Utility of the CA125 KELIM in for predicting the benefit of from HIPEC in patients with advanced ovarian cancer: pooled analysis of individual data from KGOG3042 and KOV-HIPEC01

초록

Objectives Although hyperthermic intraperitoneal chemotherapy (HIPEC) followed by interval debulking surgery (IDS) was associated with improved progression-free survival (PFS) and overall survival (OS) compared with IDS alone in patients with ovarian cancer in the KOV-HIPEC01 and KGOG-3042 trials, predictors of HIPEC efficacy are needed. The prognostic value of the modeled CA-125 elimination rate constant K (KELIM), known to be an indicator of intrinsic tumor chemosensitivity, and its association with benefit from HIPEC were explored. Methods Data from the KOV-HIPEC01 phase III trial and the KGOG-3042 study were analyzed. KELIM values were estimated for patients based on CA-125 kinetics during the first 100 days of neoadjuvant chemotherapy by the team at Lyon University. The prognostic value of the KELIM score (favorable ≥1.0 or unfavorable <1.0) in relation to HIPEC-related PFS benefit was assessed through univariable and multivariable analyses. Results KELIM was assessable in 213 patients with at least three available CA-125 measurements, including 168 patients from the KGOG-3042 trial and 45 patients from the KOV-HIPEC01 study. In multivariable analyses, both KELIM score ≥ 1.0 and treatment with HIPEC were identified as independent prognostic factors. Among patients with an unfavorable KELIM score (< 1.0), the median PFS was significantly higher in those treated with HIPEC compared to those who were not (20.04 vs 10.25 months, HR 0.44, 95 % CI 0.27–0.72). However, in patients with a favorable KELIM score (≥ 1.0), the median PFS was not significantly different between those who were treated with HIPEC and those who were not (21.29 vs 20.11 months, HR 0.82, 95 % CI 0.50–1.33). Conclusions HIPEC may be most effective in ovarian cancer patients with an unfavorable KELIM score (< 1.0). The KELIM score could serve as a relevant biomarker for identifying patients who would benefit from HIPEC during IDS.