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The prognostic significance of the CA125 nadir in patients that achieve a CA125 response.

5001 Background:In a series of patients (pts) who had received chemotherapy for epithelial ovarian cancer (EOC) at one hospital, it was observed that survival varied between the groups that attained a nadir (a)≤10 u/ml (best), (b)11-20u/ml and (c)21-30 u/ml (worst).


METHOD
To validate this observation and to assess the ability of nadir CA125 values to discriminate between treatments in a randomised clinical trial, we have analysed data from the SCOTROC trial, which found no progression-free survival (PFS) difference between docetaxel and paclitaxel when either is combined with carboplatin(C) and from the SGCTG study G44 which showed the superiority of C over treosulfan (T) in older and frailer pts.


RESULTS
556 pts in SCOTROC attained a CA125 response (Rustin et al,. J Clin Oncol 14:1545-1551;1996). 283 were randomly allocated to a development data set in which was was used to determine prognostic groups based on the Ca125 nadir. PFS of the three groups varied as expected and repeating the analysis in the remaining 273 pts confirmed the reproducibility of the finding so combined results are presented in the Table. In the G44 study 165 pts were assessable for CA125 response. Pts who received C were more likely to attain response than those receiving T (C:53/87[61%] vs T 29/78[37%], p=0.002) or Group (a) (C:18/87[21%] vs T:7/78[9%], p=0.036). Among CA125 responders there was no difference in PFS between C and T (p=0.93) Median PFS results, in months from attainment of the nadir, are shown with 95% confidence intervals in the Table. [Figure: see text] 2-year PFS in SCOTROC was in Group (a) 39%, (b)23% and (c) 4%, p<0.0001 Conclusions: The CA125 nadir following chemotherapy for EOC is a reproducible predictor of PFS. Our data suggest that the proportion of pts attaining low nadir values discriminates between treatments of differing efficacy in a clinical trial. [Table: see text].