792P - Prognostic role of the modeled CA-125 KELIM in early FIGO stage I and II ovarian cancers (OC): A GCIG individual-patient data meta-analysis

Background

The curative role of surgery in early stage I & II OC is well established. Nevertheless, a significant number of them relapse. The modeled CA-125 KELIM score estimated during 1^st-line chemotherapy is a prognostic factor, thought to be a pragmatic indicator of the tumor intrinsic chemosensitivity. We assessed the prognostic value of KELIM in patients with optimally debulked FIGO stage I & II diseases regarding PFS and OS in the GCIG meta-analysis dataset (MAOV), where different adjuvant chemotherapy regimens were assessed.

Methods

Individual patient KELIM values were previously estimated in 5,884 patients included in MAOV ( Corbaux, 2021 ). Patients with optimally resected FIGO I & II diseases were selected. The prognostic value of KELIM was assessed using univariate & multivariate analyses, according to histological subtype, and disease stage I or II.

Results

628 and 515 patients had optimally resected stages I & II OC, respectively, including clear cell (CCC) (46.7%); serous (23.7%); endometrioid (12.4%); and mucinous carcinomas (3.9%). 52% had CA-125 ≥ 35 UI/L after surgery. The respective median standardized KELIM values were 1.32, 1.18, 1.16, and 1.08 (P < 0.0001). In univariate & multivariate analyses, a favorable KELIM score ≥1.0 (vs unfavorable KELIM score <1.0) was associated with longer PFS and OS (5-year PFS, 68.3% vs 55.9%, P<0.0001, HR 0.61 [0.48-0.77]; 5-year OS, 80.7% vs 72.8 %, P<0.0001, HR 0.50 [0.36-0.68]), as was the histological subtype. CCC was associated with worse OS, HR 1.84 [1.17 – 2.90], and endometroid with better OS, HR 0.33 [0.17 – 0.66]). When assessed within histological subtypes, KELIM was a significant prognostic factor in CCC (PFS, HR 0.41 [0.30-0.56]; OS, HR 0.33 [0.23-0.47]) and in serous carcinomas (PFS, HR 0.54 [0.39-0.75]; OS, HR 0.59 [0.37-0.94]), but not in endometrioid and mucinous carcinomas.

Conclusions

KELIM during adjuvant chemotherapy plays an important prognostic role in optimally resected stage I-II ovarian cancers, especially in CCC and serous carcinomas, suggesting the potential role of chemosensitivity beyond surgery. KELIM may help identify pts at higher risk of relapse/death, requiring closer follow-up.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

GCIG.

Funding

Has not received any funding.

Disclosure

P. Corbaux: Financial Interests, Institutional, Local PI: Sensorion. B. You: Financial Interests, Personal, Advisory Role: MSD, AstraZeneca, GSK-Tesaro, Bayer, Roche-Genentech, ECS Progastrine, Novartis, LEK, Amgen, Clovis Oncology, Merck Serono. R.M. Glasspool: Financial Interests, Personal, Advisory Role: AstraZeneca, MSD, Clovis Oncology, GSK/Tesaro, Immunogen; Financial Interests, Personal, Other, Travel: GSK/Tesaro; Financial Interests, Personal, Speaker, Consultant, Advisor: GSK/Tesaro, SOTIO. A. Tinker: Financial Interests, Personal, Other, Honoraria: AstraZeneca, Eisai; Financial Interests, Personal and Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Speaker, Consultant, Advisor: GSK; Financial Interests, Personal, Advisory Role: GSK. K. Lindemann: Financial Interests, Personal, Advisory Role: GSK, AstraZeneca, Eisai; Financial Interests, Personal and Institutional, Research Grant: GSK. M.R. Mirza: Financial Interests, Personal, Advisory Board: AstraZeneca, GSK, Karyopharm, Merck, Roche, Zailab; Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK; Financial Interests, Personal, Member of Board of Directors: Karyopharm; Financial Interests, Personal, Stocks/Shares: Karyopharm; Financial Interests, Institutional, Research Grant: GSK, AstraZeneca, ultimovacs, Apexigen; Financial Interests, Institutional, Trial Chair: Deciphera; Non-Financial Interests, Advisory Role: Ultimovacs, Apexigen. I. Ray-Coquard: Financial Interests, Personal, Advisory Board: Adaptimmun, Agenus, Amgen, AstraZeneca, BMS, Clovis, Daiichi Sankyo, Deciphera, EQRX, Eisai, GSK, Macrogenics, Merck Sereno, Mersana, Novartis, Oxnea, Roche, Sutro; Financial Interests, Institutional, Other, COLIBRI translational research: BMS; Financial Interests, Institutional, Advisory Board, Translational research NEOPEMBROV trial: MSD; Non-Financial Interests, Personal, Membership or affiliation, President: GINECO; Non-Financial Interests, Personal, Principal Investigator: PAOLA-1. J. Peron: Financial Interests, Personal, Advisory Role: Fabentech; Financial Interests, Personal, Speaker, Consultant, Advisor: Eisai, Lilly; Financial Interests, Personal, Member of Board of Directors: Eisai; Financial Interests, Personal and Institutional, Research Grant: Roche. I. McNeish: Financial Interests, Personal, Advisory Board, Advisory Boards: Clovis Oncology; Financial Interests, Personal, Advisory Board, Advisory Boards and travel: AstraZeneca, GSK; Financial Interests, Personal, Advisory Board: Roche, Alkermes, OncoC4, Theolytics; Financial Interests, Personal, Advisory Board, Advisory and consultancy on development of novel therapeutics in ovarian cancer: Duke Street Bio; Financial Interests, Institutional, Funding: AstraZeneca; Non-Financial Interests, Member of Board of Directors, Trustee of this charity: Worldwide Cancer Research. All other authors have declared no conflicts of interest.