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Prognostic value of clinical and molecular markers in advanced ovarian cancer (AOC): importance of residual (Rs) disease. Translational study using tumor specimens from EORTC 55931/NCIC OV10 Phase III Randomized Clinical Trial (RCT)

Prognostic value of clinical and molecular markers in advanced ovarian cancer (AOC): importance of residual (Rs) disease. Translational study using tumor specimens from EORTC 55931/NCIC OV10 Phase III Randomized Clinical Trial (RCT)

Journal of Clinical Oncology 23(16_suppl): 5005-5005

NlmCategory="UNASSIGNED">5005 Background: Rational selection of therapy in AOC requires molecular and prognostic profiling. We analyzed clinical (clin) and molecular (mol) markers from patients (pts) who participated in a multi-centre phase III RCT that demonstrated superiority of cisplatin (c)/paclitaxel over c/cyclophosphamide, and put these results in context of progression free survival (PFS) and overall survival (OS). EORTC 55931/NCIC OV10 was a RCT that enrolled 680 pts between 1994 and 1995, with 391 from EORTC and NCIC CTG. Paraffin fixed tumor tissue was retrospectively retrieved and analyzed from 95 pts. Demographics of pts whose tissue was available were similar to the entire randomized population. 96% of pt had stage III/IV disease and 80% had Rs disease > 1cm when they commenced chemotherapy. Mol markers analyzed were P53, BCL2, P21, Mib-1, c-Erb B2, DNA ploidy, S-phase and mitotic index. Median follow-up time was 6.4 years. Mol and clin factors were analyzed as potential prognostic factors for PFS and OS, with stratification for treatment in univariate (UV) and multivariate (MV) analyses. P53 was measured independently in Amsterdam and Toronto for the entire group, with the results blinded to the testing laboratories. The concordance between the two data sets was a measure of quality control and reproducibility. The correlation between the two laboratories for P53 status was high (Cohen's Kappa coefficient 0.8; p<0.001). UV analysis: there was significant (S) correlation between size of Rs disease and PFS (p=0.002) as well as OS (p=0.02). Stage and mitotic index were S predictors of OS (p=0.05 and 0.02), but not PFS. MV analysis: only Rs tumor mass remained S for PFS (p=0.002) and OS (p=0.02). The Hazard Ratio for patients with Rs disease > 1cm compared with <1cm was 2.4 for OS and 2.8 for PFS. Other mol and clin factors provided no additional information and were not retained in the final model. Assessment of clin and mol markers in women with AOC demonstrates that Rs tumor volume is S for predicting PFS and OS. None of the mol factors measured were independent predictors of these outcomes. No significant financial relationships to disclose.

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Accession: 058637685

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PMID: 27946265

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