Phase 1/2 Trials Of Peptides Cocktail Vaccine For Resistant Cervical And Ovarian Cancer: Qol Analysis

Background: We conducted phase 2(P2) studies of peptides vaccine (PV) immunotherapy for cervical (CC) and ovarian cancer (OC) using HLA-restricted tumor specific peptides and VEGF receptor 1 (R1)and 2(R2). All HLA0201(A02) and 2402 (A24) restricted peptides used were found from human CC and OC, respectively in GMP grade. The P1 showed feasible (presented in ECCO2013), and further P2 had completed in 66 accruals and the results showed efficacy (ASCO2015 5567). Approval of IRB had obtained. This time, QOL study using GOG FACT-O had analyzed and survival data were up-dated. Methods: Heavily treated CC and OC with A24 or A02 within ECOG PS 2 were candidate. Fully written-IC had obtained. PV cocktails were as follows: for OC of A24 comprised FOXM1, MELK, HJURP, VEGFR1(R1) and R2. As for OC A02, PV comprised HIG2, R1 and R2. For CC of A24, it comprised of FOXM1, MELK and HJURP, and CC with A02, it comprised of URLC10 and HIG2. Each peptide was mixed at a dose of 1mg with adjuvant, MONTANIDE in total 1ml. Vaccination schedule included 12 subcutaneous weekly injections followed with additional 8 administrations (adm.) in two- week intervals and more 8 adm. in 1 month (m) intervals were performed. At pre- and every 8th post-adm., QOL sheet was obtained. Results: PV was well tolerated with no major adverse events (AEs), and during first 8 adm. AEs had caused by prior-chemotherapy/radiotherapy (after 1 month (m) washout) had been improved. As for QOL, physical-, functional- social-, and mental QOL were getting preferable during first 16 adm., however, during longer observation beyond 3 m they were deteriorated gradually due to disease progression. The final mOS of CC and OV was 4.9 m + (0.6-76.6m+) and 7.2m(1.1-59.1m), respectively. As for prognostic factors, significant benefits were seen among lower c-reactive protein (CRP), higher levels of peripheral lymphocytes count, younger age, and smaller residual tumors at baseline. They were strongly rerated to good QOL in p < 0.003 or more by Wilcoxon signed rank test. Conclusions: This PV immunotherapy had efficacy not only in safeness, response, and overall survival, but also in maintenance of QOL in this cohort of patients Further PV trials for other cohorts such as adjuvant therapy would be warranted. Clinical trial identification: UMIN:000003860, 000003862, 000003902, 000003902 Legal entity responsible for the study: Captivation Funding: None Disclosure: All authors have declared no conflicts of interest.