovarian cancer patients achieving initial remission who received subsequent maintenance immunotherapy with oregovomab or placebo. The relationship of time-to-relapse, survival postrelapse, and overall survival was analyzed. One hundred forty-five patients in the intent-to-treat population and the hypothesis generating subset of 67 patients (debulked to < or =2 cm, CA125 < or =65 U/mL before cycle 3, normal CA125 and no evidence of disease postchemotherapy) previously reported were evaluated for long-term outcomes. Patterns of relapse and survival were consistent in both groups for the intent-to-treat population. Median survival time was 57.5 months for oregovomab and 48.6 months for placebo with an adjusted hazard ratio of 0.72 (95% confidence interval, 0.41-1.25). Median survival has not been reached in the hypothesis generating subset of patients receiving oregovomab. Cox multivariate regression analysis identified velocity of CA125 rise at relapse to be a highly statistically significant predictor of postrelapse outcome (P = 0.006). Although time-to-relapse may be a useful surrogate of survival in ovarian cancer immunotherapy studies, 5 years of follow-up has proved insufficient to permit a definitive survival analysis and it has been extended in ongoing phase III studies of oregovomab. Velocity of CA125 rise at relapse is a highly significant predictor of survival after relapse.
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Stanford University School of Medicine, Stanford Cancer Center, Stanford, CA, USA. jberek@stanford.edu
authors.forename: Jonathan S
authors.initials: JS
authors.lastname: Berek
authors.forename: Peyton T
authors.initials: PT
authors.lastname: Taylor
authors.forename: Christopher F
authors.initials: CF
authors.lastname: Nicodemus
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007167:Immunotherapy / Q000379:methods* / Q000706:statistics & numerical data; D047908:Intracellular Signaling Peptides and Proteins; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D011379:Prognosis; D016016:Proportional Hazards Models; D011506:Proteins / Q000032:analysis*; D012008:Recurrence; D016019:Survival Analysis
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D047908:Intracellular Signaling Peptides and Proteins; C549756:NBR1 protein, human; D011506:Proteins; C107428:oregovomab