Progression-free survival in ovarian cancer patients in second remission with mucin-1 autologous dendritic cell therapy.

ObjectiveWe described progression-free survival and overall survival in patients with primary mucinous ovarian cancer receiving adjuvant gynecologic versus gastrointestinal chemotherapy regimens.MethodsWe identified all primary mucinous ovarian cancer patients receiving adjuvant gynecologic or gastrointestinal chemotherapy regimens at a single institution from 1994 to 2016. Gynecologic pathologists using strict pathologic/clinical criteria determined diagnosis. Adjuvant therapy was coded as gynecologic or gastrointestinal based on standard agents and schedules. Clinical/pathologic/treatment characteristics were recorded. Wilcoxon rank-sum test was used for continuous variables, and Fisher’s exact test for categorical variables. Progression-free and overall survival were calculated using the Kaplan-Meier method, applying landmark analysis.ResultsOf 62 patients identified, 21 received adjuvant chemotherapy: 12 gynecologic, 9 gastrointestinal. Median age (in years) at diagnosis: 58 (range 25–68) gynecologic cohort, 38 (range 32–68) gastrointestinal cohort (p=0.13). Median body mass index at first post-operative visit: 25 kg/m2(range 18–31) gynecologic cohort, 23 kg/m2(range 18–31) gastrointestinal cohort (p=0.23). History of smoking: 6/12 (50%) gynecologic cohort, 3/9 (33%) gastrointestinal cohort (p=0.66). Stage distribution in gynecologic and gastrointestinal cohorts, respectively: stage I: 9/12 (75%) and 3/9 (33%); stage II: 2/12 (17%) and 1/9 (11%); stage III: 1/12 (8%) and 5/9 (56%) (p=0.06). Grade distribution in gynecologic and gastrointestinal cohorts, respectively: grade 1: 8/12 (67%) and 1/9 (13%); grade 2/3: 4/12 (33%) and 7/9 (88%) (p=0.03). Three-year progression-free survival: 90.9% (95% CI 50.8% to 98.7 %) gynecologic, 53.3% (95% CI 17.7% to 79.6%) gastrointestinal. Three-year overall survival: 90.9% (95% CI 50.8% to 98.7%) gynecologic, 76.2% (95% CI 33.2% to 93.5%) gastrointestinal.ConclusionOngoing international collaborative research may further define associations between chemotherapy regimens and survival.

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A study of autologous dendritic cell therapy targeting mucin-1 for treatment of patients with epithelial ovarian cancer in first remission.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.tps5113 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. TPS5113-TPS5113

Author(s):

Jonathan S. Berek ◽

Jeffrey C. Goh ◽

Heidi J. Gray ◽

James Fiorica ◽

James R. Mason

Keyword(s):

Overall Survival ◽

Dendritic Cell ◽

Residual Disease ◽

Progression Free Survival ◽

Mri Imaging ◽

Autologous Dendritic Cell ◽

Mucin 1 ◽

Standard Chemotherapy ◽

Significance Level ◽

First Remission

TPS5113 Background: Cvac (Cvac) is an autologous dendritic cell immune stimulant targeting mucin-1 positive tumors. A phase IIa study demonstrated potential for treating mucin-1 positive epithelial ovarian carcinoma (EOC). A phase IIb study was designed to determine on a pilot basis if Cvac could demonstrate an effect on progression free and overall survival in patients with EOC in first or second remission. The current study, CANVAS (CANcer VAccine Study) is evaluating Cvac treatment of EOC patients in first remission after surgery and standard chemotherapy, with at least three cycles of platinum and taxane therapy. Endpoints include progression free survival, overall survival, safety evaluation and quality of life scores. Methods: Patients are eligible if they have stage III or IV mucin-1 positive EOC and have had optimal cytoreductive (<1cm residual disease) surgery. Apheresis to obtain immature dendritic cells occurs prior to chemotherapy. Cvac is manufactured during chemotherapy. Patients remain eligible for the study if they have a complete response to standard chemotherapy after surgery. Cvac or placebo is dosed every four weeks for three doses, and every twelve weeks for three additional doses. 1000 patients will be randomized to Cvac or placebo in 22 countries, with 800 expected to receive vaccine or placebo. CT or MRI imaging determines progression, and is centrally read prior to inclusion and at each timepoint. Recruitment commenced January 2012. Over 100 centers are participating in the study globally, with majority in Europe. Enrollment is expected to take 18-24 months. An interim analysis is planned after 400 PFS events, and final analysis after 620 PFS events. Observation of 620 events would have approximately 90% power to detect a hazard ratio of 0.77 in PFS at a significance level of p=0.049 (approximately a 30% increase in median PFS in the Cvac group compared with the placebo group).

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